ENA Respiratory, a biotechnology company developing a first-in-class nasal spray for the prevention of COVID-19 and other respiratory viral infections, announced today that it secured up to AU$32m investment and appointed Ruth Tal-Singer, Ph.D., to its Board of Directors. The new financing will advance INNA-051, ENA Respiratory’s lead clinical candidate being developed to activate innate immunity in the nose, the primary site of most respiratory virus infections including COVID-19. The company is poised to initiate its Phase I human safety study of INNA-051 in Australia in the coming weeks. The milestone-based financing round was jointly led by Australian life science investors Brandon Capital Partners and Minderoo Foundation, with coinvestment from Uniseed.
“The COVID-19 pandemic continues to be a major health crisis worldwide. Alongside vaccines, there is a need for complementary approaches to help protect the most vulnerable people and also provide protection against emerging variants,” said Christophe Demaison, Ph.D., co-founder and CEO of ENA Respiratory. “INNA-051 is seeking to address this need. The financing announced today from the Minderoo Foundation and existing investors will expedite development of INNA-051 with the aim to demonstrate efficacy against COVID-19 in the clinic.”
Unlike other potential prophylactic approaches to COVID, INNA-051 directly stimulates the host’s innate immune defence that plays a key role in clearing viruses and other pathogens. A goldstandard animal study performed by Public Health England (PHE) and published in the peer-reviewed journal EBioMedicine1 demonstrated that ENA’s nasal spray reduces COVID-19 viral replication by up to 96 percent. If humans respond in a similar way, the spray could be used to protect people very quickly from infection and lower community transmission. Based on its mechanism of action and non-clinical studies demonstrating efficacy against multiple, non-related respiratory viruses, INNA051 has the potential to prevent existing and emerging respiratory viral infections, such as COVID-19 and its variants.
“We recognize that in addition to vaccines, the world needs safe, convenient, broad-spectrum antiviral therapies to win the fight against COVID-19,” says Chris Smith, Ph.D., Chairman of ENA Respiratory. “INNA-051 could be incredibly helpful in protecting at-risk populations such as health workers, the elderly and immunocompromised patients against existing and emerging variants.
Because INNA-051 is not virus-specific, it could also play a key role beyond fighting the COVID-19 pandemic, in combating seasonal flu or any future respiratory viral outbreaks.”
The company also announced the appointment of Ruth Tal-Singer, Ph.D., to its Board of Directors. U.S.-based Dr. Tal-Singer is internationally recognized as an innovative, patient-focused, and highly analytical health care leader and clinical scientist with extensive research and development experience. Her wide-ranging technical and scientific knowledge comprises molecular biology, immunology, application of digital technology and experimental medicine trials. She has a proven history of successfully leading international public and private partnerships through critical advancements and progressing clinical trials and large observational cohorts. She currently serves as President and Chief Scientific Officer of the nonprofit COPD Foundation, where she leads the organization’s mission to accelerate the development and adoption of novel treatments that improve the lives of individuals with COPD, bronchiectasis and nontuberculous mycobacterial (NTM) lung disease. Previously, she held several senior roles at GSK Pharmaceuticals, including Vice President of Medical Innovation, Vice President in Respiratory R&D, and Medicine Development Leader. She was elected as GSK Senior Fellow for advancing innovation and mentoring early-career scientists.
“Dr Tal-Singer brings nearly 25 years of experience leading the research and development of respiratory therapies, from therapeutic target identification to phases I-IV research and regulatory approvals, as well as collaborations with academic and industry partners,” Dr Demaison said. “Her significant expertise in research, patient and community support, public education and advocacy will help guide us as we accelerate the development of INNA-051 to address the COVID-19 pandemic and other significant respiratory illnesses.”
Dr Tal-Singer received her critical care nursing certification from Tel Aviv University and her Ph.D. in molecular biology and microbiology from the University of Pennsylvania. Earlier in her career, she served as an officer in the Israeli Defense Forces Medical Corps and was assistant head nurse of the pediatric critical care unit at Sheba Medical Center in Israel.
“The COVID-19 pandemic showed the significant need for new therapies to prevent and treat respiratory viruses that impact millions around the globe each year,” Dr Tal-Singer said. “ENA Respiratory’s novel therapy stimulates innate immunity to target viruses in the nose. It has the potential to impact the way we treat and prevent not just COVID-19 but influenza, the common cold, and other respiratory illnesses. I’m thrilled to join the Board as the company launches its next stage of clinical research.”
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About ENA Respiratory and INNA-051
ENA Respiratory is aiming to transform the treatment and prevention of respiratory viral infections in at-risk populations. The company is based in Melbourne and Sydney, Australia. INNA-051 is a potent innate immune agonist that targets the receptor TLR2/6. As most respiratory viruses, including SARS-CoV-2 and influenza, initially infect and replicate in nasal mucosal epithelial cells and that TLR2 is expressed on the surface of these cells, INNA-051 is being developed for intranasal delivery to target the primary entry site of viral respiratory infections. Topical nasal administration of INNA-051 and close analogues have been shown in pre-clinical studies to protect treated animals from SARS-CoV-2 (causative agent of COVID-19), influenza virus (flu) and rhinovirus (common cold) infections. Key features of INNA-051 intranasal administration include limited minimal or no systemic bioavailability, minimal or no systemic pro-inflammatory cytokine release, no direct type I interferon upregulation, durable immune response supporting twice-weekly administration and compatibility with vaccine and intranasal corticosteroids.
For more information, please visit https://enarespiratory.com
About Brandon Capital Partners
Brandon Capital Partners is Australasia’s leading life science venture capital investor. As manager of the Medical Research Commercialisation Fund (MRCF), Brandon Capital works with scientists, clinicians and entrepreneurs from company formation and seed investment through to expansion capital, supporting life science companies from proof-of-concept through to commercialisation. The MRCF is a unique collaboration between major Australian pension funds, the Australian and New Zealand governments, Australian state governments and more than 50 leading medical research institutes and research hospitals. The MRCF supports the development and commercialisation of early-stage biomedical discoveries associated with member organisations, providing both capital and expertise to guide the successful development of new therapies. The MRCF has supported more than 46 start-up companies to date, most of which were founded by the MRCF. Brandon Capital currently has more than A$800 million under management and offices in Melbourne, Sydney and Palo Alto.
For more information about Brandon Capital Partners and the MRCF, visit www.brandoncapital.com.au and biocatalyst.mrcfplatform.com
About the Minderoo Foundation
Established by Andrew and Nicola Forrest in 2001, Minderoo Foundation is a modern philanthropic organisation seeking to break down barriers, innovate and drive positive, lasting change. Minderoo Foundation is proudly Australian, with more than AUD $2 billion committed to 10 key initiatives spanning from ocean research and ending slavery, to collaboration against cancer and building community projects. At the height of the pandemic, Minderoo Foundation made available up to $320 million to assist Australia’s effort in fighting COVID-19, including the purchase of millions of items of PPE equipment and quadrupling Australia’s daily testing capacity. Minderoo Foundation is a founding partner of the International COVID-19 Data Research Alliance.
For more information, please visit https://www.minderoo.org
Uniseed is Australia’s longest running early-stage commercialisation fund that makes investments in research emanating from five of Australia’s leading research organisations – The University of Queensland, The University of Sydney, The University of New South Wales, The University of Melbourne and the CSIRO. Uniseed is a mutual fund, owned by research organisations, for research organisations. The fund facilitates the commercialisation of its research partners’ most promising intellectual property and secures targeted investment in resulting products and technologies. Uniseed has supported 59 start-up companies to date, being the seed investor in most of these.
For more information, visit: www.uniseed.com
1. Proud PC, Tsitoura D, Watson RJ et al. Prophylactic intranasal administration of a TLR2/6 agonist reduces upper respiratory tract viral shedding in a SARS-CoV-2 challenge ferret model. EBioMedicine. 2021 Jan;63:103153. doi: 10.1016/j.ebiom.2020.103153. Epub 2020 Dec 3.