Cybrexa Therapeutics Receives Green Light from FDA on Investigational New Drug Application for CBX-12 (alphalex™-exatecan)
“The go ahead from the FDA on our IND application for CBX-12 is a major step in the clinical development of what we believe could be a game-changing therapeutic for many cancer patients,” said Per Hellsund, President and CEO of Cybrexa. “Preclinical studies of CBX-12 show a strong efficacy and safety profile, and we expect that the Phase I clinical trial will help us learn more about the potential applications of this therapeutic candidate. The clinical development of CBX-12 is important, not just as we move toward bringing this candidate to market, but in expanding the addressable patient populations with therapeutics that target a broader scope of solid tumors, allowing us to treat a greater number of patients.”
CBX-12 is a novel treatment for solid tumors that includes a highly potent topoisomerase I inhibitor payload that is in the same class as the payloads used by antibody-drug conjugates (ADCs) ENHERTU® and TRODELVY™. In contrast to these ADCs, CBX-12 is able to target cancer cells independent of antigen expression, which could greatly expand the addressable patient populations. The positive results from the GLP toxicology study of CBX-12 will serve as a guide for dosing regimen for the planned Phase I trial of CBX-12, which Cybrexa plans to initiate in April 2021.
About the alphalex™ Technology Platform
The Cybrexa alphalex™ technology platform – which consists of a pHLIP® peptide, linker, and small molecule anti-cancer agent (payload) – enables antigen-independent targeting of tumors and intracellular delivery of highly potent anticancer therapies, creating therapeutics that can revolutionize the standard of care. pHLIP® peptides are a family of pH-Low Insertion Peptides that target acidic cell surfaces. pHLIP® was developed at Yale University and the University of Rhode Island, and is exclusively licensed to pHLIP, Inc. alphalex™ represents the disruptive next generation in tumor targeting. View a video of the mechanism of action of the technology at www.cybrexa.com.
Cybrexa is a privately-held biotechnology company dedicated to developing next-generation tumor-targeted cancer therapies using its alphalex™ platform. The Company’s lead candidate, CBX-12, an alphalex™ -exatecan conjugate, is expected to enter Phase I/II in 2021 in advanced solid tumors. Cybrexa also has other preclinical toxin conjugate programs as well as synthetic lethality programs. Cybrexa was founded by physician-scientists and has an experienced management team that has built numerous successful life sciences companies. For more information about Cybrexa, please visit www.cybrexa.com.