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

Longeveron Inc. recently announced 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-B. The allowance impacts patients with Aging-related Frailty receiving vaccines for conditions such as Covid and the flu.

The new US 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-B in conjunction with or after patients receive vaccines to enhance vaccine immune response,” said inventor Joshua M. Hare, MD, FACC, FAHA, Co-Founder and Chief Scientific Officer and Chairman of Longeveron. “We believe this use for Lomecel-B 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-B.”

The patent covers the impact of Lomecel-B on favorable modulation of the immune system. Immune system modulation and optimization is a foundational mechanism of action of Lomecel-B 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-B 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.

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.

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. For more information, visit www.longeveron.com.