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2024-03-04 16:31:31
· 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 partiesŽ 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 (https://www.circio.com/en/targovax-and-iovaxis-therapeutics-enters-option
-agreement-for-tg-mutant-ras-vaccine-license-and-clinical-development-in-china/)
and the IND-filing here (https://www.circio.com/en/tg01-ind-application-filed-in
-china-by-circios-partner-iovaxis-therapeutics/). 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
Email: erik.wiklund@circio.com (erik.wiklund@targovax.com)
Renate Birkeli, Investor Relations
Phone: +47 922 61 624
Email: renate.birkeli@circio.com (renate.birkeli@targovax.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 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.