SERHEMA-1: AOP Health Investigates New Therapeutical Approach for Challenging Blood Cancers
AOP Health has launched the phase 1 clinical trial SERHEMA-1 to evaluate the investigative drug candidate AOP208 in patients with acute myeloid leukemia (AML) and high-risk myelodysplastic syndrome (MDS). The study marks a key milestone in the clinical development of the first-in-class oral therapy candidate targeting the serotonin receptor 1B (HTR1B).
Vienna, 08.06.2026. AOP Health has launched the phase 1 clinical trial SERHEMA-1 to evaluate the investigative drug candidate AOP208 in patients with acute myeloid leukemia (AML) and high-risk myelodysplastic syndrome (MDS), which are severe forms of cancer. This “first-in-class” approach marks a key milestone in the progression of the clinical development program for AOP208, which began with the first-in-human trial SERONCO-1 and builds on AOP Health’s expertise in delivering cancer stem-cell targeting agents.
AOP208 is an innovative, orally administered, potential new therapy which inhibits the serotonin receptor 1B (HTR1B). This target plays a role in tumor cell survival and treatment resistance but has not previously been exploited in cancer therapy. Preclinical data and early clinical safety data demonstrate the potential for further development of AOP208 in patients with relapsed/refractory AML and high-risk MDS, who have limited treatment options.
The initial AOP208 trial, SERONCO-1 (EU CT No: 2023-509532-25-00) in patients with solid tumors or lymphoma is being conducted in the Vall d’Hebron Institute of Oncology in Barcelona in a collaboration between AOP Health and Leukos Biotech with partial funding from Public-Private Collaboration initiative (CPP2021-008715) from the Spanish Ministry of Science and Innovation.
“After successfully advancing our phase I trial in solid tumors, we are now expanding development in blood cancers. AOP208 has a novel mechanism of action with potential for targeting leukemic stem cells and the tumor microenvironment in the bone marrow niche. Now we are thrilled to start a clinical trial and further investigate our compound’s potential,” says Dr. Christoph Klade, Chief Scientific Officer of AOP Health.
Phase 1 Clinical Trial SERHEMA-1 Treats First Patient
The first patient has begun treatment with AOP208 in SERHEMA-1 (EU CT No: 2025-523396-38-00), a phase I/II trial in relapsed or refractory AML and high-risk MDS. This study is taking place in specialized centers in Spain and Austria and is sponsored by AOP Health. Initiation of the SERHEMA-1 trial represents a significant step towards understanding the safety and tolerability of AOP208.
“Advancing research in rare diseases is central to our mission. We are pleased to contribute our scientific expertise to a clinical program that seeks to expand knowledge and offer therapeutic options in an area of high unmet medical need in hemato-oncology,” says Dr. Zoltan Magyarics, Vice-President of Research & Development at AOP Health.
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