28 Apr BioEclipse Receives FDA Clearance of Investigational New Drug Application for CRX100
Phase 1 Dose-Escalation Trial in Therapy-Refractory Solid Tumors to Begin in 2020
Mountain View, CA – April 28, 2020 – BioEclipse Therapeutics™ (BioEclipse), a private clinical-stage biopharmaceutical company developing first-in-class, curative immuno-oncology therapeutics, announced today that the U.S. Food and Drug Administration has cleared the Investigational New Drug (IND) application for the Company’s lead drug candidate, CRX100. This multi-mechanistic cancer immunotherapy is delivered intravenously to target and destroy multiple cancer types and to prevent disease recurrence. BioEclipse plans to initiate a Phase 1 clinical trial of its patented CRX100 in therapy-refractory solid tumors in 2020.
Pamela Contag, Ph.D., founder and CEO of BioEclipse, stated, “Our first IND clearance represents a significant milestone for BioEclipse, and validates the groundbreaking potential of our cancer immunotherapy, CRX100. This first-in-class immunotherapy may conquer the challenges of resistant and recurrent cancers by both killing primary tumors and metastatic disease along with the generation of a durable immune response against the patient’s tumor. With funds raised in the Series A-1 financing, we plan to initiate the first clinical trial of CRX100 and take further steps to achieve our mission to bring a new generation of targeted therapies to cancer patients with few treatment options.”
Dr. Contag continued, “These are exciting times for our team and our company. However, as we prepare to advance CRX100 into the clinic, we must acknowledge that we do so amid extraordinary circumstances with the COVID-19 outbreak placing immense pressure on our healthcare system. As we move ahead with the CRX100 clinical trial, the safety and well-being of the patients, and their families, as well as the medical personnel administering the trial is paramount.”
CRX100 was developed with technology exclusively licensed from Stanford University, and has the potential to provide a curative therapy to patients with hard-to-treat malignancies that span a broad range of both solid and liquid tumors. The drug combines activated immune cells with a tumor selective oncolytic virus. When used separately in patients, these two approaches display limited efficacy as cancer therapies, as described by previous clinical research. By combining these two approaches, CRX100 is designed so the immune cells carry the virus to the cancer cells and then the two work synergistically to eradicate the tumors. An additional element of the combination CRX100 therapy is mediation of an immune response against the patient’s tumor cells that can potentially limit the growth of new disease.
The BioEclipse activated immune cells preinfected with a selective oncolytic virus have been studied extensively in animal models using mice across several cancer indications, including ovarian, breast, prostate, Non-Hodgkin’s Lymphoma, hepatocellular carcinoma, colon, glioblastoma, neuroblastoma and lung. Data from these nonclinical studies demonstrate that the therapy appears to work in both solid and liquid tumors, and that a long-term immune response was generated against even hard-to-kill metastatic cancers.
“We have an urgent need for more effective treatments especially for patients with disease refractory to standard treatments,” said Oliver Dorigo, M.D., Ph.D., Director of Gynecologic Oncology at Stanford University Medical Center. “CRX100 has the potential to be effective not only in women with ovarian cancer, but in many other tumor types with an otherwise poor prognosis. This new immunotherapy is based on meticulous scientific studies and brings new hope to our patients and their families.”
The planned open-label Phase 1 dose-escalation study is designed to determine the safety, tolerability and pharmacokinetic (PK) properties of CRX100 in adult subjects with solid tumors that are relapsed, refractory or intolerant to standard care, or refusing standard therapies. The study may include patients with multiple cancer types and can enroll up to 24 patients. The study’s primary endpoint will measure the frequency of treatment-emergent adverse events and dose-limiting toxicities in each subject following dose administration. More information on the study can be accessed at www.clinicaltrials.gov (NCT04282044).
BioEclipse will collaborate with Spannerwerks, LLC, a professional services firm focused on assisting biopharmaceutical companies with the development and launch of new products, to prepare for the upcoming Phase 1 clinical trial for CRX100. The firm worked with BioEclipse to complete the IND filing for CRX100.
“CRX100 is an important step forward in cancer immunotherapy and we are proud to work with BioEclipse as it advances this technology out of the laboratory and into the clinic,” said Dara Lockert, Executive Director of Spannerwerks.
About BioEclipse Therapeutics™
BioEclipse Therapeutics™ is an emerging, clinical-stage biopharmaceutical company committed to delivering first-in-class, curative immuno-oncology therapeutics to patients with cancer. Our focus is on currently untreatable cancers where our unique multi-mechanistic combination approach could address needs of patients with cancers believed to be untreatable. BioEclipse Therapeutics™ is preparing to initiate Phase I clinical trials with, CRX-100, a patented, first in class, intravenously delivered, targeted immunotherapy against solid tumors. CRX100 is being developed to deliver potentially curative treatment to patients over a broad range of tumor types, including some rare pediatric cancers. For more information, visit www.bioeclipse.com.
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