On December 22, 2022 Targovax ASA (OSE: TRVX), a clinical-stage immuno-oncology company developing immune activators to target solid tumors, reported that the planned clinical trial with mutant RAS cancer vaccine TG01 in multiple myeloma has received regulatory approval to proceed from NOMA and REK (Press release, Targovax, DEC 22, 2022, View Source [SID1234625554]).
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The trial is a collaboration between OUS and Targovax and will test TG01 vaccination as a monotherapy in 20 KRAS or NRAS mutated multiple myeloma patients who continue to have measurable disease after completion of standard of care treatment. The aim is to assess whether anti-RAS T-cell priming induced by TG01 can enhance the clinical response.
The trial will be sponsored by OUS and led by Dr. Fredrik Schjesvold, an international leader in the field and founder of the Oslo Myeloma Center, the largest Myeloma center in the Nordics. Targovax will provide TG01 drug supply, scientific support and a financial contribution through grants awarded from Innovation Norway and the Norwegian Research Council.
Dr. Ingunn Munch Lindvig, VP & Head of Regulatory Affairs, Targovax ASA, said: "We are very pleased that the planned collaborative studies for the TG mutant RAS program continue to obtain the necessary regulatory approvals to proceed in both the EU and USA. The multiple myeloma trial plan is now approved both by the Norwegian regulatory agency NOMA and the ethics committee REK under the new European system, and Oslo University Hospital can proceed with identifying patients for inclusion into the trial."