OncoC4 announces that China's NMPA has granted Breakthrough Therapy Designation for Gotistobart (BNT316/ONC-392) aimed at treating squamous non-small cell lung cancer, enhancing prospects for patients facing limited options.

OncoC4, a late-stage biopharmaceutical company, announced that China’s National Medical Products Administration (NMPA) has granted Breakthrough Therapy Designation (BTD) to gotistobart (BNT316/ONC-392), a next-generation anti-CTLA-4 antibody, for the treatment of squamous non-small cell lung cancer (sqNSCLC) in patients who have progressed on prior immuno-oncology therapies. Developed in collaboration with BioNTech, gotistobart aims to address the urgent need for effective treatments for this aggressive lung cancer subtype, which accounts for 25-30% of all non-small cell lung cancer cases and has a five-year survival rate of just 15%.

Designation granted for gotistobart (BNT316/ONC392) for the treatment of patients with squamous non-small cell lung cancer (sqNSCLC), an aggressive subtype of lung cancer Breakthrough Therapy designation will allow for an expedited development and regulatory review of gotistobart in China...