- Positive FIH safety and tolerability data supports advancing CBX-12 into multiple Phase II studies
- Results show early signs of efficacy with a favorable safety profile
NEW HAVEN, Conn., Oct. 28, 2022 (GLOBE NEWSWIRE) — Cybrexa Therapeutics, a clinical-stage oncology biotechnology company developing a novel class of tumor-targeting peptide drug conjugate (PDC) therapeutics, today presented findings as a plenary oral presentation at the annual EORTC-NCI-AACR (ENA) Symposium on molecular targets and cancer therapeutics. This first-in-human study of CBX-12, an alphalex™ PDC in patients with advanced or metastatic solid tumors, demonstrates tolerability, safety and single-agent anti-tumor activity including two confirmed responses for patients receiving CBX-12.
“In this phase I study, CBX-12 demonstrated safety and tolerability, without significant gastrointestinal toxicity. We also saw signal of antitumor activity in multiple tumor types,” said principal investigator, Funda Meric-Bernstam, M.D., Chair of the Department of Investigational Cancer Therapeutics at The University of Texas MD Anderson Cancer Center.
Of the 18 response-evaluable patients in this heavily treated patient population with advanced or metastatic cancers, one patient with ovarian cancer achieved complete response (CR), one patient with breast cancer achieved partial response (PR), and 13 patients maintained stable disease (SD). The ongoing study is evaluating safety and tolerability, and these data have provided insights which will inform the recommended phase II dose. The study is also evaluating plasma pharmacokinetics (PK), anti-drug antibodies, and intratumoral levels of CBX-12 and exatecan, anti-tumor activity.
“This study’s data provides us with important early signs of clinical viability of Cybrexa’s alphalex technology platform, which opens the door for us to move forward rapidly with the development of our pipeline,” said Arthur DeCillis, M.D., Chief Medical Officer, Cybrexa Therapeutics.
CBX-12 is a PDC that includes the highly potent topoisomerase I inhibitor exatecan. The asset leverages Cybrexa’s alphalex technology platform, which is a novel antigen-independent PDC platform that enables targeted delivery of highly potent anticancer treatments. The alphalex technology platform consists of a pHLIP® peptide, a linker, and a small molecule anti-cancer agent (payload) and enables intracellular delivery of highly potent anticancer treatments. Further development of CBX-12 by Cybrexa will occur in the company’s New Haven, Conn.-based labs.
About the Presentation
Abstract title: CBX-12-101: A first-in-human study of CBX-12, an alphalex peptide drug conjugate (PDC) in patients with advanced or metastatic solid tumors
Time and date: Friday, 28 October, 15:15 – 15:25
Symposium information: www.eortc.org/ena
About the Trial
Patient cohorts in the Phase I trial were treated with escalating doses of CBX-12 on three dosing schedules, which were 5x daily every three weeks (Schedule A); 3x daily every three weeks (Schedule B); and once weekly (Schedule C). Evaluable patients included those with ovarian, testicular, appendiceal, breast, colorectal, small cell lung, gastric, salivary gland, pancreatic, or endometrial cancers.
Cybrexa is a privately held clinical-stage biotechnology company pioneering novel antigen-independent tumor-targeting peptide drug conjugate (PDC) therapeutics. The company is led by a dynamic team of highly successful life science entrepreneurs and veteran drug development scientists. Cybrexa investors include Advantage Capital Connecticut, Connecticut Innovations, Elm Street Ventures and HighCape Capital. It is on a mission to create therapeutics that revolutionize the standard of care in oncology. Cybrexa’s robust pipeline aims to combat breast, ovarian, non-small cell lung cancer and a range of other tumors. Its assets are built on Cybrexa’s alphalex technology platform, which consists of a pHLIP peptide, linker, and small molecule anti-cancer agent (payload) and enables intracellular delivery of highly potent anticancer treatments. 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. Cybrexa is based in New Haven, Conn. and was founded in 2017. For more information about Cybrexa, please visit www.cybrexa.com or follow us on LinkedIn and Twitter.
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