ENA Respiratory Receives USPTO Notice of Allowance for Key Patent Covering First-in-Class Antiviral Innate Immunomodulator

ENA Respiratory recently announced it has received a Notice of Allowance from the US Patent and Trademark Office (USPTO) for patent application US 18/112091 titled “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 2a 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.

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 2a 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 (eg, first responders, military or essential services personnel).

Headquartered in Melbourne, Australia, the company has raised  $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, visit https://enarespiratory.com