Longeveron Inc. 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-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.

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.