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Multiple Solid-Tumor Immunotherapy Trial Underway

Cancer on clipboard

(Nick Youngson,

8 Mar. 2021. A clinical trial is underway testing an immunotherapy for several types of stubborn solid tumor cancer, based on research in university labs. The trial began enrolling and dosing participants, testing the cancer therapy code-named CRX100 developed by BioEclipse Therapeutics in Mountain View, California, with a technology licensed from Stanford University Medical School.

CRX100 is BioEclipse Therapeutics’s lead product that combines two treatment mechanisms. The therapy harnesses cytokine-induced killer or CIK cells that are derived from T-cells and natural killer cells in the immune system with cytokine enzymes added. Combined with CIK cells are oncolytic viruses that infect and break down cancer cells, but not healthy cells. BioEclipse says CIK cells work in 48 to 72 hours, seeking out and binding to tumor cells, then releasing the cancer-killing oncolytic virus payloads.

The company says its technology produces a high ratio of effector to target cells, making it effective against large tumors as well as metastatic tumors. In addition, its treatments create a durable immune response helping prevent new tumor growth. And, says BioEclipse, CRX100 and its other therapies can be made from a patient’s own CIK cells or from donor cells, which are not rejected by patients’ immune systems.

Looking primarily for safety indicators

The early-stage clinical trial is enrolling 24 adults with advanced cases of six solid tumor cancers: triple negative breast cancer, a form of bone cancer called osteosarcoma, epithelial ovarian cancer, and colorectal, liver, and gastric cancer. The patients either have relapsing cancer, or have not responded to earlier treatments. Two sites are taking part, HonorHealth Research Institute in Scottsdale, Arizona and Moores Cancer Center at University of California in San Diego.

The trial is testing the safety of CRX100, with the study team looking primarily for adverse reactions or toxicities from escalating doses of the treatments in the 28 days following infusion. However, the researchers are also tracking distribution of CRX100 in the body, immune response by patients, and any anti-tumor activity also within 28 days.

“CRX100 is a single therapeutic designed to attack multiple characteristics of numerous cancer types,” says Pamela Contag, president and CEO of BioEclipse Therapeutics in a company statement. “With this new approach, BioEclipse is poised to address the substantial and growing unmet need for treatment options for solid tumors and metastatic disease considered by many to be untreatable.”

“Refractory disease is challenging to treat,” adds Jasgit Sachdev, Director, breast and gynecological early phase clinical trials at HonorHealth Research Institute, and a principal investigator of the study. “Data from preclinical models assessing the treatment approached used by CRX100 suggest the potential to address several types of cancer and bring hope to patients with otherwise poor prognosis.”

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