On March 31, 2019 Apexigen, Inc., a clinical-stage biopharmaceutical company, reported the presentation of new clinical data on APX005M in combination therapy in patients with metastatic pancreatic cancer (Press release, Apexigen, MAR 31, 2019, View Source [SID1234534792]). The data are being presented in a plenary session today at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, taking place March 29 – April 3, 2019 in Atlanta, GA, by Parker Institute for Cancer Immunotherapy (PICI) researchers at the University of Pennsylvania. Apexigen’s lead immuno-oncology (I-O) therapeutic, APX005M, a monoclonal antibody targeting CD40, is being evaluated in multiple clinical trials in different types of solid tumors.

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In an interim analysis of an ongoing Phase 1b clinical trial, 20 of 24 evaluable patients with metastatic pancreatic cancer demonstrated tumor shrinkage following treatment with APX005M in combination with standard-of-care chemotherapy, with or without Bristol-Myers Squibb’s PD-1 inhibitor nivolumab. Several patients remained on therapy after one year of treatment.

"Our CD40 agonist APX005M is critical for activating the body’s innate and adaptive immunity, potentially enabling the immune system to fight even the most difficult-to-treat forms of cancer," said co-author Ovid Trifan, M.D., Ph.D., Chief Medical Officer and Senior Vice President of Clinical Development of Apexigen. "We are encouraged by these interim results and are excited to see this trial advance to the next phase in evaluating a novel combination therapy for patients with metastatic pancreatic cancer. In addition to these results, we look forward to a second presentation of clinical data at AACR (Free AACR Whitepaper) tomorrow on APX005M in combination therapy for patients with metastatic or unresectable melanoma who have progressed on anti-PD-1/PD-L1 therapy. We are committed to advancing a broad clinical development program for APX005M in multiple types of cancer as we work toward transforming the standard of care for patients across a wide range of cancer indications."

First author Mark H. O’Hara, M.D., Assistant Professor of Medicine at the Perelman School of Medicine at the University of Pennsylvania, commented, "In this interim analysis of this trial, we are encouraged by the safety and activity signals from anti-CD40 immunotherapy APX005M in combination with chemotherapy with or without checkpoint inhibition as a new approach to treating metastatic pancreatic cancer. Given that most patients with metastatic pancreatic cancer have evidence of progression of their cancer within about 5 months of starting first line chemotherapy, seeing several patients stay on treatment on this trial for more than one year is exciting. We look forward to exploring the benefits of CD40 activation to treat this aggressive form of cancer."

About the Phase 1b/2 Clinical Trial
In the Phase 1b portion of the clinical trial, previously untreated patients with metastatic pancreatic ductal adenocarcinoma received APX005M in combination with gemcitabine and nab-paclitaxel, a standard-of-care chemotherapy regimen for this patient population, and half of the patients also received Bristol-Myers Squibb’s PD-1 inhibitor nivolumab. The combination therapy treatment was well-tolerated. Several patients remained on treatment for about a year, and had a durable response. 20 of 24 evaluable patients demonstrated tumor shrinkage. The trial has progressed to the Phase 2 portion.

For additional information on this trial (NCT03214250), please visit www.clinicaltrials.gov.

APX005M Data Presentations at AACR (Free AACR Whitepaper) 2019 Annual Meeting
Plenary Session Presentation Title: A Phase 1b Study of CD40 Agonistic Monoclonal Antibody APX005M Together with Gemcitabine (Gem) and nab-Paclitaxel (NP) with or without Nivolumab (Nivo) in Untreated Metastatic Ductal Pancreatic Adenocarcinoma (PDAC) Patients (Abstract #CT004)
Presenter: Mark O’Hara, M.D., Assistant Professor of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania
Plenary Session Date and Time: Sunday, March 31, 2019 2:25 PM – 2:45 PM ET
Plenary Session: Clinical Trials Plenary Session 1
Location: Georgia World Congress Center, Building A, Marcus Auditorium

Late-breaking Abstract Title: Phase Ib/II clinical trial of CD40 agonistic antibody APX005M in combination with nivolumab (nivo) in subjects with metastatic melanoma (M) or non-small cell lung cancer (NSCLC) (Abstract #CT089)
Poster Session Date and Time: Monday, April 1, 2019 1:00 PM – 5:00 PM ET
Poster Session: Phase 1 Clinical Trials
Location: Georgia World Congress Center, Exhibit Hall B, Poster Section 16

About APX005M
APX005M is a humanized monoclonal antibody designed to stimulate the anti-tumor immune response. APX005M targets CD40, a co-stimulatory receptor that is essential for activating both innate and adaptive immune systems. Binding of APX005M to CD40 on antigen presenting cells (i.e., dendritic cells, monocytes and B-cells) is believed to initiate a multi-faceted immune response that enables multiple components of the immune system (e.g., T cells, macrophages) to work in concert against cancer. APX005M is currently in Phase 2 clinical development for the treatment of cancers such as pancreatic cancer, melanoma, esophageal and gastroesophageal junction cancers, non-small cell lung cancer, renal cell carcinoma, sarcomas, and pediatric brain cancer in various combinations with immunotherapy, a cancer vaccine, chemotherapy or radiation therapy. Additional information on clinical trials for APX005M can be found at www.clinicaltrials.gov.