On December 15, 2022 Targovax ASA (OSE: TRVX), a clinical-stage immuno-oncology company developing immune activators to target hard-to-treat solid tumors, reported that it has entered into a collaboration agreement with The University of Kansas Cancer Center (KU Cancer Center) and Agenus Inc. to run a clinical trial testing mutant RAS vaccine TG01 in combination with PD-1 CPI balstilimab in pancreatic cancer following surgery and standard-of-care (SoC) chemotherapy (Press release, Targovax, DEC 15, 2022, View Source [SID1234625291]).
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Pancreatic cancer is the third leading cause of cancer-related deaths with less than 10% 5-year survival from diagnosis. Chemotherapy remains the standard-of-care (SoC) therapy, and clinical trials with CPIs or targeted agents have to date been largely unsuccessful and not led to any new product approvals. As such, there is a major unmet medical need for novel, effective agents to improve outcomes for pancreatic cancer patients.
Mutations in the RAS genes are found in over 90% of pancreatic cancers, and therefore represent a particularly attractive target in this disease. Targovax´s RAS immunotherapy TG01 targets all of the most common RAS mutations observed in pancreatic cancer and has previously demonstrated promising immune responses and survival benefit after surgery in a phase 1 trial.
The planned study will be led by gastrointestinal cancer expert Dr. Anup Kasi in a three-way clinical collaboration between KU Cancer Center, Agenus and Targovax testing TG01 vaccination combined with Agenus´ immune-stimulatory adjuvant QS-21 STIMULON and PD-1 CPI balstilimab. TG01 vaccination +/- balstilimab will be tested in 24 pancreatic cancer patients who have detectable disease by circulating tumor DNA analysis of blood samples1 following surgery and SoC. The aim is to evaluate whether mutant RAS T-cell responses generated by TG01, and further boosted by QS-21 STIMULON and balstilimab, may have the potential to eliminate remaining cancer cells to prolong time to relapse and extend patient survival.
Dr Anup Kasi, Associate Professor at The University of Kansas Cancer Center, said: "Targovax has demonstrated encouraging early data for their mutant KRAS immunotherapy, and I am very excited about the opportunity to test the enhanced TG01 vaccine at our center using ctDNA as a blood-based biomarker to track efficacy in real-time. The core aim of the study is to assess whether the expected synergy between TG01 and PD-1 checkpoint inhibitor balstilimab may prolong time to relapse in a therapeutic window where we have nothing available today."
Dr Erik Digman Wiklund, Chief Executive Officer of Targovax ASA, added: "We are continuing to execute on our strategy of bringing the TG-program forward in cost-efficient, collaborative set-ups. This study is a major milestone as our first US-based RAS vaccine trial and the first time we combine TG01 with checkpoint blockade. Dr. Kasi has developed an innovative study design deploying cutting-edge ctDNA technology to track patient responses. The scientific rationale behind the concept is solid, and we believe post-surgery pancreatic cancer is the ideal setting to test it. If successful, this can provide the first RAS-targeted immunotherapy to address this major unmet medical need."
As previously communicated, Targovax has been awarded two prestigious research grants from Innovation Norway (IN) and the Norwegian Research Council (NRC) to advance the TG program in several clinical studies. This Phase 1/2 trial at KU Cancer Center will be the first randomized study to test TG01 both as a monotherapy and in combination with PD-1 CPI. Targovax will be responsible for TG01 drug supply, scientific support and will provide a financial contribution to KU Cancer Center through the IN and NRC research grants. Agenus will provide drug supply and scientific support. The Investigational New Drug (IND) Application for TG01 has been authorized and the trial has been given the approval to move ahead by the US FDA. The study is set to be activated at KU Cancer Center on December 15.
About TG01 mutant RAS vaccine
TG01 is a RAS neoantigen therapeutic cancer vaccine adjuvanted by QS-21 STIMULON, which targets the seven most commonly found RAS mutations in pancreatic cancer. The vaccine is formulated as a polyvalent peptide mixture and covers 99% of RAS-mutated pancreatic cancer patients. TG01 has previously demonstrated robust immune responses and clear signal of clinical activity in resected pancreatic cancer in in the adjuvant setting combined with standard of care chemotherapy.