BioEclipse Initiates Enrollment in Phase 1 Dose-Escalation Trial for Solid Tumors

BioEclipse Therapeutics™ announced the initiation of patient enrollment in a Phase 1 dose-escalation trial to treat refractory solid tumors. The trial marks the first-in-human study of CRX100, an intravenously-delivered cancer therapy designed to target and destroy multiple cancer types and address disease recurrence.

Patient enrollment is underway at our first clinical trial site, Moores Cancer Center at UC San Diego Health in La Jolla, CA. Additional clinical trial sites are expected to follow. More information about this study and general information about participating in clinical trials can be found at ClinicalTrials.gov.

"The launch of this clinical trial marks a significant milestone in the clinical development of CRX100 and is a further step toward bringing patients with few treatment options a single therapeutic designed to attack multiple cancer types," said Pamela Contag, Ph.D., founder and CEO of BioEclipse. "We believe CRX100 has the potential to address the growing unmet need for treatments of solid tumors and metastatic disease believed to be untreatable, and that are currently underrepresented in clinical trials."

This open-label, Phase 1 dose-escalation study is designed 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.

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 a tumor-killing virus. As stand-alone therapies, these two agents have previously been assessed in human studies. When combined to create CRX100, the CIK cells protect the oncolytic virus and deliver it to cancer cells throughout the body. The two components then work together to attack primary tumors and metastatic disease. Data from preclinical studies shows that this combination approach also can trigger a long-lasting immune response that protects against relapse and disease recurrence.

"The initiation of this clinical trial is welcome news given the urgent need for more effective approaches, especially for patients with cancer refractory to standard treatments," said Sandip Patel, M.D., Associate Professor at University of California San Diego School of Medicine and a Principal Investigator for this study. "If CRX100's treatment approach delivers the same compelling results in humans as it has in preclinical models, it has the potential to address several types of cancer with an otherwise poor prognosis and bring new hope to our patients and their families."