Apexigen and the Pediatric Brain Tumor Consortium Announce a Clinical Collaboration to Evaluate APX005M in Children with Brain Tumors
- Study to evaluate the safety and tolerability of APX005M, a CD40 agonistic antibody, in pediatric patients with recurrent or refractory brain tumors
San Carlos, CA – March 6, 2018 – Apexigen, Inc., a clinical-stage biopharmaceutical company, and the Pediatric Brain Tumor Consortium (PBTC), today announced a clinical trial collaboration to evaluate Apexigen’s APX005M, an investigational immune activating compound that targets CD40, in pediatric patients with recurrent or refractory brain tumors. CD40 is an immune co-stimulatory receptor essential to the activation of both innate and adaptive immune responses against cancer. There is an unmet need in pediatric oncology for effective treatments for Central Nervous System (CNS) tumors. Immunotherapy is currently considered a promising area of investigation in clinical oncology and it is expected that novel immune-activating agents such as APX005M will provide additional benefit to complement the currently used immune checkpoint inhibitors.
The PBTC will conduct a Phase 1 dose escalation trial of APX005M in children at its participating academic medical centers and children’s hospitals across the United States. Objectives of the study include establishing the safety, tolerability, pharmacokinetics and preliminary evidence of activity for APX005M in the pediatric population. Ira Dunkel, M.D., Chairman of the PBTC Steering Committee, said, “We believe that CD40 activation is a very promising area of immunotherapy for cancer, and we are happy to be collaborating with Apexigen to evaluate APX005M in our pediatric patients.”
“In a Phase 1 study, APX005M has demonstrated immune stimulation in adult patients with solid tumors,” said Xiaodong Yang, M.D., Ph.D., President and CEO of Apexigen. “We are excited about the opportunity to collaborate with the PBTC to explore the effects of treatment with APX005M in this underserved pediatric population.”
APX005M is a novel, humanized investigational monoclonal antibody designed to overcome the systemic immune suppression that typically affects cancer patients through activation of CD40, a co-stimulatory receptor on the antigen presenting cells that is essential for activating both innate and adaptive immunity.
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.
Formed in 1999, the PBTC is a multidisciplinary cooperative research organization supported by the National Cancer Institute’s Cancer Therapy Evaluation Program, that is devoted to the study of correlative tumor biology and new therapies for primary CNS tumors of childhood. Its mission is to improve the treatment of primary brain tumors in children. The participating academic medical centers and children's hospitals are responsible for the diagnosis and treatment of a notable proportion of children with primary brain tumors in the United States.
In support of its mission, the PBTC rapidly and effectively conducts novel phase I and II clinical evaluations of new therapeutic drugs, new biological therapies, treatment delivery technologies and radiation treatment strategies in children from infancy to 21 years of age with primary CNS tumors. The PBTC also collaborates to characterize reliable markers and predictors (direct or surrogate) of brain tumors' responses to new therapies. The Consortium conducts research on brain tumor specimens in the laboratory to further understand the biology of pediatric brain tumors. More information is available at www.pbtc.org.
Research reported in this press release is supported by the National Cancer Institute’s Division of Cancer Treatment and Diagnosis, of the National Institutes of Health, under award number UM1CA081457. The content of this press release is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.
Vice President, Business Development
Ira Dunkel, MD