Apexigen Presents Positive Data for APX005M in Podium Presentation at Immune Checkpoint Inhibitors (ICI) Europe
APX005M Targets CD40 Ligand Binding Site with High Affinity and Demonstrates Potent Immune Activation and Anti-Tumor Activity
San Carlos, Calif., November 17, 2015 — Apexigen, Inc., a clinical-stage biopharmaceutical company discovering and developing a new generation of antibody therapeutics for the treatment of cancer, announced today that Xiaodong Yang, M.D., Ph.D., President and CEO, presented preclinical data for and clinical program updates on the Company’s proprietary CD40 agonistic antibody, APX005M. In addition, Dr. Yang led a workshop entitled “Development of Effective Combination Therapies” at the Immune Checkpoint Inhibitors (ICI) Europe conference taking place November 17-18 in Bad Homburg, Germany.
“We believe that APX005M presents all of the characteristics a CD40 agonist needs to be an efficacious cancer therapy as a single agent with an excellent safety profile,” said Dr. Yang. “Because CD40 acts upstream of the various checkpoint inhibitors, we expect that APX005M activity will be complementary to and enhance the efficacy of many of the checkpoint inhibitor drugs on the market and in development. We are currently conducting a Phase 1 dose-escalation study of APX005M in patients with advanced solid tumors and look forward to reporting on our continued clinical progress.”
Data presented today in a session entitled “First Patient In Phase 1 Clinical Trial Of Immuno-oncology Therapeutic Antibody APX005M,” illustrate the ability of APX005M to successfully mimic the endogenous immune activation process. Because it both activates CD40 through the same binding site used by the endogenous CD40 ligand and induces cross-linking via Fc receptors, APX005M induces a high degree of immune activation in a manner that is expected to provide a margin of safety and a broad therapeutic window. APX005M is currently is a Phase 1 dose-escalation trial in solid tumor patients.
CD40, a receptor on the surface of antigen presenting cells of the immune system, plays a fundamental role in the activation of both innate and adaptive immune system mechanisms. Upon activation of CD40, a cascade of events is initiated that culminates in a) the activation of dendritic cells, B cells and macrophages to process and present tumor antigen to T cells and “license” the T cells to attack tumors, b) upregulation of other critical immune pathway molecules such as PDL-1, 4-1BBL, OX40L and GITRL, and c) the activation of macrophages, neutrophils and NK cells to directly attack tumor cells. As such, CD40 activation results in a broad spectrum of immune activation against a broad array of cancer types.
APX005M is a novel, humanized monoclonal antibody designed to reverse the systemic immune suppression that typically affects cancer patients. APX005M targets CD40, a co-stimulatory receptor that is essential for activating both innate and adaptive immune systems. Binding of APX005M to CD40 initiates and amplifies a complex, multi-cellular immune response bringing components of both immune systems to work in concert against cancer, activating antigen-presenting cells (i.e., dendritic cells, monocytes and B-cells) and resulting in cancer-specific T-cell responses. APX005M is currently in Phase 1 clinical development for the treatment of solid tumors.
Apexigen is a clinical-stage biopharmaceutical company discovering and developing a new generation of antibody therapeutics for oncology, with an emphasis on new immuno-oncology agents that could harness the patient’s immune system to combat and eradicate cancer. APX005M and the Company’s additional preclinical programs were discovered using APXiMABTM, Apexigen’s proprietary product discovery platform. This platform has enabled the Company and its collaboration partners to discover and develop high-quality therapeutic antibodies against a variety of molecular targets, including targets that are difficult to drug with conventional antibody technologies. Six product candidates discovered using APXiMABTM are currently in clinical development, either internally by Apexigen or by its partners. For more information, please visit www.apexigen.com.
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