ENA Respiratory Receives USPTO Notice of Allowance for Key Patent Covering INNA-051, a First-in-Class Antiviral Innate Immunomodulator
May 08 2024 - 4:00AM
ENA Respiratory, a clinical-stage pharmaceutical company developing
innate immune modulators for the prevention of complications
associated with respiratory viral infections in at-risk
populations, announces today that it has received a Notice of
Allowance from the U.S. Patent and Trademark Office (USPTO) for
patent application US 18/112091 entitled “Novel molecules” covering
claims for its lead program, INNA-051 and its composition.
A virus-agnostic intranasal antiviral host
defence immunomodulator, INNA-051 is a potent first-in-class
agonist of toll-like receptor 2/6 (TLR2/6) which plays a key role
in recognizing pathogens and triggering the innate immune
response.
This USPTO allowance further strengthens ENA
Respiratory’s strong IP portfolio related to INNA-051, with 30
granted patents and allowed applications in the major markets,
including the US, Europe, the United Kingdom, Japan and China. The
portfolio covers seven distinct patent families, with claims
directed to the composition of matter for INNA-051 and various
backup molecules, formulations and method of use protection, as
part of a comprehensive lifecycle management strategy. ENA
Respiratory has an additional 39 pending applications in various
jurisdictions.
ENA Respiratory’s CEO, Christophe
Demaison, PhD said: “Our IP portfolio provides robust and
long-lasting protection with potential exclusivity for INNA-051 out
to at least 2042 and likely for five years post that date. This
gives us great confidence in the future global commercial value of
our innate immune modulators as we continue to drive forwards in
clinical development.”
Having demonstrated accelerated viral clearance
and local stimulation of antiviral host defences for INNA-051 in a
Phase IIa proof-of-principle study using a liquid formulation in an
influenza-challenge model, ENA Respiratory has developed an
improved dry powder formulation to take into further clinical
development. This formulation recently received FDA IND clearance
and the Company has submitted ethics approval for a Phase 1b study
in Australia. This study is expected to be initiated in mid-2024
with the aim to assess the safety, tolerability, pharmacodynamics,
and pharmacokinetics of the dry powder formulation of INNA-051 in
older adults.
About ENA Respiratory
ENA Respiratory is a clinical-stage
pharmaceutical company tackling serious respiratory viral
infections through the development of host defence immune
modulators which locally prime and boost the body’s innate immune
response – the natural first line of defence. Being virus-agnostic,
immune modulators are complementary to often virus-specific
vaccines and existing direct-acting antivirals.
The company’s lead product, INNA-051, is a
potent agonist of toll-like receptor 2/6 (TLR2/6) which plays a key
role in recognising pathogens and triggering the innate immune
response. With a safe profile supporting prophylaxis use, it has
demonstrated accelerated viral clearance and stimulation of
antiviral host defences, including IFN Type I & III responses,
in a Phase IIa proof-of-principle study using an
influenza-challenge model. INNA-051 is being developed as a
convenient, once-a-week nasal dry powder product to prevent
complications associated with respiratory viral infections in
at-risk populations, including the elderly, those with an
underlying medical condition (including chronic lung conditions,
diabetes, kidney disease, and cardiovascular disease) and
individuals with occupational risk (e.g. first responders, military
or essential services personnel).
Headquartered in Melbourne, Australia, the
company has raised US$26M (AU$44million) in equity financing from
Brandon Capital, The Minderoo Foundation and Uniseed. It is
partnered with the COPD Foundation to support the clinical
development of INNA-051 in COPD and has been awarded a
US$8.18million contract from the U.S. Department of Defence. It is
a member BLUE KNIGHT™, a joint initiative between Johnson &
Johnson Innovation and BARDA designed to accelerate next-gen
potential solutions for future pandemics.
For more information, please visit
https://enarespiratory.com
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Media – Australia
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