- The updated TG01 IND application has been filed with the Chinese NMPA, triggering a sixty-day review period
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Following IND acceptance, IOVaxis has a two-week window to exercise its exclusive TG01 license option for clinical development and commercialization in
Greater China andSingapore
IOVaxis has an exclusive option agreement to license mutant RAS cancer vaccines TG01 and TG02 for
Dr.
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.
For further information, please contact:
Phone: +47 413 33 536
Email: erik.wiklund@circio.com
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
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
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