Circio announces outcome of TG01/gemcitabine combination EU patent proceeding

• The EPO board of appeal moved to revoke the TG01/gemcitabine combination method of use patent in pancreatic cancer
• The TG01 / gemcitabine combination was discontinued in 2019; the decision has no impact on ongoing clinical studies and other IP protections for TG01

Oslo, Norway, 24 November 2023 – Circio Holding ASA (OSE: CRNA), a biotechnology company developing novel circular RNA and immunotherapy medicines, today announces that the European Patent Office (EPO) board of appeal has moved to revoke the EU Patent 3140320 “Peptide vaccine comprising mutant RAS peptide and chemotherapeutic agent” during proceedings held on 22 November 2023.

EU Patent 3140320 is a method of use patent covering the combination of TG01 with the chemotherapeutic gemcitabine (and similar agents) in pancreatic cancer. The EPO board of appeal ruled that the patent should be revoked due to a lack of sufficient inventive step based on prior publications relating to TG01 clinical studies. Method of use patents are known to be challenging to uphold due to mandatory public disclosures surrounding trial design and treatment regimen. The EPO ruling applies only in European countries.

Dr. Lubor Gaal, Chief Financial Officer of Circio Holding ASA, said: “We are disappointed by and disagree with the EPO´s ruling to revoke our TG01/gemcitabine patent for pancreatic cancer. However, this chemotherapy combination was discontinued in 2019, and the ruling has no impact on ongoing clinical studies where TG01 is being tested with novel immunotherapies and in other cancer forms outside of this patent. Moreover, TG01 remains covered by orphan drug designations in pancreatic cancer and data protection as a biologic in both the EU and USA, which provides market protection for up to 12 years.”  

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.