Category: Press Release

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

Includes new US-based global corporate investor

21st January 2021 – St. Andrews, Scotland – Pneumagen Ltd, focused on preventing and treating respiratory infections by targeting the human glycome, today announced a further GBP2.5 million investment from existing investors plus a new undisclosed global corporate investor, based in the US. The investment will be used to support the clinical development of Neumifil™ in 2021 as an intra-nasal formulation for the prevention and treatment of influenza, Respiratory Syncytial Virus (RSV) and COVID-19. This additional investment follows on from last year’s announcement of a GBP £4 million investment, and brings the total amount of financing raised to circa £9.5 million.

Neumifil™ is a first-in-class Carbohydrate Binding Module (mCBMs), generated using the Company’s proprietary GlycoTarge™ platform. This unique modality binds to receptors that are used by pathogens to enter the respiratory airways, thereby preventing infection and avoiding resistance. It is being developed for the universal treatment of respiratory tract infections (RTIs) caused by Influenza Virus and Respiratory Syncytial Virus, and now coronaviruses including SARS-CoV-2, the cause of COVID-19. Neumifil has the potential to revolutionise the treatment of RTIs, providing patients total protection against respiratory pathogens including COVID-19 variant strains or new emerging viruses with pandemic potential.

Douglas Thomson, CEO of Pneumagen, said: “Our mission is to develop our novel pan viral approach to combat infectious respiratory diseases such as influenza, RSV, COVID-19, and other emerging viruses with pandemic potential. I am delighted with this additional investment and the endorsement that the participation of our new corporate investor brings. This investment will enable us to progress Neumifil into the clinic in mid 2021, as a universal intra-nasal treatment for infectious diseases.”

It is October, which features a high point with BIO-Europe Digital, one of Europe’s largest life sciences gatherings, now fully online. We are delighted that Pneumagen is featured in Scrip’s 10 to Watch—A spotlight presentation track curated by Scrip from Informa Pharma Intelligence. Scrip’s editorial team has identified 10 emerging companies displaying innovative promise in drug discovery and development. Hear our CEO, Douglas Thomson talk about all we’re doing to develop Neumifil, a self-administered intranasal product, as a pan-viral solution for the prevention and treatment of infectious diseases including influenza, RSV and COVID-19. Our on-demand presentation is viewable by all registered delegates. https://bit.ly/3lbW25q

 Leading Virology Experts Support Development of Neumifil for Viral Infections, Including COVID-19

16 Sept 2020 – St Andrews, Scotland – Pneumagen Ltd, focused on treating infectious diseases by targeting the human glycome, today announced completion of its new Scientific Advisory Board, with the addition of Dr Richard J. Webby at the St. Jude Children’s Research Hospital, USA, and Professor Jürgen Haas at the Edinburgh Medical School, UK.

The company also announces that Dr David Howat has been appointed as Development Director. Dr. Howat has run drug development in many small biotech/pharmaceutical companies, most recently at Haoma Medica Ltd and previously at Evgen Plc. During these projects he managed CMC, safety toxicology, regulatory, and clinical trial activities.

Neumifil is a first-in-class Carbohydrate Binding Modules (mCBMs), generated using the Company’s proprietary GlycoTarge™ platform. This unique modality binds to receptors that are used by pathogens to enter the respiratory airways, thereby preventing infection and avoiding resistance. It is being developed for the universal treatment of respiratory tract infections (RTIs) caused by Influenza Virus and Respiratory Syncytial Virus, as well as SARS-CoV-2, the cause of COVID-19.

Douglas Thomson, CEO of Pneumagen, said: “I am delighted that Richard and Jürgen have joined our Scientific Advisory Board, bringing a wealth of experience to support our ambitious development programme to test the safety and efficacy of Neumifil as a universal treatment for RTIs in humans, including COVID-19. I also welcome David to the team and thank Professor David Harrison for his sterling service supporting the company to date.”

Dr Webby said, “I have long been fascinated by influenza virus ecology, vaccination, and pathogenicity, and am excited to use my knowledge to help progress the outstanding science underpinning the development of Pneumagen’s portfolio in respiratory tract infections. This approach with Neumifil could provide particular benefit in high risk groups as a potential pan-viral treatment for RTIs including pandemic viruses, including COVID-19.”

Professor Haas, Head of Infection Medicine, and Professor of Viral Genomics, at Edinburgh Medical School said, “In my lab we focus on the viral host factors determining pathogenicity and susceptibility. The development of a range of effective treatments to combat coronaviruses is crucial. I am looking forward to working with Douglas and his team to develop Neumifil into a drug that could protect people against respiratory pathogens including emerging viruses with pandemic potential.”

The complete Pneumagen SAB now comprises Dr Webby, Professor Haas, Professor Moira Whyte at the University of Edinburgh, Professor Paul Crocker at the University of Dundee, and Sir John Skehel of the Royal Society and The Francis Crick Institute. The SAB is chaired by Professor Garry Taylor, recent Master of the University of St. Andrews. Professor David Harrison at the University of St Andrews, steps down from the SAB.

Full details of the members are here: https://www.pneumagen.com/about-us.html

27th May 2020 – St Andrews, Scotland – Pneumagen (Holdings) Ltd, focused on treating infectious diseases by targeting the human glycome, today announced a GBP £4 million investment to allow the clinical development of Neumifil for the prevention and treatment of COVID-19. The investment was led by Thairm Bio (Thairm) with additional investment from the Scottish Investment Bank (SIB). The investment will progress its lead candidate, Neumifil™ into a clinical trial for COVID-19.

Neumifil is a first-in-class Carbohydrate Binding Modules (mCBMs), generated using the Company’s proprietary GlycoTarge™ platform. It is being developed for the universal treatment of respiratory tract infections (RTIs) caused by Influenza Virus and Respiratory Syncytial Virus, and now coronaviruses including SARS-CoV-2, the cause of COVID-19. Neumifil has the potential to revolutionise the treatment of RTIs, providing patients total protection against respiratory pathogens including emerging viruses with pandemic potential.

The investment follows exciting data from pre-clinical studies in COVID-19 using plaque reduction assays. The testing conducted at Public Health England’s (PHE) Porton facility, and from the University of Glasgow’s MRC Centre for Virus Research, demonstrated efficacy in inhibiting SARS-CoV-2 infection. Results from this work were announced on the 28th April 2020.

Douglas Thomson, CEO of Pneumagen, said: “I am delighted that Thairm has chosen to support our ambitious development programme to test the efficacy of Neumifil against COVID-19 in humans, planned in the first half of 2021. The continued support from the Scottish Investment Bank will ensure that this is achieved and will further support Neumifil as a universal drug for RTIs that now includes COVID-19.”

Mark Bamforth at Thairm, said “We are pleased to be able to back the development of Pneumagen’s exciting portfolio in respiratory tract infections. We believe that this approach could provide particular benefit as a protection pan-viral treatment for RTIs including pandemic viruses, such as COVID-19.”

Kerry Sharp, Director, Scottish Investment Bank, said: “Scientists globally are working around the clock to halt the spread of COVID-19. It could take several months or even years for a vaccine to be approved, so the development of effective treatments is crucial.

“The positive results of Pneumagen’s early studies are an encouraging step forward. With our continued support, we hope the company can develop a drug that will help protect people from the current pandemic and any future outbreaks.”

About Pneumagen

Pneumagen is using its platform technology, GlycoTarge, to develop glycan targeted carbohydrate-binding module domains (mCBMs) derived from bacterial glycosidases as a new universal therapeutic modality for the prevention and treatment of respiratory tract infections (RTIs). These engineered mCBMs have been shown to prevent and treat respiratory infections by binding to epithelial cell surface glycan receptors present in the respiratory tract, used by several pathogens for entry.

Pneumagen’s lead product, Neumifil, is a first-in-class mCBM40 being developed for the universal treatment of Influenza Virus (IFV), Respiratory Syncytial Virus (RSV), and coronavirus COVID-19 infections. When administered intranasally in preclinical models, Neumifil has demonstrated prevention, treatment and post-exposure prophylaxis of IFV and RSV infection with no observed toxicity. Pneumagen’s mCBMs, in development for cancer, are known as Neumonco. In vitro data have demonstrated that mCBMs target cancer cells, reducing cell proliferation, migration, metabolism and differentiation.

The Company is a spin-out from the University of St Andrews in Scotland and has access to world-class scientific expertise and capabilities in glycobiology. Please visit www.pneumagen.com for more information.

Contact details:

Katja Stout, Scius Communications

katja@sciuscommunications.com

+447789435990

Douglas Thomson, Pneumagen

douglas.thomson@pneumagen.com

+447748357352

The BBC’s Scottish News Programme The Nine interviewed Professor Garry Taylor about Pneumagen’s recent announcement of antiviral effects of their Novel Glycan Approach in targeting COVID-19 Infections.