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Open Orphan plc #ORPH – Launch of Covid-19 Antibody Testing

Open Orphan plc      (“Open Orphan” or the “Company”)

Launch of Covid-19 Antibody Testing

Open Orphan plc (ORPH), a rapidly growing specialist CRO pharmaceutical services company which is the world leader in the testing of vaccines and antivirals using human challenge study models, announces the launch of hVIVO COVID Clear Test, the Company’s antibody testing service, following the successful completion of installation, testing and training.

The antibody tests, which utilise the Quotient MosaiQ™ system and MosaiQ COVID-19 Antibody Microarray, offer best in class COVID-19 antibody testing performance and will require a full blood draw. hVIVO COVID Clear Test will be offered to large employer groups and channel partners including GP networks, nursing services, health clinics and private hospitals. Samples will be tested in the Company’s London laboratory with results returned within 48 hours.

The Company is hosting a press event at its clinic in East London at 11am today details of which can be found at: https://hvivo.com/news-media/companynews/.

Cathal Friel, Executive Chairman of Open Orphan, said: “hVIVO is a world class company with best in class scientists and facilities. We are very excited to be offering this service and I am confident our work will help large companies and clinics in the UK test their staff and patients to ensure the safety of all employees. I look forward to updating everyone on our progress in due course.”

Franz Walt, Chief Executive Officer, Quotient, said: “Antibody testing is crucial for guidance on immunity, development of vaccinations and potential revaccinations, as well as helping to answer outstanding epidemiological questions about the spread of the virus. We are incredibly proud to be collaborating with hVIVO and Open Orphan in this project and can assure them that we will provide top of the line services alongside our excellent products.”

 

For further information please contact

Open Orphan plc

+353 (0)1 644 0007

Cathal Friel, Executive Chairman

Arden Partners plc (Nominated Adviser and Joint Broker)

+44 (0)20 7614 5900

John Llewellyn-Lloyd / Benjamin Cryer / Dan Gee-Summons

finnCap plc (Joint Broker)

+44 (0) 20 7220 500

Geoff Nash / James Thompson/ Richard Chambers

Davy (Euronext Growth Adviser and Joint Broker)

+353 (0)1 679 6363

Anthony Farrell

Camarco (Financial PR)

+44 (0)20 3757 4980

Tom Huddart / Hugo Liddy

Open Orphan #ORPH – Results of Fundraising

Open Orphan plc (ORPH), a rapidly growing specialist CRO pharmaceutical services company which has a focus on orphan drugs and is the world leader in the testing of vaccines and antivirals using human challenge study models, announces that, further to its announcement at 7.00 a.m. today (the “Fundraising Announcement”), it has successfully completed the oversubscribed Fundraising which is now closed.

The Fundraising has raised approximately £12 million (net of expenses) through the placing of 109,549,098 new Ordinary Shares, an offer for subscription conducted by PrimaryBid Limited of 4,545,454  new Ordinary Shares and subscription of 727,272 new Ordinary Shares, all at an Issue Price of 11 pence per share.

The net proceeds of the Fundraising will be used to

  • Maximise available Covid-19 opportunities including accelerating the development of both a seasonal coronavirus and a Covid-19 virus challenge study model to capitalise upon Group’s inbound demand from Covid-19 vaccine developers globally. These challenge study models have the ability to speed up the development of a vaccine by 2-3 years;
  • Ramp up Covid-19 antiviral testing to the Group’s current capacity for 3,000 tests per day;
  • Expand existing laboratory testing services to 3rd party pharmaceutical and biotech companies in line with our strategy of becoming a leading services provider to the growing viral, and respiratory   diseases sector of the pharmaceutical industry; and
  • Strengthen the balance sheet to enable the Group to take advantage of the significant and growing opportunities the Board believes are available.

First Admission and Total Voting Rights

The Firm Fundraise of 44,496,864 new Ordinary Shares is conditional on First Admission, and is being carried out within the Company’s existing share authority to issue Ordinary Shares for cash.

It is expected that the Firm Fundraising Shares will be admitted to trading on AIM and Euronext Growth at 8.00 a.m. on or around 29 May 2020 (or such later date as may be agreed between the Company and Arden, but no later than 30 June 2020).

Following the First Admission of the Firm Fundraising Shares, the total number of Ordinary Shares in the Company in issue will be 593,535,138. This figure may be used by shareholders as the denominator for the calculations by which they will determine if they are required to notify their interest in, or a change to their interest in the Company under the FCA’s Disclosure and Transparency Rules.

Second Admission and Total Voting Rights

The Second Admission of 70,324,960 new Ordinary Shares is conditional upon (amongst other things) the Placing Agreement not having been terminated, First Admission occurring, the passing of the Resolutions at the General Meeting and Second Admission occurring on or before 8.00 a.m. on 12 June 2020 (or such later date and/or time as the Joint Brokers and the Company may agree, being no later than 3.00 p.m. on 30 June 2020 in respect of the Conditional Fundraise).

It is expected that the Conditional Fundraising Shares will be admitted to trading on AIM and Euronext Growth at 8.00 a.m. on or around 12 June 2020 (or such later date as may be agreed between the Company and Arden, but no later than 30 June February 2020).

Following the Second Admission of the Conditional Fundraising Shares, the total number of Ordinary Shares in the Company in issue will be 663,860,098. This figure may be used by shareholders as the denominator for the calculations by which they will determine if they are required to notify their interest in, or a change to their interest in the Company under the FCA’s Disclosure and Transparency Rules.

Cathal Friel, Executive Chairman of Open Orphan, said:

“Open Orphan is now a fast growing, and soon to be profitable, specialist CRO pharmaceutical services business with a market leading position in the rapidly expanding market of testing vaccines and antivirals. We are delighted by the heavily oversubscribed fundraise which has brought many new leading blue-chip institutional shareholders to our share register.

As a result of Covid-19, we are seeing unprecedented growth opportunities as pharma, biotech and governments around the world focus funding on finding solutions to Covid-19 and other respiratory diseases. As such, we’re developing several new revenue streams including by speeding up the development of both a seasonal coronavirus and a Covid-19 virus challenge study model to capitalise upon the Company’s inbound demand from Covid-19 vaccine developers globally. We have also opened up our laboratory services offering to third party pharma and biotech companies, as in the case of the recently announced Nearmedic contract, and from our state-of-the-art viral laboratory have launched a transformational Covid-19 antibody testing service which, unlike the home and online testing kits, offers 100% accuracy and the potential to complete up to 3,000 tests per day on a single machine. We believe that the Company has the pipeline to potentially sign up to six Covid-19 related challenge study contracts in 2020 with a further six potential contracts in 2021.

It is an exciting time at Open Orphan, and we are looking to capitalise on the opportunity to deliver rapid growth in the near term by converting some of our c. £160m pipeline of revenue opportunities.”

Capitalised terms in this Announcement shall have the meanings given to such terms in the Group’s announcement at 7.00 a.m. today.

For further information please contact

Open Orphan plc 

Cathal Friel, Executive Chairman  +353 (0)1 644 0007

Arden Partners plc (Nominated Adviser and Joint Broker)                                                                +44 (0)20 7614 5900

John Llewellyn-Lloyd / Benjamin Cryer / Dan Gee-Summons (Corporate Finance)

Fraser Marshall / Simon Johnson (Equity Sales)

finnCap plc (Joint Broker)                                                                                                                          +44 (0) 20 7220 0500

Geoff Nash / James Thompson/ Charlie Beeson (Corporate Finance)

Richard Chambers (ECM)

Davy (Euronext Growth Adviser and Joint Broker)                                                              +353 (0)1 679 6363

Anthony Farrell

Camarco (Financial PR)                                                                                                              +44 (0)20 3757 4980

Tom Huddart / Daniel Sherwen

Open Orphan #ORPH – Proposed Fundraising to raise up to £12 million and PrimaryBid.com Offer

Open Orphan plc (ORPH), a rapidly growing specialist CRO pharmaceutical services company which has a focus on orphan drugs and is the world leader in the testing of vaccines and antivirals using human challenge study models, today announces its intention to raise up to £12 million (net of expenses) (the “Fundraising”) via a placing of new Ordinary Shares (“Placing Shares”) to institutional and other investors (the “Placing”), subscription of new Ordinary Shares (“Subscription Shares”) to certain investors and an offer subscription for new Ordinary Shares by PrimaryBid (“PrimaryBid Shares”) all at a price of 11 pence per new Ordinary Share (the “Issue Price”).

Fundraising Highlights:

  • The Group intends to conduct a Fundraising to raise up to £12 million (net of expenses) via the Placing of the Placing Shares, Subscription of the Subscription Shares and an offer for subscription of the PrimaryBid Shares all at the Issue Price.
  • The Placing is to be conducted by way of an accelerated bookbuild process which will commence immediately following this Announcement and will be subject to the terms and conditions set out in Appendix I to this Announcement.
  • The Company has conditionally raised approximately £80,000 (before expenses) through the Subscription of 727,272  Subscription Shares.
  • The Group also intends to launch an offer for subscription to be conducted by PrimaryBid on behalf of the   Company  (the “PrimaryBid Offer”) on a “first come, first served” basis.
  • The net proceeds of the Fundraising will be used to
    • Maximise available Covid-19 opportunities including accelerating the development of both a seasonal coronavirus and a Covid-19 virus challenge study model to capitalise upon Group’s inbound demand from Covid-19 vaccine developers globally. These challenge study models have the ability to speed up the development of a vaccine by 2-3 years;
    • Ramp up Covid-19 antiviral testing to the Group’s current capacity for 3,000 tests per day;
    • Expand existing laboratory testing services to 3rd party pharmaceutical and biotech companies in line with our strategy of becoming a leading services provider to the growing viral, and respiratory diseases sector of the pharmaceutical industry; and
    • Strengthen the balance sheet to enable the Group to take advantage of the significant and growing opportunities the Board believes are available.
  • The Issue Price represents a premium of 3.8 per cent. to the closing price of 10.6 pence per Ordinary Share on 7 May 2020 being the date immediately before the announcement of the Quotient partnership on 11 May 2020. It represents a discount of approximately 26.4 per cent. to the closing middle market price of 14.95 pence per Ordinary Share on 21 May 2020, being the latest practicable date prior to the publication of this Announcement.

The Fundraising

The Fundraising comprises a proposed placing, an offer for subscription through PrimaryBid and subscription of new Ordinary Shares to be effected in two tranches. The first tranche of up to 44,824,000 new Ordinary Shares (the “Firm Fundraising Shares”) will utilise the Company’s existing shareholder authorities to issue the Firm Placing Shares and the Firm PrimaryBid Shares on a non-pre-emptive basis for cash (the “Firm Fundraising”). The second tranche of approximately 70,000,000 new Ordinary Shares (the “Conditional Fundraising Shares”) will be conditional (amongst other things) on the passing of resolutions to grant authority to the Directors to allot the Conditional Placing Shares, Conditional PrimaryBid Shares and Subscription Shares for cash and to disapply statutory pre-emption rights at a General Meeting. 

The Placing is subject to the satisfaction of certain conditions set out in this announcement and the appendices hereto (the “Appendices”) (together, this “Announcement”) and is being conducted by way of an accelerated bookbuild, which will be launched immediately following the publication of this Announcement. Arden Partners plc (“Arden”) and finnCap Ltd (“finnCap” and, together with Arden, the “Joint Brokers”) are acting as Joint Brokers in connection with the Placing and Arden as nominated adviser.

The Company intends to publish and send a circular (the “Circular”) to shareholders convening the General Meeting in connection with the issue of the Conditional Fundraising Shares on or around 26 May 2020. The Circular will also be available on the Company’s website: www.OpenOrphan.com .

An updated corporate presentation will be made available on the Company’s website.

A further announcement will be made following the close of the Bookbuild, confirming final details of the Placing.

For further information please contact

Open Orphan plc                                                                                                

Cathal Friel, Executive Chairman                                                                                       +353 (0)1 644 0007

Arden Partners plc (Nominated Adviser and Joint Broker)                                        +44 (0)20 7614 5900

John Llewellyn-Lloyd / Benjamin Cryer / Dan Gee-Summons (Corporate Finance)

Fraser Marshall / Simon Johnson (Equity Sales)

finnCap plc (Joint Broker)                                                                                                   +44 (0) 20 7220 0500

Geoff Nash / James Thompson/ Charlie Beeson (Corporate Finance)

Richard Chambers (ECM)

Davy (Euronext Growth Adviser and Joint Broker)                                                       +353 (0)1 679 6363

Anthony Farrell

Camarco (Financial PR)                                                                                                        +44 (0)20 3757 4980

Tom Huddart / Daniel Sherwen

 

Additional information

 

Expected timetable of principal events

2020

Announcement of the Fundraising

22 May

Announcement of the results of the Fundraising

22 May

Circular and Form of Proxy posted to Shareholders

26 May

First Admission of the Firm Fundraising Shares to trading on AIM and Euronext Growth and commencement of dealings

8.00 a.m. on 29 May

Expected date for CREST accounts to be credited in respect of Firm Fundraising Shares in uncertified form

29 May

Where applicable, expected date for despatch of definitive share certificated for Firm Fundraising Shares in certified form

within 14 days

Latest time and date for receipt of Forms of Proxy

11.00 a.m. on 9 June

General Meeting 

11.00 a.m. on 11 June

Second Admission and dealings in the Conditional Fundraising Shares

8.00 a.m. on 12 June

Expected date for CREST accounts to be credited in respect of Conditional Fundraising Shares in uncertified form

12 June

Where applicable, expected date for despatch of definitive share certificated for Conditional Fundraising Shares in certified form

within 14 days

 

Information on Open Orphan

Open Orphan is a rapidly growing niche CRO pharmaceutical services company which is a world leader in the provision of viral laboratory services and the testing of vaccine and antivirus using human challenge study models. Open Orphan comprises of two commercial specialist CRO services businesses; hVIVO and Venn Life Sciences, and Open Orphan Genomic Health Data.

hVIVO is the world leader in testing the efficacy of vaccines, antivirals and respiratory disease agents using human challenge study models. hVIVO has the world leading portfolio of challenge study such models including flu, RSV, asthma, HRV, COPD and cough which have a replacement cost in excess of £25million. These studies are run from the Group’s 24-bedroom quarantine clinic in London, which can be made into three zones to run three different vaccine company’s challenge studies at the same time. hVIVO also has a state of the art viral laboratory that is utilised in connection with its challenge studies and on contract with third parties, including for anti-body testing.

Venn Life Sciences is an integrated drug development business which offers phase I & II clinical trials design and execution, post-trial data management, statistics, trial randomisation and regulatory expertise.

Background to and Reasons for the Fundraising

On 31 January 2020, the World Health Organisation declared a global pandemic due to the Covid-19 virus that has spread across the globe, causing different governments and countries to enforce restrictions on people movements, a stop to international travel, and other precautionary measures. This has had a widespread impact economically and a number of industries have been heavily impacted. As well as the challenges faced by other industries this has presented Open Orphan with some unique opportunities as a specialist provider to pharmaceutical companies.

There is now a global urgency to quickly and effectively develop and subsequently demonstrate effective Covid-19 vaccines, in May 2020 the World Health Organisation backed Covid-19 human challenge studies to speed up Covid-19 vaccine approvals. On 9 March 2020 the Group announced that it had commenced the development of a commercial human coronavirus challenge study model, also known as a Controlled Human Infection Model (CHIM) utilising seasonal coronavirus strains such as OC43 and 229E which are from the same family of viruses as the Covid-19 virus. Following this announcement, the Group has continued development of its Covid-19 challenge study and has opened discussions with 12 of the leading Covid-19 vaccine developers around the world. hVIVO is also now developing an attenuated Covid-19 virus challenge study model. The Group has decided to self-fund the investment to develop both of these models to ensure that it retains ownership and control of the resulting challenge model. In addition to the testing of potential vaccines and antivirals, it is expected that the challenge study models will facilitate a greater understanding of the type and durability of the immune response coronavirus infections elicit. The Board believes that, based on current discussions, the Group has as potential pipeline of up to six Covid-19 related challenge study contracts in 2020 with a further potential six contracts in 2021.

Challenge Studies

Challenge studies involve, in a controlled setting, using small numbers of volunteers removed from community exposure to other infections, the inoculation of volunteers with known doses of the challenge virus and the monitoring of the disease time course. All subjects are inoculated with virus but with some receiving a placebo and others the experimental drug to test the efficacy of the drug and obtain proof of concept data much quicker than can be achieved in the field. Challenge studies can be carried out for novel therapeutics, including vaccines, immunomodulators and antivirals, as well as new diagnostics. Challenge study models can potentially speed up vaccine development and approval by 2-3 years by testing the efficacy on human volunteers over a short period of time in a quarantine clinic.

By splitting the hVIVO 24 bed quarantine clinic into 3 zones the Group is able to run up to 3 different vaccine challenge studies concurrently. The Group typically expects a complete challenge study trial to deliver project revenues of approximately £7 million with the revenue dependent in part on the size of the trial and the number of volunteers.

Open Orphan plans to have a growing, clinical trial challenge study business and also a testing capability. The challenge study business will provide third-party laboratory services whilst also providing actual testing capability of human population groups.

The fundraising will allow the Group to provide virology and laboratory testing services to third parties, such as its recent contract with Nearmedic International Ltd. This provision of third-party laboratory services is a growth area for the Group as numerous biotechnology companies across Europe do not have their own virology laboratory. This revenue stream is in line with our strategy of becoming a leading pharma services provider to the viral, and respiratory diseases sector of the pharmaceutical industry.

Use of Proceeds

It is as a result of the recent expansion of the Group’s pipeline and other recent commercial developments that the Group is looking to raise up to £12 million net of expenses. The proceeds of the Fundraising will be used to:

a.     Maximise available Covid-19 opportunities including accelerating the development of both a seasonal coronavirus and a Covid-19 virus challenge study model to capitalise upon Group’s inbound demand from Covid-19 vaccine developers globally. These challenge study models have the ability to speed up the development of a vaccine by 2-3 years;

b.     Ramp up Covid-19 antiviral testing to the Group’s current capacity for 3,000 tests per day;

c.     Expand existing laboratory testing services to 3rd party pharmaceutical and biotech companies in line with our strategy of becoming a leading services provider to the growing viral, and respiratory diseases sector of the pharmaceutical industry; and

d.     Strengthen the balance sheet to enable the Group to take advantage of the significant and growing opportunities the Board believes are available.

Current trading and prospects

All results provided are preliminary and subject to completion of the 2019 audit. The audit is substantially complete and Open Orphan’s audited accounts for the year ended 31 December 2019 are expected to be published in late June 2020.

The Company confirms that on a proforma basis including the full year of Open Orphan and hVIVO, the Group generated revenue of €27.1 million for the year ended 31 December 2019, gross profit of €4.2 million and a normalized LBITDA of €10.1 million adjusting for depreciation, amortization, one-time and non-recurring expenses / charges.

The Group’s cash and cash equivalents at 30 April 2020 was €2.6 million and debt at 30 April 2020 was €1.6 million which related to loans arranged previously by Raglan Capital.

Since the merger of Open Orphan and hVIVO, the group has successfully integrated hVIVO and Venn Life Sciences, has reduced the Group’s cost base by an annualised 5.0 million (in an addition to the €3.8 million of savings realised in 2019). Further annualised cost savings of €2.5m are expected to be implemented by year end. We have also expanded hVIVO’s laboratory services and converted the hVIVO pipeline of contracts, including:

–       a new contract with a European Biotech Company for the provision of a RSV human challenge study projected to deliver £3.2m in revenue all of which is expected to be recognised in 2020. If successful, it is anticipated that an additional follow-on larger pivotal challenge study will commence end Q4 2020, delivering significant further revenue and expected to be a minimum of £7m; and

–       a contract with a US Biotech company for the provision of an RSV human challenge study projected to deliver £3.5 million in revenue all of which is expected to be recognised in 2020.

The Group’s pipeline of potential new contracts is now in excess of £160 million and includes c.£110 million of near-term contracts within hVIVO and Venn Life Sciences along with new opportunities arising post Covid-19. This includes the delivery of Covid-19 related challenge studies, third party testing and laboratory services, and the roll out of Covid-19 antibody testing utilising the Quotient Limited system. The MosaiQ Covid-19 Antibody Microarray machine is expected to have capability to undertake up to 3,000 tests a day once fully operational, in line with expected performance as stated by Quotient Limited. The MosaiQ COVID-19 Antibody Microarray machine has demonstrated a 100% sensitivity to detect Covid-19 antibodies and a 99.8% ability to rule out the presence of Covid-19 antibodies. The Group’s plan is to develop this pipeline with channel partners to secure testing volumes.

The Directors believe that the increased investment in testing capability will result in companies, such as Open Orphan, benefitting as a provider of testing services.

The Directors believe that the recent conversion of the Group’s pipeline coupled with additional annualised savings of 2.5 million referred to above, and strong pipeline of work for the second half of 2020 should allow the Company to achieve its goal of being operationally profitable by Q3 2020.

The Subscription

Under the Subscription, the Company has conditionally raised approximately £80,000 (before expenses) by way of the subscription at the Issue Price of 727,272 new Ordinary Shares. 

The Subscription is conditional upon (amongst other things) the Placing and Subscription Agreement not having been terminated, the passing of the Resolutions at the General Meeting and Second Admission occurring on or before 8.00 a.m. on 12 June 2020 (or such later date and/or time as the Joint Brokers and the Company may agree, being no later than 3.00 p.m. on 30 June 2020 in respect of the Conditional Fundraise).

PrimaryBid Offer

PrimaryBid intends to conduct an offer for subscription for PrimaryBid Shares on behalf of the Company on the terms set out in a separate announcement to be made by the Company immediately after this announcement.

The Firm PrimaryBid Offer is conditional upon (amongst other things) the Placing and Subscription Agreement not having been terminated and First Admission occurring on or before 8.00 a.m. on 29 May 2020 (or such later date and/or time as the Joint Brokers and the Company may agree, being no later than 3.00 p.m. on 30 June 2020 in respect of the Firm Placing).

The Conditional PrimaryBid Offer is conditional upon (amongst other things) the Placing and Subscription Agreement not having been terminated, the passing of the Resolutions at the General Meeting and Second Admission occurring on or before 8.00 a.m. on 12 June 2020 (or such later date and/or time as the Joint Brokers and the Company may agree, being no later than 3.00 p.m. on 30 June 2020 in respect of the Conditional Fundraise).

The Placing and Subscription Agreement

Pursuant to the Placing and Subscription Agreement, the Joint Brokers, as agents for the Group, have conditionally agreed to use reasonable endeavours to procure subscribers at the Issue Price for the Placing Shares.

The Joint Brokers intend to conditionally place the Placing Shares with certain institutional and other investors at the Issue Price. The Firm Placing is conditional upon (amongst other things) the Placing and Subscription Agreement not having been terminated and First Admission occurring on or before 8.00 a.m. on 29 May 2020 (or such later date and/or time as the Joint Brokers and the Company may agree, being no later than 3.00 p.m. on 30 June 2020 in respect of the Firm Placing).

The Conditional Placing is conditional upon (amongst other things) the Placing and Subscription Agreement not having been terminated, the passing of the Resolutions at the General Meeting and Second Admission occurring on or before 8.00 a.m. on 12 June 2020 (or such later date and/or time as the Joint Brokers and the Company may agree, being no later than 3.00 p.m. on 30 June 2020 in respect of the Conditional Placing).

The Placing and Subscription Agreement contains customary warranties from the Company in favour of the Joint Brokers in relation to, inter alia, the accuracy of the information in this Announcement and other matters relating to the Group and its business. In addition, the Company has agreed to indemnify the Joint Brokers in relation to certain liabilities that they may incur in respect of the Placing, Subscription and PrimaryBid Offer.

The Joint Brokers (together acting in good faith) have the right to terminate the Placing and Subscription Agreement in certain circumstances prior to Second Admission, including (but not limited to): in the event that any of the warranties in the Placing and Subscription Agreement were untrue or inaccurate in any material respect, or were misleading in any respect when given or in the event of a material adverse change affecting the business, financial trading position or prospects of the Company. The Brokers shall also have a further right to terminate the Placing and Subscription Agreement, following consultation with the Company to the extent practicable, if, at any time before Second Admission there occurs any change, or development involving a prospective change, in national or international, military, diplomatic, monetary, economic, political, financial, industrial or market conditions or exchange rates or exchange controls, or any incident of terrorism or outbreak or escalation of hostilities or any declaration by the UK, the US or in any member or associate member of the European Union or elsewhere of a national emergency or war or pandemic, epidemic or any other calamity or crisis (including a significant worsening of the Covid-19 crisis in the United Kingdom) (amongst other things).

The Placing and Subscription Agreement also provides for the Company to pay all agreed costs, charges and expenses of, or incidental to, the Placing and Admission including all legal and other professional fees and expenses up to the specified amounts stipulated in the Placing and Subscription Agreement.

Fundraising Shares

The Fundraising Shares, when issued, will be fully paid and will rank pari passu in all respects with the existing Ordinary Shares in issue, including the right to receive all dividends and other distributions declared, made or paid after the date of issue.

Applications will be made to the London Stock Exchange for admission of the Firm Fundraising Shares and the Conditional Fundraising Shares to trading on AIM.

Application will be made to Euronext Dublin for admission of the Firm Fundraising Shares and the Conditional Fundraising Shares to trading on Euronext Growth.

It is expected that First Admission of the Firm Fundraising Shares (“First Admission”) will take place on or before 8.00 a.m. on 29 May 2020 and that dealings in the Firm Fundraising Shares on AIM will commence at the same time. It is expected that Second Admission of the Conditional Fundraising Shares (“Second Admission” and, together with First Admission “Admission”, as the context may require) will take place on or before 8.00 a.m. on 12 June 2020 and that dealings in the Conditional Fundraising Shares on AIM will commence at the same time.

General Meeting

The General Meeting will be held at 11.00 a.m. on 11 June 2020, at which the Resolutions will be proposed for the purposes of implementing the Second Admission as follows:

Resolution 1 – an ordinary resolution to grant the Directors authority to allot shares in the Company and to grant right to subscribe for, or convert or exchange any security into shares in the Company.

Resolution 2 – a special resolution to disapply statutory pre-emption rights otherwise applicable to the Company in respect of resolution one.

IMPORTANT INFORMATION

This Announcement has been issued by, and is the sole responsibility, of the Group. No representation or warranty express or implied, is or will be made as to, or in relation to, and no responsibility or liability is or will be accepted by the Joint Brokers or by any of their respective affiliates or agents as to or in relation to, the accuracy or completeness of this Announcement or any other written or oral information made available to or publicly available to any interested party or its advisers, and any liability therefore is expressly disclaimed.

NOTICE TO OVERSEAS PERSONS

This Announcement does not constitute, or form part of, a prospectus relating to the Group, nor does it constitute or contain any invitation or offer to any person, or any public offer, to subscribe for, purchase or otherwise acquire any shares in the Group or advise persons to do so in any jurisdiction, nor shall it, or any part of it form the basis of or be relied on in connection with any contract or as an inducement to enter into any contract or commitment with the Group. In particular, the Fundraising Shares have not been, and will not be, registered under the United States Securities Act of 1933 as amended or qualified for sale under the laws of any state of the United States or under the applicable laws of any of Canada, Australia, New Zealand, the Republic of South Africa or Japan and, subject to certain exceptions, may not be offered or sold in the United States or to, or for the account or benefit of, US persons (as such term is defined in Regulation S under the Securities Act) or to any national, resident or citizen of Canada, Australia, New Zealand, the Republic of South Africa or Japan.

The distribution or transmission of this Announcement and the offering of the Fundraising Shares in certain jurisdictions other than the UK may be restricted or prohibited by law or regulation. Persons distributing this Announcement must satisfy themselves that it is lawful to do so. Any failure to comply with these restrictions may constitute a violation of the securities laws of any such jurisdiction. No action has been taken by the Group that would permit an offering of such shares or possession or distribution of this Announcement or any other offering or publicity material relating to such shares in any jurisdiction where action for that purpose is required. Persons into whose possession this Announcement comes are required by the Group to inform themselves about, and to observe, such restrictions. In particular, this announcement may not be distributed, directly or indirectly, in or into the United States, Canada, Australia, New Zealand, the Republic of South Africa or Japan. Overseas Shareholders and any person (including, without limitation, nominees and trustees), who have a contractual or other legal obligation to forward this Announcement to a jurisdiction outside the UK should seek appropriate advice before taking any action.

FORWARD-LOOKING STATEMENTS

This Announcement includes statements that are, or may be deemed to be, “forward-looking statements”. These forward-looking statements can be identified by the use of forward-looking terminology, including the terms “believes”, “estimates”, “plans”, “projects”, “anticipates”, “expects”, “intends”, “may”, “will”, or “should” or, in each case, their negative or other variations or comparable terminology. These forward-looking statements include matters that are not historical facts. They appear in a number of places throughout this Announcement and include statements regarding the Directors’ current intentions, beliefs or expectations concerning, among other things, the Group’s results of operations, financial condition, liquidity, prospects, growth, strategies and the Group’s markets.

By their nature, forward-looking statements involve risk and uncertainty because they relate to future events and circumstances. Actual results and developments could differ materially from those expressed or implied by the forward-looking statements.

Forward-looking statements may and often do differ materially from actual results and are not guarantees of future performance. Any forward-looking statements in this Announcement are based on certain factors and assumptions, including the Directors’ current view with respect to future events and are subject to risks relating to future events and other risks, uncertainties and assumptions relating to the Group’s operations, results of operations, growth strategy and liquidity. Whilst the Directors consider these assumptions to be reasonable based upon information currently available, they may prove to be incorrect. Save as required by law or by the AIM Rules or the Euronext Growth Rules, none of the Group, Arden, finnCap, Davy nor their respective directors undertakes any obligation to publicly release the results of any revisions to any forward-looking statements in this Announcement that may occur due to any change in the Directors’ expectations or to reflect events or circumstances after the date of this Announcement.

GENERAL

Arden, which is authorised and regulated by the FCA in the United Kingdom, is acting as Nomad and Joint Broker to the Group in connection with the Fundraising. Arden will not be responsible to any person other than the Group for providing the protections afforded to clients of Arden or for providing advice to any other person in connection with the Fundraising. Arden is not making any representation or warranty, express or implied, as to the contents of this Announcement. Arden has not authorised the contents of, or any part of, this Announcement, and no liability whatsoever is accepted by Arden for the accuracy of any information or opinions contained in this Announcement or for the omission of any material information.

finnCap, which is authorised and regulated by the FCA in the United Kingdom, is acting as Joint Broker to the Group in connection with the Fundraising. finnCap will not be responsible to any person other than the Group for providing the protections afforded to clients of finnCap or for providing advice to any other person in connection with the Fundraising. finnCap is not making any representation or warranty, express or implied, as to the contents of this Announcement. finnCap has not authorised the contents of, or any part of, this Announcement, and no liability whatsoever is accepted by finnCap for the accuracy of any information or opinions contained in this Announcement or for the omission of any material information.

The Fundraising Shares will not be admitted to trading on any stock exchange other than AIM and Euronext Growth.

Nothing in this Announcement shall be effective to limit or exclude any liability for fraud or which otherwise, by law or regulation, cannot be so limited or excluded.

Neither the content of the Group’s website (or any other website) nor the content of any website accessible from hyperlinks on the Group’s website (or any other website) is incorporated into, or forms part of, this Announcement.

INTERPRETATION

Certain terms used in this Announcement are defined under the heading “Definitions” in Appendix II of this Announcement.

All times referred to in this Announcement are, unless otherwise stated, references to London time.

All references to legislation in this Announcement are to the legislation of England and Wales unless the contrary is indicated. Any reference to any provision of any legislation or regulation shall include any amendment, modification, re-enactment or extension thereof.

Words importing the singular shall include the plural and vice versa, and words importing the masculine gender shall include the feminine or neutral gender and vice versa.

Link here to view the full  Prospectus

 

Open Orphan Plc (LON: ORPH) is also pleased to announce a conditional offer for subscription via PrimaryBid(the “PrimaryBidOffer”) of new ordinary shares (“New Ordinary Shares”) at an issue price of 11 pence per New Ordinary Share (the “Issue Price”), a premium of 3.8 per cent. to the closing price of 10.6 pence per Ordinary Share on 7 May 2020 being the date immediately before the announcement of the Quotient partnership on 11 May 2020. It represents a discount of approximately 26.4 per cent. to the closing middle market price of 14.95 pence per Ordinary Share on 21 May 2020, being the latest practicable date prior to the publication of this Announcement. The Company is also conducting a placing of new Ordinary Shares to institutional and other investors at the Issue Price by way of an accelerated bookbuild process by Arden Partners plc (“Arden”) and finnCap Ltd (“finnCap” together with Arden, the “Joint Brokers”) (the “Placing”), and a subscription (the “Subscription”), as announced on 22 May 2020. The Placing, Subscription and PrimaryBid Offerare expected to raise up to £12 million (net of expenses).

  • The net proceeds of the Fundraising will be used to
  • Maximise available Covid-19 opportunities including accelerating the development of both a seasonal coronavirus and a Covid-19 virus challenge study model to capitalise upon Group’s inbound demand from Covid-19 vaccine developers globally. These challenge study models have the ability to speed up the development of a vaccine by 2-3 years;
  • Ramp up Covid-19 antiviral testing to the Group’s current capacity for 3,000 tests per day;
  • Expand existing laboratory testing services to 3rd party pharmaceutical and biotech companies in line with our strategy of becoming a leading services provider to the growing viral, and respiratory diseases sector of the pharmaceutical industry; and
  • Strengthen the balance sheet to enable the Group to take advantage of the significant and  growing  opportunities the Board believes are available.

PrimaryBid Offer

The Company values its retail investor base and is therefore pleased to provide private and other investors the opportunity to participate in the PrimaryBid Offer by applying exclusively through the www.PrimaryBid.com platform and the PrimaryBid mobile app available on the Apple App Store and Google Play. PrimaryBid does not charge investors any commission for this service.

The PrimaryBid Offer will comprise of two tranches. The first tranche will comprise of new Ordinary Shares (the “Firm PrimaryBid Shares”), which will be issued pursuant to the Company’s existing share authorities, which were granted to the directors at the general meeting of the Company held on 6 January 2020. The second tranche will comprise new Ordinary Shares (the “Conditional PrimaryBid Shares”) and together with the Firm PrimaryBid Shares, the “PrimaryBid Shares”. which will be issued pursuant to and conditional upon the granting of new share authorities at the General Meeting to be held on 11 June 2020.

The PrimaryBid Offer, the Placing  and the Subscription are conditional on the new Ordinary Shares to be issued pursuant to the PrimaryBid Offer, the Placing and the Subscription being admitted to trading on AIM (operated by the London Stock Exchange) (“Admission”). Admission of the Firm PrimaryBid Shares is expected to be take place at 8.00 a.m. on 29 May 2020. Admission of the Conditional PrimaryBid Shares is expected to be take place at 8.00 a.m. on 12 June 2020, subject to the passing of granting of new share authorities at the General Meeting to be held on 11 June 2020. The PrimaryBid Offer will not be completed without the Placing also being completed. The PrimaryBid Offer, via the PrimaryBid.com platform, will be open to individual and institutional investors from 7.00 a.m. on 22 May 2020 and will close at the same time as the bookbuilding process is completed. The PrimaryBid Offer may however close early.

Subscriptions under the PrimaryBid Offer will be considered by the Company on a “first come, first served” basis, subject to conditions, which are available to view on PrimaryBid.com.

The Company in consultation with PrimaryBid reserves the right to scale back any order at its discretion. The Company and PrimaryBid reserve the right to reject any application for subscription under the Offer without giving any reason for such rejection.

No commission is charged to investors on applications to participate in the PrimaryBid Offer made through PrimaryBid.  It is vital to note that once an application for New Ordinary Shares has been made and accepted via PrimaryBid, an application cannot be withdrawn.

For further information on PrimaryBid.com or the procedure for applications under the PrimaryBid Offer, visit www.PrimaryBid.com or call PrimaryBid.com on +44 20 3026 4750. 

The new Ordinary Shares will be issued free of all liens, charges and encumbrances and will, when issued and fully paid, rank pari passu in all respects with the Company’s existing Ordinary Shares.

Open Orphan Plc

Cathal Friel, Executive Chairman

 

 

+353 (0)1 644 0007

PrimaryBid Limited

Kieran D’Silva / James Deal

 

+ 44 (0) 203 026 4750

Arden Partners plc (Nominated Adviser and Joint Broker)

John Llewellyn-Lloyd / Benjamin Cryer (Corporate Finance)

Fraser Marshall / Simon Johnson (Equity Sales)

 

+44 (0)20 7614 5900

finnCap plc (Joint Broker)

Geoff Nash /James Thompson/Richard Chambers

 

 +44 (0)20 7220 0500

Davy (Euronext Growth Adviser and Joint Broker)

Anthony Farrell

 

 +353 (0)1 6796363

Camarco (Financial PR)

Tom Huddart / Daniel Sherwen

+44 (0)20 3757 4980

Details of the Offer

The Company highly values its retail investor base which has supported the Company alongside institutional investors. Given the longstanding support of retail shareholders, the Company believes that it is appropriate to provide retail and other interested investors the opportunity to participate in the Offer. The Company is therefore making the Offer available exclusively through PrimaryBid.com.

The Offer is offered under the exemptions against the need for a prospectus allowed under the Prospectus Rules. As such, there is no need for publication of a prospectus pursuant to the Prospectus Rules, or for approval of the same by the Financial Conduct Authority in its capacity as the UK Listing Authority. The Offer is not being made into any Restricted Jurisdiction or any other jurisdiction where it would be unlawful to do so.

There is a minimum subscription of £100 per investor under the terms of the Offer which is open to existing shareholders and other investors subscribing via PrimaryBid.com. This allocation will be filled on a “first come first served” basis.

For further details please refer to the PrimaryBid.com website at www.PrimaryBid.com. The terms and conditions on which the Offer is made, including the procedure for application and payment for New Ordinary Shares, is available to all persons who register with PrimaryBid.com.

Investors should make their own investigations into the merits of an investment in the Company. Nothing in this announcement amounts to a recommendation to invest in the Company or amounts to investment, taxation or legal advice.

It should be noted that a subscription for New Ordinary Shares and investment in the Company carries a number of risks. Investors should consider the risk factors set out on PrimaryBid.com before making a decision to subscribe for New Ordinary Shares. Investors should take independent advice from a person experienced in advising on investment in securities such as the New Ordinary Shares if they are in any doubt. d, sold, or acquired, directly or indirectly, within those jurisdictions;

Open Orphan #ORPH – Update on antibody test agreement and recent share price movement

Open Orphan plc (ORPH) the rapidly growing specialist CRO pharmaceutical services company which has a focus on orphan drugs and is the world leader in the testing of vaccines and antivirals using human challenge study models, notes the increase in the Company’s share price and media comment regarding its collaboration with Quotient Limited. Furthermore, it also notes the substantial increase in interest in antibody testing for Covid-19 following recent announcements by the UK Government.

The Company confirms that the MosaiQ COVID-19 Antibody Microarray machine is on site at hVivo’s laboratory in East London and is undergoing testing. It is expected to be fully operational within two weeks following which it will have capability to undertake up to 3,000 tests a day, in line with expected performance as stated by Quotient Limited. The Company intends to enter into discussions with channel partners to secure testing volumes with pricing to be determined as part of these negotiations. It is not the company’s intention to deal directly with consumers and while there can be no certainty on pricing until such time as terms are agreed, the Company notes current market prices ranging from c.£70 for home testing kits and upwards towards c.£150. It is the intention to supply testing capability to channel partners, who will in turn deal with the end users and the final price points. The Company will update shareholders in due course.

Further information on the Company’s approach to Covid-19 antibody testing and vaccine trials is available on the Company’s website

 

ENDS

For further information please contact

Open Orphan plc

Cathal Friel, Executive Chairman

+353 (0)1 644 0007

Arden Partners plc (Nominated Adviser and Joint Broker)

+44 (0)20 7614 5900

John Llewellyn-Lloyd / Benjamin Cryer

finnCap Ltd (Joint Broker)

+44 (0)20 7220 0500

Geoff Nash /James Thompson/Richard Chambers

Davy (Euronext Growth Adviser and Joint Broker)

+353 (0)1 679 6363

Anthony Farrell

Camarco (Financial PR)

+44 (0)20 3757 4980

Tom Huddart / Hugo Liddy

Notes to Editors:

Open Orphan is a rapidly growing specialist CRO pharmaceutical services company which has a focus on orphan drugs and is a world leader in the provision of virology and vaccine challenge study services and viral laboratory services. It has Europe’s only 24-bedroom quarantine clinic with onsite virology lab in Queen Mary’s Hospital London. hVIVO supports product development for customers developing antivirals, vaccines and respiratory therapeutics, all particularly relevant and topical in the environment of heightened awareness of Covid-19 in 2020. The Company also has a leading portfolio of 8 viral challenge study models which are: 2 FLU, 2 RSV, 1 HRV, 1 Asthma, 1 cough and 1 COPD viral challenge models. As announced in early March, Open Orphan is rapidly advancing a Coronavirus challenge study model and expects to be very active with many companies in the development of a Covid-19 vaccine. No other company in the world has such a portfolio, with only two competitors globally having 1 challenge study model each. 

Open Orphan comprises of two commercial specialist CRO services businesses (Venn and hVIVO) and is developing an early stage orphan drug genomics data platform business. This platform captures valuable genetic data from patient populations with specific diseases with designated orphan drug status and incorporating AI tools. In June 2019, Open Orphan acquired AIM-listed Venn Life Sciences Holdings plc in a reverse take-over and in January 2020 it completed the merger with hVIVO plc. Venn, as an integrated drug development consultancy, offers CMC (chemistry, manufacturing and controls), preclinical, Phase I & II clinical trials design and execution. The merger with hVIVO created a European full pharma services company broadening the Company’s customer base and with complementary specialist CRO services, widened the range of the Company’s service offerings.

Open Orphan Chairman Cathal Friel speaks to BRR Media re the new contract, other developments and the CEO’s departure

Open Orphan PLC’s (LON:ORPH) Cathal Friel speaks to Rosie Riall at BRR Media after signing a new deal with a US biotech for the provision of a respiratory syncytial virus human challenge study. Cathal also covers the channel pipeline, the hVIVO quarantine centre, flu and malaria vaccines and the planned departure of CEO Trevor Phillips.

Open Orphan #ORPH: The Times – Inside Story of coronavirus battlers. The Sun – We salute the unsung key workers.

Inside stories of coronavirus battlers Aerogen, Hibergene, Open Orphan and Nearform

Ireland was placed sixth last week in a list of nations ranked on their response to the Covid-19 crisis in terms of innovation. The league table was compiled by StartupBlink, a Swiss-Israeli company that collates data on start-ups; the United Nations-backed Health Innovation Index; the Moscow Agency of Innovations; and partners such as tech database provider Crunchbase.

While the Republic has punched above its weight largely because of multi- national medical device firms, Enterprise Ireland says more than 100 of its client companies are responding to the crisis. Here, we step inside four Irish businesses that are seeking to make a material contribution in the fight against the deadly spread of Covid-19.

Link here for the full story.

By Brian Carey and Conor McMahon

 

THE HOMES FRONT: We salute the unsung key workers who are keeping Britain going during lockdown – from binmen and bus drivers to teachers

Scientist

ANDREW Catchpole heads London’s hVIVO lab — pioneering testing of new Covid-19 vaccines.

The 44-year-old doctor said: “We have received a massive response from volunteers to take part in human testing with a non-deadly coronavirus.

“Normally 200 would respond on our website in a week. This time we had 20,000 in a few days. People want to help.

“We are trying to find a model that will speed up vaccine testing.

“At the moment we are setting up the trial and testing the virus to ensure it is safe, before we put it into people. We will take healthy volunteers and inoculate them with a virus, making them sick but in a very controlled setting.

“We are putting in lots of hours to get this running.”

By Grant Rollings, Kate Ferguson, Ben Leo

Link here for the full story.

Open Orphan #ORPH – Testing of anti-viral for treating COVID-19 underway

Open Orphan plc (ORPH) the rapidly growing specialist CRO pharmaceutical services company which has a focus on orphan drugs and is a world leader in the provision of virology and vaccine challenge study services, is pleased to announce that its London-based subsidiary hVIVO has commenced the testing of an anti-viral for treating COVID-19 on behalf of its client Nearmedic International Ltd.

hVIVO has initiated work on this contract with Nearmedic International Ltd, a specialist pharmaceutical, biotechnological and medical business headquartered in Moscow, to test using hVIVO’s virology expertise and laboratory capability an anti-viral drug with potential utility for treating SARS-CoV2 (COVID-19) infections. This drug has both potential anti-viral and anti-inflammatory activity and as such could reduce both virus infectivity and disease severity respectively.

hVIVO will be testing its utility against a panel of viruses to include influenza virus, “normal”, circulating betacoronavirus and ultimately SARS-CoV2 (COVID-19).

Cathal Friel, Executive Chairman of Open Orphan, commented:

“We are very happy to be assisting in the battle against Covid-19 and are delighted to be working with Nearmedic International Ltd. hVIVO is a world leading provider of services to global vaccine and antiviral development companiesand our scientists have considerable knowledge from previous anti-viral trials which gives us confidence in our testing. We look forward to updating the market on a regular basis in the weeks and months ahead.”

  For further information please contact:

 

Open Orphan plc

Cathal Friel, Executive Chairman

+353 (0)1 644 0007

Trevor Phillips, Chief Executive Officer

+44 (0)20 7347 5350

Arden Partners plc (Nominated Adviser and Joint Broker)

+44 (0)20 7614 5900

John Llewellyn-Lloyd / Benjamin Cryer

 

Davy (Euronext Growth Adviser and Joint Broker)

+353 (0)1 679 6363

Anthony Farrell

 

Camarco (Financial PR)

+44 (0)20 3757 4980

Tom Huddart / Daniel Sherwen

 

Notes to Editors:

Open Orphan  is a rapidly growing specialist CRO pharmaceutical services company which has a focus on orphan drugs and is a world leader in the provision of virology and vaccine challenge study services  and viral laboratory services. It has Europe’s only 24-bedroom quarantine clinic with onsite virology lab in Queen Mary’s Hospital London. hVIVO supports product development for customers developing antivirals, vaccines and respiratory therapeutics, all particularly relevant and topical in the environment of heightened awareness of Covid-19 in 2020. The Company also has a leading portfolio of 8 viral challenge study models which are: 2 FLU, 2 RSV, 1 HRV, 1 Asthma, 1 cough and 1 COPD viral challenge models. As announced in early March, Open Orphan is rapidly advancing a Coronavirus challenge study model and expects to be very active with many companies in the development of a Covid-19 vaccine.  No other company in the world has such a portfolio, with only two competitors globally having 1 challenge study model each.  

Open Orphan comprises of two commercial specialist CRO services businesses (Venn and hVIVO) and is developing an early stage orphan drug genomics data platform business. This platform captures valuable genetic data from patient populations with specific diseases with designated orphan drug status and incorporating AI tools. In June 2019,   Open Orphan acquired AIM-listed Venn Life Sciences Holdings plc in   a reverse take-over and in January 2020 it completed the merger with hVIVO plc. Venn, as an integrated drug development consultancy, offers CMC (c hemistry, manufacturing and controls) , preclinical, Phase I & II clinical trials design and execution. The merger with hVIVO created a European full pharma services company broadening the Company’s customer base and with complementary specialist CRO services, widened the range of the Company’s service offerings.

Race to stop the world getting sick: As coronavirus ravages the globe, experts work around the clock developing vaccines and trialling drugs in a desperate attempt to contain it

by Pat Hagan, Daily Mail

As the needle slipped into Jennifer Haller’s arm, the world watched and held its breath.

This was the moment last week when Jennifer became the first person to be injected with an experimental vaccine that scientists hope will help prevent future pandemics of the deadly Covid-19 coronavirus.

Mother-of-two Jennifer, 43, from Seattle, told reporters: ‘We all feel so helpless. But this is an amazing opportunity for me to do something.’

Over the next few months, hundreds more people — including many in the UK — are expected to sign up as human guinea pigs, just like Jennifer.

Last week, Boris Johnson announced that the first British patient has been put into a trial for drugs that may treat coronavirus. And a safety trial on humans, led by Oxford University, for a potential new vaccine is also expected to start next month.

This is part of a global effort, as the search gathers pace for new ways to detect, treat and prevent Covid-19.

Some, like Jennifer, will have vaccines that contain corona-like (albeit harmless) viruses injected into their bloodstream to see whether their immune systems can be trained to recognise and destroy the virus.

Others are likely to be deliberately infected with weaker versions of coronavirus and given a variety of drugs to try to stop it in its tracks. It will be science at Formula 1 pace — with some corners cut and rules bypassed.

But what does it mean to offer up your body for scientific exploration in the battle against the virus?

UK CENTRE RECRUITING HUNDREDS FOR TRIALS

In the UK, one of the centres leading the fight is FluCamp, a 24-bed privately run unit based in Whitechapel, East London, where for the past 30 years scientists have been carrying out research on cold and flu viruses.

It is the only research facility of its kind in Europe — and one of just four in the world — equipped to quarantine patients for weeks at a time while they are exposed to highly infectious viruses.

Confined to one room 24 hours a day for up to a fortnight, volunteers are subject to round-the-clock testing by health professionals clad in protective clothing.

FluCamp has announced plans to recruit hundreds of healthy volunteers over the next few months. The first stage is to select 24 participants and expose them to two virus strains that are related to Covid-19 but do not wreak the same degree of havoc on the body.

A spokesman said the clinic has been inundated with more than 20,000 enquiries from would-be human guinea pigs since it unveiled its plans on March 9.

Professor John Oxford, an expert in virology at Queen Mary, University of London and scientific adviser to hVivo — the company that runs FluCamp — says the selection process will begin in the next few weeks. ‘The plan is to test hundreds of patients but do 24 at a time, as that is how many beds the unit has,’ he says.

Link here for the full article

Wanted: People Willing to Get Sick to Find Coronavirus Vaccine

British lab is recruiting volunteers for study it says could speed development of Covid-19 vaccine

By Denise Roland March 19, 2020 7:00 am ET

Thousands of people have volunteered to be infected in the hope of finding a vaccine for the new coronavirus.

hVIVO, a clinical research group in London, has attracted more than 20,000 volunteers willing to be infected with tamer relatives of the virus that causes Covid-19 in exchange for a fee of £3,500 ($4,480). It says such experiments could play an important role in the development of a vaccine against the new coronavirus, for which there are no proven treatments or vaccines.

Unlike drugs, which are tested on people who already have a particular illness, vaccines have to be given to healthy people who are later exposed to a disease. Typically, this is done by giving an experimental vaccine to thousands of people in an area where an infection is circulating, and then tracking them for months or even years. The vaccine is considered successful if those who got the shot avoid infection.

One way of getting a quicker read on a vaccine’s effectiveness is by giving it to people who are then deliberately infected with the bug in question. Such challenge studies are routinely used in the development of vaccines for the flu, common cold and other respiratory illnesses.

Usually, a few dozen participants are tracked closely for a few weeks for signs of illness after infection. These trials don’t replace the larger field studies, but they help give direction on whether a vaccine is worth pursuing.

The CDC is updating its website each day with information about where people can be tested for the new coronavirus. However, the availability of tests varies widely, as does the time it takes to get results. Have you tried to get tested? Where did you go and what

For Covid-19, too little is known about who is most susceptible to serious illness or death to run a challenge study using the new coronavirus that causes the disease. Still, hVIVO hopes that using its relatives can nonetheless offer clues for vaccine development. Coronaviruses are a large family that cause a range of illnesses from the common cold to more serious diseases like SARS and MERS.

“It gives you a sieve and gives you some confidence that things are going to be all right,” said John Oxford, emeritus professor of virology at Queen Mary University of London, and chair of hVIVO’s advisory board. “There have been no human coronavirus vaccines, we don’t know what they’ll be like.” 

hVIVO—a subsidiary of pharmaceutical-services company Open Orphan ORPH PLC—is one of just a handful of companies that develop and run challenge studies for drug and vaccine makers.

Such studies are much faster and cheaper than full field studies and can help researchers select the most promising candidate vaccines to be taken forward into broader trials.

hVIVO is currently in early discussions with drugmakers racing to develop a coronavirus vaccine and says it will be ready to offer its challenge tests to clients in the next two to three months.

After advertising and media coverage, the company was inundated with volunteers. More than 20,000 signed up in the space of a few days, compared with a normal rate of a few people a day.

The Uncertainties of Self-Quarantine Amid Coronavirus 

Amid an increase in confirmed cases of the new coronavirus in the U.S., more companies, religious institutions and schools are asking people to stay at home if they may have come into contact with the virus. WSJ follows the case of one man under voluntary self-quarantine.

Those chosen for tests will be kept in isolation at the company’s facilities until they are no longer infectious, usually around two weeks, to mitigate the risk of them spreading the disease to friends and family.

Jamie Spicer-Lewis, a 32-year-old graphic designer and animator who lives in Birmingham, England, signed up this week after seeing an ad online while searching for information about coronavirus.

“It’s not much time out of my life and if it goes toward helping in any possible way—because there are people who are a lot more at risk than I am—then why not?” he said. The financial incentive was a “nice little cherry on top.” He said he had previously donated stem cells for blood cancer patients, a procedure that involved a three-day hospital stay, without any payment.

If chosen, he will undergo a battery of extra medical screening before joining any tests.

Still, studies using other coronaviruses may not give a good read on vaccines that specifically target the strain that causes Covid-19, said Matthew Memoli, director of the Laboratory of Infectious Diseases at the National Institute of Allergy and Infectious Diseases in Bethesda, Md.

The most advanced vaccines under development are specific to the new coronavirus, he said. Several groups, including Moderna Inc., MRNA 6.71% Sanofi SA SNY -4.37% and Johnson & Johnson JNJ -5.68% are working on new vaccines.

J&J said it isn’t planning to use human viral challenge tests, while Sanofi said it hasn’t yet finalized its plans but wouldn’t use a test not specific to Covid-19. The National Institute for Allergy and Infectious Disease, which is running the trials for Moderna’s vaccine, said it didn’t have plans to conduct infection challenge tests.

But challenge tests could be valuable in eventually developing a universal vaccine that works across the coronavirus family, Dr. Memoli said. He is developing his own challenge test for coronavirus using a related strain and hopes it will help scientists better understand how the viruses behave and inform longer-term development of treatments or vaccines.

In general, deliberate infection treads a fine ethical line and is only considered acceptable when the benefits to the wider population far outweigh the risks to participants.

For instance, ethicists say it would be difficult to justify a challenge study for a disease like Ebola because of its high death rate—about 50% on average compared with 2% to 3% so far for Covid-19.

When challenge studies have previously been used for more serious illnesses such as dengue fever and malaria, only participants deemed to be at low risk from serious illness or death were selected, and in some cases a weakened version of the pathogen was used.

“There’s a positive ethical rationale for doing challenge study experiments,” said Julian Savulescu, who leads research on collective responsibility in infectious disease at the University of Oxford. “This kind of research is one of the arrows in the quiver of tackling this kind of catastrophe.”

Link here to read the original WSJ article

Open Orphan #ORPH – Publication of positive FLU-v vaccine challenge study results in journal

Positive results from FLU-v vaccine challenge study (FLU-v 004), the second Phase IIb study of FLU-v, which has been developed by Imutex Limited, hVIVO’s 49% joint venture with the SEEK Group, have now been published in a peer review journal

FLU-v is a first-in-class ‘universal’, broad spectrum, standalone, influenza vaccine candidate

  • The publication in ‘npj Vaccines’ reported that one dose of FLU-v induced statistically significant reduction in mild to moderate influenza disease (MMID) defined as detection of viral shedding with at least one influenza symptom – reduction in confirmed influenza and symptoms
  • One dose of FLU-v also induced a statistically significant reduction in the number of subjects experiencing 2 or more influenza symptoms compared to placebo
  • This report follows recent publication of positive FLU-v Phase IIb field study results (FLU-v 003) demonstrating cellular and humoral immunogenicity of a single dose of adjuvanted FLU-v in 175 individuals
  • The npj Vaccines article concludes that the T-cell strategy employed by FLU-v has potential to offer protection against influenza infection as a vaccine and that larger studies can evaluate how the vaccine interacts with influenza strains in different cohorts
  • Imutex is currently scheduling meetings with key regulatory authorities, FDA and EMEA, hoping to gain confirmation of the remaining development pathway to approval for FLU-v

16 March 2020: Open Orphan plc (ORPH), the rapidly growing specialist CRO pharmaceutical services company which has a focus on orphan drugs and is a world leader in the provision of virology and vaccine challenge study services, today announces publication of positive results of a Phase IIb challenge study of FLU-v 004 (Study 004, NCT03180801) in npj Vaccines.  The headline results from this study were previously announced by hVIVO on 10 January 2019. FLU-v is being developed by Imutex Limited, hVIVO’s 49% joint venture with PepTcell Limited, trading as the SEEK Group (“SEEK”).

The primary endpoint was achieved in the Phase IIb challenge study conducted by hVIVO using the National Institute of Allergy and Infectious Diseases (NIAID) Flu virus strain, methodology and analysis as a result of a collaboration between SEEK and the NIAID. The randomised, double-blind, placebo-controlled, single-centre, phase IIb efficacy and safety trial was designed and led by Matthew J. Memoli, M.D., NIAID. It was conducted in 153 healthy individuals between 18-55 years of age. They were randomised to receive one or two doses of adjuvanted FLU-v or adjuvanted placebo subcutaneously on days -43 and -22, prior to intranasal challenge on day 0 with the A/California/04/2009/H1N1 human influenza A challenge virus. The challenge virus strain was developed, tested and supplied by Dr. Memoli and co-workers from NIAID’s Laboratory of Infectious Diseases. The primary objective of the study was to identify a reduction in mild to moderate influenza disease (MMID) defined as having an influenza-like symptom with a confirmed influenza virus. Single dose adjuvanted FLU-v recipients (n=40) were significantly less likely to develop MMID after challenge vs placebo (n=42) (32.5% vs 54.8% p=0.035). The authors concluded that FLU-v should continue to be evaluated and cellular immunity explored further as a possible important correlate of protection against influenza. Additional endpoints were also achieved, including a statistically significant reduction in the number of volunteers who experienced two or more symptoms. Also, FLU-v performed better than placebo, although not to statistical significance, in a number of other key endpoints such as median duration of symptoms and severity of disease as measured by an NIAID-developed FLU-PRO questionnaire, as well as reduction in the mean total number of symptoms and mean peak symptoms, and total viral shedding.

Trevor Phillips, CEO of Open Orphan, said:

“Publication of these positive results for the second FLU-v Phase IIb study (FLU-v004; challenge study) follow on from the publication earlier this week of the FLU-v 003; field study, results. 

The results demonstrate that T-cell immunity against conserved regions of the influenza virus is an important component for “universal*” vaccine strategies. Progression to larger Phase III studies with FLU-v can further describe the cellular immune response and evaluate how the vaccine interacts with influenza disease.

The efficacy of FLU-v in this wild-type human influenza challenge study (FLU-v 004) along with the supporting data from previous trials in the field, should be further examined in larger field trials where efficacy of FLU-v can be evaluated against a broader set of influenza strains and wider spectrum of disease. Along with our partner SEEK we have confidence in the potential of FLU-v as a universal flu vaccine and we are in the process of requesting meetings to continue discussions with the key regulatory authorities on the pathway for completing development of this exciting product opportunity.”

Cathal Friel, Executive Chairman of Open Orphan, said:

“The need for better, more broadly protective vaccines against influenza is a high priority worldwide, and few new vaccines have demonstrated efficacy in humans as seen in the results of the challenge study for FLU-v 004.  This is the first universal influenza vaccine that has shown this protection from influenza and reduction of symptoms in late-stage studies and together with the highly statistical immune results reported in a peer review article earlier this week means that the risk of failure in a Phase III setting is greatly reduced compared with entering into Phase III studies with no efficacy data.

As previously stated, the additional investment or cost associated with commercialising FLU-v, will come from out-licencing the final stages of development including Phase III, to potential major international pharmaceutical companies, in Europe, North America and China. We remain excited about the potential for FLU-v and in a time when vaccine development is such a key focus globally.

* A universal flu vaccine is one that is effective against all strains of the virus and does not require changing from year to year

Abstract: https://www.nature.comDOI: 10.1038/s41541-020-0174-9. Efficacy of FLU-v, a Broad-Spectrum Influenza Vaccine, in a Randomized Phase IIb Human Influenza Challenge Study

Abstract:

FLU-v, developed by PepTcell (SEEK) is a novel peptide vaccine aiming to provide a broadly protective cellular immune response against influenza A and B.

Primary objective: To identify a reduction in mild to moderate influenza disease (MMID) defined as the presence of viral shedding and clinical influenza symptoms.

Design: Randomized, double-blind, placebo-controlled, single-center, phase IIb efficacy and safety trial. (ClinicalTrials.gov:NCT03180801, EudraCT: 2016-002134-74)

Setting: hVIVO Services Ltd (London, UK)

Participants: 153 healthy individuals 18-55 years.

Intervention: One or two doses of adjuvanted FLU-v or adjuvanted placebo subcutaneously on days-43 and-22, prior to intranasal challenge on day 0 with the A/California/04/2009/H1N1 human influenza A challenge virus.

Results:  Single dose adjuvanted FLU-v recipients (n=40) were significantly less likely to develop MMID after challenge vs placebo (n=42) (32.5% vs 54.8% p=0.035).

Primary Funding Source: This research was funded in part by the Intramural Research Program of the NIH, NIAID as well as a CRADA with SEEK   

Registration: NCT03180801, EudraCT: 2016-002134-74

For further information please contact

 

Open Orphan plc  

Cathal Friel, Executive Chairman                                                                           +353 (0)1 644 0007

Trevor Phillips, Chief Executive Officer                                                                 +44 (0)20 7347 5350

Arden Partners plc (Nominated Adviser and Joint Broker)                            +44 (0)20 7614 5900

John Llewellyn-Lloyd / Benjamin Cryer

Davy (Euronext Growth Adviser and Joint Broker)                                          +353 (0)1 679 6363

Anthony Farrell

Camarco (Financial PR)                                                                                          +44 (0)20 3757 4980

Tom Huddart / Daniel Sherwen

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This is an RNS Reach announcement. RNS Reach is an investor communication service aimed at assisting listed and unlisted (including AIM quoted) companies to distribute non-regulatory news releases into the public domain. Information required to be notified under the AIM Rules for Companies, Market Abuse Regulation or other regulation would be disseminated as an RNS regulatory announcement and not on RNS Reach.

Notes to Editors:

Open Orphan is a rapidly growing specialist CRO pharmaceutical services company which has a focus on orphan drugs and is a world leader in the provision of virology and vaccine challenge study services and viral laboratory services. It has Europe’s only 24-bedroom quarantine clinic with onsite virology lab in Queen Mary’s Hospital London. hVIVO supports product development for customers developing antivirals, vaccines and respiratory therapeutics, all particularly relevant and topical in the environment of heightened awareness of the Coronavirus in 2020. The Company also has a leading portfolio of 8 viral challenge study models which are: 2 FLU, 2 RSV, 1 HRV, 1 Asthma, 1 cough and 1 COPD viral challenge models.  No other company in the world has such a portfolio, with only two competitors globally having 1 challenge study model each. 

Open Orphan comprises of two commercial specialist CRO services businesses (Venn and hVIVO) and is developing an early stage orphan drug genomics data platform business. This platform captures valuable genetic data from patient populations with specific diseases with designated orphan drug status and incorporating AI tools. In June 2019, Open Orphan acquired AIM-listed Venn Life Sciences Holdings plc in a reverse take-over and in January 2020 it completed the merger with hVIVO plc. Venn, as an integrated drug development consultancy, offers CMC (chemistry, manufacturing and controls), preclinical, Phase I & II clinical trials design and execution. The merger with hVIVO created a European full pharma services company broadening the Company’s customer base and with complementary specialist CRO services, widened the range of the Company’s service offerings

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