The TG01 IND application by Circio’s partner IOVaxis Therapeutics has been approved by the Chinese regulatory authorities

  • The IND application filed by partner IOVaxis Therapeutics to initiate TG01 clinical development in China was approved by the Chinese NMPA on 1 March 2024  
  • Following IND approval, IOVaxis has an option to exercise an exclusive license for Circio’s TG mutant RAS cancer vaccine program for Greater China and Singapore

Oslo, Norway 4 March 2024 – Circio Holding ASA (OSE: CRNA) announces that the TG01 investigational new drug (IND) application filed by partner IOVaxis Therapeutics of Nantong, China, has been approved by the Chinese National Medical Products Administration (NMPA). Following this acceptance by the NMPA, IOVaxis has the necessary regulatory approval to initiate TG01 clinical development in China.

Under the parties´ agreement, IOVaxis has an exclusive option to license mutant RAS cancer vaccines TG01 and TG02 for China, Hong Kong, Macau, and Singapore, see link to the partnership announcement here and the IND-filing here. Within two weeks of the TG01 IND approval by the NMPA, IOVaxis may elect to exercise its license option and trigger a USD 3m milestone payment to Circio.

For further information, please contact:
Erik Digman Wiklund, CEO
Phone: +47 413 33 536

Renate Birkeli, Investor Relations
Phone: +47 922 61 624

About Circio

Building next generation RNA therapeutics

Circio Holding ASA is a biotechnology company developing novel circular RNA and immunotherapy medicines.

Circio has established a unique circular RNA (circRNA) platform to develop novel circRNA medicines for rare disease, vaccines, and cancer. The proprietary circVec technology is based on a modular genetic cassette design for efficient biogenesis of multifunctional circRNA from DNA and viral vectors, which can be deployed for many purposes. The circVec platform has demonstrated enhanced and more durable protein expression than classic mRNA vector systems, and has the potential to become the new gold-standard for DNA and virus-based therapeutics in the future. The circRNA R&D activities are being conducted by the wholly owned subsidiary Circio AB based at the Karolinska Institute in Stockholm, Sweden.

In addition, Circio is developing a cancer vaccine, TG01, targeting KRAS driver mutations. TG01 is currently being tested in three clinical trials: RAS-mutated pancreatic cancer and lung and non-resectable pancreatic cancer in US, and multiple myeloma in Norway. These studies are being run through academic collaborative networks, supported by prestigious research grants from Innovation Norway and the Norwegian Research Council, creating read-outs and future optionality for the program at low cost to Circio.