Osivax Completes Enrollment for Phase 1 Trial with Broad-Spectrum Sarbecovirus Vaccine Candidate, OVX033
June 25 2024 - 5:00AM
Business Wire
- 48 healthy volunteers enrolled in first-in-human
trial
- Topline data read-out expected by Q4 2024
Osivax, a biopharmaceutical company developing vaccines to
provide broad-spectrum protection against highly mutating
respiratory viruses, today announced that it has completed
enrollment in its Phase 1 trial (NCT06128382) with OVX033, the
company’s broad-spectrum vaccine candidate against
sarbecoviruses.
The study is designed to evaluate the safety and immunogenicity
of OVX033 at three dose levels (100µg, 250µg and 500µg). To date,
no safety concerns or signals have been observed at any dose level,
justifying a dose escalation up to the maximum dose level of 500µg.
The single-center, randomized, double-blind, placebo-controlled
Phase 1 clinical study is being conducted at the Clinical
Investigation Center in Vaccinology Cochin Pasteur (CIC) in Cochin
Hospital in Paris (AP-HP, Inserm).
“Sarbecoviruses remain a threat as evidenced by the Covid-19
pandemic, which continues to have long-term consequences for global
health. By completing enrollment for our Phase 1 trial with OVX033,
we are taking a significant step forward in addressing the need for
a broad-spectrum vaccine to provide protection against these
rapidly mutating viruses,” said Dr. Nicola Groth, CMO of
Osivax.
“The data gathered from the Phase 1 trial with OVX033 will be
critical to its further development as an effective and safe
protective measure against various strains of sarbecoviruses. We
look forward to sharing the data readout later this year and thank
all volunteers participating in this study,” commented Prof.
Odile Launay, MD, PhD, Professor at Paris Cité University, the
Principal Investigator.
About OVX033
OVX033 is a first-in-class coronavirus vaccine candidate that
targets the nucleocapsid (N), a highly conserved internal antigen.
Unlike surface antigens such as Spike (S), N is much less likely to
mutate, providing a broader and more universal immune response,
with the objective of inducing broad-spectrum protection against
all current and future variants of SARS-CoV-2 as well as against
future pandemic coronavirus strains. Osivax’ oligoDOMTM technology
enables the design and production of a recombinant version of the
nucleocapsid which self-assembles into a nanoparticle, thus
triggering powerful T- and B-cell immune responses. OVX033 has
demonstrated a preclinical proof of concept for cross-protective
efficacy in hamster challenge model published in Frontiers in
Immunology. Further preclinical studies and a First-In-Human
clinical trial are ongoing.
This project is supported by the French government, through
France 2030, “Programme Investissements d’Avenir” operated by
Bpifrance as projects DOS0123291, DOS0152140 and DOS0152141.
About Osivax
Osivax is a clinical-stage biopharmaceutical company leveraging
its novel, self-assembling nanoparticle platform technology,
oligoDOMTM, to develop transformative, first-in-class
pan-respiratory virus vaccines generating superior T-cell responses
in addition to strong and sustained B-cell responses. The company
is establishing proof of concept with its broad-spectrum
“universal” influenza candidate, OVX836, which is currently in
Phase 2 clinical trials with over 1,200 volunteers tested and
encouraging efficacy proof of concept data. Osivax’ ambition is to
develop a pan-respiratory virus vaccine to prevent all strains of
influenza and all variants of Covid-19 in one single shot. The
company will expand into other infectious disease indications
through combinations and collaborations worldwide.
For further information: www.osivax.com
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Alexandre LE VERT, CEO contact@osivax.com +33 (0)9 70 30 13
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