Cybrexa Therapeutics Enters Cooperative Research and Development Agreement (CRADA) with U.S. National Cancer Institute to Develop CBX-12 (alphalex- exatecan)

- Cybrexa and NCI to collaborate on clinical development of Cybrexa's lead candidate, CBX-12, to assess the safety and efficacy in oncology patients with solid tumors -

NEW HAVEN, Conn., Feb. 24, 2021 (GLOBE NEWSWIRE) -- 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 it has entered a Cooperative Research and Development Agreement (CRADA) with the U.S. National Cancer Institute (NCI), part of the National Institutes of Health. Under terms of the agreement, Cybrexa and the NCI will collaborate on pre-clinical and potential clinical development of Cybrexa's lead therapeutic candidate, CBX-12 (alphalex-exatecan).

"This research and development agreement with the NCI is not only a validation of Cybrexa's technology, but may also allow us to significantly expand our clinical development program," said Per Hellsund, President and CEO of Cybrexa. "Collaborating with the NCI on the development of CBX-12 may allow testing of its therapeutic potential by some of the world's leading oncology researchers. This collaboration also dramatically expands our ability to conduct clinical trials in a wide number of indications, and in combination with other therapies such as immuno-oncology and PARP inhibitors."

Cybrexa and the NCI will work together initially focusing on pre-clinical studies and move on to clinical development of CBX-12, if the preclinical studies support clinical development, to demonstrate its safety and efficacy in patients with a variety of solid tumors.

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 overexpression, which should 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, as Cybrexa filed the IND on February 19, 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.

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