• CBX-12, Cybrexa’s lead therapeutic candidate for solid tumors, demonstrates anti-tumor activity and robust efficacy signals in a heavily pretreated patient population

  • CBX-12 and IO therapeutics combination trial expected to initiate late 2022

  • Plans for accelerated approval in ovarian and NSCLC to be evaluated based on Phase 2 expansion cohorts to start in late 2022

NEW HAVEN, Conn., Oct. 26, 2021 (GLOBE NEWSWIRE) -- Cybrexa Therapeutics, a clinical-stage oncology biotechnology company developing a novel class of tumor-targeting peptide drug conjugate (PDC) therapeutics, today announced favorable early Phase 1 data for its lead therapeutic candidate, CBX-12 (alphalex™-exatecan). The initial data show robust efficacy signals and tolerability in patients with metastatic cancer. These data also serve as a key demonstration of mechanism for Cybrexa’s antigen-independent PDC tumor targeting platform, alphalex™. Cybrexa intends to investigate CBX-12 in patients with breast, ovarian and non-small cell lung cancer.

“Having clear signals of efficacy at this early stage in our development program underscores the potential of our approach,” said Per Hellsund, Chief Executive Officer of Cybrexa. “The clinical benefits we’ve seen, including complete response and low incidence of serious adverse effects related to CBX-12, reinforce our belief that CBX-12 could dramatically change the lives of patients who have few or no therapeutic options.”

Of the three response-evaluable patients enrolled in the study, one patient’s disease met the criteria for a partial response at the first on-treatment assessment and became a complete response at the second assessment. Another heavily pre-treated patient who had received five previous treatment regimens, including a topoisomerase 1 inhibitor, experienced stable disease. Response was assessed using the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. All patients were over age 60 with stage four cancer.

In addition, on-treatment tumor biopsies confirmed delivery of drug, both as full conjugate and free exatecan, in the tumors for all patients with on-treatment biopsies.

“Based on data to date, we believe CBX-12 has the potential to be a disruptive tumor targeting platform technology in the clinic, as it is already showing clear initial signs of efficacy,” said Vishwas Paralkar, Ph.D., Chief Scientific Officer of Cybrexa.

Cybrexa is on track to accelerate the development of CBX-12 with multiple additional Phase 2 studies expected to be initiated in late 2022.

“It is exciting to see that CBX-12 is demonstrating anti-tumor activity and we are very hopeful of its continued success as we expand our dose-escalation program and look to accelerate the development of CBX-12 with multiple additional Phase 2 studies,” said Arthur DeCillis, M.D., Chief Medical Officer of Cybrexa.

About the alphalex™ Technology Platform

The Cybrexa alphalex™ technology platform – which consists of a pHLIP® peptide, linker, and small molecule anti-cancer agent (payload) – enables antigen-independent targeting of tumors and intracellular delivery of highly potent anticancer therapies, creating therapeutics that can revolutionize the standard of care. 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. alphalex™ represents the disruptive next generation in tumor targeting. View a video of the mechanism of action of the technology at www.cybrexa.com.

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, has entered a Phase 1/2 clinical trial in patients with advanced or metastatic 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.


Cybrexa Therapeutics
Lisa Rehm
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Source: https://www.globenewswire.com/news-release/2021/10/26/2320568/0/en/Cybrexa-Therapeutics-Announces-Data-Demonstrating-Early-Signals-of-Efficacy-and-Powerful-Potential-of-Antigen-Independent-Tumor-Targeting.html