After successful completion of phase I trial, the first patient has been dosed in a phase IIa fluorescence-guided surgical clinical trial evaluating pHLIP® ICG imaging agent in breast cancer surgery. The purpose of this study is to see whether the use of the fluorescent imaging agent pHLIP® ICG and NIRF imaging during surgery would allow the surgeon to image tumor bed and established tumor margins with high accuracy. The ClinicalTrials.gov identifier is NCT05130801, https://clinicaltrials.gov/ct2/show/NCT05130801
pHLIP, Inc. sublicensee, Cybrexa Therapeutics, has entered into an exclusive collaboration agreement with Exelixis, Inc. (Nasdaq: EXEL) providing Exelixis the right to acquire CBX-12. CBX-12 is composed of a pH-Low Insertion Peptide (pHLIP®), a linker and exatecan. Data from the ongoing phase 1 trial of CBX-12 in patients with metastatic solid tumors demonstrated preliminary anti-tumor activity in a heavily pretreated patient population. This included a complete response in a patient with ovarian cancer.
Under the terms of the agreement, Exelixis will pay Cybrexa an upfront fee of $60 million in exchange for the right to acquire CBX-12 pending certain Phase 1 results and to fund certain development and manufacturing expenses incurred by Cybrexa to advance an agreed development plan. Cybrexa may also be eligible to receive up to an additional $642.5 million, including development, regulatory, and commercial milestone payments, as well as a fee for the acquisition of CBX-12 upon evaluation of a pre-specified clinical data package.
Link to the announcement could be found here
The University of Rhode Island and Yale University granted pHLIP, Inc exclusive worldwide commercial rights for composition of matter and methods of use of pHLIP® immuno-modulator compounds protected by a patent application developed by founders of the company and filed in September 2022.
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).