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· 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 (https://www.circio.com/en/circio-joins-collaboration-to-test-the
-combination-of-tg01-vaccination-with-daratumumab-and-nivolumab-in-immunotherapy
-resistant-patients-with-mutant-ras-cancers/)). 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 (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.
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