Longeveron Announces Contract Development & Manufacturing Business & First Contract

Longeveron Inc. recently announced the launch of its contract development and manufacturing business at the company’s 15,000-sq-ft state-of-the-art Good Manufacturing Practice (GMP) facility. This facility contains 3,000 sq ft of cleanroom space, including eight ISO 7 cleanrooms and ancillary areas, as well as 1,150 sq ft of process development, quality control, and warehousing space. The company also announced the initiation of work under its first manufacturing services contract with Secretome Therapeutics, a biotechnology company developing first-in-class therapeutics from neonatal mesenchymal stem cells (nMSC).

“We are delighted to partner with Secretome Therapeutics to advance their portfolio of therapeutics in this, our first contract manufacturing agreement in a new, revenue-generating business line,” said Wa’el Hashad, Chief Executive Officer of Longeveron. “With cellular therapy manufacturing expertise and capabilities in high demand, and Longeveron’s strength in both, we see a significant opportunity to employ currently unused capacity in our state-of-the-art GMP facility. We have assembled a team of experts and proprietary technologies that enable us to take a systematic approach to rapidly develop improved cell therapies. Longeveron’s manufacturing expertise, capabilities and facility provide other pharmaceutical organizations the ability to advance their development programs without building their own manufacturing facility. We believe this contract manufacturing opportunity can expand our team’s experience and has the potential to generate approximately $4-$5 million in annual revenues once it is up and running fully.”

“Our platform of neonatal stem cell-based therapeutics has the potential to revolutionize treatment for a wide range of chronic, inflammatory diseases,” added Vinny Jindal, President and Chief Executive Officer of Secretome Therapeutics. “As we move our lead product, STM-01, into clinical studies for HFpEF and dilated cardiomyopathy this year, we look forward to tapping into Longeveron’s extensive cellular therapy knowledge and manufacturing expertise, which has supported the launch of multiple clinical studies.”

Longeveron is primarily focused on advancing development of its lead investigational therapeutic candidate, Lomecel-B, a proprietary, scalable, allogeneic cellular therapy, across multiple indications, including hypoplastic left heart syndrome (HLHS) (Phase 2 on-going), Alzheimer’s disease (Phase 2 completed), and Aging-related Frailty (Phase 2 completed).

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 pursuing three pipeline indications: hypoplastic left heart syndrome (HLHS), Alzheimer’s disease, and Aging-related Frailty. For more information, visit www.longeveron.com.