On January 19, 2021 BioEclipse Therapeutics (BioEclipse), a private clinical-stage biopharmaceutical company with a proprietary platform for developing next-generation cancer immunotherapies, reported the initiation of patient enrollment at the HonorHealth Research Institute in Scottsdale, Ariz. for a Phase 1 dose-escalation trial to treat refractory solid tumors (Press release, BioEclipse Therapeutics, JAN 19, 2021, View Source;utm_medium=rss&utm_campaign=bioeclipse-initiates-enrollment-in-phase-1-dose-escalation-clinical-trial-for-crx100-at-honorhealth-research-institute [SID1234575165]). The trial marks the first-in-human study of CRX100, an intravenously delivered agent designed to target and destroy multiple cancer types and address disease recurrence.
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"We are excited to be working with HonorHealth as we advance CRX100 into the clinic, an event that marks a major milestone for our company," stated Pamela Contag, Ph.D., President and CEO of BioEclipse. "CRX100 is a single therapeutic designed to attack multiple characteristics of numerous cancer types. 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."
This open-label, Phase 1 dose-escalation study is to determine the safety, tolerability, and pharmacokinetic (PK) properties of CRX100 in up to 24 participants 18 years or older with advanced solid tumors that do not respond to standard of care. The trial specifically targets six potential cancer indications, including: triple-negative breast cancer, colorectal cancer, hepatocellular carcinoma, osteosarcoma, epithelial ovarian cancer, and gastric cancer. Each patient will receive up to two doses of CRX100. As secondary endpoints, the trial will also investigate the effect CRX100 has on a participant’s tumor progression and overall immune response.
More information about this study and general information about participating in clinical trials can be found at ClinicalTrials.gov.
BioEclipse is currently focused on the treatment of recurring cancers with a unique multi-mechanistic approach that could address cancers believed to be untreatable. Developed with technology exclusively licensed from Stanford University, CRX100 combines activated immune cells, known as cytokine-induced killer (CIK) cells, with an oncolytic virus. When the two components were combined in preclinical animal models, they worked together to attack the cancer.
"We are excited to begin working with BioEclipse to evaluate CRX100 for the first time in human study participants, given the urgent need for better cancer therapies, especially for patients with cancers that do not respond to standard treatments," said Jasgit Sachdev, M.D., Director, Breast and Gynecological Early Phase Clinical Trials at HonorHealth Research Institute, and a Principal Investigator for this study. "Refractory disease is challenging to treat. 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."