TLR6

New US $3.13 million DOD contract extension to fund inclusion of younger adults in the ongoing Phase Ib study of INNA-051 nasal dry powder formulation and drug product optimization activities MELBOURNE, Australia, Sept. 05, 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, has been awarded an additional US $3.18 million contract from the U.S. Department of Defense (DOD). The new funding extends the US $8.18 million already committed by the DOD to support the development of INNA-051. It will be used to expand ENA’s Phase Ib study of its dry powder formulation of INNA-051 to younger adults and support product optimization ahead of Phase IIb initiation. The IND opening Phase Ib study in adults over the age of 60 was initiated in Q2 2024. A DOD-funded protocol amendment will support inclusion of individuals aged 18-45 with the aim of informing dose selection for subsequent trials. Results from the study are expected in the Q4 2024. ENA Respiratory’s CEO, Christophe Demaison, PhD said: “This new funding from the DOD is further recognition of the potential of INNA-051 to play a significant role in protecting individuals at risk of serious harm from respiratory viral infections, including those with occupational risk. We are grateful to the DOD’s Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense for its continued support.” The contract was awarded by the DOD’s Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND), Joint Project Manager for Chemical, Biological, Radiological, and Nuclear Medical (JPM CBRN Medical), in collaboration with the Defense Innovation Unit (DIU). Reference to the DOD, JPEO-CBRND, or other agency of the United States does not constitute or imply an endorsement or recommendation by the U.S. government or any agency thereof. 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 virus clearance and stimulation of antiviral host defences, including IFN Type I & III responses, in a Phase IIa proof-of-principle study using a human 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 US COPD Foundation to support the clinical development of INNA-051 in COPD and has been awarded a US$11.3 million contract from the U.S. Department of Defence. It is a member of BLUE KNIGHT™, a joint initiative between Johnson & Johnson Innovation and BARDA designed to accelerate novel potential solutions for future pandemics. For more information, please visit https://enarespiratory.comFollow us on LinkedIn: https://www.linkedin.com/company/enarespiratory-pty-ltd/ For further information please contact:Media – AustraliaKirrily Davis, E: kdavis@bcpvc.com M: +61 (0)401 220228Media – InternationalCharles ConsultantsSue Charles, E: sue.charles@charles-consultants.com M: +44 (0)7968 726585Chris Gardner, E: Chris@CGComms.onmicrosoft.com M: +44 (0)7956 031077

Advances a new formulation with improved stability in the clinicSingle ascending dose phase successfully completed, multiple ascending dose phase underway MELBOURNE, Australia, Aug. 27, 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 advanced its Phase Ib study of its dry powder formulation of INNA-051 to enable clinical progression of an improved drug product with an anticipated shelf life of over two years at room temperature. The study is designed to test the safety, tolerability, pharmacodynamics, and pharmacokinetics of INNA-051 administered intra-nasally as a new dry powder formulation to individuals aged 60 and over. The study is to recruit up to 40 participants and is being conducted at Scientia Clinical Research facility in Sydney, Australia. The first two cohorts have successfully been dosed with single ascending doses with safety in line with expectations for INNA-51’s mode of action and the multiple ascending dose phase of weekly dosing is underway. Results are expected in Q4 of this year. ENA Respiratory’s CEO, Christophe Demaison, PhD, said: “Despite advances in vaccines and antiviral treatments, serious viral respiratory infections remain a major cause of hospitalisation and mortality for older adults with comorbiditiesi, a population of over 34 million people in the US alone. INNA-051 is designed to boost the body’s innate immune response – the natural first line of defence – directly at the site of infection and prevent complications relating to viral infections whether caused by a common respiratory virus or an emerging new strain. This Phase Ib is a further important step in our clinical development plan as we aim to bring this potentially impactful new approach to patients at risk of significant harm from respiratory viral infections.” 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. Having demonstrated accelerated viral clearance and local stimulation of antiviral host defences 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 which extends product shelf life to more than 24 months at room temperature with no requirement for cold-chain storage and distribution. ENA is preparing for an international Phase IIb study to assess the safety and potential efficacy of INNA-051 in decreasing the duration and severity of illness related to community-acquired respiratory viral infections in older adults in assisted living facilities at risk due to comorbidities including COPD, asthma cardiovascular disease and diabetes. 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 Follow us on LinkedIn: https://www.linkedin.com/company/enarespiratory-pty-ltd/ For further information please contact:Media – AustraliaKirrily Davis, E: kdavis@bcpvc.com M: +61 (0)401 220228 Media – InternationalCharles ConsultantsSue Charles, E: sue.charles@charles-consultants.com M: +44 (0)7968 726585Chris Gardner, E: Chris@CGComms.onmicrosoft.com M: +44 (0)7956 031077 ____________________ i https://archive.cdc.gov/#/details?url=https://www.cdc.gov/ncird/surveillance/respiratory-illnesses/index.html

The ongoing study, conducted at the Scientia Clinical Research facility in Sydney, Australia, is focused on evaluating the safety, tolerability, pharmacodynamics, and pharmacokinetics of INNA-051 when administered intranasally. The study plans to recruit up to 40 participants, with the goal of providing robust data that will inform further clinical development. The first two cohorts have successfully received single ascending doses, with safety results aligning with expectations based on INNA-051's mode of action. With the successful completion of these initial phases, the study has now progressed to the multiple ascending dose phase, involving weekly dosing. The results from this phase are eagerly anticipated in Q4 of this year. Christophe Demaison, CEO of ENA Respiratory, emphasized the importance of this research in addressing a critical unmet need. “Despite significant advancements in vaccines and antiviral treatments, serious viral respiratory infections continue to be a leading cause of hospitalization and mortality among older adults, particularly those with comorbidities. INNA-051 is designed to enhance the body's innate immune response—the natural first line of defense—directly at the site of infection. Our goal is to prevent complications related to viral infections, whether caused by a common respiratory virus or a new emerging strain.” INNA-051 is a virus-agnostic intranasal antiviral host defense immunomodulator and is a potent first-in-class agonist of toll-like receptor 2/6 (TLR2/6). This receptor plays a key role in recognizing pathogens and triggering the innate immune response. In a phase 2a proof-of-principle study using a liquid formulation in an influenza-challenge model, INNA-051 demonstrated accelerated viral clearance and stimulated local antiviral host defenses. The new dry powder formulation now being tested extends the product’s shelf life to over 24 months at room temperature, eliminating the need for cold-chain storage and distribution, which is particularly advantageous for global deployment. googletag.cmd.push(function () { googletag.display('text-ad1'); }); Looking ahead, ENA Respiratory is preparing for an international phase 2b study to evaluate the safety and potential efficacy of INNA-051 in reducing the duration and severity of illness associated with community-acquired respiratory viral infections. This study will focus on older adults in assisted living facilities, a group particularly at risk due to comorbidities such as COPD, asthma, cardiovascular disease, and diabetes. With a safe profile that supports prophylactic use, INNA-051 is positioned to become a crucial tool in the prevention of respiratory complications in at-risk populations. ENA Respiratory’s continued progress highlights the potential of INNA-051 to transform the management of respiratory viral infections, providing a much-needed solution for vulnerable populations worldwide.