Circio Holding ASA announced that partner IOVaxis Therapeutics of Nantong, China, has filed the updated TG01 investigational new drug (IND) application with the Chinese National Medical Products Administration (NMPA), with an expected review period of sixty days. IOVaxis has an exclusive option agreement to license mutant RAS cancer vaccines TG01 and TG02 for China, Hong Kong, Macau, and Singapore. Within two weeks of TG01 IND approval by the NMPA, IOVaxis may exercise its exclusive license option and trigger a USD 3 million milestone payment to Circio.

The NMPA requested additional pre-clinical characterization of TG01 following review of the initial TG01 IND filing in 2021. The requested studies have now been performed and included in the resubmitted IND-package. The expected response time is sixty days from the submission date.

Following IND-approval, IOVaxis may exercise the exclusive license option for TG01 and TG02 within 14 days.