Author: Krishna Thapa

Expansion brings total Series B funds raised to £43.25 million

Proceeds to support the delivery of clinical Proof of Concept for MOv18 IgE

LONDON, 9 September 2024 – Epsilogen, a global leader in the development of immunoglobulin E (IgE) antibodies to treat cancer, today announces the completion of a £12.5 million Series B expansion financing bringing the Series B total to £43.25 million. This financing will fund the delivery of clinical Proof of Concept for lead asset MOv18 IgE in a phase Ib trial featuring platinum-resistant ovarian cancer (PROC) as well as further development of the company’s IgE-based pipeline. The financing was entirely conducted by existing investors including British Patient Capital, Novartis Venture Fund, Epidarex Capital, 3B Future Health Fund and ALSA Ventures.

MOv18 IgE is the first therapeutic IgE antibody to enter the clinic. This first-in-class antibody targets folate receptor alpha (FR), an antigen present on a variety of cancers including ovarian, endometrial, lung and triple negative breast cancer. In a phase I trial, MOv18 IgE was found to be safe and well tolerated with initial signs of clinical activity also seen, as reported in Nature Communications (https://www.nature.com/articles/s41467-023-39679-9). The phase Ib trial is a two-part, dose escalation and expansion trial in patients with FR-positive PROC whose disease has progressed after ≤4 prior regimens of anti-cancer therapy.
MOv18 IgE has a unique mechanism of action differentiating it from other agents currently in the clinic and on the market. Key aspects of this mechanism include high affinity binding to its main cognate receptor, FcεR1, thereby enabling immunosurveillance and potent myeloid cell driven tumour cell killing. Additionally, IgE antibodies drive modulation of the tumour immune microenvironment to become more pro-inflammatory, leading to increased intra-tumoural levels of activated T cells and tumour killing macrophages.

Tim Wilson, CEO of Epsilogen said “We are delighted to have received strong continued support from our existing investors and we thank them. The promise of IgE to treat cancer is based upon its unique mechanism of action and MOv18 IgE is the first ever to be tested in man. Everything is ready for phase Ib initiation which will occur shortly and we look forward to reporting progress from the trial.”

ENDS

About Epsilogen Ltd

Epsilogen is a global leader in the development of immunoglobulin E (IgE) antibodies to treat cancer. IgE’s natural function is to provide immunological defence against certain parasites. This functionality makes it an ideal treatment of solid tumours due to its strong potency, enhanced tumour access and long tissue half-life.
Epsilogen’s lead product candidate, MOv18 IgE, is the first therapeutic IgE antibody to enter the clinic and encouraging data from a completed Phase I trial demonstrated MOv18 IgE to be safe and well tolerated with early signs of clinical activity. Epsilogen has recently successfully completed large scale GMP manufacture of MOv18 IgE (the first time this has been achieved for an IgE antibody) and will initiate a Phase Ib trial in platinum-resistant ovarian cancer patients later this year. The company is also developing a pipeline of IgE therapies in oncology as well as proprietary platforms including IgE bispecifics and unique IgE/IgG combination antibody molecules (IgEGs) with enhanced functionality.

Epsilogen began operations in 2017 as a spin-out of King’s College London and has attracted venture capital financing from Epidarex Capital, Novartis Venture Fund, 3B Future Health, British Patient Capital, ALSA Ventures and Schroders Capital amongst others. Find out more at epsilogen.com.
For more information please contact:

Communications advisor to Epsilogen Ltd:

Simon Conway
Senior Managing Director
FTI Consulting
epsilogen@fticonsulting.com
+44 (0)20 3727 1000

Phase Ib study expected to initiate in H2 2024

Previously reported Phase I results showed MOv18 IgE to be safe and well tolerated, with evidence of anti-tumour activity

LONDON, 8 July 2024 – Epsilogen, a global leader in the development of immunoglobulin E (IgE) antibodies to treat cancer, today announces that the Clinical Trial Application for the Phase Ib trial of MOv18 IgE has been approved by the UK Medicines and Healthcare products Regulatory Agency (MHRA).

The Phase Ib study is expected to initiate later in 2024 and will evaluate the efficacy of MOv18 IgE in patients with platinum-resistant ovarian cancer (PROC).

Dr Tim Wilson, Chief Executive Officer of Epsilogen, said: “This CTA is another significant milestone for Epsilogen and the clinical development of MOv18 IgE. We look forward to progressing MOv18 IgE into a Phase Ib efficacy study later this year as we continue to demonstrate the potential of IgE antibodies as a new, differentiated class of cancer treatments.”

About MOv18 IgE
MOv18 IgE is an immunoglobulin E (IgE) antibody targeting the folate receptor alpha (FR alpha) antigen. FR alpha is present on a variety of cancers including ovarian, endometrial, lung and triple negative breast cancer. Epsilogen has successfully completed a Phase I safety study of MOv18 IgE in PROC patients. The results of the study, published in Nature Communications, found MOv18 IgE to be safe and well tolerated, with evidence of anti-tumour activity observed. Epsilogen, alongside its partner Lonza, also announced the successful completion of large-scale Good Manufacturing Practice (GMP) manufacturing of MOv18 IgE earlier this year.

About the Phase Ib study
The Phase Ib study is designed to confirm the safety and tolerability of MOv18 IgE and demonstrate efficacy in PROC. Following the dose escalation, an expansion cohort will be recruited to make a preliminary assessment of the anti-tumour activity of MOv18 IgE at a selected dose. In addition, delay to disease progression will be assessed along with a number of translational elements to generate further understanding of MOv18 IgE in the study population.

ENDS

About Epsilogen Ltd
Epsilogen is a global leader in the development of immunoglobulin E (IgE) antibodies to treat cancer. IgE’s natural function is to provide immunological defence against certain parasites. This functionality makes it an ideal treatment of solid tumours due to its strong potency, enhanced tumour access and long tissue half-life.

Epsilogen’s lead product candidate, MOv18 IgE, is the first therapeutic IgE antibody to enter the clinic and encouraging data from a completed Phase I trial demonstrated MOv18 IgE to be safe and well tolerated with early signs of clinical activity. Epsilogen has recently successfully completed large scale GMP manufacture of MOv18 IgE (the first time this has been achieved for an IgE antibody) and will initiate a Phase Ib trial in platinum-resistant ovarian cancer patients later this year. The company is also developing a pipeline of IgE therapies in oncology as well as proprietary platforms including IgE bispecifics and unique IgE/IgG combination antibody molecules (IgEGs) with enhanced functionality.

Epsilogen began operations in 2017 as a spin-out of King’s College London and has attracted venture capital financing from Epidarex Capital, Novartis Venture Fund, 3B Future Health, British Patient Capital, ALSA Ventures and Schroders Capital amongst others. Find out more at epsilogen.com.

For more information please contact:
Communications advisor to Epsilogen Ltd:

Ashley brings over 25 years’ experience in business and strategy development within the biopharmaceutical industry

Will spearhead partnering discussions as the company enters the next phase of its growth

Appointment is part of a broader expansion of Epsilogen’s team, facilities and core competencies

Dr David Chiswell is stepping down for personal reasons and will be replaced by current board member Dr Peter Finan

LONDON, 1 May 2024 – Epsilogen, a global leader in the development of immunoglobulin E (IgE) antibodies to treat cancer, today announces the appointments of Ashley Nagle as Chief Business Officer (CBO) and Peter Finan, currently a Non-Executive Director, as Non-Executive Chairman. The changes are made with immediate effect as part of a broader company expansion.

Ashley brings over 25 years of experience leading business and strategy development, licensing and deal-making within the biopharmaceutical industry. Most recently, Ashley served as VP of Business Development at RemedyBio, a discovery and development precision immunotherapy company. During his career Mr Nagle has worked with both small and large organisations, including Lonza Biologics, Almac Sciences, Fulcrum Pharma, OncoSynergy, NexGenix and SeaGull Therapeutics, where he was Chief Executive Officer. Ashley holds a BSc in Chemistry from University College Cork, an MSc in Analytical Chemistry and Environmental Sciences from the University of Aberdeen and an MBA from the University of Lincoln.

Ashley’s appointment comes amidst a broader company expansion that will enable Epsilogen to unlock the potential of both IgE antibodies and their engineered derivatives as an entirely new treatment modality for patients with cancer. Since the start of 2023, the company has expanded its management team with the appointments of Nick Robbins-Cherry as CFO, Andrew Calam as VP of Clinical Operations and Elizabeth Hardaker as VP of Biology. Over this period, Epsilogen has also built a world class scientific team based in state-of-the-art laboratories in West London. This investment has added internal core competencies in antibody discovery, evaluation, engineering, production and pharmacological assessment, all complementing its existing expertise within the IgE field.

Pete replaces Dave Chiswell as Non-Executive Chairman, who is stepping down for personal reasons after five years in the role. Pete has more than 30 years’ experience in drug discovery within the biopharmaceutical industry and is a Partner at Epidarex Capital. During his career Pete has also served as Global Head of the Respiratory Disease Area and Site Head for the Novartis Institute of BioMedical Research in the UK and as Executive Director of the Novartis Developmental and Molecular Pathways Platform based in Cambridge, Massachusetts. Pete holds a BSc and Ph.D. in Biochemistry and Molecular Biology from the University of Leeds.

Dr Tim Wilson, Chief Executive Officer of Epsilogen, commented: “I am delighted to welcome Ashley to the Epsilogen team. He has an excellent track record in business development within the biopharmaceutical industry and we expect his experience and insights to have an immediate impact. Epsilogen has made substantial progress over the last 12 months on all fronts and Ashley will spearhead our partnering discussions going forward.
I would like to thank Dave for all his passion and hard work in guiding Epsilogen as Non-Executive Chair over the last five years. His wealth of experience has been invaluable to the progress we have made so far, and we wish him the very best for the future. At the same time, I would like to welcome Pete on stepping up into the role. Pete has been a key member of the Epsilogen team for many years and was pivotal in its formation.”

Ashley Nagle, Chief Business Officer of Epsilogen, added: “I am excited to be joining a company with such a potentially disruptive therapeutic approach and one that has already generated encouraging early clinical and preclinical data. I look forward to working closely with Tim and the rest of the team to fully unlock the value of this class of antibodies and leverage my strategy and business development expertise to drive Epsilogen forward.”

Dr Dave Chiswell, outgoing Non-Executive Chairman of Epsilogen, said: “I have thoroughly enjoyed working with all of the Epsilogen team and am proud of what we have achieved together. The company is in excellent hands and is in a good position to execute the next phase of its development, as it pursues its ambition to revolutionise cancer treatment with IgE antibodies.”

ENDS

About Epsilogen Ltd
Epsilogen is a global leader in the development of immunoglobulin E (IgE) antibodies to treat cancer. IgE’s natural function is to provide immunological defence against certain parasites. This functionality makes it an ideal treatment of solid tumours due to its strong potency, enhanced tumour access and long tissue half-life. Epsilogen’s lead product candidate, MOv18 IgE, is the first therapeutic IgE antibody to enter the clinic and encouraging data from a completed Phase I trial demonstrated MOv18 IgE to be safe and well tolerated with early signs of clinical activity. Epsilogen has recently successfully completed large scale GMP manufacture of MOv18 IgE (the first time this has been achieved for an IgE antibody) and will initiate a Phase Ib trial in Platinum Resistant Ovarian Cancer Patients later this year. The company is also developing a proprietary IgEG antibody platform combining elements from both IgE and IgG antibodies into novel and proprietary antibody molecules with enhanced functionality.

Epsilogen began operations in 2017 as a spin-out of King’s College London and has attracted venture capital financing from Epidarex Capital, Novartis Venture Fund, 3B Future Health, British Patient Capital, ALSA Ventures and Schroders Capital amongst others. Find out more at epsilogen.com.

For more information please contact:

Communications advisor to Epsilogen Ltd:

Simon Conway
Senior Managing Director
FTI Consulting
epsilogen@fticonsulting.com
+44 (0)20 3727 1000

First time GMP manufacturing of a therapeutic IgE antibody has been achieved at scale

Lonza supported the expression and manufacturing of the MOv18 IgE antibody in less than ten months

LONDON, UK, and Basel, Switzerland, 5 February 2024 – Epsilogen, a global leader in the development of immunoglobulin E (IgE) antibodies to treat cancer, and Lonza, a global development and manufacturing partner to the pharma, biotech and nutrition industries, today announced successful completion of Good Manufacturing Practice (“GMP”) manufacturing of MOv18 IgE, Epsilogen’s lead IgE antibody drug candidate. This included process development and cGMP manufacturing of this complex molecule for clinical supply in less than ten months at Lonza’s Slough (UK) site.

IgE antibodies represent powerful alternatives to more commonly used IgG antibodies. They bring exciting opportunities for oncology thanks to their strong potency, long tissue half-life, and the ability to target tumour cells expressing very low antigen levels. Current research and monitoring indicate that this is the first time GMP manufacturing of a therapeutic IgE antibody has been completed at scale. Epsilogen intends to use this new material for its upcoming Phase Ib study in platinum-resistant ovarian cancer (PROC) patients, scheduled to start later in 2024.

Dr. Tim Wilson, Chief Executive Officer, Epsilogen, commented: “The successful GMP manufacture at scale of MOv18 IgE marks another major milestone in realizing the potential of IgE antibodies as a new and differentiated class of cancer therapies for the treatment of patients with solid tumours. Decades of technical achievement and financial investment have made GMP manufacture of the IgG class of therapeutic antibodies a routine process. Lonza and Epsilogen have worked together to apply Lonza’s knowledge and experience to MOv18 IgE. As a part of the IgE antibody class, it is structurally and functionally distinct from IgG. It is very gratifying to see this effort and investment pay off.

Having generated encouraging safety and tolerability data in our Phase I safety study for MOv18 IgE in patients with platinum-resistant ovarian cancer, we look forward to exploring further the signals of efficacy observed in that clinical trial and anticipate starting a Phase Ib efficacy study in this setting later in 2024. We remain optimistic about the potential of IgE antibodies as a new treatment modality to improve outcomes for patients with difficult-to-treat cancers.”

Stefan Egli, Global Head of Mammalian Biologics, Lonza, added: “This marks a significant milestone for Epsilogen, bringing its promising IgE-based product closer to the clinic. Having produced the GMP batch of this non-platform complex molecule under record time is also a statement that demonstrates the strategic value of our manufacturing services offering tailored to each molecule’s unique properties, and analytical and purification needs.”

MOv18 IgE targets the folate receptor alpha (FR alpha) antigen and Epsilogen believes that this was the first, and remains the only, IgE antibody in clinical development. Epsilogen has successfully completed a Phase I safety study of MOv18 IgE in platinum-resistant ovarian cancer patients where it was found to be safe and well-tolerated, with evidence of anti-tumour activity observed. This study and its results were reported in Nature Communications.

Final results of phase I study of MOv18 IgE in ovarian cancer published in Nature Communications
MOv18 IgE found to be safe and well tolerated with evidence of anti-tumour activity observed

London, 25 July 2023 – Epsilogen, a global leader in the development of immunoglobulin E (IgE) antibodies to treat cancer, notes the publication today of the final phase I data from the first ever clinical trial of an IgE antibody therapeutic in Nature Communications (https://www.nature.com/articles/s41467-023-39679-9). MOv18 IgE is Epsilogen’s lead IgE antibody drug candidate and binds to anti-folate receptor (FRα), a well validated target for ovarian cancer. It was administered to 26 patients with high grade serous ovarian carcinoma whose cancer had become platinum-resistant.

Results from the study, entitled “A Cancer Research UK phase I study of MOv18 IgE, a first in class chimeric IgE antibody against folate receptor-alpha, in patients with advanced solid tumours” (https://clinicaltrials.gov/ct2/show/NCT02546921), showed a manageable safety profile with transient urticaria being the most common adverse event. The urticaria always resolved within hours of dosing, either spontaneously or with the administration of systemic steroids and antihistamines.

Although the trial was not designed to demonstrate efficacy, tumour shrinkage and an associated fall in CA 125 tumour marker level was seen in one patient. Notably, the authors of the paper observed that the anti-tumour activity “occurred at doses very much lower than typically observed for IgG antibodies”, reflecting fundamental differences in Fc-receptor affinity and effector cell biology.

Professor James Spicer, Professor of Experimental Cancer Medicine at King’s College London, Consultant in Medical Oncology at Guy’s and St Thomas’ NHS Foundation Trust (GSTT) and the study’s lead investigator, said: “IgE is a completely new form of antibody therapy which has shown great promise in this phase I trial. Our findings show that the drug was well tolerated in patients and shrunk a cancerous tumour in a patient with ovarian cancer. The results pave the way to development of an entirely new class of anti-cancer drug for people with chemotherapy-resistant cancers. The immunology expertise in King’s College London laboratories allowed us to undertake this trial of a completely new form of antibody therapy.”

Dr Tim Wilson, Chief Executive Officer of Epsilogen, commented: “The data published in Nature Communications, are encouraging and add further validation to support our belief that IgE antibodies have the potential to emerge as an entirely new treatment modality for patients with cancer. We have a robust clinical development plan in place to progress MOv18 IgE further into the clinic and the data generated will assist us in the development of our other IgE antibody drug candidates”.

Research Paper Available Here

ENDS

About Epsilogen Ltd

Epsilogen is a global leader in the development of immunoglobulin E (IgE) antibodies to treat cancer. IgE’s natural function is to provide immunological defense against certain parasites. This functionality makes it an ideal treatment of solid tumours due to its strong potency, enhanced tumour access and long tissue half-life.

Epsilogen’s lead product candidate, MOv18 IgE, is the first therapeutic IgE antibody to enter the clinic and encouraging data from a completed phase I trial demonstrated MOv18 IgE to be safe and well tolerated with early signs of clinical activity. The company is also developing a proprietary IgEG antibody platform combining elements from both IgE and IgG antibodies into novel and proprietary antibody molecules with enhanced functionality.

Epsilogen began operations in 2017 as a spin out of King’s College London and has attracted venture capital financing from Epidarex Capital, Novartis Venture Fund, 3B Future Health, British Patient Capital, Alsa Ventures and Schroders Capital amongst others.

Find out more at epsilogen.com.

For more information please contact:

Communications advisor to Epsilogen Ltd:
Simon Conway
Senior Managing Director
FTI Consulting
simon.conway@fticonsulting.com
+44 (0)20 3727 1000