On January 4, 2024 INOVIO (NASDAQ:INO), a biotechnology company focused on developing and commercializing DNA medicines to help treat and protect people from HPV-associated diseases, cancer and infectious diseases, reported a clinical collaboration and supply agreement with Coherus BioSciences, Inc. (Coherus, NASDAQ: CHRS) to evaluate the combination of INO-3112 and LOQTORZI (toripalimab-tpzi) as a potential treatment for patients with locoregionally advanced, high-risk, HPV16/18 positive oropharyngeal squamous cell carcinoma (OPSCC), a type of head and neck cancer commonly known as throat cancer (Press release, Coherus Biosciences, JAN 4, 2024, View Source [SID1234638967]).
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Under the terms of the supply agreement, Coherus will provide LOQTORZI (toripalimab-tpzi), for a Phase 3 clinical trial to be conducted by INOVIO, pending alignment with the U.S. Food and Drug Administration (FDA) on study design. LOQTORZI is a PD-1 inhibitor recently approved by the FDA for the treatment of recurrent locally advanced/metastatic nasopharyngeal carcinoma (R/P NPC).
"Existing trial data highlights the strong rationale for and potential benefit of combining INO-3112 with a PD-1 inhibitor to generate tumor-specific T cells in HPV-related head and neck cancer," said Dr. Glenn Hanna, Director of the Center for Cancer Therapeutic Innovation (early drug development program) at Dana Farber Cancer Institute, Assistant Professor of Medicine at Harvard Medical School and principal investigator for the planned trial. "I look forward to advancing this research for patients by harnessing their immune system to fight against this life-altering, virally mediated cancer."
"We are very pleased to be collaborating with Coherus on this novel combination therapy and are excited about the opportunity to build on encouraging data from our previous trials involving INO-3112 in HPV-related head and neck cancer," said INOVIO’s President and Chief Executive Officer, Dr. Jacqueline Shea. "There is unique potential in combining our DNA medicines platform, which a growing body of research indicates is adept at fighting HPV-related diseases, with a proven PD-1 inhibitor to improve clinical outcomes for patients."
"We are delighted to be partnering with INOVIO on the development of the toripalimab/INO-3112 combination in HPV-related OPSCC, a tumor type that is synergistic to the current toripalimab indication in R/P NPC," said Rosh Dias, M.D., Chief Medical Officer at Coherus. "With its differentiated mechanism of action, toripalimab in combination with the INO-3112 vaccine may hold promise for these patients in earlier-stage disease, where treatment options are more limited. This partnership fits in well with our strategic vision to investigate toripalimab across additional tumor types as the PD-1 backbone in combination with novel agents of multiple modalities with the goal of improving patient benefit."
About Oropharyngeal Squamous Cell Carcinoma
Oropharyngeal squamous cell carcinoma, commonly known as throat cancer, is a type of head and neck cancer that occurs in the base of the tongue, tonsils and/or soft palate. OPSCC is typically causally related to high-risk subtypes of human papillomavirus (HPV), but some cases are carcinogen-driven due to tobacco and/or alcohol use. HPV-positive OPSCC is rapidly increasing in incidence among patients in high-income countries and has surpassed cervical cancer as the most common HPV-related cancer diagnosed in the United States, with nearly 20,000 new cases each year. HPV is thought to cause 70%-80% of all oropharyngeal cancers diagnosed in the United States.
About INO-3112
INO-3112 is a DNA medicine candidate targeting HPV 16/18 combined with a DNA plasmid for IL-12 as an immune activator. INOVIO is investigating the potential benefit of the antigen-specific T cell generation and tumor infiltration abilities of INO-3112 in HPV-related cancers, especially when used in novel combinations. Results from a Phase 1/2a trial of INO-3112 alone in 22 HPV-positive head and neck squamous cell carcinoma (HNSCC) patients, published in Clinical Cancer Research in 2019, included the observation of T cell responses and infiltration of CD8+ T cells into the head and neck tumors. In early 2023, updated results were published in Clinical Cancer Research from a Phase 1b/2a trial of INO-3112 in combination with AstraZeneca’s PD-L1 checkpoint inhibitor, durvalumab, showing an ORR of 27.6% (4 CR, 4 PR) in 29 evaluable patients and increased peripheral HPV-specific T cells and tumoral CD8+ T cells.
About LOQTORZI (toripalimab-tpzi)
LOQTORZI is a next generation anti-PD-1 monoclonal antibody that blocks PD-L1 binding to the PD-1 receptor at a unique site with high affinity and activates anti-tumor immunity demonstrating improvement in the overall survival of cancer patients in several tumor types. LOQTORZI was recently approved by the FDA for the treatment of recurrent locally advanced/metastatic NPC. For more information about LOQTORZI, including important safety information, please visit www.loqtorzi.com.