The results of the first clinical trial in humans of Omomyc (OMO-103), a specific inhibitor of the oncogene MYC developed by Peptomyc, member company of CataloniaBio & HealthTech and a spin-off of the Vall d’Hebron Institute of Oncology (VHIO), demonstrate that the new drug is safe and shows promising antitumor activity. The study, published in the journal Nature Medicine, includes the results of this phase I trial as well as a deep molecular study of Omomyc, and the identification of potential biomarkers for the drug's activity.
Omomyc is a therapeutic protein developed through more than 20 years of work by Dr. Laura Soucek, ICREA Professor, director of the Experimental Therapies Program, head of the Antitumor Therapy Modeling Group at VHIO, and co-founder of the spin-off Peptomyc. She demonstrated in preclinical laboratory studies that this protein can enter cells and reaching their nucleus, where the oncogene MYC is located. Once in the nucleus, Omomyc inhibits MYC's ability to promote the growth of cancerous tumors.
"The objective of the study was to assess the drug's safety, which was found to be very well tolerated by patients with only mild side effects such as chills or nausea", explains Dr. Emiliano Calvo, medical oncologist at START-HM CIOCC and last author of the study along with Dr. Laura Soucek, co-founder of Peptomyc. "But even at very low doses, we already see clinical benefits in patients. In 8 out of 12 patients who underwent a CT scan after 9 weeks of treatment, we observed disease stabilization where tumor growth had halted."
Molecular characterization and biomarkers
"As this was the first time this drug was used in humans, one of our goals was to demonstrate that it indeed has an effect on its target MYC and to identify possible biomarkers", explains Dr. Laura Soucek, corresponding author of the study, who led all the molecular characterization of the drug's activity along with Peptomyc's co-founder Marie-Eve Beaulieu.
The researchers analyzed available tumor biopsies before and after treatment and confirmed that the transcriptional signature of MYC was modulated by the drug, demonstrating OMO-103's activity against the target, and that there was a direct and specific correlation between MYC deactivation and the clinical benefits for patients.
The results of OMO-103's first clinical trial in humans have led to the initiation of a currently active phase Ib clinical trial evaluating the drug's activity in combination with standard treatment in patients with metastatic pancreatic cancer.
Collaboration with Abzu for results analysis
Peptomyc collaborated with Abzu's team, also members of CataloniaBio & HealthTech, in analyzing the study's data. "Submitting Luminex data to QLattice technology allowed us to identify a predictive distinctive signature for disease stabilization in response to OMO-104, independent of the oncological indication or prior treatment," explain those at Abzu.
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