On June 22, 2023 Circio Holding ASA (OSE: CRNA), reported that the first multiple myeloma (MM) patient has been dosed with mutant RAS cancer vaccine TG01 at Oslo University Hospital (OUS) (Press release, Circio, JUN 22, 2023, View Source [SID1234632842]). The study is led by multiple myeloma expert Dr. Fredrik Schjesvold in a clinical collaboration between OUS and Circio. OUS is the study sponsor, with Dr. Schjesvold as the principal investigator, in collaboration with project lead Dr Hanne Norseth and Research medical student Hedda Monsen. Circio will provide TG01 drug supply, scientific support and a financial contribution.
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Mutations in the RAS genes are commonly found in pancreatic cancer, colon cancer myeloma and lung cancer but outside of lung cancer there are no RAS-targeted therapies available for these patients. TG01 is a mutant RAS therapeutic cancer vaccine adjuvanted by QS-21 STIMULON, which targets the seven most commonly found RAS mutations. TG01 has previously demonstrated robust immune responses and survival benefit in resected pancreatic cancer combined with standard of care chemotherapy.
In this study, TG01 vaccination will be tested as a monotherapy in 20 KRAS or NRAS mutated myeloma patients who have either high risk smoldering myeloma or have evidence of disease after completion of standard of care (SoC) therapy. The treatment period is 12 months. In the first 3 months TG01 is given every other week, and thereafter it is given once every second month for 9 months. The aim is to assess whether anti-RAS T-cell priming induced by TG01 can delay the disease progression and enhance the clinical response.
Dr. Fredrik Schjesvold, Founder and Leader Oslo Myeloma Center, at Oslo University Hospital, and President of the Nordic Myeloma Study Group, said: "There are no targeted therapy options available for RAS-mutated multiple myeloma patients which continue to have a clear need for better and more tolerable treatments. I believe the TG01 vaccine has the potential to eliminate residual disease and delay recurrence following standard of care treatment, and we look forward to work with Circio to test this therapeutic concept at our center."
Margrethe Sørgaard, VP and Head of Clinical Development of Circio Holding ASA, added: "Having the first patient dosed in Dr. Schjesvold´s study in multiple myeloma is an important milestone for the TG program. It is the first time the TG01 cancer vaccine will be tested in this indication, and the first time the new and enhanced vaccine format of sub-cutaneous single-injection TG01 adjuvanted by QS-21 STIMULON has been administered to a patient in Europe. We firmly believe that TG01 can bring targeted clinical benefit, with a favorable safety profile, to this underserved area of RAS-mutated multiple myeloma."
About TG01 mutant RAS vaccine
Oncogenic mutations in the RAS family of genes drive up to 30% of all cancers and remain a major unmet medical need with few good treatment alternatives. Circio was recently awarded two prestigious research grants from Innovation Norway and the Norwegian Research Council, totaling NOK 18m, to advance its TG mutant RAS cancer vaccine program.
About Agenus, QS-21 STIMULON
Agenus is a clinical-stage immuno-oncology company focused on the discovery and development of therapies that engage the body’s immune system to fight cancer and infections. In March 2022, Circio announced a collaboration with Agenus to utilize the proprietary adjuvant QS-21 STIMULON as an immune-stimulatory component of the TG vaccines for future development and commercialization. QS-21 STIMULON has consistently demonstrated powerful antibody and cell-mediated immune responses both in cancer trials and as a component of the commercial Shingrix*, Mosquirix* and Arexvy* vaccines. QS-21 STIMULON is expected to further potentiate the TG vaccines by driving stronger anti-RAS T-cell responses.