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 .
US FDA accepts IND application for AskBio's AB-1009
EspeRare and n-Lorem partner to expand European access to ASO therapies for rare genetic diseases
Bionpharma and STEERLife's Etravirine tablets approved by US FDA
Kestra partners with Biobeat to add cuffless blood pressure monitoring to wearable defibrillator
argenx secures FDA priority review for VYVGART in seronegative myasthenia gravis
Abbisko Therapeutics reports US FDA acceptance of pimicotinib NDA
Formosa Pharmaceuticals licenses APP13007 ophthalmic therapy to Samil for South Korea
Summit Therapeutics submits FDA application for ivonescimab in EGFR-mutated lung cancer
Sanofi's Teizeild approved in EU to delay stage 3 type 1 diabetes