· The trial will be sponsored by
The University of Kansas Cancer Centerand led by Dr. Anup Kasi, a leading expert in gastrointestinal cancers · Collaboration partner Agenuswill provide PD-1 checkpoint inhibitor (CPI) balstilimab and vaccine adjuvant QS-21 STIMULONT · The trial has been given approval to proceed by the US Food and Drug Administration(FDA), and will be activated on December 15 Oslo, Norway, 15 December 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 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. 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 Kasiin a three-way clinical collaboration between KU Cancer Center, Agenusand Targovaxtesting TG01 vaccination combined with Agenus´ immune-stimulatory adjuvant QS-21 STIMULONT 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 samples 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: " Targovaxhas 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. Kasihas 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, Targovaxhas 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 Centerwill be the first randomized study to test TG01 both as a monotherapy and in combination with PD-1 CPI. Targovaxwill be responsible for TG01 drug supply, scientific support and will provide a financial contribution to KU Cancer Centerthrough the IN and NRC research grants. Agenuswill 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 Centeron 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. About Agenus, QS-21 STIMULON and balstilimab Agenusis 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, Targovaxannounced a collaboration with Agenusto 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 Centertrial, 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. 1 Signatera ctDNA assay, provided by Natera *Trademarks owned by 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: [email protected] Media enquires: Andreas Tinglum- Corporate Communications ( Norway) Phone: +47 9300 1773 Email: [email protected] About TargovaxActivating 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'sfocus is to activate the patient's immune system to fight cancer, and to bring benefit to cancer patients with few available treatment alternatives. Targovaxis developing its product candidates in different cancer indications, including melanoma, mesothelioma, and multiple myeloma, and has demonstrated a favorable safety and tolerability profile. Targovax'slead 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. Following very encouraging clinical data in several indications, both as monotherapy and in combinations, ONCOS-102 is progressing into a randomized phase 2 trial in melanoma patients resistant to PD-1 checkpoint inhibitor treatment. Building on successful clinical studies which have provided deep mechanistic insights into the tumor biology and the human immune systems, Targovaxis researching circular RNA (circRNA) as novel cancer medicines. In addition, Targovaxhas a KRAS immunotherapy program, with lead cancer vaccine candidate, TG01, expected to enter the clinic in an enhanced format in the second half of 2022. Together this provides Targovaxwith a rich pipeline of innovative future immunotherapy product candidates to follow ONCOS-102.
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