US-based Apexigen has partnered with Yale Cancer Center to conduct a Phase I/II clinical trial of its APX005M candidate in conjunction with cabiralizumab and Opdivo to treat advanced solid tumours.
Opdivo and cabiralizumab will be supplied by Bristol-Myers Squibb (BMS), which will also sponsor the clinical study.
In alliance with Five Prime Therapeutics, BMS is developing cabiralizumab as an antibody to block colony stimulating factor-1 receptor (CSF1R) and reduce immunosuppressive tumour-associated macrophages (TAMs).
APX005M is an investigational drug designed to trigger the CD40 immune co-stimulatory receptor, which is required to regulate the activation of innate and adaptive immune responses against cancer.
The Phase I/II trial will assess the safety, tolerability and preliminary activity of the combination therapy in metastatic non-small cell lung cancer (NSCLC), metastatic melanoma and renal cell carcinoma (RCC) patients who progressed on previous anti-PD-1/PD-L1 therapy.
Apexigen president and CEO Xiaodong Yang said: “There is an urgent need to find effective therapies for the growing number of patients who have not responded to checkpoint inhibitors.
“CD40 has a fundamental role in the activation of both innate and adaptive immunity, and we believe that CD40 activation by APX005M will become a key component of a number of promising new I-O therapeutic regimens for treating cancer patients.”
Researchers at Yale Cancer Center reported preclinical data indicating positive outcomes for the combination of CD40 activation and CSF-1R inhibition.
It was observed that the combination alters TAMs and activates T cells in tumours. This changes their microenvironment to elicit protective T cell responses in unresponsive tumours, as well as those that are not sensitive to immune checkpoint blockades.
