Press Release

HIGH POINT, N.C., May 24, 2023 (GLOBE NEWSWIRE) -- vTv Therapeutics Inc. (Nasdaq: VTVT), a clinical stage biopharmaceutical company focused on the development of an adjunctive therapy to insulin for the treatment of type 1 diabetes ("T1D"), today announced that the United States Patent and Trademark Office recently issued a patent to Cantex Pharmaceuticals, Inc. that covers claims related to the use of azeliragon as a potential treatment of glioblastoma multiforme (GBM). Azeliragon is a small molecule inhibitor of the receptor for advanced glycation end products (RAGE) discovered by vTv and licensed to Cantex Pharmaceuticals. Cantex has ongoing azeliragon 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 clinical trials of azeliragon in newly diagnosed glioblastoma, and in brain metastases in combination with stereotactic radiosurgery. Earlier this year, Cantex received Food and Drug Administration Orphan Drug Designation for azeliragon for the treatment of glioblastoma.

On June 22, 2021, vTv and Cantex entered into a licensing agreement under which Cantex obtained exclusive worldwide rights to develop and commercialize azeliragon. Under the terms of the agreement, the companies will allocate downstream profits under a tiered arrangement if successfully developed and launched.

Prior to the Cantex agreement, vTv was developing azeliragon for the treatment of Alzheimer’s disease. Through these efforts, vTv generated a significant body of clinical data supporting the safety and tolerability profile of azeliragon. Evidence suggests that RAGE—ligand interactions play a vital role in cancer, as well as in a range of inflammatory diseases.

“We would like to congratulate Cantex on receipt of this important addition to the azeliragon patent estate covering its use as a potential therapy for GBM. Coupled with the Orphan Drug Designation granted for this indication in early 2023, Cantex is building robust protections around this novel small molecule RAGE inhibitor, aimed at maximizing the commercial opportunities for azeliragon should its clinical development be successful,” said Paul Sekhri, President and Chief Executive Officer of vTv Therapeutics. “We will be closely following the ongoing GBM study as well as Cantex’s development efforts in other indications where RAGE is implicated.”

About Azeliragon
Azeliragon is an orally administered small molecule, 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 glioblastoma microenvironment. By preventing interaction of RAGE with these ligands, azeliragon may inhibit glioblastoma and overcome its resistance to effective treatment. Azeliragon was originally under development for Alzheimer's disease by vTv Therapeutics from whom Cantex licensed it. 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 is also developing azeliragon for the treatment of brain metastasis, pancreatic cancer, and breast cancer. In addition, a phase 2/3 trial is currently enrolling hospitalized COVID-19 patients, evaluating the efficacy of azeliragon in the prevention of acute kidney injury.

About vTv Therapeutics
vTv Therapeutics Inc. is a clinical stage biopharmaceutical company focused on developing oral, small molecule drug candidates. vTv has a pipeline of clinical drug candidates led by programs for the treatment of type 1 diabetes and cystic fibrosis related diabetes. vTv’s development partners are pursuing additional indications in type 2 diabetes, chronic obstructive pulmonary disease, renal disease, primary mitochondrial myopathy, and pancreatic cancer. For more information, please visit www.vtvtherapeutics.com.

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.

Forward-Looking Statements
This release contains forward-looking statements, which involve risks and uncertainties, including statements regarding the potential grant of the FDA Approval. These forward-looking statements can be identified by the use of forward-looking terminology, including the terms “anticipate,” “believe,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and, in each case, their negative or other various or comparable terminology. All statements other than statements of historical facts contained in this release, including statements regarding the agreements and transactions described in this release are forward-looking statements. These statements involve known and unknown risks, uncertainties and other important factors, including the risk that the FDA Approval is not received on a timely basis or at all, that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Important factors that could cause our results to vary from expectations include those described under the heading “Risk Factors” in our Annual Report on Form 10-K and our other filings with the SEC. These forward-looking statements reflect our views with respect to future events as of the date of this release and are based on assumptions and subject to risks and uncertainties. Given these uncertainties, you should not place undue reliance on these forward-looking statements. These forward-looking statements represent our estimates and assumptions only as of the date of this release and, except as required by law, we undertake no obligation to update or review publicly any forward-looking statements, whether as a result of new information, future events or otherwise after the date of this release. We anticipate that subsequent events and developments will cause our views to change. Our forward-looking statements do not reflect the potential impact of any future acquisitions, merger, dispositions, joint ventures or investments we may undertake. We qualify all of our forward-looking statements by these cautionary statements.

Contacts:

Investors:

Lee Roth

Burns McClellan

lroth@burnsmc.com

Media:

Selina Husain / Robert Flamm, Ph.D.

Burns McClellan, Inc.

shusain@burnsmc.com / rflamm@burnsmc.com

Source: vTv Therapeutics Inc.