U.S. patent allowance impacts Aging-related Frailty patients receiving vaccines and builds upon a growing patent estate protecting the use of Lomecel-B™

MIAMI, Jan. 29, 2024 (GLOBE NEWSWIRE) — Longeveron Inc. (NASDAQ: LGVN) (“Longeveron” or “Company”), a clinical stage biotechnology company developing cellular therapies for life-threatening and chronic aging-related conditions , today announces it received a notice of patent allowance from the United States Patent and Trademark Office (PTO) for Medicinal Signaling Cells (MSCs), the technology behind its lead investigational product Lomecel-BTM . The allowance impacts patients with Aging-related Frailty receiving vaccines for conditions such as Covid and the flu.

The new U.S. patent adds to the intellectual property from previous patents issued to Longeveron in the European Union and Japan. Longeveron currently is conducting a trial of Aging-related Frailty in Japan aligned with the Japan Pharmaceuticals and Medical Devices Agency (PMDA). The Phase 2 trial design is intended to provide support for a limited approval under Japan’s Act on the Safety of Regenerative Medicine (ASRM). The patent allowance claims relate to the use of MSCs to enhance an immune response to a vaccine, or to induce an immune response, in patients with Aging-related Frailty whose immune system did not previously react to the vaccines.

“These newly allowed claims extend our patent estate to include the use of Lomecel-BTM in conjunction with or after patients receive vaccines to enhance vaccine immune response,” said inventor Joshua M. Hare, M.D., FACC, FAHA, Co-Founder and Chief Scientific Officer and Chairman of Longeveron. “We believe this use for Lomecel-BTM and the broader potential it holds for patients in our current Aging-related Frailty and Alzheimer’s disease trials reflects the broader potential of Lomecel-BTM.”

The patent covers the impact of Lomecel-BTM on favorable modulation of the immune system. Immune system modulation and optimization is a foundational mechanism of action of Lomecel-BTM in all of Longeveron’s indications presently under development.

Longeveron recently announced the results of its Phase 2 Alzheimer’s disease trial, which showed that in addition to meeting the primary endpoint of safety, it provided further support that analysis of cognitive function and daily living data consistently showed favorable results. Administering Lomecel-BTM over placebo in a dose-response fashion, was associated with slowing and in some cases improving certain measurements of cognitive function (MoCA, MMSE).

In addition to trials in Aging-related Frailty and Alzheimer’s disease, Longeveron is also conducting a Phase 2 trial for Hypoplastic Left Heart Syndrome (HLHS), a rare and often fatal cardiac condition in newborn infants.

Longeveron’s Patent Application 16/075,276 was titled Mesenchymal Stem Cells as Vaccine Adjuvants and Methods for Using the Same.

About Lomecel-B

Lomecel-B™ is a living cell product made from specialized cells isolated from the bone marrow of young healthy adult donors. These specialized cells, known as medicinal signaling cells (MSCs), are essential to our endogenous biological repair mechanism. MSCs have been shown to perform a number of complex functions in the body, including the formation of new tissue. They also have been shown to respond to sites of injury or disease and secrete bioactive factors that are immunomodulatory and regenerative. We believe that Lomecel-B™ may have multiple potential mechanisms of action that may lead to anti-inflammatory, pro-vascular regenerative responses, and therefore may have broad application for a range of rare and aging related diseases.

About Longeveron Inc.

Longeveron is a clinical stage biotechnology company developing regenerative medicines to address unmet medical needs. The Company’s lead investigational product is Lomecel-B™, an allogeneic medicinal signaling cell (MSC) therapy product isolated from the bone marrow of young, healthy adult donors. Lomecel-B™ has multiple potential mechanisms of action encompassing pro-vascular, pro-regenerative, anti-inflammatory, and tissue repair and healing effects with broad potential applications across a spectrum of disease areas. Longeveron is currently advancing Lomecel-B™ through clinical trials in three indications: hypoplastic left heart syndrome (HLHS), Alzheimer’s disease, and Aging-related Frailty. Additional information about the Company is available at www.longeveron.com.

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 operations, 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 in the U.S., Japan and other jurisdictions; the Company’s plans relating to the further development of its product candidates, including additional disease states or indications it may pursue; 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; market and other conditions; the Company’s financial performance and ability to continue as a going concern, and the period over which it estimates its existing cash and cash equivalents will be sufficient to fund its future operating expenses and capital expenditure 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, 2022, filed with the Securities and Exchange Commission on March 14, 2023 and its Quarterly Reports on Form 10-Q filed with the SEC. 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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