Proof-of-concept study to evaluate the safety, tolerability and efficacy of MOv18 IgE in patients with platinum-resistant ovarian cancer

LONDON, 3 December 2024 – Epsilogen, the global leader in the development of immunoglobulin E (IgE) antibodies to treat cancer, today announces that it has commenced a Phase Ib study evaluating MOv18 IgE in patients with platinum-resistant ovarian cancer (PROC).

The Phase Ib, open-label, dose escalation and expansion trial (NCT06547840) will enrol 45 patients with PROC whose disease has progressed after no more than four lines of prior therapy. The trial will assess the safety, tolerability and efficacy of MOv18 IgE in ascending dose cohorts.

MOv18 IgE is an IgE antibody targeting the folate receptor alpha (FR alpha) antigen which is selectively expressed by a variety of cancers including ovarian, non-small cell lung, endometrial and triple negative breast cancer. It is the first ever IgE antibody therapeutic to enter clinical testing and the Phase Ib trial will generate extensive translational data to allow further understanding of IgE’s unique mechanism of action in man. A previous Phase I safety study of MOv18 IgE found it to be safe and well tolerated, with evidence of anti-tumour activity observed, as reported in Nature Communications (https://www.nature.com/articles/s41467-023-39679-9).

Dr Tim Wilson, CEO of Epsilogen, said: “We are pleased to have initiated the Phase Ib study of MOv18 IgE, following the encouraging Phase I data. This is a key step in our goal of bringing this exciting new therapeutic modality to cancer patients”.

ENDS

About Epsilogen Ltd

Epsilogen is the global leader in the development of immunoglobulin E (IgE) antibodies to treat cancer. IgE possesses highly potent immune effector function underpinning its natural role in providing defence against animal venoms and certain parasites. IgE-activated macrophages permeate tumours, drive antibody-dependent cell-mediated cytotoxicity (ADCC) and phagocytosis (ADCP) and release pro-inflammatory mediators including IL-6, IL-1 β, CXCL10 and CCL2. This warms up the tumour microenvironment (TME) attracting and activating CD4+ and CD8+ T cells which destroy the tumour. IgE’s unique and multifaceted mechanism of action is ideal for the treatment of solid tumours.

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 found it to be safe and well tolerated with early signs of clinical activity. Epsilogen has initiated a Phase Ib trial in platinum-resistant ovarian cancer patients. The company is also developing a pipeline of IgE antibodies 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/Tim Stamper/Amy Byrne
FTI Consulting
epsilogen@fticonsulting.com
+44 (0)20 3727 1000

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:

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.