The first patient has been dosed in a phase I/IIa fluorescence-guided surgical clinical trial evaluating pHLIP® ICG imaging agent. The purpose of this study is to see whether the use of the fluorescent imaging agent pHLIP® ICG and NIRF imaging during surgery is a safe approach that may allow the surgeon to image tumor bed and established tumor margins. The ClinicalTrials.gov identifier is NCT05130801, https://clinicaltrials.gov/ct2/show/NCT05130801
The U.S. Food and Drug Administration (FDA) has provided green light to initiate first in human clinical studies of pHLIP® ICG imaging agent. pHLIP® ICG will be administered to breast cancer patients in a phase 1/2a fluorescence-guided surgical trial at Memorial Sloan Kettering Cancer Center. Fluorescence guidance by pHLIP® ICG during surgical procedures is expected to improve visualization of primary tumor masses and satellite cancerous lesions and allow accurate margin delineation to improve surgical outcomes.
Cybrexa Therapeutics announced that the first patient has been dosed in a Phase 1/2 clinical trial evaluating CBX-12 (alphalex™-exatecan), the company’s lead therapeutic candidate. CBX-12 or alphalex™-exatecan is a pHLIP® Exatecan peptide conjugate: http://cybrexa.com/news/#
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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The Memorial Sloan Kettering Cancer Center and the University of Rhode Island granted pHLIP, Inc exclusive worldwide commercial rights for the composition of matter and methods of use of pHLIP® compounds protected by a patent application developed by founders of the company and filed in September 22, 2020.
Inventors of pHLIP® technology and founders from Yale University and the University of Rhode Island received a renewal of their NIH grant for the next 4 years (2020-2024) for the investigation and development of new pHLIP® Drug Conjugates (PDCs).