Policy & Regulation
Orion Biotechnology updates the US FDA's Pre-IND guidance of OB-002O for the potential treatment of solid tumours
11 June 2019 -

Pharmaceutical company Orion Biotechnology Canada Ltd reported on Monday that it received feedback from the Food and Drug Administration (FDA) to facilitate the preparation and submission of the Pre-Investigational New Drug (PIND) application of its lead candidate OB-002O in 2020.

The company added that the PIND was focused on the development of OB-002O as an agent for the treatment of solid tumours. The OB-002 is a chemokine analogue CCR5 antagonist that is being developed in a topical form for HIV prevention (OB-002H) as well as an intravenous immunotherapy agent (OB-002O).

According to the company, 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.

In conjunction, the 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, concluded the company .

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