Issued claims will protect use of a biomarker to assess response to Lomecel-B in patients with blood vessel dysfunction.
Miami, Florida – August 25, 2022 – Longeveron Inc. (NASDAQ: LGVN), a clinical stage biotechnology company developing cellular therapies for chronic, aging-related and life-threatening conditions, today announced that the European Patent Office (EPO) has issued a notice of its intent to grant the Company a patent (EP Application No. 15861319.0) related to methods to treat endothelial dysfunction and monitor the efficacy of allogeneic mesenchymal cell therapies, also known as medicinal signaling cells (MSCs). The cells are administered to patients with cardiovascular disease through the monitoring of a protein, Vascular Endothelial Growth Factor (VEGF), which is a signal protein produced by many cells that stimulates the formation of blood vessels.
“We are extremely pleased to receive this notice from the European patent office,” said Chris Min, M.D., Ph.D., Interim Chief Executive Officer and Chief Medical Officer at Longeveron. “This patent will bolster our robust intellectual property portfolio and support our goal of delivering effective cell therapies for a range of aging-related and life-threatening conditions.”
The patent is titled “Methods for Monitoring Efficacy of Allogeneic Mesenchymal Stem Cell Therapy in a Subject.” Longeveron’s lead investigational product is Lomecel-B™, a cell therapy product derived from MSCs. Many of Longeveron’s clinical studies point to Lomecel-B™ exerting affects through pro-vascular functions and/or reducing endothelial dysfunction, a condition where the lining of blood vessels are abnormal leading to diminished health of blood vessels and blood flow regulation.
The Company is evaluating the use of MSCs to treat several indications, including Hypoplastic Left Heart Syndrome (HLHS), a rare and life-threatening congenital heart defect that affects approximately 1,000 babies per year. Longeveron received both a Rare Pediatric Disease Designation and Orphan Drug Designation from the Food and Drug Administration in 2021 to test Lomecel-B™ on HLHS infants. Longeveron is currently evaluating Lomecel-B™ in a Phase 2a trial.
Longeveron is also conducting a trial of Lomecel-B in patients with Alzheimer’s disease in the US and for aging frailty in Japan.
Now that the European Patent Office has issued an Intention to Grant, Longeveron will await grant of the patent and then begin the process of registering the patent in a number of nation members of the European Patent Organization. In those jurisdictions where the patent is registered, the patent is expected to expire in November of 2035.
About Longeveron Inc.
Longeveron is a clinical stage biotechnology company developing cellular therapies for specific aging-related and life-threatening conditions. The Company’s lead investigational product is the Lomecel-B™ cell-based therapy product, which is derived from culture-expanded medicinal signaling cells (MSCs) that are sourced from bone marrow of young, healthy adult donors. Longeveron believes that by using the same cells that promote tissue repair, organ maintenance, and immune system function, it can develop safe and effective therapies for some of the most difficult disorders associated with the aging process and other medical disorders. Longeveron is currently sponsoring Phase 1 and 2 clinical trials in the following indications: Alzheimer’s disease, hypoplastic left heart syndrome (HLHS), Aging Frailty, and Acute Respiratory Distress Syndrome (ARDS). Additional information about the Company is available at www.longeveron.com.
Cautionary Note Regarding Forward-Looking Statements
Certain statements in this press release that are not historical facts are forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, which reflect management’s current expectations, assumptions, and estimates of future performance and economic conditions, and involve risks and uncertainties that could cause actual results to differ materially from those anticipated by the statements made herein. Forward-looking statements are generally identifiable by the use of forward-looking terminology such as “believe,” “expects,” “may,” “looks to,” “will,” “should,” “plan,” “intend,” “on condition,” “target,” “see,” “potential,” “estimates,” “preliminary,” or “anticipates” or the negative thereof or comparable terminology, or by discussion of strategy or goals or other future events, circumstances, or effects. Factors that could cause actual results to differ materially from those expressed or implied in any forward-looking statements in this release include, but are not limited to, statements about the ability of Longeveron’s clinical trials to demonstrate safety and efficacy of the Company’s product candidates, and other positive results; the timing and focus of the Company’s ongoing and future preclinical studies and clinical trials and the reporting of data from those studies and trials; the size of the market opportunity for the Company’s product candidates, including its estimates of the number of patients who suffer from the diseases being targeted; the success of competing therapies that are or may become available; the beneficial characteristics, safety, efficacy and therapeutic effects of the Company’s product candidates; the Company’s ability to obtain and maintain regulatory approval of its product candidates; the Company’s plans relating to the further development of its product candidates, including additional disease states or indications it may pursue; existing regulations and regulatory developments in the U.S., Japan and other jurisdictions; the Company’s plans and ability to obtain or protect intellectual property rights, including extensions of existing patent terms where available and its ability to avoid infringing the intellectual property rights of others; the need to hire additional personnel and the Company’s ability to attract and retain such personnel; the Company’s estimates regarding expenses, future revenue, capital requirements and needs for additional financing; the Company’s need to raise additional capital, and the difficulties it may face in obtaining access to capital, and the dilutive impact it may have on its investors; the Company’s financial performance, and the period over which it estimates its existing cash and cash equivalents will be sufficient to fund its future operating expenses and capital expenditures requirements. Further information relating to factors that may impact the Company’s results and forward-looking statements are disclosed in the Company’s filings with the Securities and Exchange Commission, including Longeveron’s Annual Report on Form 10-K for the year ended December 31, 2021, filed with the SEC on March 11, 2022, and the Company’s Quarterly Reports on Form 10-Q for the periods ended March 31, 2022, and June 30, 2022. The forward-looking statements contained in this press release are made as of the date of this press release, and the Company disclaims any intention or obligation, other than imposed by law, to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise.
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