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.
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: https://clinicaltrials.gov/study/NCT06650514.
About Peptomyc
Peptomyc (www.peptomyc.com) is a spin-off from VHIO – the Vall d’Hebron Institute of Oncology – and ICREA – the Catalan Institute of Research and Advanced Studies, founded in December 2014 in Barcelona, Spain. The company is focused on the development of innovative cell penetrating mini-proteins targeting the MYC oncoprotein for cancer treatment and based on Dr. Soucek’s scientific research in Omomyc (the best direct MYC inhibitor known to date). It is the first company to have successfully completed a Phase 1 clinical trial with a direct MYC inhibitor.
Disclosures Regarding Forward-Looking Statements
Peptomyc is including the following cautionary statement in this document to make applicable and take advantage of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 (or equivalent law) for any forward-looking statements made by, or on behalf of, the Company. Forward-looking statements include statements concerning plans, objectives, goals, projections, strategies, future events or performance, and underlying assumptions and other statements which are other than statements of historical facts. Certain statements contained herein, including, without limitation, those that are identified by the use of the words “anticipates,” “estimates,” “expects,” “forecasts,” “intends,” “plans,” “predicts,” “projects,” “believes,” “seeks,” “will,” “may” and similar expressions, are “forward-looking statements”. Forward-looking statements involve risks and uncertainties, which could cause actual results or outcomes to differ materially from those expressed in the forward-looking statements. The Company’s expectations, beliefs and projections are expressed in good faith and are believed by the Company to have a reasonable basis, but there can be no assurance that management’s expectations, beliefs, or projections will result or be achieved or accomplished.