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Targovax: First patient dosed with TG01 in the USA

  • The first patient has been dosed with TG01 at The University of Kansas Cancer Center
  • In this study, mutant RAS vaccine TG01 is being tested in in pancreatic cancer in combination with PD-1 checkpoint inhibitor balstilimab from collaboration partner Agenus

Oslo, Norway, 14 March 2023 – Targovax ASA (OSE: TRVX), today announces that the first patient has been dosed with cancer vaccine TG01 in the combination study with PD-1 checkpoint inhibitor (CPI) balstilimab in mutant RAS pancreatic cancer in the USA. The study is led by gastrointestinal cancer expert Dr. Anup Kasi in a three-way clinical collaboration between Kansas University Cancer Center (KUCC), Agenus and Targovax, and represents the first time a patient is given the enhanced TG01 vaccine with immune-stimulatory adjuvant QS-21 STIMULON™ from Agenus.

Pancreatic cancer is the third leading cause of cancer-related deaths with less than 10% 5-year survival from diagnosis, and chemotherapy remains the standard-of-care therapy for the vast majority of patients. Oncogenic RAS mutations are present in more than 90% of cases, but there are no approved therapies available against this important genetic driver. As such, there is a major unmet medical need for novel, effective agents to improve outcomes for pancreatic cancer patients.

In this study, 24 pancreatic cancer patients who have detectable tumor DNA in the blood following surgery and follow-up treatment will be randomly allocated to either TG/QS-21 vaccination alone or vaccination combined with PD-1 CPI balstilimab. 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: “I am very pleased to have dosed the first patient with the enhanced TG01 vaccine at our center. The aim of the study is to assess whether the expected synergy between TG01 and balstilimab can prolong time to relapse in a therapeutic window where we have nothing available today. To assess the clinical benefit, we are using cutting-edge ctDNA technology as a blood-based biomarker to track efficacy in real-time. If this concept works as anticipated, it has the potential to provide a novel targeted treatment alternative to a patient group with high unmet medical need.”

Dr Lone Ottesen, Chief Medical Officer of Targovax ASA, added: “Having the first patient dosed in the Kansas study represents a major milestone for our mutant RAS program. It is the first time we test the TG01 cancer vaccine with adjuvant QS-21 STIMULON, the first time we combine TG01 with a PD-1 checkpoint inhibitor, and the first time TG01 enters the clinic in the USA. The scientific rationale behind the study is solid, and we believe minimal residual disease after surgery in pancreatic cancer is the ideal setting to test it. If successful, this can provide the first RAS-targeted therapy in pancreatic cancer.”

About TG01 mutant RAS vaccine 
Mutations in the RAS genes are found in over 90% of pancreatic cancers, but there are no RAS-targeted therapies available for this patient group. TG01 is a mutant RAS therapeutic cancer vaccine adjuvanted by QS-21 STIMULON, which targets the seven most commonly found RAS mutations in pancreatic cancer. TG01 has previously demonstrated robust immune responses and survival benefit in resected pancreatic cancer combined with standard of care 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 infections. In March 2022, Targovax 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* and Mosquirix* vaccines. QS-21 STIMULON is expected to further potentiate the TG vaccines by driving stronger anti-RAS T-cell responses. In this KU Cancer Center trial, the collaboration has been broadened to also include supply of Agenus´ PD-1 CPI balstilimab for combination with TG01. Balstilimab is designed to block the protein PD-1 and mobilize a patient’s T cells to attack the tumor. Balstilimab has been evaluated in over 750 patients to date and demonstrated strong clinical activity and excellent tolerability in multiple tumor types. 

*Trademarks owned by GSK.

For further information, please contact:
Erik Digman Wiklund, CEO
Phone: +47 413 33 536

Renate Birkeli, Investor Relations
Phone: +47 922 61 624

Media enquires:
Andreas Tinglum – Corporate Communications (Norway)
Phone: +47 9300 1773

About Targovax

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 to bring benefit to cancer patients with few available treatment alternatives. Targovax is developing its product candidates in different cancer indications, including melanoma, mesothelioma, multiple myeloma and pancreatic cancer.

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 against the tumor. ONCOS-102 has demonstrated a favorable efficacy, immunological and safety profile in several indications, both as monotherapy and in combinations, and ONCOS-102 is progressing into a randomized phase 2 trial in melanoma patients resistant to PD-1 checkpoint inhibitor treatment.

Targovax has also established a cutting-edge circular RNA (circRNA) program 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 due to enter clinical trials in an enhanced format in pancreatic cancer and multiple myeloma during early 2023. This provides Targovax with a rich pipeline of innovative future therapeutic candidates to follow ONCOS-102.

Source: Targovax