The first patient has been dosed in Circio's TG01 triple combination study

• The first enrolled patient was dosed on 31 January in Washington, D.C., USA
• In this phase 2 study, the TG01 mutant RAS cancer vaccine is being tested in combination with daratumumab (Janssen) and nivolumab (BMS)
• This is the first time TG01 is tested in non-small cell lung cancer (NSCLC)

Oslo, Norway, 1 February 2024 – Circio Holding ASA (OSE: CRNA), a biotechnology company developing novel circular RNA and immunotherapy medicines, today announces that the first patient has been dosed in the collaborative phase 2 trial sponsored by Georgetown University. In this study, mutant RAS cancer vaccine TG01 is being tested in combination with daratumumab (anti-CD38, Janssen) and nivolumab (anti-PD1, BMS) in patients with RAS-mutated pancreatic cancer (PDAC) and patients with non-small cell lung cancer (NSCLC).

Mutations in the RAS-family of genes are a major cause of cancer and found in over 90% of PDAC and 30% of NSCLC cancer patients. RAS-mutated cancers typically have poor prognosis with few targeted treatment alternatives, and the medical need for novel therapeutic options remains high.

To further study this unmet medical need, a phase 2 trial has been initiated to test the combination of daratumumab (Janssen), nivolumab (BMS) and TG01 in advanced PDAC and anti-PD1 resistant NSCLC (see announcement Nov 16 2023). The study will enroll 54 KRAS-mutated patients in total, 27 immunotherapy-naïve PDAC patients and 27 NSCLC patients who have progressed on prior anti-PD1 therapy.

Ola Melin, Head of the TG program at Circio, said: “The externally sponsored clinical program with our enhanced TG01 cancer vaccine is progressing well. The Georgetown study is now the third active clinical trial with patients on treatment, and comes in addition to the multiple myeloma study at Oslo University Hospital and the pancreatic cancer study at Kansas University. Collaborations are the core of the TG01 development strategy, and we are continuing to execute on the plan to advance our KRAS program through external development in multiple settings and geographies.”

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 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.