TIDMORPH
Open Orphan PLC
16 March 2020
RNS REACH
Open Orphan plc
("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 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
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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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 (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.
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END
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