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EPICS Therapeutics Announces First Cohort Dosed with EP102 in First-In-Patient Oncology Trial and Securement of Additional Financing

Gosselies, Belgium - September 22nd, 2025

EPICS Therapeutics announces a new stage of development with the start of its first-in-patient clinical trial of EP102, a proprietary oral METTL3 inhibitor for the treatment of solid tumors. The recruitment of the first cohort is completed and all patients have started treatment. In parallel, the company has secured additional financing, ensuring resources to progress the program to its key clinical endpoints by the end of 2027.

Summary

• This First-in-Patient trial is approved across 12 hospitals in 5 European countries, with up to 78 patients targeted for enrolment.

• Preclinical studies indicate that EP102 has the potential to be best-in-class and an effective therapy for the treatment of ovarian, lung, breast, and pancreatic tumors where a significant unmet medical need remains.

• Additional support from EPICS’ investor base ensures that the company has sufficient runway to obtain clinical endpoints planned in 2027.

  Reflecting on the importance of this step for patients and the company, Graeme Fraser, PhD, CEO, said: “EP102 represents a new approach for the treatment of cancer emerging from the nascent field of RNA epigenetics.

  The science behind EP102

  EP102 is a potent, orally available small molecule inhibitor of METTL3, the enzyme responsible for catalyzing N6-methyladenosine (m6A), the most abundant mRNA modification. m6A regulates cellular proliferation and lineage determination. In cancer, METTL3 is often overexpressed and, in addition, m6A is abundantly expressed in certain tumor types, consequently driving tumor growth and malignant cell survival.

  METTL3 works like an editor for the cell’s instruction manual. By placing tiny chemical marks (m6A) on messenger RNA, METTL3 influences protein synthesis and, in turn, directs cell fate — whether to grow, divide, or specialize. When METTL3 goes into overdrive, as is the case in cancer cells, the result is a flood of signals instructing cells to keep multiplying, fueling tumor growth. EP102 is designed to block this overactivity, thereby reducing the excess signaling and restoring cellular control.

  “It is an honor to collaborate with sites that truly understand the challenges that come with executing such complicated clinical trials. We express our gratitude to study participants and their families for taking part. We expect that EP102 will provide a treatment benefit to cancer patients that are underserved by current treatment options. Our current trial prioritizes tumor types where we believe METTL3 to be particularly implicated,” said Steven Ramael, MD, Director of Clinical Development.

  About the EP102 First-in-Patient trial

  The ongoing first-in-patient trial of EP102 is designed to evaluate safety and pharmacokinetics in up to 78 patients with advanced solid tumors expected to respond to therapies that target DNA damage response pathways.

  The trial was approved in July 2025 via the EU Clinical Trials Information System (CTIS, EU CT#2025-521305-40) and is being conducted at up to 12 clinical sites across Belgium, the Netherlands, Spain, Czech Republic, and France. Preliminary safety and pharmacokinetic data from initial cohorts are expected in Q2 2026. The treatment phase of the study is anticipated to be fully completed in Q4 2027.

  The study is also registered on ClinicalTrials.gov (Identifier: NCT07163325) for international reference.

  About EPICS Therapeutics

  Epics Therapeutics is a clinical-stage Belgian, private, drug discovery and development company that invents and develops small molecule drugs targeting RNA epigenetics* and G- Protein Coupled Receptor* mechanisms involved in cancer development. By targeting these mechanisms, Epics Therapeutics aims to translate science into life-changing therapies for patients.

  The current financing round was led by Newton BioCapital with participation from existing investors including Wallonie Entreprendre (WE), SFPIM, BioCap, Fund+ and BNP Paribas Fortis Private Equity.

  *RNA epigenetics refers to the post-genomic changes in protein synthesis directed by chemical marks added to RNA molecules, such as N6-methyladenosine (m6A). These marks do not change the genetic code itself, but they influence how the instructions in RNA are read and used to make proteins. In healthy cells, this helps regulate growth and differentiation. In cancer, these marks are applied in an aberrant manner, tipping the balance toward uncontrolled cell proliferation.

  *G-protein coupled receptors are a large family of receptors expressed on the cell surface that respond to signals like hormones, neurotransmitters, or metabolites. When activated, they trigger G-proteins in the cell membrane to transduce signals inside the cell that affect how the cell behaves with application to a broad range of physiological outputs, including in the field of cancer.

  For more information, visit www.epicstherapeutics.com