June 10, 2019

Orion Biotechnology Announces Receipt of Pre-IND Guidance From the United States FDA on the Further Development of OB-002O as a Potential Treatment for Solid Tumors

OTTAWA, Ontario, June 10, 2019 /PRNewswire/ — Orion Biotechnology Canada Ltd., today announced that it has received feedback from the Food and Drug Administration (FDA) on a Pre-Investigational New Drug (PIND) application which was submitted in March 2019. The PIND was focused on the development of OB-002O as an agent for the treatment of solid tumors. OB-002 is a chemokine analogue CCR5 antagonist that is currently being developed in a topical form for HIV prevention (OB-002H) and is also being developed as an intravenous immunotherapy agent (OB-002O). CCR5 antagonism has been shown to induce anti-cancer effects in preclinical and Phase 1 clinical studies of colorectal cancer (Halama et al. Cancer Cell 2016) and is an active area of cancer drug development. Orion has previously shown that use of OB-002 alone, or in combination with a checkpoint inhibitor, was efficacious in the CT-26 syngeneic colorectal cancer model which provided the rationale for this Pre-IND submission. The feedback from the FDA will facilitate preparation and submission of an IND in 2020.

“We are excited to be rapidly moving from positive preclinical studies to the development of regulatory submissions to support Phase 1 studies of OB-002O in patients with advanced cancer as this is such an unmet area of medical need,” said Dr. McGowan, Chief Medical Officer at Orion Biotechnology.

“There is an urgent need to develop new therapeutic options for patients with advanced cancer. We hope that OB-002O alone, or in combination with other agents, will provide benefit for patients who have exhausted other options,” added Mark Groper, CEO at Orion Biotechnology.

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