- Positive FIH security and tolerability information helps advancing CBX-12 into a number of Phase II research
- Results present early indicators of efficacy with a positive security profile
NEW HAVEN, Conn., Oct. 28, 2022 (GLOBE NEWSWIRE) — Cybrexa Therapeutics, a clinical-stage oncology biotechnology firm creating a novel class of tumor-targeting peptide drug conjugate (PDC) therapeutics, immediately introduced findings as a plenary oral presentation on the annual EORTC-NCI-AACR (ENA) Symposium on molecular targets and most cancers therapeutics. This first-in-human examine of CBX-12, an alphalex™ PDC in sufferers with superior or metastatic stable tumors, demonstrates tolerability, security and single-agent anti-tumor exercise together with two confirmed responses for sufferers 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,” stated 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 sufferers on this closely handled affected person inhabitants with superior or metastatic cancers, one affected person with ovarian most cancers achieved full response (CR), one affected person with breast most cancers achieved partial response (PR), and 13 sufferers maintained steady illness (SD). The ongoing examine is evaluating security and tolerability, and these information have supplied insights which is able to inform the beneficial section II dose. The examine can also be evaluating plasma pharmacokinetics (PK), anti-drug antibodies, and intratumoral ranges of CBX-12 and exatecan, anti-tumor exercise.
“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,” stated Arthur DeCillis, M.D., Chief Medical Officer, Cybrexa Therapeutics.
CBX-12 is a PDC that features the extremely potent topoisomerase I inhibitor exatecan. The asset leverages Cybrexa’s alphalex expertise platform, which is a novel antigen-independent PDC platform that permits focused supply of extremely potent anticancer therapies. The alphalex expertise platform consists of a pHLIP® peptide, a linker, and a small molecule anti-cancer agent (payload) and allows intracellular supply of extremely potent anticancer therapies. Further improvement of CBX-12 by Cybrexa will happen within the firm’s New Haven, Conn.-based labs.
About the Presentation
Abstract title: CBX-12-101: A primary-in-human examine of CBX-12, an alphalex peptide drug conjugate (PDC) in sufferers with superior or metastatic stable tumors
Time and date: Friday, 28 October, 15:15 – 15:25
Symposium info: www.eortc.org/ena
About the Trial
Patient cohorts within the Phase I trial have been handled with escalating doses of CBX-12 on three dosing schedules, which have been 5x each day each three weeks (Schedule A); 3x each day each three weeks (Schedule B); and as soon as weekly (Schedule C). Evaluable sufferers included these with ovarian, testicular, appendiceal, breast, colorectal, small cell lung, gastric, salivary gland, pancreatic, or endometrial cancers.
About Cybrexa
Cybrexa is a privately held clinical-stage biotechnology firm pioneering novel antigen-independent tumor-targeting peptide drug conjugate (PDC) therapeutics. The firm is led by a dynamic crew of extremely profitable life science entrepreneurs and veteran drug improvement scientists. Cybrexa traders embody Advantage Capital Connecticut, Connecticut Innovations, Elm Street Ventures and HighCape Capital. It is on a mission to create therapeutics that revolutionize the usual of care in oncology. Cybrexa’s strong pipeline goals to fight breast, ovarian, non-small cell lung most cancers and a spread of different tumors. Its property are constructed on Cybrexa’s alphalex expertise platform, which consists of a pHLIP peptide, linker, and small molecule anti-cancer agent (payload) and allows intracellular supply of extremely potent anticancer therapies. pHLIP peptides are a household of pH-Low Insertion Peptides that focus on acidic cell surfaces. pHLIP was developed at Yale University and the University of Rhode Island and is solely licensed to pHLIP Inc. Cybrexa relies in New Haven, Conn. and was based in 2017. For extra details about Cybrexa, please go to www.cybrexa.com or observe us on LinkedIn and Twitter.
Contacts
Cybrexa Therapeutics Investor Relations
Stephen Basso
Cybrexa Therapeutics Media Relations
Tara DiMilia
