Apexigen Announces New Data from a Phase 2 Trial Evaluating its CD40 Antibody, Sotigalimab, in Combination with Pembrolizumab in Patients with Metastatic Melanoma Presented at the AACR Annual Meeting 2022

Excerpt from the Press Release:

-The combination of intratumoral sotigalimab and systemic pembrolizumab induced broad innate and adaptive immune activation in local and distant tumors-

-Oral presentation on April 12, 2022 at 3:35 pm (CDT)-

SAN CARLOS, Calif., April 12, 2022 (GLOBE NEWSWIRE) — Apexigen, Inc., a clinical-stage biopharmaceutical company focused on discovering and developing a new generation of antibody therapeutics for oncology, today announced the presentation of data from a Phase 2 clinical trial evaluating intratumoral sotigalimab (sotiga), Apexigen’s monoclonal antibody targeting CD40, in combination with systemic pembrolizumab in anti-PD-L1 treatment-naïve patients with advanced or metastatic melanoma. Broad innate and adaptive immune activation was observed in both local and distant (non-injected) lesions. Encouraging anti-tumor activity was observed in patients with PD-L1-negative tumors as well as in patients with elevated LDH, a poor prognostic indicator for response to anti-PD-1 therapy.   These data were featured in an oral presentation at the American Association for Cancer Research (AACR) Annual Meeting, taking place in New Orleans, Louisiana from April 8-13, 2022.

“We are encouraged by these exciting data demonstrating the clinical utility of sotiga, a potentially first- and best-in-class CD40 agonist with unique epitope specificity and Fc receptor engagement, and its ability to harness the innate and adaptive arms of the immune system for maximal therapeutic effect,” said Frank Hsu, M.D., Chief Medical Officer of Apexigen. “These findings further support the potential to combine sotiga with other anti-cancer therapies across multiple indications to initiate and boost effective anti-tumor immunity and provide clinical benefit.”

Adi Diab, M.D., Associate Professor of Melanoma Medical Oncology at The University of Texas MD Anderson Cancer Center and Principal Investigator of the study, commented, “The results from this ongoing study show the combination of intratumoral sotiga and systemic pembrolizumab leads to increased immunologic activity and encouraging clinical responses with a favorable safety and tolerability profile. Further, this combination stimulated innate and adaptive immune responses in both local and distant lesions. Together, these results suggest sotiga-based combinations warrant further investigation for patients with metastatic melanoma and offer the potential to pave the way for novel strategies to improve immunologic activity and deliver sustained clinical benefit.”

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