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NEW HAVEN, Conn., February 6, 2024— Cybrexa Therapeutics, a clinical-stage oncology biotechnology company developing a novel class of tumor-targeting peptide drug conjugate (PDC) therapeutics, today announced the Company will regain all rights to CBX-12 (alphalex™ exatecan), a clinical-stage, first-in-class peptide drug conjugate that utilizes Cybrexa’s proprietary alphalex technology to enhance delivery of exatecan to tumor cells, as its collaboration partner, Exelixis, Inc., has provided a notice of termination for the right to acquire CBX-12.
“We appreciate the excellent collaboration we had with Exelixis and the advances we made working together on the CBX-12 clinical program. This collaboration has positioned Cybrexa to move CBX-12 into phase II trials later this year,” said Per Hellsund, President & CEO, Cybrexa.
About CBX-12
CBX-12 is a clinical-stage, first-in-class peptide drug conjugate (PDC) that utilizes Cybrexa’s proprietary alphalex technology to enhance delivery of exatecan to tumor cells and is composed of a pH-Low Insertion Peptide (pHLIP®), a linker and exatecan. CBX-12 is designed to increase the efficacy and reduce the toxicity of topoisomerase I inhibition by delivering exatecan, a highly potent, second-generation topoisomerase I inhibitor, directly to the tumor cells. As an antigen-independent therapy, CBX-12 may have broad utility in patients who are not eligible for antigen-targeted therapies, including monoclonal antibodies and antibody-drug conjugates (ADCs), and has potential for use in combination regimens with other anti-cancer agents and immunotherapies. 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, including one complete response in a patient with ovarian cancer and three partial responses, two in breast and one in ovarian. Based on this data, the company is considering the initiation of Phase 2 trials in breast, ovarian, colorectal, and gastric cancers.
About the alphalex™ Technology Platform
The Cybrexa alphalex™ technology is a novel antigen-independent, peptide-drug conjugate (PDC) platform that enables targeted delivery of highly potent anticancer treatments and aims to revolutionize the standard of care in oncology. The platform consists of a pH-Low Insertion Peptides (pHLIPs®) peptide, linker, and small molecule anti-cancer agent. 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., and Cybrexa is a sublicensee of pHLIP, Inc.
About Cybrexa
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 enables intracellular delivery of highly potent anticancer treatments. 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.
Investor Contact:
Per Hellsund, CEO, Cybrexa Therapeutics
860-799-1517
[email protected]
Media Contact:
Tara DiMilia, TellMed Strategies
908-884-7024
[email protected]
NEW HAVEN, Conn., Oct. 10, 2023 (GLOBE NEWSWIRE) — Cybrexa Therapeutics, a clinical-stage oncology biotechnology company developing a novel class of tumor-targeting peptide drug conjugate (PDC) therapeutics, today announced it will present data findings on its preclinical candidate, CBX-15 (alphalex™-MMAE) for the treatment of triple negative breast cancer in a poster session at the 35th AACR-NCI-EORTC (ANE) Symposium. The event is taking place October 11-15, 2023, in Boston, Massachusetts.
“In this preclinical study, CBX-15 demonstrated anti-tumor activity and efficacy without toxicity,” said Vishwas Paralkar, PhD, Chief Scientific Officer, Cybrexa Therapeutics. “These compelling data instill confidence and align with the Company’s strategy to progress CBX-15 to Phase 1 clinical trials in 1Q of 2024. This achievement marks a pivotal milestone in our evolving therapeutic pipeline and offers optimism for the future landscape of cancer treatment.”
CBX-15 rapidly regressed tumors in animal models, resulting in complete responses without damaging healthy tissues such as bone marrow, and invoked an increased resistance to live tumor rechallenge and a doubling of bone marrow-resident CD4 T-cells 50 days post-dose.
Details for the poster session are as follows:
Abstract Title: Evaluation of antigen-agnostic anti-tumor activity and immunological memory induced by CBX-15 (alphalexTM-MMAE) in the rat syngeneic breast cancer model
Poster Number: B141
Session: Poster Session B
Session Date and Time: Friday, October 13, 2023 | 12:30 p.m. – 4:00 p.m. ET
Session Location: Level 2, Exhibit Hall D
About the study
This study evaluated the efficacy and anti-tumor immunological memory induced by CBX-15 in animal models bearing syngeneic 13762 mammary adenocarcinoma tumors (N= 344). The development of anti-tumor immunological memory was examined in CBX-15-cured subjects by in vivo/ex vivo rechallenge with live tumor cells and subsequent assessment of tumor rejection, cytokine release by T-cells, tumor immune cell infiltration, and memory T-cell composition of bone marrow.
About CBX-15
CBX-15 is a peptide-drug conjugate consisting of alphalex™–monomethyl auristatin E (MMAE). The alphalex™ is a unique variant of pH-Low Insertion Peptide1 (pHLIP®) designed to target the low pH microenvironment of cancer cells, a universal feature of all rapidly growing tumors. The peptide of CBX-15 forms an alpha helix only in low pH conditions, resulting in unidirectional insertion of the peptide and delivery of MMAE across the cancer cell membrane, and avoidance of delivery to healthy tissues, including immune cells.
About the alphalex™ Technology Platform
The Cybrexa alphalex™ technology is a novel antigen-independent, peptide-drug conjugate (PDC) platform that enables targeted delivery of highly potent anticancer treatments and aims to revolutionize the standard of care in oncology. The platform consists of a pH-Low Insertion Peptides (pHLIPs®) peptide, linker, and small molecule anti-cancer agent. 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., and Cybrexa is a sublicensee of pHLIP, Inc.
About Cybrexa
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 enables intracellular delivery of highly potent anticancer treatments. 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.
Investor Contact:
Per Hellsund, CEO, Cybrexa Therapeutics
860-799-1517
[email protected]
Media Contact:
Tara DiMilia, TellMed Strategies
908-884-7024
[email protected]
1 Wyatt LC, Lewis JS, Andreev OA, Reshetnyak YK, Engleman DM. Applications of pHLIP Technology for Cancer Imaging and Therapy. Trends Biotechnol. 2017. 35(7):653-664.
NEW HAVEN, Conn. – May 25, 2023 – Cybrexa Therapeutics, a clinical-stage oncology biotechnology company developing a novel class of tumor-targeting peptide drug conjugate (PDC) therapeutics, today announced that new data for its lead compound, CBX-12, a first-in-class investigational PDC, will be presented at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting being held in Chicago on June 2-6. The maximum tolerated dose (MTD) for CBX-12 was established on two different dosing paradigms, with myelosuppression being the primarydose-limiting toxicity. In addition, treatment with CBX-12 resulted in four objective responses.
“We are encouraged by the promise of CBX-12, as it has continued to demonstrate multiple objective responses as a single agent, and the side effects, including myelosuppression, appear to be manageable,” said principal investigator, Anthony Tolcher, M.D., CEO, Founder and Director of Clinical Research, NEXT Oncology, a research institution that conducted this study along with Yale Cancer Center and University of Texas MD Anderson Cancer Center.
Among the single-agent antitumor activity demonstrated by CBX-12 in the study, one patient achieved a complete response in ovarian, and three achieved partial responses, two in breast and one in ovarian, per the RECIST 1.1 criteria. The study also evaluated the safety profile of CBX-12, and results highlight its potential to reduce the toxicity of topoisomerase I inhibition through its proprietary alphalex™ technology that enables intracellular drug delivery. Further, the MTD were established at 45 mg/m2 for three consecutive days in a 21-day cycle and 60 mg/m2 weekly.
“As we look toward initiating Phase 2 trials in breast, ovarian, colorectal, and gastric cancers, we are bolstered by the continued signs of safety and tolerability that we are seeing with CBX-12,” said Mike Needle, M.D., Chief Medical Officer, Cybrexa Therapeutics. “Importantly, the data demonstrate that the use of Cybrexa’s proprietary alphalex technology allows for higher dose administration compared to unconjugated exatecan.”
About the Presentation
Abstract title: CBX-12-101: A first-in-human study of CBX-12, an alphalex peptide drug conjugate (PDC) in patients (pts) with advanced or metastatic solid tumors
Presenting Author: Ildefonso Ismael Rodriguez-Rivera
Time and date: Saturday, June 3, 2023, 9:00 a.m. EST; Hall A
Abstract information: #3087; https://meetings.asco.org/abstracts-presentations/224760
About the Trial
The trial is a first-in-human study. Patient cohorts in the Phase 1 trial were treated with escalating doses of CBX-12 in a 3 + 3 design on three dosing schedules: 5x daily every three weeks (Part A); 3x daily every three weeks (Part B); and once weekly (Part C).
About the alphalex™ Technology Platform
The Cybrexa alphalex™ technology is a novel antigen-independent, peptide-drug conjugate (PDC) platform that enables targeted delivery of highly potent anticancer treatments and aims to revolutionize the standard of care in oncology. The platform consists of a pH-Low Insertion Peptides (pHLIPs®) peptide, linker, and small molecule anti-cancer agent. 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., and Cybrexa is a sublicensee of pHLIP, Inc.
About Cybrexa
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 enables intracellular delivery of highly potent anticancer treatments. 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.
About the Cybrexa and Exelixis Collaboration Agreement
In November 2022, Cybrexa and Exelixis, Inc. announced they have entered into an exclusive collaboration agreement providing Exelixis the right to acquire CBX-12. This collaboration underscores Exelixis’ commitment to expanding its clinical pipeline building upon its biotherapeutics and targeted drug therapy expertise.
Investors Contact:
Stephen Basso, CFO/COO, Cybrexa Therapeutics
475-655-7952
[email protected]
Media Contact:
Tara DiMilia, TellMed Strategies
908-884-7024
[email protected]