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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.com – DOI: 10.1038/s41541-020-0174-9. Efficacy of FLU-v, a Broad-Spectrum Influenza Vaccine, in a Randomized Phase IIb Human Influenza Challenge Study
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
Camarco (Financial PR) +44 (0)20 3757 4980
Tom Huddart / Daniel Sherwen
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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
Open Orphan plc (ORPH), a rapidly growing specialist pharmaceutical services company which has a focus on orphan drugs, is pleased to announce that admission to trading on AIM and Euronext Growth of its existing ordinary share capital and the new ordinary shares to be issued as consideration in connection with the Merger, will commence at 8.00 a.m. today.
· Completion of merger between Open Orphan and hVIVO creating a European full pharma services company in a compelling strategic combination
· Enhanced management and Board with a strong operational track record and M&A experience
o Cathal Friel, moving to Executive Chairman with a full-time hands-on role in the business
o Trevor Phillips and Tim Sharpington becoming CEO and COO, respectively, of the enlarged group
o New board with the appointment of Michael Meade as an additional non-executive director, along with Brendan Buckley and Mark Warne as non-executive directors and Trevor Philips and Cathal Friel as executive directors
· Combination creates a platform of highly specialised, complementary CRO service providers
· Combined robust pipeline of over £100 million at January 2020. The Group is focused on building long term contracts with recurring revenues. Open Orphan has confirmed signed contracts of €10.5m as of January 2020 which is the highest in its history with an additional €4m at an advanced stage with clients under an existing MSA. Open Orphan is successfully moving Venn away from short-term contracts to long-term, 3-year contracts with recurring revenues e.g. IPSEN (Nov ’19) and a German Tier One pharma company (Jan ’20). hVIVO has a solid pipeline of identified and pitched for contracts of £81.2m as of January 2020, which is significantly higher than the prior two years
· A number of joint Open Orphan and hVIVO pitches have already been submitted to hVIVO clients with the now expanded Venn service capability
· Estimated operational synergies of £3.1m in 2020 rising to £4.4m in 2021 – longer-term revenue synergy potential through utilisation of Open Orphan’s Phase II capabilities for hVIVO’s challenge study clients
· New combined revenue model unlocks potential for substantial revenue growth and sustainable profitability – by combining Open Orphan’s existing preclinical, phase 1 and Phase 2, regulatory and other services along with hVivo which is an industry leading services provider in viral challenge studies and laboratory services creating a leading European specialist pharma services company
· Proposed placing to raise £5m – underwritten by up to £2.5m by Raglan Capital – to support the Group’s growth plans
Cathal Friel, Executive Chairman of Open Orphan commented:
“I am hugely excited by the combination of Open Orphan and hVIVO. We have a fantastic team, substantial revenue potential and the opportunity to grow quickly in the year ahead. I am personally participating in the placing as I believe in the strategy of the business and its ability to deliver substantial returns to shareholders in the next 12 months.”
Trevor Phillips, CEO of Open Orphan commented:
“We now have an industry leading team with the ability to generate substantial revenue growth and profitability, delivering the leadership’s vision to create a successful European full pharma services company. With the now complementary and wider specialist CRO services offering, it gives us the opportunity to generate substantially larger revenues and over the full-time course of the customer relationship. With a robust combined pipeline, I am confident we have the solid platform to achieve our goals.”
Strategy – delivering on our pipeline and enhancing returns through business synergies
Since the acquisition of Venn Life Sciences by Open Orphan in June 2019, the Company has focused on transitioning Venn from short term contracts to long term contracts with recurring revenues, reducing its overheads and taking actions to increase profitability. Before the merger, hVIVO had successfully refocused its business model and completed a business turnaround with operational efficiency measures and headcount reductions implemented. The Merger is expected to bring further benefits as a result of hVIVO now being able to provide the Venn offering, preclinical, Phase I and Phase II to customers to its challenge study customers. The combined Group will now be able to offer a wider range of services to a broader customer base.
In addition to the Company’s focus on delivering the pipeline, it plans to supplement returns through immediate cost savings and operational synergies and near and medium term revenue synergies. In the short term, the combination of Open Orphan and hVIVO is expected to result in substantial cost savings through the elimination of subcontractor costs where they can be replaced by new capabilities within the enlarged Group. The Group estimates savings of up to £1.7m in FY20 rising to £2.3m in FY21. Furthermore, the Group intends to rationalise a number of duplicate costs resulting in £0.2m of cost savings in FY20 rising to £0.4m in FY21.
The Group expects to deliver total synergies of £3.1m in 2020 rising to £4.4m in 2021. This combined with identified longer-term revenue synergies by extending hVIVO relationships and utilising Phase II capability of Open Orphan to gain contracts for Phase II execution and lab services as existing challenge customers migrate to field trials is anticipated to see the Group well positioned for future growth.
Delivering the strategy is an enhanced leadership team with a track record of operational success and creating shareholder value. The new management of hVIVO, who joined eighteen months ago, has a track record of successfully restructuring and re-positioning the business for profitability having delivered significant savings of £11m since 2017 at hVIVO. The Open Orphan management has a successful history of M&A, business integration and delivering shareholder value and have significantly rationalised the Venn business and taken action to improve profitability. The combined group has the relevant expertise to deliver substantial revenue growth and profitability.
Open Orphan is proposing a placing of £5m to support the enlarged Group’s business plan (the Placing”). The proceeds of the Placing will be used to fund the rapid growth and synergies programme of the business. An improved balance sheet is expected to allow hVIVO to convert its current strong pipeline of proposals. The Placing is being underwritten by Cathal Friel’s vehicle, Raglan Capital, up to £2.5m; Raglan Capital also intends to participate in the Placing.
It is expected that further announcements regarding the Placing will be made in due course.
Open Orphan intends shortly to exercise its rights pursuant to the provisions of sections 974-991 of the Companies Act 2006 to compulsorily acquire the remaining hVIVO Shares. The compulsory acquisition will be settled on the same terms as the Merger and the relevant hVIVO shareholders will be entitled to receive 2.47 Open Orphan shares for every one hVIVO share. Statutory notices are expected to be posted in the coming days to any hVivo shareholders who have not accepted the Merger offer with further details.
Open Orphan plc Tel: +353 1 644 0007
Cathal Friel, Executive Chairman
Trevor Phillips, Chief Executive Officer Tel: +44 (0)20 7347 5350
Arden Partners (Nominated Adviser and Joint Broker) Tel: +44 (0)20 7614 5900
John Llewellyn-Lloyd / Ruari McGirr / Benjamin Cryer
Davy (Euronext Growth Adviser and Joint Broker) Tel: +353 (0)1 679 6363
Anthony Farrell (Corporate Finance)
Camarco (Financial PR) Tel: +44 (0)20 3757 4980
Tom Huddart / Dan Sherwen
Notes to Editors on Open Orphan:
Open Orphan is a rapidly growing European full pharmaceutical services company with a focus on orphan drug and specialist services, comprising two commercial specialist CRO services businesses (Venn and hVIVO) and a developing early stage orphan drug genomics data platform business capturing 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 and hVIVO, as an industry leading services provider in viral challenge studies and laboratory services, supports product development for customers developing antivirals, vaccines and respiratory therapeutics. 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 is pleased to announce that at the Company’s General Meeting held earlier today in relation to the Company’s proposed merger with hVIVO plc and the Proposed Placing, all of the Resolutions put to the meeting were duly passed.
The Board is excited by the growth potential of the Enlarged Group following completion of the merger and looks forward to updating Shareholders on the Company’s progress going forward.
The Offer remains subject to fulfilment of all other conditions set out in Part III of the Offer Document, and has not yet been declared unconditional in all respects.
As described in the Company’s admission document dated 9 December 2019 (“Admission Document”), Dr Trevor Phillips will be appointed as Chief Executive Director of the Company with effect from completion of the Acquisition and Michael Meade and Dr Mark Warne will be appointed as Non-Executive Directors of the Company with effect from the same time.
Additionally, David Kelly, Michael Ryan, Maurice Treacy and Christian Milla will resign as directors of the Company with effect from completion of the Acquisition. Maurice Treacy and Christian Milla will remain employees of the Company.
Admission of the Enlarged Share Capital
Application will be made for the admission of the Consideration Shares and the Existing Ordinary Shares to trading on AIM and Euronext Growth, which is expected to become effective and dealings commence at 8.00 a.m. on 20 January 2020.
The Company anticipates that admission of the Placing Shares will follow the admission of the Consideration Shares and the Existing Ordinary Shares and the Company will update shareholders in due course.
Unless otherwise defined, capitalised terms used in this announcement are as defined in the Admission Document.
Open Orphan plc
Cathal Friel, Chief Executive Officer
+353 (0)1 644 0007
Arden Partners plc (Nominated Adviser and Joint Broker)
John Llewellyn-Lloyd / Ben Cryer
+44 (0)20 7614 5900
JE Davy (Euronext Adviser and Joint Broker)
+353 (0)1 679 6363