On December 12, 2023 Circio Holding ASA (OSE: CRNA) reported 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 (Press release, Circio, DEC 12, 2023, View Source [SID1234638488]).
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IOVaxis has an exclusive option agreement to license mutant RAS cancer vaccines TG01 and TG02 for China, Hong Kong, Macau, and Singapore, see link to press release here. Within two weeks of TG01 IND approval by the NMPA, IOVaxis may exercise its exclusive license option and trigger a USD 3m milestone payment to Circio.
Dr. John Wang, CEO of IOVaxis Therapeutics, said: "Following broad additional pre-clinical characterization of the TG01 product, we have now filed a substantially expanded IND-package, which we are confident meets the requirements of the NMPA. We have been impressed by previous clinical data for TG01 and are eager to bring this innovative mutant RAS immunotherapy to patients in China. Once we have the IND approval, we intend to initiate a phase 1 study in pancreatic cancer as soon as possible, and then rapidly expand to other KRAS indications and combinations."
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 its exclusive license option for TG01 and TG02 within 14 days.
Dr. Erik Digman Wiklund, CEO of Circio Holding ASA, added: "This partnership with IOVaxis is an important component of our aim to bring TG01 development forward through strategic collaborations in multiple settings and geographies. Dr. Wang and his team have shown strong commitment to meet the requirements of the Chinese regulatory authorities and generated a substantial pre-clinical data package to support the filing. We are very pleased to have such a dedicated partner and expect that the IND will now be accepted in China, as it has already been in Europe and the USA."