CANTEX PHARMACEUTICALS OBTAINS EXCLUSIVE WORLDWIDE RIGHTS TO INTELLECTUAL PROPERTY FROM GEORGETOWN UNIVERSITY FOR AZELIRAGON AS A POTENTIAL TREATMENT OF CANCER-RELATED COGNITIVE DECLINE

Cantex to Expand Collaboration with Georgetown’s Lombardi Comprehensive Cancer Center

Weston, FL, June 1, 2023 — Cantex Pharmaceuticals, Inc., a clinical-stage pharmaceutical company focused on developing transformative therapies for cancer and other life-threatening medical conditions for which new treatments are urgently needed, today announced that it has obtained an exclusive worldwide license from Georgetown University for intellectual property related to the potential use of azeliragon to treat, prevent or alleviate cancer-treatment related cognitive decline. This exclusive worldwide license expands Cantex’s existing robust azeliragon composition of matter patent, its overall intellectual property portfolio and additional regulatory exclusivities.

Cancer-related cognitive decline involves problems with memory, attention, concentration, and executive functioning that may result from some cancer treatments. This condition commonly occurs in women receiving intensive neoadjuvant chemotherapy to reduce the size of a breast cancer prior to surgery.

Pre-clinical studies performed at Georgetown’s Lombardi Comprehensive Cancer Center suggest clinical investigation is warranted to explore the potential for azeliragon to treat, prevent or alleviate cognitive symptoms, sometimes referred to as “chemo-brain”, that are associated with cancer chemotherapy. Pre-clinical studies at Georgetown have also identified a striking anti-metastatic effect of azeliragon in animal models of triple-negative breast cancer, suggesting that azeliragon should also be investigated for the potential benefit of reducing the risk of metastatic breast cancer. Georgetown is currently enrolling patients in a pilot clinical trial of Cantex’s azeliragon in women with breast cancer receiving neoadjuvant chemotherapy.

“Neoadjuvant chemotherapy has made a critically important contribution to the curative treatment of early breast cancer. Side effects of this treatment, including cognitive disturbances, can be debilitating, significantly impairing activities of daily life. Although neoadjuvant chemotherapy combined with surgery is potentially curative, local recurrence and metastasis can occur. With the clinical trial in progress at Georgetown, and subsequent randomized studies, Cantex’s collaboration with Georgetown seeks to understand if azeliragon can alleviate cognitive decline caused by chemotherapy,” said Stephen Marcus, M.D., CEO of Cantex.

Marc Lippman, M.D., MACP FRCP, Professor of Oncology, Co-Director of the Breast Cancer Program at the Lombardi Comprehensive Cancer Center at Georgetown University, commented: “Speaking on behalf of my many colleagues and collaborators at Georgetown, we are pleased that our pre-clinical findings warrant clinical study of Cantex’s azeliragon to see if it can prevent or mitigate cancer treatment-related cognitive decline, while reducing the risk of metastasis. Through this collaboration with Cantex, we are eager to see this therapy move toward definitive randomized controlled clinical trials.” Marc Lippman is a co-inventor on a patent application that has been filed by Georgetown University related to the technology described.

About Azeliragon

Azeliragon is an orally administered capsule, taken once daily, that inhibits interactions of the receptor for advanced glycation endproducts (known as RAGE) with certain ligands, including HMGB1 and S100 proteins in the tumor microenvironment. Azeliragon was originally under development for Alzheimer’s disease by vTv Therapeutics Inc. (NASDAQ:VTVT) from which Cantex licensed worldwide rights to azeliragon. Clinical safety data from these trials, involving more than 2000 individuals dosed for periods up to 18 months, indicate that azeliragon is very well tolerated. Cantex has ongoing clinical trials in metastatic pancreatic cancer, neoadjuvant therapy of breast cancer, and hospitalized COVID patients to prevent acute kidney injury, and will soon initiate FDA-approved phase 2 clinical trials of azeliragon in newly diagnosed glioblastoma, and in brain metastases in combination with stereotactic radiosurgery. These trials are based on robust pre-clinical data as well as the extensive clinical safety information from randomized placebo-controlled clinical trials.

About Cantex Pharmaceuticals, Inc.

Cantex Pharmaceuticals, Inc. is a privately held, clinical-stage pharmaceutical company focused on developing transformative therapies for cancer and other life-threatening medical conditions for which new treatments are urgently needed. For more information, please visit www.cantex.com.

Contact Data:

Tiberend Strategic Advisors, Inc.

Investors
Daniel Kontoh-Boateng
(862) 213-1398
dboateng@tiberend.com

Media
Casey McDonald
+1 646-577-8520
cmcdonald@tiberend.com

Cantex Pharmaceuticals, Inc.

Stephen G. Marcus, M.D.
+1 954-315-3660
smarcus@cantex.com

Juan F. Rodriguez
+1 954-315-3660
jrodriguez@cantex.com