{"id":496127,"date":"2021-05-19T17:33:15","date_gmt":"2021-05-19T21:33:15","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/apexigen-announces-presentation-of-phase-2-clinical-data-on-cd40-antibody-sotigalimab-apx005m-in-combination-therapy-for-metastatic-pancreatic-cancer-at-the-asco-2021-annual-meeting\/"},"modified":"2021-05-19T17:33:15","modified_gmt":"2021-05-19T21:33:15","slug":"apexigen-announces-presentation-of-phase-2-clinical-data-on-cd40-antibody-sotigalimab-apx005m-in-combination-therapy-for-metastatic-pancreatic-cancer-at-the-asco-2021-annual-meeting","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/apexigen-announces-presentation-of-phase-2-clinical-data-on-cd40-antibody-sotigalimab-apx005m-in-combination-therapy-for-metastatic-pancreatic-cancer-at-the-asco-2021-annual-meeting\/","title":{"rendered":"Apexigen Announces Presentation of Phase 2 Clinical Data on CD40 Antibody, Sotigalimab (APX005M), in Combination Therapy for Metastatic Pancreatic Cancer at the ASCO 2021 Annual Meeting"},"content":{"rendered":"
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\n Clinical benefit observed in 1-year overall survival with addition of sotigalimab to standard of care gemcitabine\/nab-paclitaxel; 48.1% as compared to the 35% historical standard of care control<\/em>
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\n Identification of biomarker signature associated with sotigalimab clinical benefit has potential to identify patients most likely to respond to sotigalimab treatment across Apexigen\u2019s clinical trials<\/em>\n <\/p>\n

SAN CARLOS, Calif., May 19, 2021 (GLOBE NEWSWIRE) — Apexigen, Inc., a clinical-stage biopharmaceutical company focused on discovering and developing a new generation of antibody therapeutics for oncology, today announced the presentation of clinical data from the Parker Institute for Cancer Immunotherapy\u2019s Phase 2 clinical trial evaluating sotigalimab, Apexigen\u2019s monoclonal antibody targeting CD40, in combination therapy for patients with metastatic pancreatic cancer at the American Society of Clinical Oncology (ASCO) 2021 Annual Meeting, being held virtually June 4-8, 2021. Sotigalimab, Apexigen\u2019s lead immuno-oncology therapeutic, 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.<\/p>\n

\u201cThese important new data will play a critical role in our development plans for sotigalimab,\u201d said Xiaodong Yang, M.D., Ph.D., Chief Executive Officer of Apexigen. \u201cWe were thrilled to partner with the Parker Institute for Cancer Immunotherapy, Cancer Research Institute and Bristol Myers Squibb, providing our potential best-in-class CD40 therapeutic for their pancreatic cancer study to help address one of the greatest outstanding challenges in oncology. We are encouraged by the clinical benefit observed with the novel combination regimen of sotigalimab and standard of care gemcitabine\/nab-paclitaxel. We believe the improvements observed in one-year overall survival, while not statistically significant as compared to the historical standard-of-care control, may provide meaningful benefit in a subset of patients with pancreatic cancer.\u201d<\/p>\n

Dr. Yang continued, \u201cBeyond these promising data, we are particularly encouraged by the pharmacodynamic effects of sotigalimab. These include an increase in activated myeloid dendritic cells and M1 macrophages, which demonstrates the on-mechanism and differentiated activity of sotigalimab. In addition, the identification of a unique biomarker signature that was associated with clinical benefit of treatment with sotigalimab plus chemotherapy may play a critical role in guiding our clinical strategy, as well as enabling the identification and selection of patients most likely to benefit from sotigalimab. Based on these clinical and biomarker data, we expect an additional Phase 2 trial with more patients and a biomarker-based patient selection strategy may be needed before launching a Phase 3 trial in this indication. We look forward to leveraging these important learnings in our ongoing and future studies, building upon our foundation of compelling single-agent activity in immunotherapy-na\u00efve melanoma, durable activity in PD-1 refractory melanoma, and promising activity in our target combinations of chemotherapy and\/or radiation in other solid tumors. To maximize the full therapeutic potential\u00a0of sotigalimab, we have implemented a broad and comprehensive clinical development strategy and are currently conducting several Phase 2 trials across indications, lines of therapies and combination settings, from which we anticipate multiple milestones and near-term data readouts.\u201d<\/p>\n

The poster titled, \u201cGemcitabine and nab-Paclitaxel \u00b1 Nivolumab \u00b1 CD40 Agonistic Monoclonal Antibody Sotigalimab (APX005M) in Participants with Untreated Metastatic Pancreatic Adenocarcinoma: Phase 2 Final Results\u201d, will be presented by Mark O\u2019Hara, M.D., an assistant professor of Medicine, in the division of Hematology-Oncology in the Perelman School of Medicine at the University of Pennsylvania (Abstract #4019<\/a>; Track: Gastrointestinal Cancer\u2014Gastroesophageal, Pancreatic, and Hepatobiliary). The poster has been selected for presentation as part of a Poster Discussion Session from 9:00-10:00 a.m. ET on Friday, June 4, 2021. The poster will also be available on-demand through the ASCO conference portal, starting at 9:00 a.m. ET.<\/p>\n

Summary of the data:<\/p>\n