On March 11, 2025 Peptomyc SL, a Spanish clinical-stage biotech company spin-off of the Vall d’Hebron Institute of Oncology (VHIO) and the Catalan Institute of Research and Advanced Studies (ICREA) in Barcelona, reported that in February the first patient of its Phase 2 clinical trial in pediatric and adult patients with advanced osteosarcoma was successfully treated with OMO-103, the first direct pan-Myc inhibitor to have successfully completed a Phase 1 clinical trial (Press release, Peptomyc, MAR 11, 2025, View Source [SID1234651072]).
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This investigator-initiated trial conducted by VHIO in Barcelona, Spain, is sponsored by The Osteosarcoma Institute (OSI), whose mission is to dramatically increase treatment options and survival rates in osteosarcoma patients through identifying and funding the most promising and breakthrough osteosarcoma clinical trials and science. This trial is also supported in collaboration with Curing Kids Cancer, The Morgan Adams Foundation, and The Kristen Ann Carr Fund.
Dr. Claudia Morales Valverde, Senior Researcher of the Genitourinary, Central Nervous System (CNS) Tumors, Sarcoma, and Cancer of Unknown Primary Site Group at VHIO in Barcelona and Principal Investigator of the trial said, "This is the first use of a MYC inhibitor in osteosarcoma patients, and we are glad to conduct this seminal study at the Vall d’Hebron Institute of Oncology (VHIO) – Vall d’Hebron University Hospital." Peptomyc Chief Medical Officer, Dr. Manuela Niewel added, "MYC is an oncogene deregulated in the majority of human cancers and especially amplified in osteosarcomas. Inhibiting MYC with OMO-103, we hope to make a difference for this underserved patient population."
Peptomyc Chief Executive Officer, Dr. Laura Soucek concluded "We are extremely grateful to the OSI and VHIO for this study and for having enabled this important milestone for osteosarcoma patients."
The Phase 2 trial (OSTEOMYC) aims at evaluating the safety and clinical activity, pharmacodynamics, and pharmacokinetics of OMO-103 in advanced osteosarcoma. The primary efficacy endpoint is progression-free survival (PFS) at 16 weeks per RECIST criteria. Secondary endpoints include Overall Response Rate (ORR) per RECIST and overall survival. The trial is enrolling patients at Vall d’Hebron University Hospital in Barcelona, Spain. More information about the trial is available at: View Source