ENA Respiratory Receives USPTO Notice of Allowance for Key Patent Covering INNA-051, a First-in-Class Antiviral Innate Immunomodulator

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MELBOURNE, Australia, May 08, 2024 (GLOBE NEWSWIRE) -- 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.

澳大利亚墨尔本，2024年5月8日（环球通讯社）--ENA Respiratory是一家临床阶段制药公司，开发先天免疫调节剂，用于预防高危人群呼吸道病毒感染相关并发症，今天宣布已收到美国的津贴通知。

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..

专利和商标局（USPTO）的专利申请US 18/112091，标题为“新型分子”，涵盖其主要程序INNA-051及其组成的权利要求。。

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.

INNA-051是一种病毒不可知的鼻内抗病毒宿主防御免疫调节剂，是toll样受体2/6（TLR2/6）的有效一流激动剂，在识别病原体和触发先天免疫反应中起关键作用。

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.

美国专利商标局的这一津贴进一步加强了ENA呼吸公司与INNA-051相关的强大知识产权组合，在美国、欧洲、英国、日本和中国等主要市场拥有30项授权专利和允许的应用。该组合涵盖了七个不同的专利系列，其权利要求针对INNA-051的物质组成以及各种备用分子，配方和使用方法保护，作为全面生命周期管理战略的一部分。

ENA Respiratory has an additional 39 pending applications in various jurisdictions..

ENA呼吸系统在各个司法管辖区还有39个待决申请。。

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.”.

ENA呼吸公司首席执行官克里斯托弗·德梅森博士说：“我们的知识产权组合为INNA-051提供了强大而持久的保护，至少在2042年之前，并且可能在该日期后的五年内具有排他性。这使我们对我们的先天免疫调节剂的未来全球商业价值充满信心，因为我们将继续推动临床开发。”。

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.

在流感攻击模型中使用液体制剂进行的IIa期原理验证研究中，ENA呼吸系统已经证明了INNA-051的病毒清除加速和抗病毒宿主防御的局部刺激，ENA呼吸系统开发了一种改进的干粉制剂，用于进一步的临床开发。

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..

该制剂最近获得FDA IND批准，该公司已提交澳大利亚1b期研究的伦理批准。这项研究预计将于2024年年中开始，旨在评估INNA-051干粉制剂在老年人中的安全性，耐受性，药效学和药代动力学。。

About ENA Respiratory

关于ENA呼吸

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..

ENA Respiratory是一家临床阶段制药公司，通过开发宿主防御免疫调节剂来应对严重的呼吸道病毒感染，该调节剂可局部引发并增强身体的先天免疫反应，这是天然的第一道防线。免疫调节剂对病毒不可知，通常与病毒特异性疫苗和现有的直接作用抗病毒药物互补。。

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.

该公司的主导产品INNA-051是toll样受体2/6（TLR2/6）的有效激动剂，在识别病原体和触发先天免疫反应方面起着关键作用。在使用流感攻击模型的IIa期原理验证研究中，它以支持预防使用的安全概况证明了加速病毒清除和刺激抗病毒宿主防御，包括IFN I型和III型应答。

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.

INNA-051是一种方便的，每周一次的鼻用干粉产品，用于预防高危人群（包括老年人，有潜在疾病（包括慢性肺部疾病，糖尿病，肾脏疾病和心血管疾病）和有职业风险的个体（例如。

first responders, military or essential services personnel)..

急救人员、军事或基本服务人员）。。

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.

该公司总部位于澳大利亚墨尔本，已从Brandon Capital、Minderoo Foundation和Uniseed筹集到2600万美元（4400万澳元）的股权融资。它与COPD基金会合作，支持INNA-051在COPD中的临床开发，并已获得美国818万美元的合同。

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..

国防部。它是成员BLUE KNIGHT™，是强生创新和BARDA的联合倡议，旨在加速未来流行病的下一代潜在解决方案。。

For more information, please visit https://enarespiratory.com

有关更多信息，请访问https://enarespiratory.com

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Media – Australia

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Kirrily Davis, E: kdavis@bcpvc.com M: +61 (0)401 220228

Kirly Davis，E：kdavis@bcpvc.comM： +61（0）401 220228

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