- The updated TG01 IND application has been filed with the Chinese NMPA, triggering a sixty-day review period
- Following IND acceptance, IOVaxis has a two-week window to exercise its exclusive TG01 license option for clinical development and commercialization in Greater China and Singapore
Oslo, Norway 12 December 2023 – Circio Holding ASA (OSE: CRNA) announces 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, 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.”
For further information, please contact:
Erik Digman Wiklund, CEO
Phone: +47 413 33 536
Email: erik.wiklund@circio.com
Renate Birkeli, Investor Relations
Phone: +47 922 61 624
Email: renate.birkeli@circio.com
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 two clinical trials in RAS-mutated pancreatic cancer and multiple myeloma in the USA and 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.