FDA clears its IND for new immunotherapeutic for treating prostate cancer

Calibr, the drug development division of Scripps Research, announced today that the U.S. Food and Drug Administration (FDA) has cleared its investigational new drug application (IND) for CCW702, a novel immunotherapeutic for the treatment of patients with metastatic castration-resistant prostate cancer.

CCW702 has the potential to be effective in patients who have failed prior treatments and have exhausted their treatment options, because it works differently than traditional chemotherapeutics and androgen deprivation therapies. We are truly excited about the opportunity to evaluate the safety and anti-tumor activity of this molecule in patients."

Travis Young, PhD, Vice President of Biologics, Calibr

Young led the pre-clinical development of the molecule.

CCW702 is a first-of-its-kind molecule designed to redirect a patient's own immune system to eliminate malignant cancer cells. The molecule uses a unique design that combines the specificity of a validated imaging agent for prostate cancer with the potency of immunotherapy. In preclinical work, this design proved highly effective at completely eliminating tumors in animal models of prostate cancer.

The launch of this clinical study--Calibr's fourth overall and second being run independently by the institute--is another major milestone for the new model being pioneered at Scripps Research, where innovative discoveries are translated into new medicines within the nonprofit enterprise.

CCW702 began as a research project in the laboratory of Peter Schultz, PhD, at Scripps Research and progressed to the IND stage by Calibr through support from the Wellcome Trust. The molecule is manufactured using unnatural amino acid technology pioneered in Schultz's laboratory in collaboration with Ambrx Inc.

"This program exemplifies the relationship between Scripps Research and Calibr in the ability to bring high-risk, high-reward programs forward into clinical trials to create impact for patients and value for the institute that stimulates and supports further research," says Schultz, president and CEO of Scripps Research. "This model has the potential to be transformative in the way new medicines are developed."

Clinical development of CCW702 will be led by Calibr's new Chief Medical Officer Pamela D. Garzone, PhD. Her leadership will be critical as Calibr advances additional programs into the clinic over the next 18 months, with another IND filing expected by the end of the year.