TIDMORPH
RNS Number : 5166F
Open Orphan PLC
10 March 2020
Open Orphan plc
("Open Orphan" or the "Company")
Positive results from Phase IIb field study of FLU-v vaccine
(FLU-v 003), which has been developed by Imutex Limited, hVIVO's
49% joint venture with the SEEK Group. FLU-v is a first-in-class
'universal', broad spectrum, standalone, influenza vaccine
candidate and the results have now been published in a peer review
journal
-- The publication in the Annals of Internal Medicine journal
concluded adjuvanted FLU-v is immunogenic and merits Phase III
development to explore efficacy
-- Compelling data package from two Phase II studies shows that
a single dose of adjuvanted FLU-v induces cellular and antibody
responses (FLU-v 003) and that it has a clinical impact in reducing
disease, symptom and viral load (FLU-v 004)
-- Imutex currently scheduling meetings with key regulatory
authorities, FDA and EMEA, hoping to gain confirmation of the
remaining development pathway to approval for FLU-v
10 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 field study of FLU-v 003 (Study
003, NCT02962908) in the Annals of Internal Medicine journal . The
headline results from this study were previously announced by hVIVO
on 18 June 2018. FLU-v is being developed by Imutex Limited,
hVIVO's 49% joint venture with the SEEK Group.
The Primary and secondary endpoints were achieved in a Phase IIb
study, done within the UNISEC* Consortium and funded by the
European Commission under the Seventh Framework Programme for
Research and Technological Development (FP7). 175 healthy adults
were randomly assigned to either an injection of adjuvanted (1
dose) or nonadjuvanted (2 doses) FLU-v or adjuvanted or
nonadjuvanted placebo to compare the safety, immune response, and
exploratory efficacy of different formulations and dosing regimens.
They found that a single dose of adjuvanted FLU-v elicited a
greater immune response compared with placebo. Adverse events were
mostly mild to moderate injection site reactions. The authors
conclude that a Phase III trial is warranted to explore
efficacy.
*Universal Influenza Vaccines Secured, European Union funded
consortium for the advancement of universal influenza vaccines.
Trevor Phillips, CEO of Open Orphan, said:
"FLU-v is a universal influenza vaccine that targets conserved
internal regions of the flu virus. There have been two positive
Phase II studies; FLU-v 003, testing immunogenicity and FLU-v004,
testing efficacy in a human challenge study. Both Phase II studies,
FLU-v 003 and FLU-v 004 are externally supported by UNISEC and
NIAID (National Institute of Allergy and Infectious Diseases, part
of the U.S. National Institutes of Health) respectively which gives
strong external endorsement from key EU and US organisations. The
full results from this positive Phase II immunogenicity study
underscores both our, and our partner SEEK's, confidence in the
potential of FLU-v as a universal flu vaccine.
The advantages of FLU-v over the seasonal flu vaccine are that
the composition of the FLU-v vaccine will remain the same year
after year and it is manufactured synthetically, enabling
year-round manufacturing and thus, increasing the number of doses
available worldwide. It will not be subject to a strict vaccination
window as is the case with seasonal flu vaccines. Also, being a
universal vaccine, it should provide protection against new strains
of flu virus which the seasonal flu vaccine is not able to do.
Imutex continues to explore options for the FLU-v vaccine
programme and is scheduling meetings with key regulatory
authorities, FDA and EMEA, hoping to gain further insight into
Phase III preparation, a key area of interest expressed by
potential partners."
Cathal Friel, Executive Chairman of Open Orphan, said:
"The market potential for a broad spectrum universal influenza
vaccine is significant and has become increasingly important and
valuable in recent weeks when governments around the world are
finally waking up and realising that universal flu vaccines need to
be commercialised and there must be a better way forward than
reliance on the traditional annual flu vaccination process which
has variable efficacy, offers little protection against emerging
strains and is available in limited quantities. A universal flu
vaccine can and should be targeted at the entire population base.
We now await publication of the positive results data from the
NIAID FLU-v study (004) in a peer reviewed journal while still
focusing on the Company's strategy of achieving profitability in
the near term and as we target the rapidly growing CRO
pharmaceutical services sector.
As previously announced to the market, the newly enlarged Open
Orphan group, of which hVIVO is a subsidiary of, is now very much
targeted upon delivering a profitable pharmaceutical services
business and will no longer be spending shareholders' funds on the
drug discovery processes. The additional investment or cost
associated with commercialising FLU-v, will come from out-licencing
the final stages including Phase III trials of FLU-v's study, to
major international pharmaceutical companies, in Europe, North
America, and very importantly also in China. But we are
increasingly excited about FLU-v potentially finally entering phase
III clinical trials and now is one of the most opportune times to
be doing that. "
Abstract: http://annals.org/aim/article/doi/10.7326/M19-0735
Immunogenicity, Safety, and Efficacy of a Standalone Universal
Influenza Vaccine, FLU-v, in Healthy Adults
A Randomized Clinical Trial
Background: FLU-v is a broad-spectrum influenza vaccine that
induces antibodies and cell-mediated immunity.
Objective: To compare the safety, immunogenicity, and
exploratory efficacy of different formulations and dosing regimens
of FLU-v versus placebo.
Design: Randomized, double-blind, placebo-controlled, single
center phase 2b clinical trial. ClinicalTrials.gov: NCT02962908;
EudraCT: 2015-001932-38
Setting: The Netherlands.
Participants: 175 healthy adults aged 18 to 60 years.
Intervention: 0.5-mL subcutaneous injection of 500 <MU>g
of adjuvanted (1 dose) or nonadjuvanted (2 doses) FLU-v (A-FLU-v or
NA-FLU-v) or adjuvanted or nonadjuvanted placebo (A-placebo or
NA-placebo) (2:2:1:1 ratio).
Measurements: Vaccine-specific cellular responses at days 0, 42,
and 180 were assessed via flow cytometry and enzyme linked
immunosorbent assay. Solicited information on adverse events (AEs)
was collected for 21 days after vaccination. Unsolicited
information on AEs was collected throughout the study.
Results: The AEs with the highest incidence were mild to
moderate injection site reactions. The difference between A-FLU-v
and A-placebo in the median fold increase in secreted
interferon--<GAMMA> (IFN-<GAMMA>) was 38.2-fold (95%
CI, 4.7- to 69.7-fold; P = 0.001) at day 42 and 25.0-fold (CI, 5.7-
to 50.9-fold; P < 0.001) at day 180. The differences between
A-FLU-v and A-placebo in median fold increase at day 42 were
4.5-fold (CI, 2.3- to 9.8-fold; P <0.001) for IFN-<GAMMA>
-producing CD4+ T cells, 4.9-fold (CI, 1.3- to 40.0-fold; P <
0.001) for tumour necrosis factor-<ALPHA>
(TNF-<ALPHA>), 7.0-fold (CI, 3.5- to 18.0-fold; P < 0.001)
for interleukin-2 (IL-2), and 1.7-fold (CI, 0.1- to 4.0-fold; P =
0.004) for CD107a. At day 180, differences were 2.1-fold (CI, 0.0-
to 6.0-fold; P = 0.030) for IFN-<GAMMA> and 5.7-fold (CI,
2.0- to 15.0-fold; P < 0.001) for IL-2, with no difference for
TNF-<ALPHA> or CD107a. No differences were seen between
NA-FLU-v and NA-placebo.
Limitation: The study was not powered to evaluate vaccine
efficacy against influenza infection.
Conclusion: Adjuvanted FLU-v is immunogenic and merits phase 3
development to explore efficacy.
Primary Funding Source: SEEK and the European Commission
Directorate-General for Research and Innovation, European Member
States within the UNISEC (Universal Influenza Vaccines Secured)
project.
Ann Intern Med. doi:10.7326/M19-0735
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 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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