Apexigen Presents Clinical Data On CD40 Antibody APX005M In Metastatic Melanoma At The AACR Annual Meeting 2019
SAN CARLOS, Calif., April 1, 2019 /PRNewswire/ -- Apexigen, Inc., a clinical-stage biopharmaceutical company, today presented new clinical data on APX005M at the American Association for Cancer Research (AACR) Annual Meeting, taking place March 29 - April 3, 2019 in Atlanta, GA. Apexigen's lead immuno-oncology (I-O) therapeutic APX005M, a monoclonal antibody targeting CD40, is being evaluated in multiple ongoing clinical trials in different types of solid tumors.
"We are excited to have new clinical data presented at AACR on our CD40 antibody APX005M in combination therapy, highlighting the breadth of our clinical development program targeting difficult-to-treat types of cancer," said Ovid Trifan, M.D., Ph.D., Chief Medical Officer and Senior Vice President of Clinical Development of Apexigen. "Yesterday, clinical data in metastatic pancreatic cancer were presented in a plenary session, showing APX005M in combination therapy was well-tolerated and induced promising tumor shrinkage in 20 of 24 evaluable patients. Today, we are presenting clinical data from our ongoing Phase 1b/2 clinical trial in patients with metastatic melanoma demonstrating that APX005M is well tolerated in combination with nivolumab and triggers responses in patients who have progressed on anti-PD-1 therapy. Together, these data speak to the promise of APX005M and we are encouraged by these early results. We look forward to continuing to advance our broad clinical development program for this therapy as a new treatment option for patients living with cancer."
"If a patient with metastatic melanoma does not respond to currently approved immune checkpoint inhibitors, there are no approved treatment options left, unless the tumor has a BRAF mutation," said Harriet Kluger, M.D., Professor of Medicine at Yale Cancer Center. "We are eager to assess whether combining APX005M with nivolumab can reverse the course of this disease for these patients."
About the Phase 1b/2 Clinical Trial
In the Phase 1b portion of this clinical trial, APX005M was well tolerated and no dose-limiting toxicities (DLTs) were observed. The RP2D for APX005M is 0.3 mg/kg. Of the 5 subjects with metastatic melanoma, 1 had a confirmed partial response (PR), 2 had prolonged stable disease (SD) (>8 months), and 2 had progressive disease (PD) as the best overall response.
The Phase 2 dose-expansion portion of this clinical trial followed a Simon 2-stage design and included two parallel cohorts of patients treated with the RP2D of APX005M with nivolumab. The primary endpoints are 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.
In the Phase 2 portion of this clinical trial, the first stage of the cohort enrolled 10 subjects, in addition to the two subjects that carried over from the Phase 1 portion. Of these 12 subjects, 2 had confirmed PR, 3 had SD, and 7 had PD as best overall response.
For additional information on this trial (NCT03123783), please visit www.clinicaltrials.gov.
APX005M Data Presentation at AACR 2019 Annual Meeting
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SOURCE Apexigen, Inc.