Phase 1/2 Clinical Trial of Apexigen’s APX005M in Combination with Pembrolizumab (Keytruda®) Opens for Metastatic Melanoma Patients
(San Carlos, California - March 21, 2017) - Apexigen, Inc., a clinical-stage biopharmaceutical company focusing on discovering and developing antibody-based therapeutics for the treatment of cancer with an emphasis on new Immuno-Oncology (I-O) agents, today announced the initiation of patient enrollment in a Phase 1/2 clinical trial at The University of Texas MD Anderson Cancer Center. This trial is designed to evaluate Apexigen’s CD40 agonistic antibody APX005M in combination with pembrolizumab (Keytruda®) in patients with metastatic melanoma.
“APX005M has demonstrated robust immune system activation and an excellent safety profile and we are eager to explore the therapeutic benefit of combining our antibody with pembrolizumab for patients living with melanoma,” said Ovid Trifan, M.D., Ph. D., Chief Medical Officer at Apexigen. “We expect that APX005M’s anti-tumor immune response through antigen-presenting cells will become a cornerstone of many new therapeutic I-O combinations that can help treat cancer patients in the coming years.”
“The field of immuno-oncology is making significant advances in the treatment of cancer patients. We are excited that APX005M may play a pivotal role in driving even more advances in I-O treatment to benefit cancer patients,” said Xiaodong Yang, M.D., Ph.D., President and Chief Executive Officer of Apexigen.
This Phase 1/2 clinical trial plans to enroll patients with metastatic melanoma and will evaluate the safety, tolerability and preliminary efficacy of APX005M, administered locally into the tumor, combined with systemic administration of pembrolizumab. During the initial dose-escalation part of this trial, the maximum tolerated dose of APX005M in combination with pembrolizumab will be determined. In the subsequent dose-expansion part of this trial, the primary endpoint will measure overall response rate for patients using the immune-related Response Criteria (irRC) criteria and the secondary endpoint will assess the immune-related best overall response. Additional information on this clinical trial is available at www.clinicaltrials.gov (identifier: NCT02706353).
APX005M is a novel, humanized monoclonal antibody that stimulates the anti-tumor immune response in the tumor microenvironment through antigen-presenting cells (APC) of the immune system. APC activation complements the action of immune checkpoint inhibitors, such as pembrolizumab, a PD-1 inhibitor, which releases T cells from immunosuppression. In a recently completed clinical trial, APX005M demonstrated robust immune activation and an excellent safety profile. Preclinical data strongly suggest that combination of a CD40 agonistic antibody with an immune checkpoint inhibitor, such as an anti-PD-1, anti-PD-L1 and/or anti-CTLA4 antibody, will result in synergistic anti-tumor efficacy.
About Metastatic Melanoma
According to the American Cancer Society’s estimates, approximately 87,110 individuals will be diagnosed with melanoma and 9,730 people will die from this form of cancer in 2017 in the United States. Patients diagnosed with metastatic melanoma, or Stage IV melanoma, have a
5-year survival rate of between 15% and 20%.
About Apexigen, Inc.
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. Seven 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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