Author: Michael

• Neumifil is a novel broad-spectrum anti-viral product that was shown to be well-tolerated with no safety signals at all doses tested
• Pneumagen plans to conduct a Phase 2 Influenza challenge study in the second half of 2022 to demonstrate clinical proof of efficacy of Neumifil

St Andrews, UK – 12th May 2022 – Pneumagen, a clinical stage biotech company developing Neumifil, a broad-spectrum antiviral, intranasal drug for the prophylaxis and treatment of viral respiratory tract infections (RTIs), today reports positive topline data from a Phase 1 study with Neumifil designed to evaluate safety and tolerability in healthy volunteers.

The Phase 1, single centre, two-part randomized, double-blind placebo-controlled dose escalation study enrolled a total of 60 healthy volunteers who were evaluated for safety and tolerability of single and multiple doses of Neumifil.

Top line data from the trial show that Neumifil is well tolerated with no dose limiting toxicities and a safety profile that strongly supports further development. No serious adverse events were reported at any of the doses evaluated in the study.

Dr. Geoff Kitson, Pneumagen’s Chief Medical Officer commented, “The availability of an effective intranasal broad-spectrum anti-viral therapeutic for patients who experience viral induced exacerbations of underlying pulmonary pathology would be transformational and would provide an early treatment option with significantly improved quality of life. This successful Phase 1 safety study is the first important step in our development path that could make Neumifil available to vulnerable and at-risk patients, offering them protection against a range of respiratory viruses.“

Neumifil is a unique multivalent carbohydrate binding molecule (mCBM) generated using Pneumagen’s proprietary GlycoTarge™ technology platform, that acts by binding to epithelial cell surface sialic acid receptors in the respiratory tract, thereby stopping viral entry at the site of infection by reducing their ability to enter host cells. Neumifil has shown potent anti-viral activity against a broad range of infections caused by influenza viruses, Respiratory Syncytial Virus (RSV), SARS-CoV-2 and rhinovirus in pre-clinical studies, and its differentiated mechanism of action means it is less susceptible to direct viral resistance.

Douglas Thomson, CEO of Pneumagen commented, “We are encouraged by these first clinical data, which confirm that Neumifil is well tolerated and safe. These data represent the first clinical evidence supporting the development of this new intranasal therapeutic for patients who experience viral induced exacerbations of chronic lung disease, including those with COPD and asthma. Neumifil has the potential to deliver a significant impact on decreasing the risk of hospitalization, complications and death for the many susceptible patients around the world.”

A Phase 2, proof of concept, controlled human influenza challenge study of Neumifil to be conducted by hVIVO is planned to commence in the second half of 2022. Following this trial, which is designed to demonstrate clinical proof of concept, Pneumagen plans to initiate full development studies in 2023, in patients who experience viral induced exacerbations of underlying pulmonary pathology.

For further information, please contact: 

Pneumagen                                                        

Douglas Thomson, CEO

Email: info@pneumagen.com

MEDiSTRAVA Consulting (Financial PR)    

Frazer Hall, David Dible, Sandi Greenwood, Evelyn McCormack

Email: Pneumagen@medistrava.com

About Pneumagen

Pneumagen is a clinical- stage biotech company developing Neumifil, its lead product, as an intranasal drug for the prophylaxis and treatment of a broad range of viral respiratory tract infections (RTIs).

Neumifil is a novel, engineered multivalent Carbohydrate Binding Molecule (mCBM), which is being developed for the pan-antiviral prevention of Influenza Virus (IFV), RSV, coronavirus infections including COVID-19 and human rhinovirus. Neumifil acts by directly binding and preventing the entry of the viral pathogens into the lungs with reduced susceptibility to direct viral resistance. Neumifil was generated using Pneumagen’s proprietary GlycoTarge™ technology that acts by stopping viruses at the site of infection, reducing their ability to enter cells.

In addition to Neumifil, Pneumagen is harnessing its GlycoTarge™ platform to enable the development of a pipeline of intranasal therapies targeting other infectious lung diseases.

Pneumagen was established in 2016 as a spin-out from the University of St Andrews in Scotland giving Pneumagen access to world-class scientific expertise and capabilities in viral RTI’s specifically related to glycobiology.

St Andrews, UK – 10 May 2022 – Pneumagen, a clinical stage biotech company developing Neumifil, a novel intranasal spray which is designed to provide patients at risk with an easy to use, pan-anti-viral treatment to reduce, prevent and manage respiratory disease exacerbations caused by viral infections, announces the appointment of Dr. John Beadle, Founder and former Chief Executive Officer of PsiOxus Therapeutics Ltd, as a Non-Executive director of the company.

Douglas Thomson, CEO of Pneumagen, commented “I am delighted that we have been able to attract someone of John’s calibre to join Pneumagen’s Board. His successful career founding, funding and growing innovative biotech companies will provide invaluable experience to Pneumagen at this key time in our development as we advance the clinical studies of Neumifil.  I look forward to accessing John’s experience and counsel, alongside the other members of our Board.”

John Beadle is a highly entrepreneurial CEO and leader with broad experience in building successful innovation driven biotechnology companies. During his career, he has helped build and worked with strong management teams to deliver exceptional scientific, clinical and commercial results.

John has a strong medical and business background (MD MBA) and has led innovative leading-edge companies and programs across several ATMP (Advanced Therapy Medicinal Products) fields including nucleotide-based vaccines, stem cell therapies, gene therapies and immuno-oncology.

His most recent role was as Founding CEO of PsiOxus, a clinical stage oncology company pioneering systemic immune oncology products designed to drive sustained reprogramming of the tumor microenvironment to overcome resistance to therapy. His previous roles include Founder and Chief Medical Officer of PowderMed; Entrepreneur in Residence at Imperial College, London; Site Head at Pfizer; and Vice President of Global Medical Operations at GlaxoSmithKline.

John Beadle added “I believe that Pneumagen can make a significant difference to the treatment of viral respiratory tract infections with its world-class science, strong IP and highly experienced management team. Neumifil represents a truly innovative, pan-viral treatment approach for patients at risk of viral induced exacerbations in a world where, as we know only too well, the threat from infectious diseases is significant and where access to new effective anti-virals is clearly needed.”

John received his medical degree from the University of the Witwatersrand in South Africa, a DA, Anaesthesia from the South African College of Medicine, and an MBA from the London Business School.

END

About Pneumagen

Pneumagen is a clinical- stage biotech company developing Neumifil, its lead product, as an intranasal drug for the prophylaxis and treatment of a broad range of viral respiratory tract infections (RTIs).

Neumifil is a novel, engineered multivalent Carbohydrate Binding Molecule (mCBM), which is being developed for the universal treatment of Influenza Virus (IFV), Respiratory Syncytial Virus (RSV), and coronavirus infections including COVID-19. Neumifil acts by directly binding and preventing the entry of the viral pathogens into the lungs with reduced susceptibility to direct viral resistance. Neumifil was generated using Pneumagen’s proprietary GlycoTarge™ technology that acts by stopping viruses at the site of infection, reducing their ability both to enter cells and to migrate to the lungs.

In addition to Neumifil, Pneumagen is harnessing its GlycoTarge™ platform to enable the development of a pipeline of intranasal therapies targeting other infectious lung diseases.

Pneumagen was established in 2016 as a spin-out from the University of St Andrews in Scotland giving Pneumagen access to world-class scientific expertise and capabilities in viral RTI’s specifically related to glycobiology.

For further information, please contact: 

Pneumagen           

Douglas Thomson, CEO

Email: info@pneumagen.com

MEDiSTRAVA Consulting (Financial PR)        

Frazer Hall, David Dible, Sandi Greenwood

Email: Pneumagen@medistrava.com

St Andrews, UK – 13 April 2022 – Pneumagen, a clinical stage pharmaceutical company developing Neumifil, a first in class pan-antiviral for the prevention, treatment and management of viral induced respiratory infections is pleased to announce that its CEO, Douglas Thomson, will present at this year’s BioTrinity during a session focused on scientific updates in Infectious Diseases.

Presentation details

Date: Wednesday, 27th April 2022

Time: 15:10pm BST

Location: 155 Bishopsgate, London

Douglas Thomson will provide an overview of the company and the clinical advancement of its lead, self-administered intranasal product Neumifil, being developed for the treatment of a broad range of viral respiratory tract infections such as influenza, respiratory syncytial virus (RSV) and coronaviruses including SARS-CoV-2. Neumifil is currently in a Phase 1 clinical trial with top line results expected in the first half of 2022.

END

About Pneumagen

Pneumagen is a clinical- stage biotech company developing Neumifil, its lead product, as an intranasal drug for the prophylaxis and treatment of a broad range of viral respiratory tract infections (RTIs).

Neumifil is a novel, engineered multivalent Carbohydrate Binding Molecule (mCBM), which is being developed for the universal treatment of Influenza Virus (IFV), Respiratory Syncytial Virus (RSV), and coronavirus infections including COVID-19. Neumifil acts by directly binding and preventing the entry of the viral pathogens into the lungs with reduced susceptibility to direct viral resistance. Neumifil was generated using Pneumagen’s proprietary GlycoTarge™ technology that acts by stopping viruses at the site of infection, reducing their ability both to enter cells and to migrate to the lungs.

In addition to Neumifil, Pneumagen is harnessing its GlycoTarge™ platform to enable the development of a pipeline of intranasal therapies targeting other infectious lung diseases.

Pneumagen was established in 2016 as a spin-out from the University of St Andrews in Scotland giving Pneumagen access to world-class scientific expertise and capabilities in viral RTI’s specifically related to glycobiology.

For further information, please contact:

Pneumagen                                                                                       

Douglas Thomson, CEO

Email: info@pneumagen.com

MEDiSTRAVA Consulting (Financial PR)

Frazer Hall, David Dible, Sandi Greenwood, Evelyn McCormack

Email: Pneumagen@medistrava.com

St Andrews, UK – 19th January 2022 – Pneumagen, a clinical stage biotech company developing Neumifil, a pan-antiviral, intranasal drug for the prophylaxis and treatment of viral respiratory tract infections (RTIs), today announced it has raised a further £3.8m to advance clinical development and manufacturing of its lead product Neumifil.

Neumifil is being developed to offer pan-antiviral protection against respiratory viruses such as influenza, respiratory syncytial virus (RSV) and coronaviruses including SARS-CoV-2 with a self-administered intranasal product.  Currently, Neumifil is being assessed in a Phase I study with top line results anticipated in the first half of 2022.

The latest funding round brings total capital secured to date by Pneumagen to circa £14m and will enable the Company to:

• Advance further development of Neumifil into Phase II. An influenza controlled human challenge study will be conducted by hVIVO, a subsidiary of Open Orphan plc, a world leader in the testing of antivirals using human challenge study models. The study  will be conducted in the United Kingdom and is planned to commence in the second half of 2022

• Conduct further GMP manufacturing by FUJIFILM Diosynth Biotechnologies, a leading contract development and manufacturing organisation and one of the world’s most renowned, high quality manufacturing companies

• Conclude extended GLP toxicology studies to support the Phase II programme

The financing round was co-led by existing investors, Thairm Bio and Scottish Enterprise.

Neumifil is a unique multivalent carbohydrate binding molecule (mCBM) generated using Pneumagen’s proprietary GlycoTarge™ technology platform that acts by binding to epithelial cell surface sialic acid receptors in the respiratory tract, thereby stopping viruses at the site of infection, reducing their ability to both enter cells in the respiratory tract and migrate to the lungs. Neumifil has shown potent anti-viral activity against a broad range of infections caused by influenza viruses, RSV and SARS-CoV-2 in pre-clinical studies, and its differentiated mechanism of action means it is less susceptible to direct viral resistance.

Douglas Thomson, CEO of Pneumagen, commented, “This further funding ensures that we can continue the rapid clinical development progress of Neumifil. Our agreements with hVIVO and FUJIFILM Diosynth Biotechnologies are significant operational advances as we execute our Phase II clinical programme in 2022.”

“Neumifil has the potential to significantly improve the lives of patients suffering from viral respiratory tract infections. As a pan-antiviral, easy to use, self-administered novel treatment option, Neumifil has the potential to have a significant impact on decreasing the risk of hospitalisation and death, through the prevention and treatment of multiple respiratory viral infections, for patients who suffer from viral exacerbations of underlying chronic lung disease.”

Thairm Bio’s Mark Bamforth said, “We are pleased to provide this financing to Pneumagen, which reflects the great confidence we have in the Company’s business strategy and execution, the highly committed management team and the significant potential of Neumifil to become a key treatment option for patients with a broad range of viral RTIs.”

Kerry Sharp, Director of Growth Investments at Scottish Enterprise, said, “Having been impressed by Pneumagen’s development following our initial investment in 2016, Scottish Enterprise is underlining our support for the Company and cementing our partnership with Thairm Bio through further co-investment. Helping Pneumagen scale up its clinical development and manufacturing capabilities can unlock the potential of its lead product, Neumifil.”

Cathal Friel, Executive Chairman of Open Orphan, said, “We are delighted to partner with Pneumagen for this important study to test its highly promising pan-antiviral product Neumifil, using hVIVO’s Influenza human challenge study model. Neumifil has the potential to be an important prophylactic and treatment against a range of viral respiratory tract infections and we look forward to working alongside Pneumagen as we bring to bear our world-leading experience in conducting these types of trials.”

Paul Found, Chief Operating Officer, FUJIFILM Diosynth Biotechnologies UK, said, “FUJIFILM Diosynth Biotechnologies is delighted to support the clinical advancement of Pneumagen’s Neumifil candidate for the prevention and treatment of RTIs. Our deep expertise and capabilities in the development and optimisation of microbial-based processes will enable us to support Pneumagen as they scale-up for mid-to-late stage clinical trials.”

For further information, please contact: 

Pneumagen            

Douglas Thomson, CEO

Email: info@pneumagen.com

MEDiSTRAVA Consulting (Financial PR)          

Frazer Hall, David Dible, Sandi Greenwood

Email: Pneumagen@medistrava.com

End

About Pneumagen

Pneumagen is a clinical- stage biotech company developing Neumifil, its lead product, as an intranasal drug for the prophylaxis and treatment of a broad range of viral respiratory tract infections (RTIs).

Neumifil is a novel, engineered multivalent Carbohydrate Binding Molecule (mCBM), which is being developed for the universal treatment of Influenza Virus (IFV), Respiratory Syncytial Virus (RSV), and coronavirus infections including COVID-19. Neumifil acts by directly binding and preventing the entry of the viral pathogens into the lungs with reduced susceptibility to direct viral resistance. Neumifil was generated using Pneumagen’s proprietary GlycoTarge™ technology that acts by stopping viruses at the site of infection, reducing their ability both to enter cells and to migrate to the lungs.

In addition to Neumifil, Pneumagen is harnessing its GlycoTarge™platform to enable the development of a pipeline of intranasal therapies targeting other infectious lung diseases.

St Andrews, UK – 10 November 2021 – Pneumagen, a clinical stage biotech company developing Neumifil, a universal, intranasal drug for the prophylaxis and treatment of viral respiratory tract infections (RTIs), announces the start of a Phase 1 study evaluating the safety and tolerability of single and multiple ascending doses of Neumifil in healthy volunteers. Pneumagen is developing Neumifil for a broad range of viral RTIs including influenza and COVID-19.

Initiation of this Phase 1 study is supported by preclinical studies that demonstrated prevention, treatment and post exposure prophylaxis of influenza viral infection and respiratory syncytial virus (RSV) infection, with no observed toxicity. Neumifil has also been shown to be efficacious against COVID-19, significantly reducing clinical signs in animal models.

Viral RTIs affect millions of people globally and are a leading cause of death around the world and a major burden on healthcare services. There is a clear need for new and improved options to tackle RTIs given the issues around influenza outbreaks, viral exacerbation of respiratory diseases such as asthma and COPD, together with the emergence of viruses with pandemic potential and the development of resistance to current anti-viral drugs.

“The start of this Phase 1 study is a major milestone for Pneumagen, and we are very pleased that we have made the step to become a clinical stage biotech company. We are extremely excited by the prospect of developing Neumifil as both a prophylactic and treatment for multiple viral respiratory tract infections, including influenza and COVID-19. As an easy-to-use nasal spray that could be prescribed to those at risk of viral exacerbations, Neumifil has the potential to prevent more serious disease, hospitalisation and the need for critical care for patients” said Douglas Thomson, CEO of Pneumagen. “Neumifil is being developed as a safe, effective and convenient to self-administer option with the potential to transform the treatment of viral pandemics and infectious diseases” he added.

The Phase 1 trial is a single center, two-part, randomized, double blind, placebo controlled, dose escalating study to assess the safety and tolerability of single and multiple doses of Neumifil in healthy volunteers. Part A aims to assess the safety and tolerability of single ascending intranasal doses of Neumifil, while Part B aims to assess the safety and tolerability of multiple-ascending intranasal doses of Neumifil.

Top line results from the study are expected in the first half of 2022.

Pneumagen is confident that Neumifil, as both a prophylactic and a treatment, could significantly expand the treatable RTI population given its ease of use, potential universal activity, and absence of exposure to direct viral resistance. Neumifil is a novel, engineered multivalent carbohydrate binding molecule (mCBM), generated using Pneumagen’s proprietary GlycoTarge technology that acts by stopping viruses at the site of infection, reducing their ability both to enter cells and to migrate to the lungs.

Pneumagen’s engineered mCBMs have been shown to prevent and treat viral RTIs by masking the epithelial cell surface sialic acid receptor glycans present in the respiratory tract which are used by many viral pathogens for entry and infection.

By directly preventing the binding and entry of pathogens, mCBMs have the advantage of being effective across multiple different viral types and strains including influenza viruses, parainfluenza viruses, respiratory syncytial virus and coronaviruses, including SARS-COV-2, and are not subject to direct viral resistance unlike other more conventional therapies.

In addition, Neumifil can have a dual mechanism of action, for instance in the treatment of COVID-19, where it can target and bind with high affinity to glycans on the viral spike protein that plays a key role in viral entry into the host cell, as well as targeting glycans on the angiotensin-converting enzyme 2 (ACE2) receptor on host cells, the human receptor for SARS-CoV-2.

Pneumagen has designed Neumifil to be simple and convenient to self-administer as a nasal spray and the aim is to develop a formulation that enables straightforward storage and distribution, eliminating the need for a cold chain.

For further information, please contact:

Pneumagen
Douglas Thomson, CEO
Email: info@pneumagen.com

MEDiSTRAVA Consulting (Financial PR)
Frazer Hall, David Dible, Sandi Greenwood
Email: Pneumagen@medistrava.com

St Andrews, UK – 1 November 2021 – Pneumagen, a clinical stage biotech company developing Neumifil, a novel intranasal spray which is designed to provide patients at risk with an easy to use, pan-anti-viral treatment to reduce, prevent and manage respiratory disease exacerbations caused by viral infections, announces the appointment of Mingkui Zhou Ph.D. as Head of Research.

Dr. Zhou will be responsible for providing scientific leadership, developing, managing and implementing its preclinical and research programmes with a focus on enhancing the Company’s innovative GlycoTarge™ platform and building a pipeline of novel anti-viral therapies.

Neumifil was generated using Pneumagen’s proprietary GlycoTarge™ platform that develops first in class multivalent Carbohydrate Binding Molecules (mCBM’s). It acts by preventing the nasal passages from acting as an entry point for respiratory viruses. Pneumagen is leveraging its GlycoTarge™ platform through an active research programme to extend its use to other viruses e.g., AdV and HSV as well as different glycans.

Douglas Thomson, CEO of Pneumagen, commented “I am delighted to welcome Mingkui to Pneumagen as our Head of Research. He brings impressive drug discovery experience in the areas of virology and immunology. Dr. Zhou’s extensive technical and therapeutic expertise in infectious diseases enhances our proprietary GlycoTarge™ platform and development capabilities which have significant potential to generate a broader portfolio of candidates targeting other anti-viral diseases. His leadership will be crucial as we progress our development of anti-viral therapeutic programmes.”

“I am excited to join Pneumagen at such a dynamic time as the company continues to advance Neumifil,” said Dr. Zhou. “I look forward to working with the Pneumagen team and developing the GlycoTarge™ platform to bring meaningful therapies to patients where there is an unmet medical need.”

Dr. Zhou joins Pneumagen from Ossianix, a private preclinical biotechnology company. Previously, he was at Immunocore, a late-stage biotechnology Nasdaq listed company where he was a Senior Scientist and lead in key projects involving antibody discovery, bispecific engineering, in vitro and in vivo screening and lead molecule characterisation and development.

Dr. Zhou completed post-doctoral work in infectious diseases at Harvard Medical School & Dana-Farber Cancer Institute. He holds a Ph.D. in Pharmaceutical Sciences (magna cum laude) from Goethe University Frankfurt, Germany, an M.Sc. in Biochemistry and Molecular Biology Tongji University, Shanghai, China and a B.Eng. in Bioengineering East China University of Science and Technology, Shanghai, China.

For further information, please contact:

Pneumagen
Douglas Thomson, CEO
Email: info@pneumagen.com

MEDiSTRAVA Consulting (Financial PR)
Frazer Hall, David Dible, Sandi Greenwood
Email: Pneumagen@medistrava.com

Neumifil Binds with Equally High Affinity to Spike Proteins of Wuhan, UK and South African Variants

8th March 2021 – St. Andrews, Scotland – Pneumagen Ltd, a biotech company developing a universal pan-viral intranasal drug for protection against respiratory tract infections (RTIs), today announced a further milestone in the development of Neumifil™ for the treatment of COVID-19. Utilizing a hamster model of COVID-19 infection, researchers showed Neumifil was efficacious, significantly reducing clinical signs and weight loss in animals infected with SARS-CoV-2.

Pneumagen scientists located at the University of St. Andrews confirmed that Neumifil binds with equally high affinity to SARS-CoV-2 spike proteins from the Wuhan (Wuhan-Hu-1), UK (B.1.1.7) and South Africa (B.1.351) variants. In further experiments, Pneumagen also demonstrated high affinity Neumifil binding to the ACE2 receptor, which is used by the SARS-CoV-2 virus to infect the host.

Neumifil is a first-in-class Carbohydrate Binding Module (mCBMs), generated from the Company’s proprietary GlycoTarge™ platform. It is being developed for the universal treatment of RTIs caused by influenza viruses, RSV, and coronaviruses including SARS-CoV-2. Neumifil has the potential to revolutionize the treatment of RTIs, providing patients total protection against respiratory pathogens including COVID-19 variant strains.

Douglas Thomson, CEO of Pneumagen, said, “This exciting data confirms Neumifil’s potential as a treatment against variant strains of COVID-19. Neumifil, our universal pan-viral intranasal product, targets glycans to provide both prophylaxis and treatment for COVID-19, and other emerging viruses with pandemic potential. We are preparing for a Phase I clinical study in mid-2021.”

The underlying science and mechanism of action of Neumifil is well defined and validated. Neumifil binds with high affinity to terminal sialic acid glycans on the viral spike protein, which remain present in the UK and South African variants. Furthermore, Neumifil binds to ACE2 (the human receptor for SARS-CoV-2). Glycans on both the viral spike protein and ACE2 have been shown to be important in virus-host recognition [1,2,3]. The ability to target not only the virus’s spike protein (including new variants) but also its target on the host, reduces Neumifil’s susceptibility to viral resistance compared to more conventional approaches.

References

1. Shajahan, A. et al. Comprehensive characterization of N- and O- glycosylation of SARS-CoV-2 human receptor angiotensin converting enzyme 2. (2020) Anal. Glycobiol. doi: 10.1093/glycob/cwaa101

2. Zhao, P. et al. Virus-Receptor Interactions of Glycosylated SARSCoV-2 Spike and Human ACE2 Receptor (2020) Cell Host & Microbe. 28, 586–601

3. Casalino, L. et al. Beyond Shielding: The Roles of Glycans in the SARS-CoV-2 Spike Protein (2020) ACS Cent. Sci. 6, 10, 1722–1734