Epitopea Announces Approval of OVACT Clinical Trial Application for CryptiVax-1001 in Advanced High-Grade Serous Ovarian Cancer - Epitopea

Appoints Leading Oncologist Professor Susana Banerjee of The Royal Marsden as Chief Investigator CAMBRIDGE, UK and MONTREAL, CANADA, 23 April 2026 – Epitopea, a transatlantic biotech developing off-the-shelf, durable, RNA-based cancer immunotherapies, today announced that it has received approval from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) and the Regional Ethics Committee (REC) for its clinical trial application (CTA) for its first-in-human clinical trial (OVACT) of its lead program, CryptiVax™-1001, targeting advanced high-grade serous ovarian cancer. Epitopea also announces the appointment of Professor Susana Banerjee (MBBS MA PhD FRCP), a Consultant Medical Oncologist and Research Lead for the Gynaecology Unit at The Royal Marsden NHS Foundation Trust and Professor in Women’s Cancers at the Institute of Cancer Research, as Chief Investigator of the OVACT trial. Dr. Klaus Edvardsen, MD, Chief Medical Officer of Epitopea, commented, “We are excited by the achievement of this significant regulatory milestone, which is a credit to our dedicated clinical and wider Epitopea team. We also welcome Professor Banerjee to her role as Chief Investigator of our first clinical trial. Her world-class expertise in ovarian cancer and leadership in global clinical development will bring invaluable insights as we transition to a clinical-stage company.” OVACT is a Phase 1/1b dose escalation and expansion trial designed to evaluate the safety, tolerability, immunogenicity, and early clinical activity of CryptiVax™-1001 in HRP+/BRCA-wildtype high-grade serous ovarian cancer patients. High-Grade Serous Ovarian Cancer(HGSOC) remains one of the most difficult-to-treat solid tumors, with most patients (~80%) presenting with advanced or metastatic disease. While most women respond to first-line platinum chemotherapy, nearly all ultimately relapse and progress to platinum-resistant disease. Existing maintenance options leave a major therapeutic gap among HRP+/BRCA-wildtype patients, who represent roughly half of the ovarian cancer population. Professor Banerjee added: “There is a substantial unmet need in homologous recombination proficient (HRP) ovarian cancer, where available maintenance therapies deliver limited durable benefit. Epitopea’s CryptiVax™-1001 vaccine, which targets a novel repertoire of tumor-specific antigens, has the potential to meaningfully extend remission for patients with few effective treatment options.” Epitopea’s pipeline is enabled by CryptoMapTM, a proprietary discovery engine that identifies tumor-presented antigens arising from the dark genome, a previously inaccessible source of novel, tumor-specific targets. These antigens, known as CryptigensTM, demonstrate high inter-patient sharing, enabling development of true off-the-shelf mRNA immunotherapies. About Epitopea Epitopea is a transatlantic cancer immunotherapeutics company developing accessible, off-the-shelf RNA-based immunotherapies for hard-to-treat solid tumors. Epitopea’s pipeline is built on Cryptigen™ TSAs, a new class of tumor-specific antigens identified by CryptoMap™, the company’s proprietary immunopeptidomics and genomics platform that uncovers aberrantly expressed antigens arising from previously uncharacterised regions of the genome. The company’s lead candidate, CryptiVax™-1001, is an off-the-shelf mRNA therapeutic vaccine in development for high-grade serous ovarian cancer. It is designed to drive targeted immune responses using a set of tumor-specific antigens chosen for broad patient coverage. Many patients with advanced cancers, including high-grade serous ovarian cancer, have limited durable treatment options and few effective therapies beyond biomarker-selected populations. Epitopea aims to address this unmet need with broadly applicable, tumor-selective immunotherapies. Backed by leading life-science investors, Epitopea operates from Cambridge, UK, and Montreal, Canada. For more information, visit www.epitopea.com and follow the company on LinkedIn. For further information Epitopea Dr. Alan C. Rigby – CEO [email protected] Scius Communications (for Epitopea) Katja Stout +44 7789 435990 [email protected] Daniel Gooch +44 7747 875479 [email protected] Related News European Biotechnology Magazine By admin on June 11, 2026 RNA medicine enters its ­ second act By Joachim Eeckhout, June 11, 2026 INNOVATION The COVID-19 pandemic trans- formed RNA technologies into one of the […] Read more Drug Discovery World By admin on April 24, 2026 MHRA approves clinical trial for ovarian cancer therapy By Bruno Quinney, April 24, 2026 The UK’s Medicines and Healthcare products Regulatory […] Read more European Biotechnology Magazine By admin on April 23, 2026 Epitopea wins UK approval for therapeutic vaccine trial By Uta Mommert, April 23, 2026 CryptiVax-1001 is set to enter first-in-human testing […] Read more Revealing Novel Targets For Next Generation Immunotherapies Quick Links HomeAbout Us PlatformNews & Events Contact Information CareersDisclaimerPrivacy & Cookie Policy Terms & Conditions Follow us on social media © 2022 – 2026 Epitopea Ltd | All Rights Reserved Created by FDM Digital

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