- Targovax has entered into an agreement with Oslo University Hospital (OUS) to test TG01 in a phase 1/2 trial in 20 patients with RAS mutant multiple myeloma
- 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
- The trial will be the first time TG vaccination is tested in patients together with the new adjuvant QS-21 STIMULON™ from collaboration partner Agenus
Oslo, Norway, 10 May 2022 – Targovax ASA (OSE: TRVX), a clinical-stage immuno-oncology company developing immune activators to target hard-to-treat solid tumors, today announces that it has entered into a clinical trial collaboration agreement with Oslo University Hospital (OUS) to run a phase 1/2 study testing polyvalent mutant RAS vaccine TG01 in multiple myeloma (MM) following standard of care (SoC) therapy.
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. Targovax 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. These grants include funding towards several clinical studies, of which the first to open will be a TG01 phase 1/2 trial in MM patients with relevant KRAS and NRAS mutations (approx. 15-20% of MM patients) to be run in Oslo, Norway.
The trial is a collaboration between OUS and Targovax and will test TG01 vaccination as a monotherapy in 20 KRAS or NRAS mutated MM patients who continue to have measurable disease after completion of SoC treatment. The aim is to assess whether anti-RAS T-cell priming induced by TG01 can enhance the clinical response. OUS will sponsor and be responsible for running and funding the trial, with Dr. Schjesvold as the principal investigator. Targovax will provide TG01 drug supply, scientific support and financial contribution.
Dr. Fredrik Schjesvold, Founder and Leader Oslo Myeloma Center, at Oslo University Hospital, and President of the Nordic Myeloma Study Group, said: “RAS-mutant multiple myeloma has poor prognosis and there are currently no available targeted treatment options for this patient population. Prior data clearly demonstrates the capability of TG01 to induce robust anti-RAS T-cell responses and eliminate residual disease in cancer patients, and suggest that TG vaccination could be a valuable tool to deepen and prolong responses in multiple myeloma. Being a Norwegian product makes it particularly interesting, and we very much look forward to collaborating with Targovax to test this concept in practice at our center.”
Earlier in 2022, Targovax announced a collaboration with Agenus to utilize their proprietary vaccine adjuvant QS-21 STIMULON™ as an immune-stimulatory component of the TG vaccines for future development and commercialization. QS-21 has consistently demonstrated powerful antibody and cell-mediated immune responses both in cancer trials and commercially as a component of the Shingrix® and Mosquirix™ vaccines. QS-21 should further potentiate the TG vaccines by driving stronger anti-RAS T-cell responses. The OUS trial will be the first study in patients of TG01 adjuvanted by QS-21.
Dr. Erik Digman Wiklund, Chief Executive Officer of Targovax ASA, added: “Following promising data from the first generation TG01 vaccine in pancreatic cancer, we have focused on enhancing our mutant RAS platform and establishing a cost-efficient, collaborative development plan to bring the program forward. We are now ready to bring TG01 back into the clinic in a new and improved format and are excited to work with Dr. Schjesvold and his team to assess the potential of TG01 in multiple myeloma. This trial will be the first step in a broader exploratory program with multiple collaboration partners aimed at testing TG01 vaccination in various RAS mutant cancer types and treatment combinations.”
Activating the patient’s immune system to fight cancer
Targovax (OSE:TRVX) is a clinical stage immuno-oncology company developing immune activators to target hard-to-treat solid tumors. Targovax’s focus is to activate the patient’s immune system to fight cancer, and thereby bring benefit to cancer patients with few available treatment alternatives. Targovax is assessing its product candidates in different cancer indications, including melanoma, mesothelioma, and colorectal cancer, and has demonstrated a favorable safety and tolerability profile.
Targovax’s lead clinical candidate, ONCOS-102, is a genetically modified oncolytic adenovirus, which has been engineered to selectively infect cancer cells and activate the immune system to fight the cancer. On the back of very encouraging clinical data in several indications, both as monotherapy and in immunotherapy and chemotherapy combinations, the next development step for ONCOS-102 will be to further improve immune activation and clinical response in melanoma patients resistant to PD1 checkpoint blockade.
Building on successful phase 1/2 studies demonstrating clinical benefit and providing deep mechanistic insights, Targovax is expanding its ONCOS program into delivery of circular RNA and targeting KRAS mutant cancers with the aim of establishing a platform for development of a rich pipeline of innovative future immunotherapy product candidates.