Oncolys BioPharma Inc. completed an exclusive licensing agreement with Transposon Therapeutics, Inc. (hereinafter, Transposon) for OBP-601 (Censavudine, TPN-101), a nucleoside reverse transcriptase inhibitor, in June 2020. The company announced that the review process has completed for the Investigational New Drug application (IND) submitted by Transposon to the Food and Drug Administration (FDA) for Phase 2 clinical trials in US targeting two neurodegenerative diseases.
The target diseases for the two clinical trials to be started by Transposon are progressive supranuclear palsy (PSP), amyotrophic lateral sclerosis (ALS), and frontotemporal degeneration (FTD). These are designated intractable diseases for which effective treatment methods do not yet exist.
Both clinical trials are double-blind, placebo-controlled studies.
OBP-601 was licensed to the company from Yale University in 2006, and then sub-licensed to Bristol-Myers Squibb Co. (hereinafter, BMS) in 2010. Phase 2b clinical trials were completed for OBP-601 as an anti-HIV drug, but the license agreement ended in 2014 due to a shift in strategy by BMS.
Thereafter, the company licensed OBP-601 to Transposon, leading to the current IND.
The company will continue to hold joint development committee meetings with Transposon and support the development of OBP-601 as a novel therapeutic drug for neurodegenerative diseases.