Autotelic Bio announced on the 18th that its immunotherapy candidate 'ATB-301' was selected as a pharmaceutical commercialization navigator designation for the Ministry of Food and Drug Safety's 'Pharm Navi' project.

ATB-301 is a new drug candidate of combination therapy of TGF-β2 inhibitor 'Trabedersen' and Interleukin-2 (IL-2). ATB-301 was selected for the TIPS Program (Private Investment-led Technology Startup Project) R&D support project supported by the Ministry of SMEs and Startups in August 2018.

The Ministry of Food and Drug Safety's 'Pharm Navi' Project has been implemented since 2014 as a new drug development support project similar to the U.S.' Fast Track' with the goal of promoting pharmaceutical commercialization and supporting global expansion.

Through Pharm Navi, Autotelic Bio will receive institutional and technical support from the Ministry of Food and Drug Safety for drug development trends, regulatory approval information, educational programs for pharmaceutical staff, and overal strategies of quickly entering into clinical trials so that the research and development results of ATB-301, a next-generation immunotherapy anticancer drug candidate, can be quickly transformed into commercialization.

Autotelic Bio said, "ATB-301 is a combination therapy of Trabedersen and IL-2, in which Trabedersen can selectively inhibit TGF-β that is known to be an important factor in increasing the limited response rate of immunotherapy drugs, while IL-2 can stimulate the immune system and activate the immune system."

Autotelic Bio is currently discussing scale-up production under GMP for non-clinical anticancer efficacy tests and clinical trials, and is aiming to enter phase 1 clinical trials in 2020.