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Longeveron Receives Notice of United States Patent Allowance for the Technology Behind its Lead Investigation Product Lomecel-B™

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Longeveron Inc. announces receipt of a notice of patent allowance from the United States Patent and Trademark Office for Medicinal Signaling Cells (MSCs), the technology behind its lead investigational product Lomecel-BTM. The new patent impacts patients with Aging-related Frailty receiving vaccines for conditions such as Covid and the flu, adding to the company's growing patent estate. Longeveron is conducting a trial of Aging-related Frailty in Japan and recently announced positive results from its Phase 2 Alzheimer’s disease trial. The patent covers the impact of Lomecel-BTM on favorable modulation of the immune system, which is foundational in all of Longeveron’s indications under development.
Positive
  • Receipt of a notice of patent allowance from the United States Patent and Trademark Office for Medicinal Signaling Cells (MSCs)
  • The new patent impacts patients with Aging-related Frailty receiving vaccines for conditions such as Covid and the flu
  • Positive results from Phase 2 Alzheimer’s disease trial
  • The patent covers the impact of Lomecel-BTM on favorable modulation of the immune system
Negative
  • None.

The recent patent allowance by the U.S. Patent and Trademark Office for Longeveron's use of Medicinal Signaling Cells (MSCs) in enhancing vaccine response in Aging-related Frailty patients marks a significant milestone in the biotechnology and pharmaceutical industry. The patent extends Longeveron's intellectual property portfolio, which is crucial for maintaining competitive advantage and securing market position. The protection of such innovations is essential, as it provides the company with exclusive rights to commercialize their findings, potentially leading to a stronger foothold in the aging-related treatment market.

From a business perspective, the patent can act as a barrier to entry for competitors, thereby potentially increasing Longeveron's market share and revenue streams. The patent's coverage of immune system modulation by Lomecel-B™ could also open avenues for further therapeutic applications and partnerships, which can be strategically leveraged for business growth. However, the actual commercial impact will depend on the outcomes of ongoing clinical trials and the subsequent regulatory approvals.

The announcement of a new patent allowance typically has a positive impact on a biotech company's stock performance, as it can be perceived as a validation of the company's research and development capabilities. For Longeveron, this development could attract investor interest due to the potential for Lomecel-B™ to address a sizeable market in aging-related conditions, including Alzheimer's disease. The financial implications of this patent could be substantial if the product demonstrates efficacy and safety in ongoing trials, leading to market approval and adoption.

Investors will be closely monitoring the progress of Longeveron's clinical trials in Japan, as well as the Phase 2 Alzheimer's disease trial results. Positive trial outcomes could lead to increased valuation of the company. However, it is important to note that the biotech sector is highly volatile and investment risks are significant, particularly for companies in the clinical stage without a product on the market. Investors should consider the long development timelines and regulatory hurdles that could affect Longeveron's financial future.

The patent allowance for Longeveron's MSC technology to enhance vaccine response in Aging-related Frailty patients is not only a legal milestone but also a potential clinical advancement. The company's focus on aging-related conditions, including Alzheimer's disease and Hypoplastic Left Heart Syndrome (HLHS), indicates a targeted approach to some of the most challenging medical conditions. The use of MSCs as vaccine adjuvants could represent a novel method to improve immune responses in a population with typically weakened immune systems.

Clinically, the success of Lomecel-B™ in trials could lead to new standards of care for frailty and cognitive impairments in the elderly. However, the clinical community will scrutinize the safety and efficacy data from the Phase 2 trials before any widespread adoption. It is also crucial to consider the regulatory pathways and the unique challenges in gaining approval under Japan’s Act on the Safety of Regenerative Medicine, which will require careful navigation by Longeveron. The broader implications for patient care hinge on these clinical and regulatory outcomes.

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.

Investor Contact
Mike Moyer
LifeSci Advisors
Tel: 617-308-4306
Email: mmoyer@lifesciadvisors.com


FAQ

What is the notice Longeveron Inc. received from the United States Patent and Trademark Office?

Longeveron Inc. received a notice of patent allowance for Medicinal Signaling Cells (MSCs), the technology behind its lead investigational product Lomecel-BTM.

What conditions do the new patent impact?

The new patent impacts patients with Aging-related Frailty receiving vaccines for conditions such as Covid and the flu.

What recent trial results did Longeveron Inc. announce?

Longeveron Inc. recently announced positive results from its Phase 2 Alzheimer’s disease trial.

What does the new patent cover?

The patent covers the impact of Lomecel-BTM on favorable modulation of the immune system.

Longeveron Inc.

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About LGVN

longeveron llc is a leading global regenerative medicine company developing innovative cellular therapeutics for chronic life-threatening diseases. our lead investigational product candidate (lmsc) is based on a specialized cell known as a mesenchymal stem cell that is derived from the bone marrow of healthy young adult donors. our allogeneic, ‘off-the-shelf’ product is under investigation for chronic conditions of the elderly, and other life- threatening diseases, for which no approved therapeutics currently exist: • aging frailty syndrome • alzheimer’s disease • hypoplastic left heart syndrome • the metabolic syndrome