Epsilogen and Lonza Announce Successful Large-Scale GMP Manufacturing of MOv18, an IgE Antibody Targeting Ovarian Cancer

Epsilogen

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

GMP material to be used in Phase Ib study in platinum-resistant ovarian cancer (PROC) patients scheduled to start this year. Previously reported Phase I safety study results in PROC patients showed MOv18 IgE to be safe and well-tolerated, with early evidence of anti-tumour activity observed

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.

Epsilogen announces successful completion of first ever clinical trial of an IgE antibody; phase I data for MOv18 IgE demonstrates potential of IgE therapy in cancer

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

Epsilogen announces significant expansion of management team with three new senior hires

Appointments allow company to consolidate its position as a global leader in the discovery and development of IgE antibody-based therapeutics

London, 26 April 2023 – Epsilogen Ltd, a global leader in the development of novel immunoglobulin E (IgE) antibodies to treat cancer, announced three new senior hires in what is a significant expansion of their management team. Nick Robbins-Cherry joins as Chief Financial Officer, Andrew Calam as Vice President of Clinical Operations and Elizabeth Hardaker as Vice President of Biology.

Nick Robbins-Cherry, CFO, brings over 30 years of experience in fundraising, public markets and private equity, gained through financial and commercial roles in international pharmaceuticals and technology businesses. Most recently, Nick was CFO of Ixaka Ltd, a private cell and gene therapy company. Prior to this, Nick was CFO at Midatech Pharma PLC, a listed pharmaceutical business with operations in the UK and Spain. He successfully steered Midatech through its IPO on AIM, a dual listing on NASDAQ and subsequent fundraises. Nick is a Chartered Accountant and holds an MBA.

Andrew Calam, VP of Clinical Operations, has over 25 years of experience in the life sciences industry, holding both management and executive positions in the contract research organisation (CRO) and biotechnology sectors, leading and supporting pharmaceutical development. Andrew started his career within the bioanalytical space, before turning his focus to project management. He has a track record of leading multinational teams with responsibility for all aspects of clinical trial management from phase I to phase III trials. Prior to joining Epsilogen, Andrew worked as an Executive Director of Clinical Development at Syneos Health where he was responsible for the development, oversight, execution and management of several clinical programs for targeted cancer therapies.

Elizabeth Hardaker, VP of Biology, joins Epsilogen with over 15 years’ experience in the pharmaceutical industry. Most recently, Elizabeth was a Senior Director at AstraZeneca, leading a team supporting preclinical research in Oncology. Previously, Elizabeth worked at Evotec in the inflammation and immunology group, and Novartis in the respiratory group. Throughout her career Elizabeth has been the biology lead on a number of projects across the drug discovery process, ranging from target validation to clinical trials. Elizabeth has a PhD from the National Heart and Lung Institute, Imperial College and a Masters in Biochemistry from Bath University.

Tim Wilson, Chief Executive Officer of Epsilogen, commented:
“We are delighted to have Elizabeth, Andrew and Nick join our leadership team and we are pleased that we have been able to attract such high-calibre people to Epsilogen. They join the Company at an exciting stage of its development with lead asset MOv18 IgE having successfully completed a phase I clinical trial in ovarian cancer patients and progress being made within our IgE-based therapeutic platforms.”

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 phase I trial demonstrated MOv18 IgE to be safe and well tolerated with early signs of clinical activity also seen. The company is also developing a proprietary IGEGTM 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 investment funding from top tier investors including Epidarex Capital, Novartis Venture Fund, British Patient Capital, 3B Future Health Fund, ALSA Ventures and Schroders Capital. Find out more at epsilogen.com.

For more information please contact:

Communications advisor to Epsilogen Ltd:
Simon Conway / Rob Winder
FTI Consulting
epsilogen@fticonsulting.com
+44 (0)20 3727 1000

Epsilogen announces completion of oversubscribed £30.75 million ($41.20 million) Series B financing

Financing led by Novartis Venture Fund and joined by new investors 3B Future Health Fund, British Patient Capital, Schroders Capital and Caribou Property alongside founding investor Epidarex Capital and ALSA Ventures

Proceeds from the round will fund continued clinical development of MOv18 IgE in platinum-resistant ovarian cancer and will support further development of IgE-based antibody candidates to treat cancers

London, 2 March 2022 – Epsilogen Ltd, a global leader in the development of novel immunoglobulin E (IgE) antibodies to treat cancer, announced it has secured £30.75 million ($41.20 million) in an oversubscribed Series B financing round. The round was led by new investor Novartis Venture Fund and joined by new investors 3B Future Health Fund and British Patient Capital, Schroders Capital and Caribou Property. The new syndicate joins founding Series A investor Epidarex Capital and Series A investor ALSA Ventures both of whom also committed further capital in this Series B fundraising round. In connection with the closing of the financing, Dr Marianne Uteng of Novartis Venture Fund and Dr Marianne Bjordal of 3B Future Health Fund will join Epsilogen’s Board of Directors.

The proceeds from the financing will enable Epsilogen to establish clinical proof of concept for lead drug candidate MOv18 IgE in a phase Ib trial in platinum-resistant ovarian cancer, an aggressive cancer with poor treatment alternatives. MOv18 IgE targets the folate receptor alpha (FR alpha) antigen and is the world’s first IgE antibody to enter the clinic. Previously announced data from a phase I trial shows MOv18 IgE to be safe and well tolerated with early signs of clinical activity also seen.

The financing will also enable Epsilogen to progress the development of its proprietary IGEGTM antibody platform which combines elements from both IgE and IgG antibodies into novel and proprietary antibody molecules with enhanced functionality.

Dr Tim Wilson, Chief Executive Officer of Epsilogen, commented: “This significant, new financing round will not only fund demonstration of clinical Proof of Concept for MOv18 but also allow Epsilogen to maintain its position as the leading pioneer in the development of IgE therapeutic antibodies for the treatment of cancer. We are very pleased to have attracted new investors of the calibre of Novartis Venture Fund, 3B Future Health Fund, British Patient Capital, Schroders Capital and Caribou Property. We also appreciate the continued support and investment from our existing investors Epidarex Capital and ALSA Ventures.”

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 phase I trial demonstrated MOv18 IgE to be safe and well tolerated with early signs of clinical activity also seen. The company is also developing a proprietary IGEGTM 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 utilising the world class IgE expertise of Professor Sophia Karagiannis. Initial capital was provided by founding investor Epidarex Capital. Find out more at epsilogen.com.

 

About Novartis Venture Fund
Novartis Venture Fund is a financially driven corporate life science venture fund whose purpose is to foster innovation, drive significant patient benefit and generate superior returns by creating and investing in innovative life science companies at various stages of their development. For more information, go to nvfund.com.

 

About 3B FUTURE Health Fund II
3B Future Health Fund II S.C.A. SICAV-RAIF is a Luxemburg based investment fund with focus on early stage investment opportunities in Europe and the U.S. in areas of high unmet patient need, mainly oncology and rare disease therapeutics. The Fund is the second investment fund sponsored by Riccardo Braglia, Executive Chairman to Helsinn Group, a global pharmaceutical company headquartered in Lugano, Switzerland. For more information, visit: 3bfuturehealth.com.

 

About British Patient Capital
British Patient Capital is the trading name of British Patient Capital Limited, a wholly-owned commercial subsidiary of British Business Bank plc, the UK government’s economic development bank. It forms part of the British Business Bank’s plc’s commercial arm. Its mission is to enable long-term investment in innovative firms led by ambitious entrepreneurs who want to build large scale businesses. Launched in June 2018, British Patient Capital has £2.5bn to invest over 10 years in venture and venture growth capital to support high growth potential innovative UK businesses in accessing the long-term financing they require to scale up. Find out more at britishpatientcapital.co.uk

 

About Schroders Capital
Schroders Capital is a leading global private markets investor and part of Schroders Group. With over USD 70 billion assets under management, the firm manages a range of investment strategies, including private equity, private debt, real estate, infrastructure, securitised products and asset-based finance, insurance-linked securities and impact investing on behalf of institutions, consultants, family offices and individual investors. Schroders Capital operates out of 19 offices globally and employs over 500 professionals, combining global market coverage with local, on-the-ground presence. The private equity team of Schroders Capital provides its clients access to a broad range of private equity opportunities through direct, co-investment, secondaries and primary investments across buyout, growth and venture capital with a focus on fundamental value generation through transformational change. Sustainability is an integrated part of the firm’s investment process and Schroders Capital is rated A+ by the UNPRI. To learn more, please visit schroderscapital.com.

 

About Epidarex Capital
Epidarex Capital is a transatlantic venture capital firm with a track record of building exceptional life science companies in emerging hubs in the US and UK. Epidarex’s experienced team of early stage investors partner with entrepreneurs and leading research institutions to transform world-class science into highly innovative products addressing major unmet needs in the global healthcare market. For more information, visit epidarex.com.

 

About ALSA Ventures
ALSA Ventures is a London based venture capital firm with a focus on novel therapeutics. Supported by a team of highly experienced industry professionals, ALSA seeks to identify and work closely with pioneering entrepreneurs and scientists, complementing the operational strengths of the ALSA team with the vision and scientific excellence of the partners it works with. For more information, visit alsaventures.com.

For more information please contact:

Communications advisor to Epsilogen Ltd:
Simon Conway / Rob Winder
FTI Consulting
epsilogen@fticonsulting.com
+44 (0)20 3727 1000

Epsilogen Announces Formation of Clinical Advisory Board

Expert oncologists will work with Epsilogen to guide the clinical program for its lead candidate, MOv18 IgE

London, 9 November 2020 – Epsilogen Ltd, a global leader in the development of novel immunoglobulin E (IgE) antibodies to treat cancer, today announces the formation of its Clinical Advisory Board. Comprised of three distinguished gynaecologic oncologists, the advisory group will work closely with Epsilogen as it progresses MOv18 IgE, the company’s lead product, towards phase I/IIa clinical trials. The Clinical Advisory Board includes Dr Robert Coleman, Dr Susana Banerjee and Dr Thomas Herzog.

Dr Tim Wilson, Chief Executive Officer of Epsilogen, commented: “In Dr Coleman, Dr Banerjee and Dr Herzog, we are bringing aboard three of the world’s leading experts in ovarian and gynaecologic cancers. Their advice and guidance will be crucial as we embark on the next stage of Epsilogen’s development, in which our lead product MOv18 IgE will move to phase I/IIa clinical trials and closer to patients. We are thrilled to have formed this Clinical Advisory Board and we look forward to working with them closely over the coming years.”

Clinical Advisory Board Members

Dr Robert Coleman is Chief Scientific Officer at The US Oncology Network, one of the largest networks of integrated, community-based oncology practices in the US. Dr Coleman leads one of the largest research programs in the country drawing from a network of more than 1,000 experienced investigators and dedicated clinical staff who specialise in oncology clinical trials. Dr Coleman’s work has been published extensively in more than 600 peer-reviewed articles, book chapters and textbooks, including over 300 peer-reviewed articles. He is the current President of the International Gynaecologic Cancer Society and has served as President of the Society of Gynaecologic Oncology. He serves on the Board of Directors for GOG-Foundation as is Co-Director for GOG-Partners.

Dr Susana Banerjee, is a Consultant Medical Oncologist and Research Lead for the Gynaecology Unit at The Royal Marsden NHS Foundation Trust and Reader in Women’s Cancers at the Institute of Cancer Research, London, UK. Dr Banerjee has been involved in international specialist groups including the European Organisation for Research and Treatment of Cancer (EORTC) Executive Steering Committee for Gynaecological Cancers, and European Society of Medical Oncology (ESMO) Scientific Committee. She has led national and international trials, authored over 120 peer-reviewed articles and currently serves on the European Society of Medical Oncology (ESMO) Executive Board. Dr Banerjee graduated from Cambridge University and gained a PhD from the Institute of Cancer Research.

Dr Thomas Herzog is the Deputy Director of the University of Cincinnati Cancer Center and an endowed professor of Obstetrics and Gynaecology at the UC College of Medicine. Dr Herzog is a National Institutes of Health and American Cancer Society funded researcher with over 300 published manuscripts. Dr Herzog has served on the board of directors or leadership council of the Society of Gynaecologic Oncology, the Foundation for Women’s Cancer, American College of Surgeons Board of Governors, American Board of Obstetrics and Gynaecology, GOG Foundation and the International Gynaecologic Cancer Society.

About Epsilogen Ltd

Epsilogen is a global leader in the development of immunoglobulin E (IgE) antibodies to treat cancer. IgE has several key features that make it ideal for the treatment of solid tumours including greater potency, enhanced tumour access and a long tissue half-life.

Epsilogen’s lead product candidate, MOv18 IgE, is the first therapeutic IgE antibody to enter clinical trials and is currently in a phase I study sponsored by Cancer Research UK in ovarian cancer patients. Encouraging Interim data from this trial was presented at the AACR Virtual Annual Meeting in April, with results supporting for the first time, the safety and potential efficacy of an IgE antibody as a treatment for advanced cancer.

The company has raised Series A finance from Epidarex Capital, ALSA Ventures and the UCL Technology Fund.

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

Epsilogen announces further UK government funding for further development of a novel IgE antibody cancer immunotherapeutic

Company receives second Innovate UK Smart Grant
Collaboration with King’s College London

London, 21 October 2020 – Epsilogen Ltd, a global leader in the development of novel immunoglobulin E (IgE) antibodies to treat cancer, today announced the award of a £1 million Smart Grant from the UK’s innovation agency, Innovate UK. Epsilogen will collaborate with King’s College London and use the Smart Grant in a project to further develop the company’s novel cancer immunotherapeutic, EPS 201.

The project directly follows and is founded upon the outputs from Epsilogen’s previous Biomedical Catalyst Primer grant, which sought to move the Company’s EPS 201 programme closer to the clinic. EPS 201 is a novel IgE-based therapeutic targeting HER2 positive (HER2+ve) solid tumours, harnessing the potent IgE-mediated immune response already showing promise clinically with Epsilogen’s lead drug MOv18-IgE.

EPS201 could address a large unmet need in breast cancer patients with HER2+ve cancers that fail to meet the HER2 expression level needed for Herceptin treatment. Currently, these patients have a five-year survival of less than 70%, which is much lower than that for HER2 negative patients.

Epsilogen’s share of the grant is £0.7m, with the remaining £0.3m being used by King’s to fund the research scientist and laboratory team working on the project.

Dr Tim Wilson, Chief Executive Officer of Epsilogen, commented: “We are proud to have been awarded another grant from Innovate UK for our pioneering work developing IgE-based therapeutics. It is a recognition of our progress to date and the potential that our therapies have in treating patients with cancer. We are looking forward to continuing our very successful collaboration with King’s College London and Professor Karagiannis, whose ground-breaking work is the foundation of the company we are today.”

Dr Sophia Karagiannis, Professor of Translational Cancer Immunology and Immunotherapy from King’s College London, commented: “IgE therapies have a clear differentiation from IgG-based therapies, given their completely unique anti-cancer mode of action. Furthermore, EPS 201 has potential to address a large unmet need in breast cancer patients with HER2 positive cancers, making it an ideal candidate for further funding and investigation.”

 

About Epsilogen Ltd

Epsilogen is a global leader in the development of immunoglobulin E (IgE) antibodies to treat cancer. IgE has several key features that make it ideal for the treatment of solid tumours including greater potency, enhanced tumour access and a long tissue half-life.

Epsilogen’s lead product candidate, MOv18 IgE, is the first therapeutic IgE antibody to enter clinical trials and is currently in a phase I study in cancer patients with advanced solid tumours, principally ovarian. Encouraging Interim data from this trial was presented at the AACR Virtual Annual Meeting in April, with results supporting for the first time, the safety and potential efficacy of an IgE antibody as a treatment for advanced cancer.

The company has raised Series A finance from Epidarex Capital, ALSA Ventures and the UCL Technology Fund.

About King’s College London

King’s College London is one of the top 10 UK universities in the world (QS World University Rankings, 2018/19) and among the oldest in England. King’s has more than 31,000 students (including more than 12,800 postgraduates) from some 150 countries worldwide, and some 8,500 staff.

King’s has an outstanding reputation for world-class teaching and cutting-edge research. In the 2014 Research Excellence Framework (REF), eighty-four per cent of research at King’s was deemed ‘world-leading’ or ‘internationally excellent’ (3* and 4*).

About Innovate UK

Innovate UK is the UK’s innovation agency. It works with people, companies and partner organisations to find and drive the science and technology innovations that will grow the UK economy. For further information visit www.innovateuk.gov.uk

 

For more information please contact:

Communications advisor to Epsilogen Ltd:
Simon Conway
Senior Managing Director
FTI Consulting
simon.conway@fticonsulting.com

Epsilogen announces further UK government funding to develop next generation antibody treatments for ovarian cancer

Company receives grant from Innovate UK Smart Grant

London, 20 July 2020 – Epsilogen Ltd, a global leader in the development of novel immunoglobulin E (IgE) antibodies to treat cancer, today announced the award of a £0.5 million grant from the UK’s innovation agency, Innovate UK. Epsilogen will use the Smart Grant to further develop its proprietary novel IGEGTM platform and generate new therapeutic candidates to treat ovarian cancer.

IGEGTM antibodies combine key structural elements of both IgE and IgG antibodies into a novel and proprietary antibody structure. Uniquely, an IGEGTM antibody molecule is able to bind to both IgE receptors and IgG receptors thereby retaining the enhanced immunological potency of IgE but gaining additional functionality from the IgG molecule such as binding Natural Killer cells.

Epsilogen’s lead product candidate, MOv18 IgE, is the first therapeutic IgE antibody to enter clinical trials and is currently in a phase I study in cancer patients with advanced solid tumours, principally ovarian. Encouraging Interim data from this trial was recently presented at the AACR Virtual Annual Meeting in April, with results supporting for the first time, the safety and potential efficacy of an IgE antibody as a treatment for advanced cancer.

Dr Tim Wilson, Chief Executive Officer of Epsilogen, commented: “Epsilogen is a pioneer in the use of IgE antibodies and engineered IgE derivatives to treat cancer. We are very pleased to have been awarded our third grant from Innovate UK. Our goal is to harness the potency of the IgE-mediated immune response and thereby provide patients with new safe and effective treatment options for these serious diseases”.

 

About Epsilogen Ltd

Epsilogen is a global leader in the development of immunoglobulin E (IgE) antibodies to treat cancer. IgE has several key features that make it ideal for the treatment of solid tumours including greater potency, enhanced tumour access and a long tissue half-life.

The company has raised Series A finance from Epidarex Capital, ALSA Holdings and the UCL Technology Fund.

About Innovate UK

Innovate UK is the UK’s innovation agency. It works with people, companies and partner organisations to find and drive the science and technology innovations that will grow the UK economy. For further information visit www.innovateuk.gov.uk

For more information please contact:

Communications advisor to Epsilogen Ltd:
Simon Conway
Senior Managing Director
FTI Consulting
simon.conway@fticonsulting.com

Key Opinion Leader Webinar on IgE Antibodies to Treat Cancer

Lead therapeutic candidate MOv18 IgE is the world’s first IgE drug to enter clinical trials.

Epsilogen, a global leader in the development of immunoglobulin E (IgE) antibodies to treat cancer, hosted a Key Opinion Leader (KOL) webinar for the investment community on its IgE platform on Monday, June 29, 2020 at 11am ET (4pm BST).

Epsilogen to Host Key Opinion Leader Webinar on IgE Antibodies to Treat Cancer

Lead therapeutic candidate MOv18 IgE is the world’s first IgE drug to enter clinical trials

Live webinar and conference call on Monday June 29th @ 11am ET / 4pm BST

 

 

London, June 23, 2020 – Epsilogen, a global leader in the development of immunoglobulin E (IgE) antibodies to treat cancer, announced today that it will host a Key Opinion Leader (KOL) webinar for the investment community on its IgE platform on Monday, June 29, 2020 at 11am ET (4pm BST).

Epsilogen’s lead product candidate, MOv18 IgE, is in a Phase I clinical trial in folate receptor alpha positive cancer patients. This is the world’s first IgE drug to enter clinical trials. Interim data show that MOv18 IgE has an acceptable safety profile and a preliminary efficacy signal was also seen. Epsilogen has also developed the IGEG™ platform of hybrid IgE/IgG antibodies which combine the functionality of IgE and IgG antibodies into a single molecule.

The webinar will feature presentations by KOLs Bristi Basu, MD, University of Cambridge, and James Spicer, MD, King’s College London, who have together played a key role in advancing development of MOv18 IgE. Dr. Basu’s presentation will include highlights of the interim data from the ongoing Phase 1 clinical study of MOv18 IgE in ovarian cancer that were presented at the recent AACR Virtual Annual Meeting I.

The Epsilogen management team, led by Tim Wilson PhD, will discuss the company’s proprietary IgE technology platforms and will outline plans to further develop MOv18 IgE and other therapeutic candidates.

Drs. Basu and Spicer, as well as members of the Epsilogen management team, will be available for questions are the conclusion of the call.

Dial in & Webcast Information
Domestic: 877-705-6003
International: 201-493-6725
Conference ID: 13705401
Webcast: Click Here for Webcast

Bristi Basu, MD is a Cancer Research UK Consultant Medical Oncologist in Experimental Cancer Therapeutics at Cambridge University Hospitals NHS Trust (UK). She trained in Medicine at Oxford University before undertaking clinical specialty training in Medical Oncology at Cambridge. During this time, she completed a PhD in cancer cell biology and drug discovery at the University of Cambridge. She has worked with experimental cancer therapy agents in several early phase trials both at Addenbrooke’s Hospital, Cambridge and at the Drug Development Unit, Royal Marsden Hospital, Surrey.

James Spicer, MD is the Professor of Experimental Cancer Medicine, King’s College London, and Consultant in Medical Oncology, Guy’s and St. Thomas’ Hospitals London, UK. Dr Spicer is Professor of Experimental Cancer Medicine at King’s College London, and Consultant in Medical Oncology at Guy’s and St Thomas’ Hospitals. He runs the King’s Health Partners Cancer Early Phase Trials program. He is joint lead of the King’s Experimental Cancer Medicine Center, funded by Cancer Research UK/National Institute for Health Research. Dr Spicer’s interests include the care of patients with thoracic malignancies, including lung cancer and mesothelioma, and clinical trials in these diseases. His translational research focus is on novel treatment including immunotherapies. He is a member of CRUK’s New Agents Committee and other UK national funding panels.

About Epsilogen Ltd

Epsilogen is a global leader in the development of immunoglobulin E (IgE) antibodies to treat cancer. IgE has several key features that make it ideal for the treatment of solid tumours including greater potency, enhanced tumour access and a long tissue half-life.

The company has raised Series A finance from Epidarex Capital, ALSA Ventures and the UCL Technology Fund.

For more information, visit www.epsilogen.com

For more information please contact:

Tim Wilson
Chief Executive Officer
Epsilogen Ltd
tim@epsilogen.com
+44 (0)20 3657 7612

U.S. Investor Contact
Hans Vitzthum
hans@lifesciadvisors.com
Phone: +1 (617) 535-7743

 

Encouraging interim data from a phase 1 clinical study evaluating MOv18 IgE in cancer patients with advanced solid tumours presented at the AACR Virtual Annual Meeting

MOv18 IgE is the first therapeutic IgE antibody to enter clinical trials

Results support, for the first time, the safety and potential efficacy of an IgE antibody as a treatment for advanced cancer

London, 27 April 2020 – Epsilogen (formerly IGEM Therapeutics), a global leader in the development of immunoglobulin E (IgE) antibodies to treat cancer, today announces that encouraging interim data from the ongoing phase 1 clinical study of MOv18 IgE was presented at the American Association for Cancer Research (AACR) Virtual Annual Meeting I. Epsilogen recently in-licensed exclusive global rights to MOv18 IgE from Kings College London (KCL), UK.

Lead investigator, Professor James Spicer of KCL, presented results from the study, which is being funded, sponsored and conducted by Cancer Research UK’s Centre for Drug Development. The trial is evaluating MOv18 IgE, a first-in-class IgE antibody, specific for anti-folate receptor alpha (FR alpha), in patients with advanced cancer. The primary objectives of the study are safety and tolerability of the study drug, which is administered by intravenous (IV) infusion. Secondary objectives include anti-tumour activity, as measured by computed tomography (CT) scans and tumour markers.

Results were presented on the first 24 patients enrolled in the study. Most of these patients had ovarian cancer, the most common cancer in which FR alpha is overexpressed. MOv18 IgE, at the doses administered, was found to be well tolerated in almost all patients, with urticaria1 being the most frequently observed adverse event. Importantly, given the role of IgE in mediating allergic reactions, only one patient exhibited any symptoms of anaphylaxis (500 μg dose). The episode was quickly resolved using standard management. This patient was the only one out of the 24 treated to date with a positive baseline basophil2 activation test (BAT). BAT is a flow cytometry-based in vitro assay, in which expression of activation markers is measured on the surface of basophils in whole patient blood following stimulation with IgE antibody. A positive baseline BAT assay has been used as an exclusion criterion for patients enrolled subsequent to the single anaphylaxis event. The investigators believe that the BAT could be employed as a risk mitigator for anaphylaxis in further studies with the drug.

The phase 1 study was not designed to assess efficacy as the primary endpoint. However, the investigators believe that there was a transient signal of anti-tumour activity in CT scans and in a temporary CA125 biomarker decrease for one patient with ovarian cancer, where their ascites3 were also reduced.

Professor James Spicer, of KCL and lead investigator of the phase 1 study said: “This phase 1 study, evaluating MOv18 IgE in advanced cancer patients, is the first time in which an IgE antibody has been tested in humans as a potential therapeutic. I believe that the encouraging data generated in this trial support the safety and potential efficacy of IgE as new class of antibody treatment for cancer.”

Dr Tim Wilson, Chief Executive Officer of Epsilogen commented: “This data, presented at the prestigious AACR conference, builds on compelling preclinical data and provides the strongest suggestion to date that IgE antibodies can viably form the basis of an efficacious new class of biologic. We believe that IgE antibody therapeutics potentially offer significant advantages over those based on IgG, which currently account for over $120bn in worldwide drug sales – especially in the treatment of solid tumours. These include greater potency, better tumour access and longer tissue half-life.

“Following Epsilogen’s recent in-licensing of MOv18 IgE, the Company look forward to progressing the further clinical development of this promising new treatment for ovarian cancer.


The presentation abstract can be found here
The slides presentation by Prof Spicer are available here

Outline of the Phase 1 study (NCT number: NCT02546921)

This multi-centre, dose escalation, phase 1 study, enrols patients with histologically, or cytologically-proven, advanced, unresectable solid tumours where FR alpha on their tumour was detected in a previous biopsy. Eligible patients must also have adequate organ function and no history of severe allergy. Additionally, patients must not require concomitant medication, or have comorbidities, that increase the risk of anaphylaxis. Patients are being administered their allocated dose of MOv18 IgE by IV infusion. Per protocol, following baseline assessment, patients initially receive drug once weekly for six weeks. Following an interim CT assessment, patients may then go on to receive three additional maintenance drug dose, every two weeks. The primary objectives of the study are safety and tolerability of the study drug. Secondary objectives are anti-tumour activity, as measured by CT scanning and/or tumour markers. To date, patients have been assigned to six different dose cohorts ranging from 70μg to 3mg.

1 – hives
2 – a type of white blood cell
3 – a build up of fluid in the lining of the abdomen and a common issue in patients with advanced ovarian cancer

END

About Epsilogen Ltd (formerly IGEM Therapeutics)

Epsilogen is a global leader in the development of immunoglobulin E (IgE) antibodies to treat cancer. IgE has several key features that make it ideal for the treatment of solid tumours including greater potency, enhanced tumour access and a long tissue half-life.

The company has raised Series A finance from Epidarex Capital, ALSA Ventures and the UCL Technology Fund.

For more information, visit www.epsilogen.com

 

About King’s College London

King’s College London is one of the top 10 UK universities in the world (QS World University Rankings, 2018/19) and among the oldest in England. King’s has more than 31,000 students (including more than 12,800 postgraduates) from some 150 countries worldwide, and some 8,500 staff.

King’s has an outstanding reputation for world-class teaching and cutting-edge research. In the 2014 Research Excellence Framework (REF), eighty-four per cent of research at King’s was deemed ‘world-leading’ or ‘internationally excellent’ (3* and 4*).

World-changing ideas. Life-changing impact: https://www.kcl.ac.uk/news/headlines.aspx

 

About Cancer Research UK’s Centre for Drug Development

Cancer Research UK has an impressive record of developing novel treatments for cancer. The Cancer Research UK Centre for Drug Development has been pioneering the development of new cancer treatments for more than 25 years, taking over 160 potential new anti-cancer agents into clinical trials in patients. It currently has a portfolio of around 20 new anti-cancer agents in preclinical development, Phase I or early Phase II clinical trials. Six of these new agents have made it to market including temozolomide for brain cancer, abiraterone for prostate cancer and rucaparib for ovarian cancer. Two other drugs are in late development Phase III trials.

 

About Cancer Research UK

  • Cancer Research UK is the world’s leading cancer charity dedicated to saving lives through research.
  • Cancer Research UK’s pioneering work into the prevention, diagnosis and treatment of cancer has helped save millions of lives.
  • Cancer Research UK receives no funding from the UK government for its life-saving research. Every step it makes towards beating cancer relies on vital donations from the public.
  • Cancer Research UK has been at the heart of the progress that has already seen survival in the UK double in the last 40 years.
  • Today, 2 in 4 people survive their cancer for at least 10 years. Cancer Research UK’s ambition is to accelerate progress so that by 2034, 3 in 4 people will survive their cancer for at least 10 years.
  • Cancer Research UK supports research into all aspects of cancer through the work of over 4,000 scientists, doctors and nurses.
  • Together with its partners and supporters, Cancer Research UK’s vision is to bring forward the day when all cancers are cured.

For further information about Cancer Research UK’s work or to find out how to support the charity, please call 0300 123 1022 or visit www.cancerresearchuk.org. Follow us on Twitter and Facebook.

 

For more information please contact:

Tim Wilson
Chief Executive Officer
Epsilogen Ltd
tim@epsilogen.com
+44 (0)20 3657 7612

Communications advisor to Epsilogen:
Simon Conway
FTI Consulting
epsilogen@fticonsulting.com
+44 (0)20 3727 1000