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OmniSpirant is excited to announce the appointment of Andy Fisher to its board of directors. For nearly 20 years, Andy held leadership positions at United Therapeutics Corporation, a global biotechnology company focused on chronic and life-threatening conditions in areas of unmet medical need. Most recently, he was Chief Strategy Officer and Deputy General Counsel. A lawyer by background, Andy was previously a partner at Mahon Patusky Rothblatt & Fisher.  Andy brings a wealth of experience to lead OmniSpirant in the US and help the company realize the full potential of its transformative technology.

About OmniSpirant Limited – OmniSpirant is an Irish based global biotech founded in 2016 to develop first-in-class inhaled regenerative gene therapies. OmniSpirant’s transformational RNA delivery platform technology,  OmniSomes, utilizes stem cell extracellular vesicles (exosomes) to deliver novel regenerative gene therapy. The company has identified a pipeline of respiratory and oncology target indications, each of which has highly disruptive potential to address multibillion dollar markets. OmniSpirant is currently raising a €45M Series A round of financing to clinically translate this exciting technology.

Contact: Gerry McCauley MPharm, CEO, OmniSpirant Limited, gmccauley@omnispirant.com

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PRESS RELEASE
We are excited to progress the development of OS001 for CF in collaboration with Prof Lorraine Martin and Dr Lisa Douglas in Queen’s University Belfast. Funding support from Emily’s Entourage in the USA and The CF Trust in the UK is matched by their scientific expertise which will help to shape further exciting product development. Link to full press release:

https://www.einpresswire.com/article/617192171/emily-s-entourage-grants-220k-to-queen-s-university-belfast-to-advance-omnispirant-s-gene-therapy-for-cystic-fibrosis

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OmniSpirant Limited are delighted and honoured to announce the launch of INSPIRE, a €12.8 million lung cancer project funded by Horizon Europe. In one of the largest ever grants for preclinical research in lung cancer, OmniSpirant in collaboration with our European partners spanning across biotechnology, medical devices, cancer research, academia and patient advocacy, are already actively working on the project deliverables, and recently met in Galway, Ireland for the official kick-off meeting (see the picture below taken on the 28th of October 2022 at OmniSpirant’s R&D facility in Kilcolgan, Galway).

OmniSpirant has put together a team of expert collaborators in developing and refining a clear and high impact program of work. Participating partners include Aerogen Ltd. (Ireland), Trinity College Dublin (Ireland), RemedyBio (Ireland), Myriad Associates (Ireland), EVerZom (France), Biopharma Excellence (Pharmalex) (Germany), Deutsches Krebsforschungszentrum (DKFZ) (Germany) and Lung Cancer Europe (Switzerland). Over the next 3 years of the project, this world-class consortium will progress the development of a regenerative gene therapy as a transformative new treatment for lung cancer. The INSPIRE project aims to make an important and tangible impact on Europe’s Beating Cancer Plan and the EU Mission on Cancer.

Lung cancer (#lungcancer) presents a significant health policy challenge with over 470,000 cases reported annually in Europe, accounting for 11% of all cancers. Cancer costs European countries €124 billion every year, with lung cancer incurring the largest total cost, amounting to €19 billion, mostly due to losses relating to premature death. The state-of-the-art approved treatments, such as targeted therapy and immune checkpoint inhibitors are prone to treatment resistance. The overall 5-year survival rates for people with lung cancer remain extremely poor in comparison to other common cancers, highlighting the desperate need for innovative lung cancer treatments.

OmniSpirant, as leaders and coordinators of the INSPIRE project along with consortium partners, will work to drive significant progress of the development of a novel, effective and affordable gene therapy treatment, which will improve drug access and better outcomes for people with lung cancer. This project will help in placing Europe as a leader in the fight against lung cancer and in the development of treatments for other debilitating lung diseases.

OmniSpirant is an Irish biotech founded in 2016 to develop first-in-class inhaled regenerative gene therapies. OmniSpirant received EU funding in 2018 via the Horizon 2020 SME Instrument to develop advanced therapies for the treatment of cystic fibrosis. OmniSpirant also received the EU seal of excellence in 2020. The company’s new gene therapies are based on its proprietary OmniSome™ platform technology, which utilises tiny particles, known as extracellular vesicles (EVs), secreted by stem cells carrying gene therapy cargoes. The OmniSome™ platform of products are currently being developed as first-in-class inhaled regenerative gene therapies for cystic fibrosis, and now targeting lung cancer via the INSPIRE project. The company also has plans to use this platform to develop treatments for other lung diseases including alpha-1 antitrypsin deficiency (AATD), acute respiratory distress syndrome (ARDS) and idiopathic pulmonary fibrosis (IPF).

“We are delighted to collaborate with our pan-European partners in developing this exciting new approach” said OmniSpirant CEO Gerry McCauley. “We are at the forefront of harnessing extracellular vesicles to deliver RNA based therapeutics in the fight against lung cancer and in developing our platform to address a host of chronic pulmonary conditions, which today have suboptimal treatment.”

The INSPIRE project consists of expert partners from across the EU:

Aerogen Ltd. – the world leader in high-performance aerosol drug delivery in the acute and critical care sector. Their award-winning vibrating mesh technology, which is the heart of their Aerogen Solo, has been used in the treatment of more than 16million patients in more than 75 countries.

Trinity College Dublin – Trinity Translational Medicine Institute (https://www.tcd.ie/ttmi/) at St James’s Hospital (https://www.stjames.ie/research/) translating novel discoveries from bench to bedside.

RemedyBio – an Irish biotechnology company inspired by functional biology for the discovery and development of new immune therapies using the power of its Nanoreactor Technology for the analysis of individual cells and cell interactions.

Myriad Associates – Specialists in Horizon Europe and national funding project coordination, R&D Tax Credits and Grant Funding. Offices in UK, Ireland and France .

EVerZom – a French SME with a patented large-scale EV production process.

DKFZ – Deutsches Krebsforschungszentrum – the largest biomedical research institute in Germany investigating the biological mechanisms of cancer to develop novel approaches to cancer treatment.

Biopharma Excellence (Pharmalex) – world leaders in regulatory consulting for biopharmaceutical products.

Lung Cancer Europe – a European non-profit umbrella organisation, with the vision that Europeans impacted by lung cancer will have equity in access to optimal care so that they have the best possible outcomes and quality of life.

INSPIRE is fully funded (grant number 101057777) under the funding call HORIZON-HLTH-2021-TOOL-06 by The Horizon Europe Funding programme that promotes the collaboration of EU-based SME and academic partners in addressing major societal challenges.

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StartUs insights analysis of the global respiratory drug development landscape highlights OmniSpirant’s inhaled regenerative gene therapy platform:

Omnispirant explores Inhaled Gene Therapy

In the last decade, advances in gene sequencing and gene editing have made gene therapy more feasible than ever before. For the treatment of respiratory diseases, gene therapy offers a way to correct deleterious mutations or reverse disease-causing states. Inhaled gene therapy takes a direct route to deliver deoxyribonucleic acid (DNA) to the airways and lungs. Pharma startups are working on solutions to enhance the delivery of therapeutic cargo through this method.

Irish startup Omnispirant works on inhaled gene therapy to treat respiratory disorders. The startup’s platform technology uses inhaled engineered stem cell exosomes that enable efficient intracellular delivery of therapeutic cargo. The exosomes penetrate the mucus, have low immunogenicity, and are non-genotoxic. Omnispirant is specifically leveraging its platform to develop an inhaled gene therapy for the treatment of CF.”

The full article and report can be accessed here:

https://www.startus-insights.com/innovators-guide/5-top-startups-developing-drugs-respiratory-diseases

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Pictured from left to right: Dr Janusz Krawczyk, Dr Róisín Dwyer, Prof John Laffey, Dr Ronan MacLoughlin, Gerry McCauley, Dr Daniel O’Toole and Dr Katie Gilligan

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NUI Galway, OmniSpirant Limited and Aerogen Limited have been awarded major funding to develop a new aerosol treatment that will transform respiratory medicine, with potential benefits across acute and chronic lung diseases, including COVID-19

An Irish consortium led by OmniSpirant Limited, a start-up biotechnology therapeutics company, Aerogen Limited and the National University of Ireland Galway have been awarded €11.6 million of funding under the Disruptive Technologies Innovation Fund (DTIF).

The funding will be used to develop a new exosome based inhaled treatment for Acute Respiratory Distress Syndrome (ARDS) which is responsible for the vast majority of COVID-19 deaths. Research from the JAMA Internal Medicine suggests that more than 40% of individuals in the study hospitalised for severe and critical COVID-19 developed ARDS, and over 50% of those diagnosed died from the disease.

This cutting edge treatment also has the potential to treat Chronic Obstructive Pulmonary Disease (COPD). COPD is a disease that affects hundreds of millions of patients worldwide, it is the third leading cause of death globally and is currently lacking any effective treatments. The Global Burden of Disease Study reports a prevalence of 251 million cases of COPD globally in 2016. Globally, it is estimated that 3.17 million deaths were caused by the disease in 2015, 5% of all deaths globally in that year.

The three-year grant funded programme aims to complete Phase 1 clinical trial studies in ARDS patients and to complete the preclinical development needed to support clinical studies in COPD patients.

Professor John Laffey, Professor of Intensive Care Medicine at NUI Galway and Consultant in Intensive Care Medicine, Galway University Hospitals, said: “Current pharmacologic therapies are of marginal benefit for COVID-19 patients suffering with ARDS, and advanced support of respiratory function in Intensive Care Units remains the main therapeutic approach. Aerosolized delivery of engineered cell products that can target the inflammatory response to COVID-19 could prevent or even reverse severe COVID-19 induced respiratory injury, which would be game-changing in reducing mortality from this devastating infection. It also shows very promising anti-infection benefits, which in addition to having knock-on benefits for COPD patients, could also be applied to other aggressive lung conditions such as Cystic Fibrosis patients.”

OmniSpirant will provide the technological expertise to produce exosomes from genetically modified stem cells. OmniSpirant have also developed a method to enhance the delivery of these exosomes into lung tissues. These exosomes will then be delivered by an inhaled aerosol to recode diseased lung cells in patients, using Aerogen’s expertise and best in class technology in this area. The Centre for Cell Manufacturing at NUI Galway will industrialise the scalable manufacturing process for this new treatment.

Gerry McCauley MPharm, MPSI, CEO OmniSpirant Limited, said: “We have entered the age of advanced therapeutics, where cell based and gene therapies have curative potential for complex diseases. Our proprietary technologies unlock huge potential to effectively deliver novel treatments into the lung to address many serious lung diseases. Specifically, the DTIF funding is aimed at developing OS002, an innovative treatment which could address two major global pandemics. The death rate for ARDS shows that it has a mortality rate of 30-40% of those diagnosed with the disease. This currently lacks effective treatments and due to COVID-19 is causing a devastating global death toll. Even in a world without COVID-19 ARDS affects an estimated three million people every year. Secondly, OS002 could also prove transformational for chronic lung diseases, particularly the 100’s of millions of COPD patients globally who are currently suffering with no access to effective treatment options.”

Aerogen Ireland was founded in 1997 and are world leaders in the field of aerosol delivery devices. Drug delivery of cell therapies by aerosol of this nature has traditionally been complex and Aerogen are partnering on this new and novel treatment to provide the expertise and the technology which will be used to develop devices to deliver the exosome treatments by aerosol.

Dr Ronan MacLoughlin, Head of Respiratory Science at Aerogen Limited, said: “Aerogen are delighted to be involved in this potentially transformative project that leans on a unique combination of disruptive technologies. Over 12 million patients have benefited from Aerogen technology to date and we look forward to bringing to bear Aerogen’s unique expertise in this field and working with OmniSpirant and the Centre for Cell Manufacturing Ireland at NUI Galway over the coming years in bringing this technology to patients worldwide.”

The Centre for Cell Manufacturing Ireland (CCMI) at NUI Galway is the first and only approved cell manufacturing facility in Ireland. This purpose built fully-licensed centre is designed to manufacture Advanced Therapeutic Medicinal Products, such as stem cells, for use in human clinical trials.

Dr. Janusz Krawczyk, Clinical Director of the Centre for Cell Manufacturing Ireland (CCMI), NUI Galway, said: “In collaborating with OmniSpirant and Aerogen, the CCMI will apply our unique expertise to develop the manufacturing process of exosome-based therapy. The Centre is ideally placed, with experience and expertise in bringing treatments such as this from bench to pre-clinical stage to early clinical trials. I am delighted to see the CCMI involved in a second DTIF project which ensures that this unique resource in Ireland fulfils its translational potential in stem cell therapy and regenerative medicine. The programme is also aligned with NUI Galway’s ambition to partner with national and multinational industry to ensure that research discoveries have a beneficial impact on patient care. This partnership will confirm the University’s leadership in world-class research and positions Ireland as a strategic global leader in the development of new regenerative medicine technology.”

Dr Imelda Lambkin, Enterprise Ireland, said: “The Disruptive Technologies Innovation Fund administered by Enterprise Ireland is a big opportunity for both large companies and SMEs to collaborate with research bodies to produce technologies that have the potential to really change a market or sector. Indeed, the funding awarded to OmniSpirant Limited, Aerogen Limited and NUI Galway to develop a new treatment for Covid-19 will potentially save lives. The third call for the Disruptive Technologies Innovation Fund will open later this month and we strongly encourage companies and researchers with a disruptive idea or technology to apply.”

The Disruptive Technologies Innovation Fund is a €500 million Project Ireland 2040 fund confirmed under the National Development Plan in 2018.

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