Cybrexa Therapeutics Announces First Patient Received Dose of First-in-Class Peptide-Drug Conjugate CBX-12 in Phase 2 Study in Ovarian Cancer

The primary patient population for the CBX-12 Phase 2 study is women with platinum-resistant or refractory ovarian cancer who are naïve to TOP1-targeted agents

The start of the study follows the positive phase 1 study results showed a 40% response rate in TOP1-naïve ovarian cancer patients, in addition to activity in five other solid tumor types and a favorable safety profile

The trial marks an important milestone in driving pipeline progress with multiple Phase 2 programs planned for CBX-12 in 2025 as a monotherapy and in combination

NEW HAVEN, Conn., Oct. 7, 2024 (GLOBE NEWSWIRE) — Cybrexa Therapeutics, a clinical-stage oncology biotechnology company developing a new class of tumor-targeting peptide-drug conjugate (PDC) therapies, today announced that the first patient has been dosed in a Phase 2 clinical trial evaluating CBX-12 in patients with platinum-resistant or refractory ovarian cancer. CBX-12 is a premium PDC that utilizes Cybrexa’s proprietary alphalex™ technology to enhance the delivery of exatecan, a potent, established topoisomerase 1 (TOP1) inhibitor, directly to tumor cells while sparing healthy tissue. This trial initiation follows promising Phase 1 results, which demonstrated broad activity of CBX-12 in ovarian, breast, non-small cell lung cancer (NSCLC), thymus, gallbladder and colorectal cancers, along with a manageable safety profile.

“The first patient administration marks an important milestone for the Phase 2 clinical trial in ovarian cancer and for patients facing this aggressive disease,” said Per Hellsund, President and Chief Executive Officer of Cybrexa. “CBX-12 recently demonstrated significant antitumor activity, broad application potential and a favorable safety profile in a Phase 1 study, including encouraging response rates in TOP1-naïve ovarian and breast cancer patients. We are extremely excited about the potential of CBX-12 not only as a standalone treatment, but also as a promising candidate for future combination therapies and look forward to its continued advancement and additional Phase 2 studies in solid tumors planned are for 2025.”

The Phase 2 study is a randomized, open-label study designed to evaluate the safety, tolerability and efficacy of CBX-12 in women with platinum-resistant or refractory ovarian cancer at two doses: 125 mg/m2² every 21 days or 100 mg/m2² every 21 days.

Cybrexa plans an additional Phase 2 study of CBX-12 in colorectal cancer in 2025 in collaboration with the National Cancer Institute (NCI), as well as other Phase 2 studies evaluating CBX-12 as a monotherapy and in combination for a range of solid tumors . Leveraging its alphalex platform to develop multiple promising agents in oncology, Cybrexa is developing its broader pipeline, including CBX-15, expected to enter the clinic in 2025 for the treatment of solid tumors using MMAE (monomethylauristatin E) as payload.

Unlike antibody-drug conjugates, CBX-12 does not rely on antigen expression for targeting, but rather uses a pH-low insertion peptide (pHLIP ^®) to selectively deliver its payload into the cytoplasm of cancer cells. The results of the Phase 1 study demonstrated that CBX-12 is well tolerated and shows promising activity in a range of advanced or metastatic solid tumors, highlighting the versatility of the alphalex platform and its ability to improve the delivery of cancer therapies and at the same time limiting off-target therapy. effects. The results of the Phase 1 study were recently presented during a poster session at the European Society for Medical Oncology Congress (ESMO 2024).

For more information about the Phase 2 trial of CBX-12, please visit ClinicalTrials.gov (NCT06315491).

About CBX-12

CBX-12 is a first-in-class peptide-drug conjugate (PDC) that utilizes Cybrexa’s patented alphalex™ technology to enhance exatecan delivery to tumor cells and is composed of a pH-Low Insertion Peptide (pHLIP^®), a left, and exatecan. CBX-12 is designed to increase the efficacy and reduce the toxicity of topoisomerase 1 inhibition by delivering exatecan, a highly potent second-generation topoisomerase 1 inhibitor, directly to tumor cells. As an antigen-independent therapy, CBX-12 may have broad utility in patients ineligible for antigen-targeted therapies, including monoclonal antibodies and antibody-drug conjugates (ADCs), and has potential for use in combination regimens with other antigen-drug conjugates. cancer drugs and immunotherapies.

About the alphalex™ technology platform

The Cybrexa alphalex technology is a novel antigen-independent, peptide-drug conjugate 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 Peptide (pHLIP^®), a linker and a small molecule anticancer 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 licensed exclusively to pHLIP, Inc., and Cybrexa is a sublicensee of pHLIP, Inc.

About Cybrexa Therapeutica

Cybrexa is a privately held clinical-stage biotechnology company pioneering novel, antigen-independent, tumor-targeted peptide-drug conjugate (PDC) therapies. The company is led by a dynamic team of highly successful life science entrepreneurs and experienced drug development scientists. Cybrexa is on a mission to create therapies that revolutionize the standard of care in oncology, and its robust pipeline aims to fight breast, ovarian, non-small cell lung cancer and a range of other tumors. The assets are built on Cybrexa’s alphalex™ technology platform, which enables intracellular delivery of highly potent anti-cancer treatments. Cybrexa is based in New Haven, Connecticut and was founded in 2017. For more information, visit www.cybrexa.com or follow us on LinkedIn and X.

CONTACT: Investor contact person:

Per Hellsund, CEO, Cybrexa Therapeutics

860-717-2731

(email protected)

Media contact:

Robin Fastenau, Scientific PR

(email protected)