MOv18 IgE / Epsilogen, Cancer Research UK - LARVOL DELTA

A phase Ib, open-label trial of MOv18 IgE in patients with advanced ovarian cancer. (ASCO 2025) - P1 | "Clinical Trial Registration Number: NCT06547840 The abstract will be released to the public on May 22, 2025 at 5:00 PM EDT"

Clinical • Metastases • Oncology • Ovarian Cancer • Solid Tumor

Epsilogen Announces Acquisition of TigaTx, Inc. to Create World’s Leading Pan-Isotype Cancer Antibody Company (Businesswire) - "Epsilogen...announces that it has completed the acquisition of TigaTx, Inc., a biotechnology company developing engineered immunoglobulin A (IgA) antibodies, to create the world’s leading pan-isotype cancer antibody company....The acquisition bolsters Epsilogen’s pipeline by adding EPS 401 (formerly TIGA-001), an anti-EGFR IgA antibody, scheduled to enter the clinic in 2026. MOv18 IgE is currently in a Phase Ib trial for treatment of platinum-resistant ovarian cancer (PROC)."

M&A • New trial • Platinum resistant • Ovarian Cancer

Hyperinflammatory repolarisation of ovarian cancer patient macrophages by anti-tumour IgE antibody, MOv18, restricts an immunosuppressive macrophage:Treg cell interaction. (PubMed, Nat Commun) - "We demonstrate that IgE induces hyperinflammatory repolarised states of patient-derived macrophages to inhibit Treg cell immunosuppression. These processes may collectively promote immune activation in ovarian cancer patients receiving IgE therapy."

Journal • Epithelial Ovarian Cancer • Gynecologic Cancers • Oncology • Ovarian Cancer • Solid Tumor • CD68 • CD8 • FOLR1

Non-Allergic Urticarial Skin Reactions Associated With MOv18 IgE, a First-In-Class IgE Antibody Recognising Folate Receptor Alpha. (PubMed, Allergy) - P1 | "Urticarial skin reactions following MOv18 IgE treatment were unlikely to result from allergic mechanisms or skin antigen recognition. The clinical presentation is consistent with infusion-related reactions commonly observed with monoclonal antibody treatments."

Journal • Allergy • Dermatology • Immunology • Oncology • Urticaria • FOLR1

A Phase Ib, Open-Label Trial Of MOv18 IgE In Patients With Advanced Ovarian Cancer (ESGO 2025) - "Treatment will continue until disease progression, unacceptable toxicity, withdrawal of consent or death.A range of translational endpoints will be evaluated. Primary objectives are to evaluate the safety and tolerability of MOv18 IgE and make a preliminary assessment of efficacy in PROC.NCT06547840Results Trial ongoingConclusion Trial ongoing"

Clinical • Metastases • Breast Cancer • Oncology • Ovarian Cancer • Solid Tumor • Triple Negative Breast Cancer • FOLR1

Physiochemical and functional evaluation of the first-in-class anti-cancer IgE antibody drug, MOv18, through process development and good manufacturing practice production. (PubMed, MAbs) - "Furthermore, we screened patient blood ex vivo for potential type I hypersensitivity reaction to MOv18 IgE, using the basophil activation test, to identify patients not predicted to be hypersensitive to MOv18 IgE administration. This study supports the production of functionally active clinical grade (IMP) recombinant IgE and paves the way for the development of a new therapeutic antibody class for a range of antigenic specificities and disease settings."

Journal • Immunology • Oncology

Epsilogen Announces Initiation of Phase Ib Trial of MOv18 IgE (Businesswire) - "Epsilogen...announces that it has commenced a Phase Ib study evaluating MOv18 IgE in patients with platinum-resistant ovarian cancer...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."

Trial status • Ovarian Cancer

A Study of MOv18 IgE in Folate Receptor Alpha-expressing Platinum Resistant Ovarian Cancer (clinicaltrials.gov) - P1 | N=45 | Recruiting | Sponsor: Epsilogen Ltd | Not yet recruiting ➔ Recruiting

Enrollment open • Metastases • Oncology • Ovarian Cancer • Solid Tumor

Epsilogen Completes £12.5 Million Series B Financing Expansion (Businesswire) - "Epsilogen...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."

Financing • Gynecologic Cancers • Oncology • Ovarian Cancer • Solid Tumor

Systematic mutational analysis reveals an essential role of N275 in IgE stability. (PubMed, Biotechnol Bioeng) - "However, the ongoing clinical trial of MOv18 IgE has highlighted the potential of using IgE antibodies in cancer therapy...In summary, our study unveils an intricate relationship between N-glycosylation sites and the structural-functional dynamics of IgE antibodies. Furthermore, it offers novel insights into the IgE scaffold, paving the way for the development of more effective and stable IgE-based therapeutics."

Biomarker • Journal • Oncology

A Study of MOv18 IgE in Folate Receptor Alpha-expressing Platinum Resistant Ovarian Cancer (clinicaltrials.gov) - P1 | N=45 | Not yet recruiting | Sponsor: Epsilogen Ltd

Metastases • New P1 trial • Oncology • Ovarian Cancer • Solid Tumor

Epsilogen announces CTA approval for Phase Ib trial of MOv18 IgE in platinum-resistant ovarian cancer (Businesswire) - "Epsilogen...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)."

New P1 trial • Ovarian Cancer

Epsilogen and Lonza Announce Successful Large-Scale GMP Manufacturing of MOv18, an IgE Antibody Targeting Ovarian Cancer (Businesswire) - "Epsilogen...and Lonza...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."

Commercial • Ovarian Cancer

Safety and anti-tumour activity of the IgE antibody MOv18 in patients with advanced solid tumours expressing folate receptor-alpha: a phase I trial. (PubMed, Nat Commun) - P1 | "The safety profile is tolerable and maximum tolerated dose has not been reached, with evidence of anti-tumour activity observed in a patient with ovarian cancer. These results demonstrate the potential of IgE therapy for cancer."

Journal • Metastases • P1 data • Dermatology • Immunology • Oncology • Ovarian Cancer • Solid Tumor • Urticaria • FOLR1

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 (Businesswire) - P1 | N=26 | NCT02546921 | "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...Results from the study...showed a manageable safety profile with transient urticaria being the most common adverse event....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."

P1 data • Gynecologic Cancers • Oncology • Ovarian Cancer • Solid Tumor