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April 2019

FDA Acceptance of IND Application for Phase I Trial of OS2966 in Patients with Recurrent Glioblastoma

By | news

OncoSynergy, Inc., a patient-focused oncology company committed to advancing therapeutics to address dire unmet medical needs, announced today that the U.S. Food and Drug Administration (FDA) has accepted its Investigational New Drug (IND) application for OS2966, a first-in-class therapeutic targeting CD29. This IND approval enables OncoSynergy to initiate a Phase I clinical trial evaluating OS2966 in patients with recurrent glioblastoma, the most aggressive intrinsic brain cancer.

“I remember the exact moment at the lab bench, over a decade ago, when the concept for OS2966 began to take shape,” said, Co-Founder and Chief Executive Officer of OncoSynergy, Shawn Carbonell, MD, PhD. “Now, with the accomplishment of this major milestone, OncoSynergy is officially a clinical-stage company. We are grateful for all the support from advisors, investors, collaborators, and, most recently, FDA.”

OncoSynergy has partnered with Infuseon Therapeutics, a Cleveland Clinic spin-out, and Michael Vogelbaum, MD, PhD, Program Leader of Neuro-Oncology and Chief of Neurosurgery at Moffitt Cancer Center, and an inventor of the Infuseon Cleveland Multiport Catheter.

“I worked with Dr. Vogelbaum to design an innovative trial that made the most sense for patients and specifically addressed the challenges associated with treatment of glioblastoma,” said Co-Founder and Chief Medical Officer of OncoSynergy, Anne-Marie Carbonell, MD. “We strived to build a collaborative relationship with FDA and I am grateful to have worked with an excellent and highly responsive review team.”

OS2966 is the first-ever clinical-ready CD29 antibody under development for treatment of diverse cancers and targets fundamental interactions in the tumor microenvironment driving growth and treatment resistance. OncoSynergy has demonstrated the preclinical potential of OS2966 in the setting of treatment resistant solid and hematologic malignancies and in unique immunotherapy combinations.

Founding Scientific Advisory Board (SAB) member and eminent cell biologist at the Lawrence Berkeley National Laboratory, Mina J. Bissell, PhDcommented, “For decades, I have asked tough biological questions to understand how cancer growth and progression are regulated at the level of tissue organization.” Dr. Bissell continued, “It is exciting to see OncoSynergy translate this approach with OS2966, and take into account the critical context of the tumor microenvironment.”

OS2966 has been awarded FDA Orphan Drug Designation in the treatment of glioblastoma and ovarian cancer. The target of OS2966, CD29 (also known as beta1 integrin), is overexpressed in the majority of cancers representing a tremendous opportunity in oncology.

Jean Pierre Bizzari, MD, former Celgene Group Head of Clinical Oncology Development, current Board Member of the European Organization of Research and Treatment of Cancer (EORTC), and member of OncoSynergy’s SAB stated, “I have dedicated my professional life to helping patients by advancing novel cancer therapeutics. I am thrilled to see OncoSynergy advance their first-in-class therapeutic, OS2966, to the clinic for patients suffering from glioblastoma, a devastating brain cancer.”