AOP Health’s First-in-class Investigational Cancer Drug Enters Phase 1 Trial
AOP Orphan Pharmaceuticals GmbH (AOP Health), in collaboration with Leukos Biotech, has reached a significant milestone in cancer therapy. The first patient has been enrolled in the phase I clinical trial SERONCO-1, investigating a novel drug candidate with a unique mechanism of action. This trial focuses on patients with solid tumors and lymphomas, building on AOP Health’s success in targeting cancer stem cells to address unmet medical needs.
A New Hope in Cancer Treatment
The novel compound, AOP208, blocks a protein on the surface of the cancer stem cell, the serotonin receptor 1B, which may prove to be critical to treating the root cause of the disease. Developed by Leukos Biotech and based on research from the Josep-Carreras Leukemia Research Institute, AOP208 is administered orally.
Ruth Risueño, Chief Scientific Officer at Leukos Biotech, emphasised the importance of this approach:
“We wanted to find a new way to attack cancer stem cells, as they are responsible for the initiation and maintenance of the tumor. Our work showed that the serotonin receptor is key to this process. Since no suitable molecule that could block the receptor existed, we invented a new one. Now we are thrilled to start a clinical trial and take our compound to the next level.”
Global Development and Commercial Rights
AOP Health has licensed AOP208 and holds exclusive global commercial rights, including in the USA, Europe, Korea, and Taiwan, excluding mainland China.
Understanding AOP208’s Safety and Tolerability
The first-in-human trial on AOP208, named the SERONCO-1 trial, led by Dr. Irene Braña at the Vall d’Hebron Institute of Oncology (VHIO), has begun enrolling patients with solid tumors (including metastatic cancer) and lymphomas. The trial is partially funded by the Spanish Ministry of Science and Innovation.
The treatment of the first patient with AOP208 marks a crucial step in understanding the drug’s safety and tolerability. SERONCO-1 will also explore AOP208’s impact on tumor proliferation.
Christoph Klade, Chief Scientific Officer of AOP Health, highlighted the significance of this research:
“AOP208 targets a receptor on cancer stem cells which has not been in the center of attention in cancer therapy so far, making it a first-in-class investigational drug in oncology. This pathway may have a role in several types of leukemia but importantly also various solid tumors including breast and lung cancer.”
In addition to SERONCO-1, AOP Health plans a second clinical trial on AOP208 for patients with acute myeloid leukemia, a cancer with a currently poor prognosis.
Martin Steinhart, CEO of AOP Health, reaffirmed the company’s commitment:
“We are committed to AOP Health’s founding idea of creating solutions for unmet patient needs in rare indications. We take this idea seriously, demonstrated by our investment of 25 million euros a year in research and development.”
This pioneering approach by AOP Health and Leukos Biotech offers new hope in the fight against cancer, targeting the disease at its roots and potentially transforming cancer therapy.
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