GREENWICH, CONN. February 25, 2021
OncoSynergy announced that it has submitted an FDA application for a first-in-human trial of its Orphan Drug designated experimental therapeutic OS2966 for malignant brain cancer.
OncoSynergy, a venture-backed oncology company launched from UCSF and the JLABS South San Francisco incubator, announced that it has submitted an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) for the initiation of a phase I clinical study of OS2966 in patients with recurrent/progressive glioblastoma.
OS2966 is the first-ever clinical-ready CD29 antibody under development for the treatment of diverse cancers. In particular, OncoSynergy has demonstrated the preclinical potential of OS2966 in the setting of treatment resistant malignancies and in unique immunotherapy combinations. The FDA has granted 2 Orphan Drug Designations for OS2966 including in the treatment of glioblastoma, the most common malignant primary brain cancer in adults.
As a patient-focused company founded by physicians, OncoSynergy has been committed to advancing solutions to address dire unmet medical needs. “This IND submission marks a major advancement in OncoSynergy’s mission to bring novel therapeutics from the bench to the bedside of patients suffering from the most formidable diseases,” said Chief Medical Officer and Co-Founder of OncoSynergy, Anne-Marie Carbonell, MD. “We are thrilled to emerge as a clinical-stage company, but most importantly, we look forward to bringing OS2966 to patients with glioblastoma.”
OncoSynergy has forged a strategic alliance with Infuseon Therapeutics, a spinout of the Cleveland Clinic. The Infuseon Cleveland Multiport Catheter (ICMC), a cutting-edge FDA 510(k) cleared medical device, will be used to deliver OS2966 to the site of disease. Michael Vogelbaum, MD, PhD, Chief Medical Officer of Infuseon Therapeutics and Program Leader of Neuro-Oncology and Chief of Neurosurgery at Moffitt Cancer Center, is an inventor of ICMC. He stated, “This two-part trial represents an innovative therapeutic approach for tackling this difficult disease and we are excited to take the collaboration with OncoSynergy to the next level.”
OS2966 was manufactured in partnership with AGC Biologics A/S, a world-class contract development and manufacturing organization. “AGC Biologics is very pleased to have supported OncoSynergy in preparation for clinical trials with their innovative oncology molecule, OS2966 and we look forward to continuing the partnership with positive outcomes from these trials,” said Gustavo Mahler, PhD, President and CEO of AGC.
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