Apexigen designed the CD40 agonist to reverse the immune suppression that affects many cancer patients. It does this by activating several immune mechanisms.

CD40 is a receptor whose activation triggers a complex response that involves both arms of the immune system — innate and adaptive — working together against cancer.

Apexigen is hoping that APX005M becomes an effective treatment for tumors affecting the central nervous system. The goal is for it to complement immune checkpoint inhibitors.

“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,” Ira Dunkel, MD, chairman of the consortium’s steering committee, said in a press release.

Under the collaboration, the consortium will conduct a dose-escalation trial (NCT03389802) of APX005M at several academic medical centers and children’s hospitals.

The main objectives of the study will be to determine the treatment’s safety and  pharmacokinetics — or how it works in the body — and patients’ ability to tolerate it. Researchers will also look for preliminary evidence of its anti-cancer activity.

This will be the second Phase 1 trial of APX005M. The first (NCT02482168) evaluated APX005M in adults with solid tumors. Both studies are recruiting participants.

“In a Phase 1 study, APX005M has demonstrated immune stimulation in adult patients with solid tumors,” said Xiaodong Yang, the president and chief executive officer of Apexigen. “We are excited about the opportunity to collaborate with the PBTC [the consortium] to explore the effects of treatment with APX005M in this underserved pediatric population.”

Apexigen is also recruiting patients for a Phase 1/2 open-label, dose-escalation trial (NCT03123783) of APX005M, administered in combination with Opdivo (nivolumab), as a treatment for adults with non-small cell lung cancer or metastatic melanoma.

The Phase 1 portion is intended to establish the maximum tolerated dose and the recommended Phase 2 dose of APX005M when administered with Opdivo. The Phase 2 portion will evaluate the combo’s safety and effectiveness.

In July 2017, Apexigen entered into an agreement with Neon Therapeutics to evaluate  APX005M in combination with NEO-PV-01 in a Phase 1b trial.

The study was designed to evaluate the safety, tolerability, and effectiveness of NEO-PV-01 in combination with APX005M. Researchers wanted to see if APX005M could activate the specialized immune cells called antigen presenting cells that are essential to an NEO-PV-01-triggered immune response. There is no record of the study enrolling any patients yet.

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