CBX-11 selected based on robust efficacy and safety in combination with chemotherapy demonstrated in preclinical models
Positive pre-IND Meeting with FDA supports on track plan to file IND in Q4 2019
New Haven, Conn., January 2, 2019 – Cybrexa Therapeutics, a biotechnology company developing a new class of cancer therapeutics through its alphalex™ tumor-targeting platform, today announced that it has selected CBX-11 as its lead clinical development candidate for the treatment of patients with various solid tumors.
In addition, the company announced positive feedback from its pre-Investigational New Drug (IND) meeting with the U.S. Food and Drug Administration (FDA), concluding that the FDA agrees with the company’s proposed IND as well as the Phase 1 clinical development plans for CBX-11.
Cybrexa plans to submit the IND application for CBX-11 by the fourth quarter of 2019, with a Phase 1 clinical trial evaluating CBX-11 anticipated to begin in the first quarter of 2020.
CBX-11 combines Cybrexa’s proprietary alphalex™ technology with an already-approved oral small molecule poly ADP-ribose polymerase (PARP) inhibitor. CBX-11 will be evaluated as a monotherapy and in combination with chemotherapy.
Vishwas Paralkar, PhD, Cybrexa Chief Scientific Officer said, “The combination of PARP inhibitors with DNA damaging chemotherapy is believed to have significant anti-cancer potential. However, these combinations are often associated with potentially life-threatening toxicity, including bone marrow suppression. Our alphalex™ technology platform enables direct intracellular delivery of small molecule cancer therapeutics into tumor cells, while limiting off-target toxicity. We believe by leveraging alphalex™ with an approved PARP inhibitor taken in combination with chemotherapy, we will be able to mitigate toxic effects and provide potent, effective therapy for patients with various solid tumors.”
Multiple preclinical studies have demonstrated that the alphalex technology enhances the therapeutic index of the PARP inhibitor, improves tumor control and overall survival while limiting toxicity.
Per Hellsund, President and CEO of Cybrexa, commented, “Selection of our lead clinical candidate is the first step in establishing the human proof-of-concept data for our alphalex™ technology and marks a major milestone for Cybrexa. The positive feedback from our pre-IND meeting with the FDA is extremely encouraging and will be valuable as we prepare our IND application to launch our first-in-human Phase 1 trial of CBX-11.”
About the alphalex™ Technology Platform
The Cybrexa alphalex™ technology platform enables the delivery of small molecules across the cell membrane under low pH conditions, which is a universal feature of cancer cells. As a result, alphalex™ technology – which consists of a novel peptide, linker and small molecule anti-cancer agent – allows for antigen-independent, intracellular delivery of small molecule anti-cancer agents directly into the tumor cell. 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 an entirely new class of cancer therapies using its alphalex™ platform to deliver anti-cancer agents directly into tumor cells. The Company’s lead candidate, CBX-11, an alphalex™-PARP inhibitor combination, is in preclinical development with advancing plans to initiate clinical development. Cybrexa was founded by physician-scientists, and has an experienced management team that has built numerous successful life sciences companies and raised hundreds of millions of dollars in venture capital. For more information about Cybrexa, please visit www.cybrexa.com.