ONCOS-102 mesothelioma study published in Journal for ImmunoTherapy of Cancer

• ONCOS-102 combined with chemotherapy demonstrated 34.1% overall survival (OS) rate at 30 months in first line patients, compared to 0% in the chemotherapy-only group
• ONCOS-102 promoted robust immune responses, including an association between T-cell infiltration and patient survival

Oslo, Norway, 4 September 2023– Circio Holding ASA (OSE: CRNA), a biotechnology company developing novel circular RNA and immunotherapy medicines, today announces that the completed phase 1/2 trial of ONCOS-102 in combination with Standard of Care (SoC) chemotherapy in malignant pleural mesothelioma (MPM) has been published in the Journal for ImmunoTherapy of Cancer (JITC), the prestigious immunology journal of the Society for Immunotherapy of Cancer (SITC).  

The study was a randomized phase 1/2 trial adding ONCOS-102 to SoC chemotherapy (pemetrexed/cisplatin) in first and later line MPM to assess safety, immune activation and clinical efficacy in a total of 31 patients. The ONCOS-102 and SoC combination showed a favorable safety profile, robust immune responses in injected tumors and a signal of clinical benefit. In first line patients, the OS rate at 30 months was 34.1% for ONCOS-102-treated patients, which is a clear improvement over the first-line SoC-only control group where the OS rate was 0%.

Title of publication: ONCOS-102 plus pemetrexed and platinum chemotherapy in malignant pleural mesothelioma: a randomized phase 2 study investigating clinical outcomes and the tumor microenvironment

For the full publication, please see link: https://jitc.bmj.com/content/11/9/e007552

Margrethe Sørgaard, VP and Head of Clinical at Circio, said: “Mesothelioma remains a challenging disease with poor prognosis and few available treatment options. In this exploratory trial, ONCOS-102 demonstrated a clear signal of clinical benefit for this underserved patient group, particularly in an early treatment setting. Importantly, the study also showed that ONCOS-102 can be safely and effectively combined with chemotherapy and drive robust immune activation in an immunologically cold tumor type, thereby demonstrating the versatility of the product and expanding future development opportunities.”

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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 cancer, vaccines, rare disease, protein replacement therapy and cell therapy. The proprietary circVec technology is based on a modular genetic cassette design for efficient biogenesis of multifunctional circRNA that can be deployed for many purposes. The most advanced concept, circAde, builds on the company´s validated adenovirus platform to deliver circRNA for durable expression of therapeutic proteins directly into cancer cells. This unique approach is the only currently known circRNA program capable of targeting solid tumors. The circVec platform has broad potential applications, and Circio´s strategy is to generate one or more lead candidates for in house development in specific disease indications and in parallel seek partnerships for other technical applications and therapeutic areas. 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 to Circio's circRNA program, the Company's' clinical stage immunotherapy programs are designed to activate the patient´s own immune system to fight cancer cells and provide benefit to patients with no or few treatment alternatives. ONCOS-102 has demonstrated an excellent safety profile, strong immune responses and clinical efficacy in several cancer types in Phase 1/2 studies, both as monotherapy and in combinations with checkpoint inhibitors or standard-of-care chemotherapy. A phase 2 trial to confirm the therapeutic activity of ONCOS-102 in melanoma patients resistant to PD-1 checkpoint inhibitor treatment has been designed, and Circio is seeking external financing and/or partnerships to continue the clinical development.               

Circio’s second clinical stage program is an immunotherapy targeting KRAS driver mutations. TG01 has previously shown robust immune responses and encouraging clinical benefit in surgically resected pancreatic cancer and 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 broad future optionality for the TG01 program at low cost to Circio.