On June 16, 2021 Apexigen, Inc., a clinical-stage biopharmaceutical company focused on discovering and developing a new generation of antibody therapeutics for oncology, and the Nordic Society of Gynaecological Oncology – Clinical Trial Unit (NSGO-CTU) reported an agreement to initiate a collaborative Phase 2 clinical study evaluating sotigalimab, Apexigen’s monoclonal antibody targeting CD40, in combination therapy for patients with recurrent BRCA wild type ovarian cancer. Sotigalimab, Apexigen’s lead immuno-oncology therapeutic candidate, is a potentially first-in-class and best-in-class CD40 agonist, with unique epitope specificity and Fc receptor engagement for optimal therapeutic effect and tolerability (Press release, Apexigen, JUN 16, 2021, View Source [SID1234590990]).
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"We are excited to collaborate with the NSGO-CTU and ENGOT, premier organizations with tremendous experience conducting gynaecological oncology clinical trials," said Xiaodong Yang, M.D., Ph.D., President and CEO of Apexigen. "The poor survival in advanced ovarian cancer is due both to late diagnosis as well as a lack of effective second-line therapy. Robust preclinical and early clinical data underscore the utility of next-generation immune-modulating therapies, such as sotigalimab. We believe combining sotigalimab treatment with chemotherapy or chemotherapy plus radiation shows promise in offering new therapeutic options for patients with recurrent BRCA wild type ovarian cancer. We’re fortunate to have the opportunity to explore these combinations with the NSGO-CTU and ENGOT as we continue to address the greatest outstanding challenges in oncology."
"Our purpose at the NSGO-CTU and ENGOT is to improve management options in gynaecological cancer indications by conducting and coordinating clinical trial efforts across countries," added Mansoor Raza Mirza, M.D., Medical Director of the NSGO-CTU and Chair of ENGOT. "The evaluation of sotigalimab, a novel and promising agent, in this Phase 2 randomized study is an important next step to improve the standard of care for patients with ovarian cancer. We look forward to working with Apexigen to reach our mutual goal."
About Sotigalimab (APX005M)
Sotigalimab is a novel, humanized monoclonal antibody that stimulates the anti-tumor immune response. Sotigalimab targets CD40, a co-stimulatory receptor that is essential for activating both innate and adaptive immune systems. Binding of sotigalimab to CD40 on antigen presenting cells (i.e., dendritic cells, monocytes and B-cells) initiates a multi-faceted immune response bringing multiple components of the immune system (e.g., T cells, macrophages) to work in concert against cancer. Sotigalimab is currently in Phase 2 clinical development for the treatment of cancers such as esophageal and gastroesophageal junction cancers, melanoma, rectal cancer and sarcoma in various combinations with immunotherapy, chemotherapy, radiation therapy or a cancer vaccine. Additional information on clinical trials for sotigalimab can be found at www.clinicaltrials.gov.