Longeveron

Longeveron's ELPIS I study showed 100% 5-year survival with no heart transplants for HLHS patients treated with Lomecel-B™, compared to 83% survival in the SVR trial. ELPIS I met safety endpoints, and ELPIS II Phase 2b trial is ongoing to further evaluate Lomecel-B™.

Patients treated with Lomecel-B™ in ELPIS I showed 100% 5-year survival post-Glenn surgery, with none requiring heart transplant, compared to 83% survival in the Single Ventricle Reconstruction Trial. ELPIS I met its safety primary endpoint with 100% survival and transplant-free status. ELPIS II Phase 2b trial is ongoing, evaluating Lomecel-B™ as an adjunct therapy for HLHS.

Longeveron Inc. announced its submission on Lomecel-B inhibition of MMP14 activity for mild Alzheimer’s treatment was selected for a late-breaking poster presentation at the CTAD24 conference in Madrid, October 29-November 1, 2024.

Longeveron Inc. to present Lomecel-B data on Alzheimer's treatment at CTAD24 in Madrid, highlighting potential cellular therapy insights.

Longeveron Inc. to present long-term survival data on cell-based therapy for Hypoplastic Left Heart Syndrome at the Congenital Heart Surgeons’ Society 51st Annual Meeting.

Alzheimer's disease research saw a decade of stagnation until FDA approved aducanumab in 2021. Since then, therapies like donanemab and lecanemab have shown promise. NKGen's SNK01, an NK cell therapy, and Longeveron's Lomecel-B, an MSC therapy, are in phase 2 trials, demonstrating efficacy and safety. Other novel therapies, including Biogen's BIIB080 and AAV2-BDNF gene therapy, are also in development.

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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, to explore potential partnerships and strategic opportunities for its Alzheimer's disease cellular therapy program, which has shown positive results in Phase 1 and Phase 2a clinical trials. The company will also highlight its contract development and manufacturing business at its 15,000 square feet facility with 8 cGMP cleanroom suites. Longeveron's lead investigational therapeutic candidate, Lomecel-B™, has demonstrated promising results in the CLEAR MIND Phase 2a clinical trial for mild Alzheimer's disease and has received both Regenerative Medicine Advanced Therapy (RMAT) designation and Fast Track designation from the FDA for this indication.

Longeveron Inc. announced a positive Type C meeting with the FDA, advancing Lomecel-B™ for HLHS treatment. ELPIS II trial may lead to BLA submission, following ELPIS I's success. Lomecel-B™, derived from MSCs, shows promise for cardiac regenerative therapy. HLHS affects 1,000 U.S. infants annually, with current treatments offering limited survival rates.

Alzheimer’s disease, affecting nearly 7 million in the U.S., sees high clinical trial failure rates. Longeveron and Lexeo Therapeutics lead with novel cell and gene therapies. Longeveron’s Lomecel-B, showing promise in Phase IIa trials, targets broader Alzheimer’s symptoms, while Lexeo’s gene therapies focus on APOE4-associated Alzheimer’s. Both aim to overcome traditional treatment limitations, offering hope for new, effective therapies.