· The first patient was administered TG01 at the University of Kansas Cancer Center. This study will test mutant RAS vaccine TG01 in pancreatic cancer in combination with PD-1 checkpoint inhibitor balstilimab by collaboration partner Agenus Oslo, Norway, 14 March 2023 – Targovax ASA (OSE: TRVX) today announced that dem cancer vaccine TG01 was administered to the first patients in the combination study with the PD-1 checkpoint inhibitor (CPI) balstilimab in mutant RAS pancreatic cancer in the USA. The study is led by Dr. Gastrointestinal cancer expert Anup Kasi, in a triple clinical collaboration between Kansas University Cancer Center (KUCC), Agenus and Targovax, and represents the first time a patient has received the improved TG01 vaccine with immunostimulating adjuvant QS -21 STIMULON by Agenus. Pancreatic cancer is the third leading cause of cancer-related death with a 5-year survival rate of less than 10% from diagnosis, and chemotherapy remains the standard of care for the vast majority of patients. Oncogenic RAS mutations are present in more than 90% of cases, but there are no approved therapies against this important genetic driver. Therefore, there is a great unmet medical need for novel, potent agents to improve outcomes for patients with pancreatic cancer. In this study, 24 pancreatic cancer patients who have detectable tumor DNA in their blood after surgery and follow-up treatment will be randomized to receive either TG/QS-21 vaccination alone or vaccination in combination with PD-1 CPI-balstilimab . The aim is to assess whether mutant RAS T-cell responses generated by TG01 and further enhanced by QS-21 STIMULON and balstilimab may have the potential to eliminate remaining cancer cells to prolong the time to relapse and extend patient survival. dr Anup Kasi, associate professor at the University of Kansas Cancer Center, said, “I am very pleased to have administered the improved TG01 vaccine to the first patient at our center. The aim of the study is to assess whether the expected synergy between TG01 and balstilimab can increase the time to relapse in a therapeutic window where nothing is available to us today. To assess clinical utility, we use state-of-the-art ctDNA technology as a blood-based biomarker to track real-time efficacy. If this concept works as expected, it has the potential to provide a novel targeted treatment alternative for a patient population with high unmet medical needs.” Dr. Lone Ottesen, Chief Medical Officer of Targovax ASA, added, “The administration of the first patient in Kansas study represents an important milestone for our mutant RAS program. It is the first time we have tested the TG01 cancer vaccine with the adjuvant QS-21 STIMULON, the first time we have tested TG01 with a PD-1 checkpoint Inhibitor combine, and the first time TG01 enters the clinic in the US.The scientific rationale behind the study is sound, and we believe minimal residual disease following surgery for pancreatic cancer is the ideal. If successful, this could be the first RAS -directed therapy in pancreatic cancer.” About the TG01 mutant RAS vaccine Mutations in the RAS genes are detected in over 90 % of pancreatic cancer cases found, but no RAS-targeted therapies are available for this patient population. TG01 is a mutant RAS therapeutic cancer vaccine adjuvanted with QS-21 STIMULON that targets the seven most commonly found RAS mutations in pancreatic cancer. TG01 has previously demonstrated robust immune responses and survival benefits in resected pancreatic cancer when combined with standard chemotherapy. About Agenus, QS-21 STIMULON and Balstilimab 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 infection. In March 2022, Targovax announced a collaboration with Agenus to utilize the proprietary adjuvant QS-21 STIMULON as the immunostimulatory component of TG vaccines for future development and commercialization. QS-21 STIMULON has consistently demonstrated strong antibody and cell-mediated immune responses both in cancer studies and as a component of the commercial Shingrix* and Mosquirix* vaccines. QS-21 STIMULON is expected to further potentiate TG vaccines by eliciting stronger anti-RAS T cell responses. In this KU Cancer Center study, the collaboration was expanded to include delivery of Agenus’ PD-1 CPI balstilimab for combination with TG01. Balstilimab is designed to block the PD-1 protein and mobilize a patient’s T cells to attack the tumor. Balstilimab has been studied in over 750 patients to date and has demonstrated strong clinical activity and excellent tolerability across multiple tumor types. *Trademarks of GSK. For further information please contact: Erik Digman Wiklund, CEO Phone: +47 413 33 536 Email: [email protected] Renate Birkeli, Investor Relations Phone: +47 922 61 624 Email: renate. [email protected] Media Enquiries: Andreas Tinglum – Corporate Communications (Norway) Phone: +47 9300 1773 Email: [email protected] Immunoactivators against hard-to-treat solid tumors. Targovax is focused on activating the patient’s immune system to fight cancer and helping cancer patients with few treatment alternatives available. Targovax is developing its product candidates in multiple cancer indications, including melanoma, mesothelioma, multiple myeloma and pancreatic cancer. Targovax’s lead clinical candidate, ONCOS-102, is a genetically engineered oncolytic adenovirus designed to selectively infect cancer cells and activate the immune system against the tumor. ONCOS-102 has demonstrated a favorable efficacy, immune and safety profile in multiple indications, both as monotherapy and in combination, and ONCOS-102 is in a randomized Phase 2 study in melanoma patients refractory to treatment with PD -1 checkpoint inhibitors are resistant. Targovax has also established a state-of-the-art circular RNA program (circRNA) with the intent to develop next-generation RNA therapeutics for various applications, building on clinical experience and deep mechanistic insights from its first-generation products. In addition, Targovax has a KRAS immunotherapy program with lead candidate TG01 set to enter clinical trials in early 2023 in an expanded format in pancreatic cancer and multiple myeloma. This provides Targovax with a rich pipeline of innovative future therapeutic candidates that will follow ONCOS-102.
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