Apexigen, Inc. Announces First Patient Dosed in Phase 1b/2 Clinical Trial of APX005M in Combination with Opdivo (nivolumab) in Advanced Solid Tumors
- Category: Antibodies
- Published on Monday, 17 July 2017 16:33
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--Trial Enrolling Second-line Metastatic Non-small Cell Lung Cancer (NSCLC) Patients Who Have Failed Prior Chemotherapy and Metastatic Melanoma Patients Who Have Failed Prior I-O Therapy--
SAN CARLOS, CA, USA I July 17, 2017 I Apexigen, Inc., a clinical-stage biopharmaceutical company focused on discovering and developing antibody-based therapeutics for the treatment of cancer with an emphasis on new Immuno-Oncology (I-O) agents, today announced that the first patient has been dosed in a new multicenter Phase 1b/2 clinical trial. Under a clinical trial collaboration, with Bristol-Myers Squibb Company Apexigen is evaluating the safety, tolerability and preliminary efficacy of Apexigen's APX005M in combination with Bristol-Myers Squibb's Opdivo (nivolumab) in second-line metastatic NSCLC patients who have failed prior chemotherapy and in metastatic melanoma patients who have failed prior I-O therapy.
"We are excited to dose the first patient in this clinical trial to evaluate the potential of a new treatment approach, combining our CD40 agonist APX005M with Opdivo, a PD-1 immune checkpoint inhibitor," said Xiaodong Yang, M.D., Ph.D., President and CEO of Apexigen. "Previously, APX005M has demonstrated safety and activity in a Phase 1 clinical trial and dosing the first patient in this Phase 1b/2 trial is an important milestone as we advance our clinical development plans for our novel I-O agents."
In the Phase 1b dose-escalation portion of this clinical trial, patients with non-small cell lung cancer or metastatic melanoma plan to be enrolled to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of APX005M in combination with nivolumab. In the Phase 2 dose-expansion portion of this trial, additional patients plan to be enrolled and all will be treated with the RP2D of APX005M with nivolumab. The primary endpoints will be safety and overall response rate (ORR) measured by RECIST 1.1 criteria. Secondary endpoints include determining the pharmacokinetic (PK) profile of APX005M, assessing the incidence of APX005M anti-drug antibodies (ADA), and evaluating the duration of response (DOR) and median progression-free survival (PFS) for patients.
Additional information on this clinical trial is available at www.clinicaltrials.gov (identifier: NCT03123783).
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. APX005M is engineered to selectively activate CD40 in tumor tissues, rather than broadly in the bloodstream like other CD40 agonists. This selective approach has demonstrated potent immune activation with few safety signals, which offers our antibody the potential for a broad therapeutic window to fight cancer.
About Non-small Cell Lung Cancer
Lung cancer is the leading cause of cancer death. According to the American Cancer Society's estimates, approximately 222,500 individuals will be diagnosed with lung cancer and 155,870 people will die from this form of cancer in 2017 in the United States. Non-small cell lung cancer (NSCLC) is the most common type of lung cancer.
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 APXiMAB™, 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 APXiMAB™ are currently in clinical development, either internally by Apexigen or by its partners. For more information, please visit www.apexigen.com.