Cybrexa Therapeutics Receives Green Light from FDA on Investigational New Drug Application for CBX-12 (alphalex™-exatecan)

Cybrexa plans to initiate Phase I clinical trial in April 2021

NEW HAVEN, CT, USA I March 22, 2021 I Cybrexa Therapeutics, an oncology-focused biotechnology company developing a new class of therapeutics through its alphalex™ Peptide Drug Conjugate (PDC) tumor targeting platform, today announced that the U.S. Food and Drug Administration (FDA) has provided the green light regarding the Investigational New Drug (IND) application for CBX-12 (alphalex™-exatecan), the company’s lead therapeutic candidate.

“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. 

About Cybrexa
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.  

SOURCE: Cybrexa

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