Category: Press Release

• Pneumagen has previously reported positive results from both Phase 1 and a clinical proof of concept Phase 2 Human Influenza Challenge study demonstrating the potential of Neumifil
• New preclinical data, published in peer-reviewed journal Antiviral Research, show Neumifil demonstrates broad-spectrum efficacy against a wide range of viruses including influenza virus, respiratory syncytial virus, coronavirus and rhinovirus
• These studies confirm Neumifil’s ability to block virus engagement of host receptors to inhibit infection with reduced risk of antiviral resistance
• Findings support further clinical development of Neumifil in vulnerable populations to provide broad-spectrum protection against recurring seasonal infections or newly emerging viral threats

St Andrews, UK – 3 July 2024 – Pneumagen, a clinical stage biotech company developing Neumifil (HEX17), a broad-spectrum antiviral, intranasal drug for the prophylaxis and treatment of viral respiratory tract infections (RTIs), announces the publication of new preclinical data evaluating Neumifil in a wide range of viral disease models. These preclinical data are published in the peer-reviewed journal, Antiviral Research in a paper entitled, “HEX17(Neumifil): An intranasal respiratory biotherapeutic with broad-acting antiviral activity,” and confirm the potential of Neumifil as a first in class protein-based antiviral prophylactic for respiratory viral infections. The article can be accessed online at https://doi.org/10.1016/j.antiviral.2024.105945.

The publication highlights that Neumifil (HEX17) demonstrates consistent broad-spectrum efficacy against a wide range of viral respiratory pathogens including influenza virus, respiratory syncytial virus, coronavirus and human rhinovirus in multiple in vivo and in vitro studies. These viruses pose a severe threat to human health, particularly in the very young or old, or in those with pre-existing respiratory conditions such as asthma or chronic obstructive pulmonary disease (COPD).

This new research, showing protection against multiple key respiratory pathogens, taken together with a previously reported positive Phase 2 human influenza challenge study, which demonstrated an encouraging clinical safety and efficacy profile (Phase 2 Results here) is strongly supportive of further clinical development of Neumifil for the prevention of respiratory viral infections in high-risk subjects, such as those with COPD.

Professor Garry Taylor, Chair of the Scientific Advisory Board of Pneumagen said: “There is an urgent need for broad-acting antiviral strategies to prevent respiratory tract infections. Emerging or re-emerging viral diseases, including most recently H5N1, caused by new or genetic variants of existing viruses represent a severe threat to human health, particularly in those with pre-existing respiratory conditions such as asthma or chronic obstructive pulmonary disease (COPD). As confirmed by this comprehensive early preclinical data set, Neumifil shows great promise as a potential wide-ranging antiviral prophylactic that could significantly reduce the risk and severity of infections in these high-risk groups, ensuring better health outcomes and providing an important new weapon against existing and emerging viral threats.”

Douglas Thomson CEO of Pneumagen added: “Publication of the impressive results from our wide-ranging preclinical studies with Neumifil provides important confirmation of its broad-spectrum activity. Based on our early data, we have moved rapidly to progress Neumifil into clinical development and our positive Phase 1 and Phase 2 CHIM studies further reinforce our confidence in Neumifil as a potentially important treatment option for at-risk patients. We now look forward to advancing Neumifil into further clinical studies where its broad spectrum of activity offers significant promise. These trials are expected to include the evaluation of Neumifil’s ability to reduce the incidence of exacerbations in COPD patients.”

END

About Pneumagen

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

Neumifil is a novel, engineered, multivalent, Carbohydrate Binding Module (mCBM). It acts by directly binding and preventing the entry into the host of the viral pathogens. Neumifil was generated using Pneumagen’s proprietary GlycoTarge™ technology.

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 infections specifically related to glycobiology.

For further information, please contact:

Pneumagen                                                                              

Douglas Thomson, CEO

Email: info@pneumagen.com

MEDiSTRAVA Consulting (Financial PR)                             

Frazer Hall, Sandi Greenwood

Email: Pneumagen@medistrava.com

• Neumifil delivers statistically significant reductions in influenza symptomatic infection rate, symptom severity and viral load
• Strategy to advance clinical development of Neumifil to be based on these positive data and pre-clinical data package demonstrating Neumifil’s activity against a broad range of viruses

St Andrews, UK – 23^nd May 2024 – Pneumagen, a clinical stage biotech company developing Neumifil (HEX17), a broad-spectrum antiviral, intranasal drug for the prophylaxis and treatment of viral respiratory tract infections (RTIs), presented positive results from its Phase 2, proof-of-concept, Controlled Human Infection Model (CHIM) study in which healthy volunteers were challenged with influenza virus following administration of Neumifil. These data were featured during an oral presentation* at the American Thoracic Society (ATS) in San Diego on 21^st May.

The presentation, entitled “HEX17, a Novel Broad-spectrum Antiviral Intranasal Drug, Demonstrates Efficacy Against Influenza in a Controlled Human Infection Model Conducted in Healthy Adults,” was delivered by Dr Geoff Kitson, Chief Medical Officer of Pneumagen.

“We are very pleased to present detailed data from our Phase 2 Clinical trial of Neumifil,” said Douglas Thomson, Chief Executive Officer of Pneumagen. “Based on these promising proof-of-concept results presented at ATS, that reinforce the clinically significant reduction in both the incidence and severity of symptomatic influenza infection, we now look forward to advancing Neumifil into further clinical studies where its broad spectrum of activity offers significant potential. These trials are expected to include the evaluation of Neumifil’s ability to reduce the incidence of exacerbations in patients with Chronic Obstructive Pulmonary Disease (COPD), which represents a significant at-risk population.”

Dr Geoff Kitson, Chief Medical Officer and presenting author, commented “Viral respiratory infection is of enormous global concern, particularly in patients with underlying pulmonary disease, in whom viral infections can induce exacerbations. The significant reductions in both symptoms and viral load, demonstrate the potential of this new antiviral drug not only to alleviate patients suffering but also to curtail the spread of virus within communities.

Neumifil’s activity in protecting against a broad range of viral infections shows it has the potential to become an important medicine for the prevention of exacerbations in people with COPD or asthma.”

Key highlights from the presentation delivered at ATS:

• Randomised, double-blind, placebo-controlled study conducted at a single centre in the UK
• Study in healthy adults evaluating two dosing regimens (single dose, 3 days before infection or three daily doses on the three days leading up to infection with influenza virus) of Neumifil, administered as an intranasal spray to participants who were subsequently infected with influenza virus
• Neumifil demonstrated a clinically significant reduction in the incidence of symptomatic influenza infection
• Neumifil significantly reduced viral load and severity of symptoms compared to placebo
• Neumifil was well tolerated with a safety profile in line with data from the first in human study

* Abstract 6721, Geoff Kitson, Marion Byford, Lindsey Cass, David Howat, Brigitte Koehn, Douglas Thomson

 END

About Pneumagen

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

Neumifil is a novel, engineered, multivalent, Carbohydrate Binding Module (mCBM). It acts by directly binding and preventing the entry into the host of the viral pathogens. Neumifil was generated using Pneumagen’s proprietary GlycoTarge™ technology.

In addition to Neumifil, Pneumagen is harnessing its GlycoTarge™ platform to enable the development of a pipeline of therapies targeting other infectious 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 infections specifically related to glycobiology.

For further information, please contact:

Pneumagen                                                                              

Douglas Thomson, CEO

Email: info@pneumagen.com

MEDiSTRAVA Consulting (Financial PR)                              

Frazer Hall, Sandi Greenwood

Email: Pneumagen@medistrava.com

Data to be presented in oral and ePoster presentations

 St Andrews, UK – 2 May 2024 – 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 announces that clinical results from a human challenge study with Neumifil (HEX17) will be presented at the 2024 American Thoracic Society (ATS) Conference, which will be held virtually and in person in San Diego, CA, May 17-22.

The data will be presented in both oral and ePoster presentation sessions and will highlight important clinical results about the company’s proprietary drug, Neumifil. These will include the evaluation of Neumifil’s ability to reduce the incidence of viral induced exacerbations in patients with Chronic Obstructive Pulmonary Disease (COPD).

Pneumagen’s abstract is available on the ATS’s 2024 online programme:

Oral presentation details are as follows:

• Title: HEX17, A Novel Broad-spectrum Antiviral Intranasal Drug, Demonstrates Efficacy Against Influenza in a Controlled Human Infection Model Conducted in Healthy Adults
• Abstract Number: 6721
• Mini Symposium: C18: Translating Science in Respiratory Infections
• Date & Time: Tuesday May 21 at 9:15 AM – 11.15 AM EST
• Location: San Diego Convention Centre, Room 6C-F (Upper Level)
• Presenter: Geoff Kitson, Chief Medical Officer
• https://www.abstractsonline.com/pp8/#!/11007/presentation/7604

ePoster presentation details are as follows:

• Title: HEX17, A Novel Broad-spectrum Antiviral Intranasal Drug, Demonstrates Efficacy Against Influenza in a Controlled Human Infection Model Conducted in Healthy Adults
• Date: Tuesday May 21 – Friday September 6 (available online between those dates)
• Poster Session: Translating Science in Respiratory Infections
• Authors: Geoff Kitson et al

***

About Pneumagen

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

Neumifil is a novel, engineered, multivalent, Carbohydrate Binding Module (mCBM). It acts by directly binding and preventing the entry into the host of the viral pathogens. Neumifil was generated using Pneumagen’s proprietary GlycoTarge™ technology.

In addition to Neumifil, Pneumagen is harnessing its GlycoTarge™ platform to enable the development of a pipeline of therapies targeting other infectious 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 infections specifically related to glycobiology.

For further information, please contact:

Pneumagen                                                                              

Douglas Thomson, CEO

Email: info@pneumagen.com

MEDiSTRAVA Consulting (Financial PR)                              

Frazer Hall, Sandi Greenwood

Email: Pneumagen@medistrava.com

• Study achieves primary & secondary endpoints in a randomised, placebo-controlled challenge study
• Neumifil delivers a statistically significant reduction in both symptomatic infection rate & severity
• Favourable safety and tolerability profile

St Andrews, UK – 2^nd October 2023 – 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 announced positive results from its Phase 2, Proof of Concept, Controlled Human Infection Model (CHIM) study where patients were challenged with influenza virus following administration of Neumifil.

Neumifil demonstrated a clinically significant reduction in the incidence of symptomatic influenza infection and in the severity of symptoms, which achieved statistical significance, compared to placebo. Neumifil was well tolerated with no new emergent adverse events or safety signals from the study compared to the first in human study.

The Phase 2, CHIM study, was a single centre, randomised, double-blind, placebo-controlled study in 104 healthy adults evaluating two dose regimens of Neumifil, administered as an intranasal spray to participants who were subsequently infected with influenza virus.

Based on these positive clinical results, taken together with a pre-clinical data package demonstrating Neumifil’s activity against a broad range of viruses, Pneumagen now plans to advance Neumifil into further clinical studies. This will include the evaluation of Neumifil’s ability to reduce the incidence of viral induced exacerbations in patients with Chronic Obstructive Pulmonary Disease (COPD).

Douglas Thomson, Chief Executive Officer at Pneumagen said: “We are extremely pleased that this Phase 2, Proof of Concept study met all of its key objectives. The positive and clinically meaningful results we have delivered mark a critical step forward in the development of Neumifil and substantiate Pneumagen’s commitment to delivering a novel treatment option for patients suffering from virus induced exacerbations of respiratory diseases. These excellent results mean we can progress Neumifil with great confidence into further clinical studies to explore the efficacy and safety profile of our novel drug candidate in a larger at risk COPD patient population.”

About Pneumagen

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

Neumifil is expected to advance into further clinical studies in 2024.

Neumifil is a novel, engineered, multivalent, Carbohydrate Binding Module (mCBM). It acts by directly binding and preventing the entry into the host of the viral pathogens. Neumifil was generated using Pneumagen’s proprietary GlycoTarge™ technology.

In addition to Neumifil, Pneumagen is harnessing its GlycoTarge™ platform to enable the development of a pipeline of therapies targeting other infectious 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 infections specifically related to glycobiology.

For further information, please contact:

Pneumagen                                                                              

Douglas Thomson, CEO

Email: info@pneumagen.com

MEDiSTRAVA Consulting (Financial PR)                             

Frazer Hall, Sandi Greenwood

Email: Pneumagen@medistrava.com

• Neumifil is being developed for the prevention and treatment of virus induced exacerbations in patients with respiratory disease
• Advancing Neumifil into a Phase 2b clinical study due to start in 2024

St Andrews, UK – 1^st June 2023 – 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 announced that it has secured £8 million in financing from existing and new investors to support the continued Phase 2 development of Neumifil in Chronic Obstructive Pulmonary Disease (COPD) patients suffering from virus induced exacerbations.

Pneumagen secured the latest funds from existing investors, Thairm Bio and Scottish Enterprise, new investor Esperante Ventures, the directors, as well as several US based investors.

The latest funding round will enable the company to advance the clinical development of Neumifil for individuals with COPD suffering from virus induced exacerbations.

Neumifil is currently being evaluated in a Phase 2a proof of concept human challenge study in healthy participants subsequently infected with influenza virus. Initial results are expected in mid-2023.

Douglas Thomson, Chief Executive Officer at Pneumagen said: “We are very pleased to announce this funding from our existing and new investors. This financing speaks to their confidence in our strategy and the significant progress we have made. The funds will be used to support the continuing development of Neumifil, including preparing for a Phase 2b study in COPD patients which is planned to begin in 2024.”

Thairm Bio’s Mark Bamforth said, “We are delighted to continue our support for Pneumagen for the further development of Neumifil, which has a highly promising profile based on early pre-clinical and clinical data. We have been impressed by Pneumagen’s progress and believe Neumifil could address a large unmet medical need by preventing virus induced exacerbations, which can be potentially lethal for some patients suffering from serious underlying respiratory disease.”

“We are excited to make our initial investment in Pneumagen,” said Dean Slagel, Managing Director at Esperante Ventures. “We were attracted by the quality of Pneumagen’s leadership and multiple milestones that Douglas and the Pneumagen team have delivered as they work to position Neumifil as a treatment option for respiratory tract infections.”

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

• Neumifil is a novel intranasal spray being developed to provide those at-risk with an easy to use, broad-spectrum antiviral treatment to reduce and prevent respiratory disease exacerbations caused by viral infections
• By directly targeting host cells in the nose, Neumifil blocks and prevents the entry of viral pathogens

St Andrews, UK – 18 April 2023 – 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 announced that the US Patent and Trademark Office (USPTO) has issued a US Patent for HEX17, the active pharmaceutical ingredient in Neumifil.

Neumifil, Pneumagen’s lead product, is being developed for the broad-spectrum prevention of viral induced exacerbations including those caused by influenza virus (IFV), respiratory syncytial virus (RSV), rhinovirus and coronavirus infections including COVID-19.

Neumifil is currently being evaluated in a Phase 2a proof of concept challenge study in healthy participants subsequently infected with influenza virus. A Phase 2 study, evaluating Neumifil in patients who are at high risk of viral induced exacerbations of their underlying disease, such as COPD, is due to start in 2024.

Neumifil’s active component, HEX17, is a multivalent, glycan-targeting carbohydrate binding module (mCBM). It was generated using Pneumagen’s proprietary GlycoTarge™ technology that identifies novel mCBMs for further development.

Douglas Thomson, CEO of Pneumagen, commented: “This US patent grant is a key milestone for Pneumagen, which builds further significant value for Neumifil, our novel first in class host cell-targeted antiviral. We are continuing to make excellent progress in developing this lead product and look forward to seeing further results from our clinical programme. The large patient population targeted by Neumifil presents a significant unmet need, given the limited treatment options available and the potentially fatal consequences of exacerbations of their underlying disease.”

Pneumagen has multiple patent families protecting its core intellectual property including granted US and European patents and has filed further patent applications covering the CBM technology, its application and medical use.

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 – 6 January 2023 – 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), announces the appointment of James Noble as non-executive Chairman of its Board of Directors.

James brings over 30 years of industry experience to the Board from both public and private biotech and healthcare companies. He is currently Chairman at Orexo AB, Sutura Therapeutics and Celleron Therapeutics and non-executive director of Nasdaq listed company Lava Therapeutics N.V. He has previously held non-executive roles at several prominent biotech companies including MediGene AG, PowderJect, Oxford GlycoSciences, CuraGen, Advanced Medical Solutions and GW Pharmaceuticals.

In 2008, James founded Adaptimmune, a Nasdaq listed T-cell therapy company, where he worked as Chief Executive Officer until 2019 and is currently on the Board. Prior to that, he served as Chief Executive Officer of Immunocore, which he also co-founded. James holds an M.A. degree from the University of Oxford.

Douglas Thomson, CEO of Pneumagen, commented, “We are very pleased to welcome James to the Board who brings a wealth of strategic, corporate and financial expertise to Pneumagen. James’ considerable experience will be invaluable as we progress our Phase 2 clinical trial with our lead asset, Neumifil. We look forward to leveraging James’ global network and deep knowledge of the biotech sector as we continue our commitment to deliver an important new therapy to vulnerable patients at risk from viral RTIs.”

James Noble added “I am honoured to take on the role as Chairman of the Board of Directors at Pneumagen, a company that has already delivered highly encouraging early clinical data. I look forward to working closely with the company’s impressive team and driving forward the strategy to deliver such a potentially important new product for patients at high-risk of viral-induced exacerbations caused by respiratory viruses.”

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