• Cantex's once daily, orally administered, azeliragon inhibits interactions of the receptor for advanced glycation end products (RAGE)
• Researchers showed RAGE inhibition to be a potential target for treatment of triple-negative breast cancer suppressing tumor progression and metastasis

WESTON, Fla., Aug. 10, 2023 /PRNewswire/ -- 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 the publication in the peer-reviewed journal, npj Breast Cancer, a Nature Portfolio journal published in partnership with Breast Cancer Research Foundation, with results from in vitro and in vivo models for triple-negative breast cancer showing suppression of metastasis and tumor progression by RAGE inhibition. Cantex's azeliragon, currently in phase 2/3 development for the treatment of major cancers, complications of cancer treatment, and the treatment of other life-threatening illnesses, is a RAGE inhibitor that is orally administered and taken once daily.

In the paper titled, "RAGE inhibitor TTP488 (Azeliragon) suppresses metastasis in triple-negative breast cancer," researchers investigated whether azeliragon impairs triple-negative breast cancer progression and metastasis and the mechanisms by which RAGE inhibition by azeliragon mediates breast cancer progression and metastasis. The authors showed that azeliragon exerts a potent anti-metastatic effect in orthotopic xenograft and experimental metastasis models of triple-negative breast cancer, which they corroborated by demonstrating that RAGE inhibition impairs biological mechanisms that drive cancer metastasis.

"This is a major publication supporting the role of RAGE inhibition in progressive and deadly cancers like triple-negative breast cancer," said Stephen G. Marcus, M.D., Cantex's Chief Executive Officer. "We congratulate the authors on their critically important work and look forward to collaborating with them as we seek to unlock the potential of azeliragon and RAGE inhibition to treat triple-negative breast cancer and other major cancers, for which improved treatment is greatly needed."

"Our results show that azeliragon impairs metastasis of triple-negative breast cancer, clarifying signaling and cellular mechanisms through which RAGE mediates metastasis," said Barry Hudson, PhD, associate professor of oncology at Georgetown University's Lombardi Comprehensive Cancer Center and senior author of the study. "Importantly, given the favorable safety profile that azeliragon has displayed in human studies, we believe there is strong rationale for studying its potential in clinical trials to treat or prevent metastatic triple-negative breast cancer."

The authors of the peer-reviewed article were comprised of cell and cancer biology researchers at the University of Miami, Miller School of Medicine, and Georgetown University. Cantex recently announced the expansion of collaboration with researchers at Georgetown's Lombardi Comprehensive Cancer Center and the licensing from Georgetown University of intellectual property related to the potential use of azeliragon to treat, prevent or alleviate cancer-treatment related cognitive decline. Hudson and study co-author Marc Lippman, at Georgetown University, are named inventors on the patent application related to the Georgetown license.

About Azeliragon

Azeliragon is an orally administered capsule, taken once daily, that inhibits interactions of the receptor for advanced glycation end products (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 neoadjuvant therapy of breast cancer, metastatic pancreatic cancer, and hospitalized COVID-19 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 as well as in combination with whole brain radiation therapy. 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.

About vTv Therapeutics Inc.

vTv Therapeutics Inc. is a clinical stage biopharmaceutical company focused on developing oral, small molecule drug candidates, led by cadisegliatin (TTP399) for the treatment of type 1 diabetes. To learn more please visit vtvtherapeutics.com.

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