FDA Clears Way for Trial of Immunotherapy in Advanced Prostate Cancer, Scripps Research Says

FDA Clears Way for Trial of Immunotherapy in Advanced Prostate Cancer, Scripps Research Says
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immunotherapy trial planned

The U.S. Food and Drug Administration (FDA) has signed off on a clinical trial that will test CCW702, an immunotherapy developed by Calibr at Scripps Research, as a possible treatment of metastatic castration-resistant prostate cancer (mCRPC).

CCW702 is a bispecific antibody, acting as a bridge between cancer and immune cells. Specifically, the treatment binds the CD3 protein located on the surface of the immune T-cells, and the prostate-specific membrane antigen (PSMA) on prostate cancer cells. This simultaneous binding helps to recruit cytotoxic T-cells to the vicinity of cancer cells, promoting their killing.

This new approach could be promising for prostate cancer patients who fail to respond to hormone therapy.

“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,” Travis Young, vice president of Biologics at Calibr and leader of CCW702’s pre-clinical work, said in a press release.

“We are truly excited about the opportunity to evaluate the safety and anti-tumor activity of this molecule in patients,” Young added.

Preclinical studies report that CCW702 is highly selective, lasts longer in circulation than current bispecific antibodies, and is very effective at eliminating tumors in mouse models of prostate cancer. Treated mice showed tumor shrinkage shortly after its administration, while those in an untreated control group had rapid tumor growth.

The animals also showed no signs of toxicity, like loss of body weight.

The antibody was initially developed by Peter Schultz, PhD, at Scripps Research in collaboration with Ambrx, a company specializing in antibody production for therapeutics. Calibr, a nonprofit translational research institute, is in charge of the clinical development of CCW702.

“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,” said Schultz, who is also the president and CEO of Scripps Research.

“This model has the potential to be transformative in the way new medicines are developed,” he added.

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