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.

About Orion Biotechnology Canada, Ltd.

Orion Biotechnology Canada Ltd, is a privately held pharmaceutical company leveraging advanced receptor pharmacology to develop novel therapies for serious chronic illnesses and life-threatening diseases. Since 2017, Orion Biotechnology has been developing a robust pipeline of first-in-class chemokine analogue drug candidates, including our lead candidate, OB-002 – a CCR5 receptor antagonist. Our close ties to diverse institutions and experts around the globe, as well as our proprietary drug discovery platform, continue to stimulate the rapid discovery of promising new treatments. Learn more at www.orionbiotechnology.com.

Forward-Looking Statements

This press release contains forward-looking information, which reflects Orion's current expectations regarding future events. Forward-looking information is based on a number of assumptions and is subject to a number of risks and uncertainties, many of which are beyond Orion's control, that could cause actual results and events to differ materially from those that are disclosed in or implied by such forward-looking information. These forward-looking statements are made as of the date of this press release and, except as expressly required by applicable law, Orion assumes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.

Contact: Ross MacLeod
Orion Biotechnology
Canada Ltd.
Phone: +1.343.291.1032
[email protected]

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