Open Orphan PLC - Publication of positive results in journal
("Open Orphan" or the "Company")
Positive results from FLU-v vaccine challenge study (FLU-v 004), the second Phase IIb study of
FLU-v, which has been developed by
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
The primary endpoint was achieved in the Phase IIb challenge study conducted by hVIVO using the
"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."
"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
* 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)
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/
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
Registration: NCT03180801, EudraCT: 2016-002134-74
For further information please contact
Cathal Friel, Executive Chairman +353 (0)1 644 0007
Trevor Phillips, Chief Executive Officer +44 (0)20 7347 5350
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
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