SAN CARLOS, Calif., July 17, 2017 /PRNewswire/ — 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).