Longeveron to Explore Partnerships for Alzheimer's Cell Therapy at Cell & Gene Meeting
核心洞察
Longeveron will attend the Cell & Gene Meeting on the Mesa to seek partnerships for its Alzheimer's cell therapy program.
The company's Lomecel-B™ showed promising Phase 2a results, slowing disease worsening in mild Alzheimer's patients.
Lomecel-B™ has received Regenerative Medicine Advanced Therapy (RMAT) and Fast Track designations from the FDA.
Longeveron Inc. (NASDAQ: LGVN) will participate in the Alliance for Regenerative Medicine's Cell & Gene Meeting on the Mesa, October 7-9, 2024, in Phoenix, Arizona. The company aims to explore potential partnerships and strategic opportunities for its cellular therapy program in Alzheimer's disease (搜索) (AD). Longeveron will also highlight its contract development and manufacturing business.
Alzheimer's Disease Program
Longeveron's lead investigational therapeutic candidate, Lomecel-B™, is a proprietary, scalable, allogeneic cellular therapy. The CLEAR MIND Phase 2a clinical trial in mild Alzheimer's disease (搜索) showed that Lomecel-B™ treated patients experienced an overall slowing or prevention of disease worsening compared to placebo. The trial met its primary safety and secondary efficacy endpoints, demonstrating statistically significant improvements in pre-specified clinical and biomarker endpoints in specific Lomecel-B™ groups compared to placebo.
Full results from the CLEAR MIND study were presented at the 2024 Alzheimer's Association International Conference (AAIC). Top-line results were announced on October 5, 2023, with additional clinical data and imaging biomarker results reported on December 20, 2023.
The U.S. FDA has granted Lomecel-B™ both Regenerative Medicine Advanced Therapy (RMAT) designation and Fast Track designation for the treatment of mild Alzheimer’s disease.
Contract Development and Manufacturing
Longeveron provides contract development and manufacturing services to pharmaceutical company clients at its 15,000 square feet current Good Manufacturing Practice (cGMP) facility in Miami, Florida. This facility contains 3,000 square feet of cleanroom space, including eight ISO 7 cleanrooms and ancillary areas, as well as 1,150 square feet of process development, quality control and warehousing space.
Longeveron has assembled a team of experts and proprietary technologies that enable it 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.