Cybrexa Therapeutics Completes Successful Pre-IND Meeting With FDA for CBX-12 (alphalex™-exatecan), a Novel Treatment for Solid Tumors

Udgivet den 07-07-2020  |  kl. 11:00  |  

Positive pre-IND Meeting with FDA supports plan to file IND in fourth quarter 2020

NEW HAVEN, Conn., July 07, 2020 (GLOBE NEWSWIRE) -- Cybrexa Therapeutics, an oncology-focused biotechnology company developing a new class of therapeutics through its alphalex™ tumor targeting platform, today announced that it successfully completed a pre-IND (Investigational New Drug) meeting with the U.S. Food and Drug Administration (FDA) regarding its proposed IND and Phase I/II study for its lead candidate, CBX-12 (alphalex™-exatecan).

Cybrexa plans to submit the IND application for CBX-12 during the fourth quarter of 2020 and to initiate a Phase I/II clinical trial evaluating CBX-12 in advanced solid tumors in the first half of 2021. The Phase I portion of the study will establish the safety profile and a recommended Phase II dose (RP2D).  This initial clinical trial will also evaluate efficacy across a number of solid tumors and establish proof of mechanism for the alphalex™ platform.

CBX-12 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. alphalex™ conjugates have efficacy in the substantial patient populations that cannot be effectively treated with ADCs, as ADCs can be used only in patients that overexpress antigens.

CBX-12 was selected based on its strong efficacy and solid safety profile in preclinical models. Preclinical efficacy and safety data for CBX-12 was recently presented in a poster at the American Association for Cancer Research (AACR) Virtual Annual Meeting II. 

Per Hellsund, President and CEO of Cybrexa, said, "CBX-12 will be the first therapeutic generated from the alphalex™ platform to move into the clinic. Not only is this validating for our pipeline, but it also represents the first time a tumor selective drug that is antigen-independent, delivers payload intracellularly, and is capable of penetrating large tumor masses as well as treating small metastases, will enter into human studies.

Vishwas Paralkar, PhD, Cybrexa Chief Scientific Officer, added, "We are excited to prepare our IND filing and first-in-human study. We anticipate that CBX-12 will demonstrate efficacy in several solid tumors and believe there is potential for the drug in combination with immuno-oncology therapies as well."

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  

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  

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