Longeveron® Presents Lomecel-B™ Data for Alzheimer’s Disease Indication in Late Breaking Poster Presentation at the Clinical Trials on Alzheimer’s Disease Conference (CTAD24)
Longeveron presented data on Lomecel-B, their cellular therapy for mild Alzheimer's disease (AD), at the CTAD24 conference. The presentation highlighted that Lomecel-B's ability to inhibit MMP14 correlates with improved clinical outcomes in mild AD patients. Research from the Phase 2a CLEAR MIND trial showed that patients receiving Lomecel-B lots with higher MMP14 inhibitory activity demonstrated enhanced responses versus placebo on various measures, including cognitive function, quality of life, and brain volume. The findings suggest that MMP14 inhibition may protect TIE2 receptor integrity and contribute to the immunomodulatory and pro-vascular effects of Lomecel-B in mild AD treatment.
Longeveron ha presentato dati su Lomecel-B, la loro terapia cellulare per la malattia di Alzheimer (AD) lieve, alla conferenza CTAD24. La presentazione ha evidenziato che la capacità di Lomecel-B di inibire MMP14 è correlata a risultati clinici migliorati nei pazienti con AD lieve. La ricerca proveniente dallo studio di fase 2a CLEAR MIND ha mostrato che i pazienti che ricevevano Lomecel-B con una maggiore attività inibitoria di MMP14 mostravano risposte migliori rispetto al placebo su vari parametri, inclusi funzione cognitiva, qualità della vita e volume cerebrale. I risultati suggeriscono che l'inibizione di MMP14 potrebbe proteggere l'integrità del recettore TIE2 e contribuire agli effetti immunomodulativi e pro-vascolari di Lomecel-B nel trattamento dell'AD lieve.
Longeveron presentó datos sobre Lomecel-B, su terapia celular para la enfermedad de Alzheimer (EA) leve, en la conferencia CTAD24. La presentación destacó que la capacidad de Lomecel-B para inhibir MMP14 se correlaciona con mejores resultados clínicos en pacientes con EA leve. La investigación del ensayo CLEAR MIND de fase 2a mostró que los pacientes que recibieron lotes de Lomecel-B con mayor actividad inhibitoria de MMP14 demostraron respuestas mejoradas en comparación con el placebo en varias medidas, incluyendo función cognitiva, calidad de vida y volumen cerebral. Los hallazgos sugieren que la inhibición de MMP14 puede proteger la integridad del receptor TIE2 y contribuir a los efectos inmunomoduladores y pro-vasculares de Lomecel-B en el tratamiento de la EA leve.
론지버론은 CTAD24 회의에서 경증 알츠하이머병(AD)을 위한 세포 치료제인 로메셀-B에 대한 데이터를 발표했습니다. 발표는 로메셀-B의 MMP14 억제 능력이 경증 AD 환자에서 개선된 임상 결과와 연관되어 있음을 강조했습니다. 2상 CLEAR MIND 시험의 연구 결과, MMP14 억제 활성이 높은 로메셀-B를 받은 환자들이 인지 기능, 삶의 질, 뇌 용적 등 여러 지표에서 위약에 비해 향상된 반응을 보였다는 사실이 나타났습니다. 이 발견들은 MMP14 억제가 TIE2 수용체의 무결성을 보호하고 경증 AD 치료에 있어 로메셀-B의 면역조절 및 혈관형성 효과에 기여할 수 있음을 시사합니다.
Longeveron a présenté des données sur Lomecel-B, sa thérapie cellulaire pour la maladie d'Alzheimer (MA) légère, lors de la conférence CTAD24. La présentation a souligné que la capacité de Lomecel-B à inhiber MMP14 est corrélée à une amélioration des résultats cliniques chez les patients atteints de MA légère. La recherche du procès CLEAR MIND de phase 2a a montré que les patients recevant Lomecel-B avec une plus grande activité inhibitrice de MMP14 avaient des réponses améliorées par rapport à un placebo sur divers paramètres, notamment la fonction cognitive, la qualité de vie et le volume cérébral. Les résultats suggèrent que l'inhibition de MMP14 pourrait protéger l'intégrité du récepteur TIE2 et contribuer aux effets immunomodulateurs et pro-vasculaires de Lomecel-B dans le traitement de la MA légère.
Longeveron hat auf der CTAD24-Konferenz Daten zu Lomecel-B, ihrer Zelltherapie für leichte Alzheimer-Krankheit (AD), präsentiert. Die Präsentation hob hervor, dass die Fähigkeit von Lomecel-B, MMP14 zu hemmen, mit verbesserten klinischen Ergebnissen bei Patienten mit leichter AD korreliert. Forschungen aus der Phase-2a-Studie CLEAR MIND zeigten, dass Patienten, die Lomecel-B mit höherer MMP14-hemmender Aktivität erhielten, im Vergleich zur Placebo-Gruppe in verschiedenen Maßstäben, einschließlich kognitiver Funktionen, Lebensqualität und Gehirnvolumen, verbesserte Reaktionen zeigten. Die Ergebnisse deuten darauf hin, dass die Hemmung von MMP14 die Integrität des TIE2-Rezeptors schützen und zu den immunmodulatorischen und pro-gefäßerweiternden Effekten von Lomecel-B in der Behandlung von leichter AD beitragen könnte.
- Phase 2a CLEAR MIND trial showed improved cognitive function, quality of life, and brain volume in mild AD patients
- Demonstrated correlation between MMP14 inhibition and enhanced clinical outcomes
- Positive safety profile reported for Lomecel-B treatment
- None.
Insights
The presentation reveals significant mechanistic insights into Lomecel-B's therapeutic potential for Alzheimer's disease. The key finding that higher MMP14 inhibitory activity correlates with improved clinical outcomes represents a important breakthrough in understanding the treatment's mechanism of action. The data shows that lots with higher MMP14 inhibitory activity demonstrated enhanced responses in multiple critical measures, including the composite Alzheimer's disease score (CADS) and left hippocampal volume.
The discovery of Lomecel-B's ability to protect TIE2 receptor integrity through MMP14 inhibition provides a clear biological pathway for its therapeutic effects. This mechanism could explain both the immunomodulatory and pro-vascular benefits observed in clinical trials. The correlation between MMP14 inhibition and clinical improvements suggests this could be used as a potency marker for manufacturing optimization, potentially leading to more consistent and effective treatments.
This data strengthens Longeveron's position in the competitive Alzheimer's treatment landscape. The identification of a specific mechanism of action (MMP14 inhibition) adds significant value to the company's intellectual property portfolio and could facilitate regulatory discussions. The correlation between MMP14 inhibitory activity and clinical outcomes provides a clear path for optimizing manufacturing processes to enhance treatment efficacy.
For investors, this mechanistic understanding reduces development risk by providing a rational basis for the observed clinical benefits. It also opens possibilities for developing potency assays that could streamline manufacturing and quality control processes. The publication in JPAD and presentation at CTAD24 provides valuable peer validation and increases visibility within the scientific community.
- Findings offer potential mechanistic and clinical insights in the development of cellular therapy Lomecel-B™ for mild Alzheimer’s disease (AD)
- Lomecel-B™ capacity to inhibit MMP14 correlates with improved clinical and biomarker outcomes in mild AD
- Immunomodulatory and pro-vascular effects of Lomecel-B™ in mild AD potentially driven by ability to exert MMP14 inhibition which may protect TIE2 receptor integrity in human AD patients
MIAMI, Oct. 29, 2024 (GLOBE NEWSWIRE) -- Longeveron Inc. (NASDAQ: LGVN), a clinical stage regenerative medicine biotechnology company developing cellular therapies for life-threatening and chronic aging-related conditions, today announced that its submission entitled “Lomecel-B inhibition of MMP14 activity predicts Lomecel-B bioactivity in the treatment of mild Alzheimer’s disease” was presented as a late breaking poster presentation at the 17th edition of the Clinical Trials on Alzheimer’s Disease Conference (CTAD24) taking place October 29 -November 1, 2024 in Madrid, Spain.
“As a medicinal signaling cell therapy that has multiple potential mechanisms of action to address inflammatory responses in the brain, Lomecel-B™ offers the potential to address the underlying pathology of Alzheimer’s disease,” said Joshua Hare, M.D., Co-founder, Chief Science Officer, and Chairman at Longeveron. “This data adds to the positive clinical information from the Phase 2a CLEAR MIND clinical trial that showed Lomecel-B™ improved cognitive function, quality of life, and brain volume in the treatment of mild Alzheimer’s disease. We are very encouraged by the safety profile and efficacy evidence that support the differentiated therapeutic potential of Lomecel-B™ in Alzheimer’s disease.”
From the Poster:
Matrix metalloprotease (MMP) activity is reportedly upregulated in AD. The researchers hypothesized that excess MMP14 activity may contribute to AD pathogenesis, at least in part, by cleaving TIE2 (Tyrosine kinase with Immunoglobulin and Epidermal growth factor homology domains), a cell-surface tyrosine kinase receptor for the angiopoietins, which activates downstream signaling pathways that regulate endothelial cell health and inflammatory responses. They tested the hypothesis that Lomecel-B™ capacity to inhibit MMP14 correlates with improved clinical and biomarker outcomes in mild AD.
The researchers measured MMP14 inhibitory (MMP14i) activity, levels of TIMP2 (tissue inhibitor of metalloprotease 2), and VEGF-A (vascular endothelial growth factor-A) in the lots of Lomecel-B used in the CLEAR MIND trial. Supernatant from Lomecel-B CLEAR MIND lots contained MMP14i activity, high levels of TIMP2 and VEGF-A protein. Patients receiving Lomecel-B lots with higher levels of MMP14i activity demonstrated enhanced responses vs. placebo on the composite Alzheimer’s disease score (CADS, the study secondary endpoint) than those who received low potency lots. Similar associations were evident with responses in the MoCA, ADCS-ADL, and left hippocampal volume. High MMP14i lots were also more effective in suppressing elevations in soluble (degraded) TIE2 in study patients, suggesting a potential role for MMP14i in AD treatment.
Poster Conclusion:
Together these findings suggest that ability to exert MMP14 inhibition may protect TIE2 receptor integrity and underlie, at least in part, the immunomodulatory and pro-vascular effects of Lomecel-B in mild AD. The findings offer potential mechanistic and clinical insights in the development of cellular-based therapy for AD.
| Late Breaking Poster Presentation | |
| Date: | Tuesday, October 29, 2024, 3:00 p.m. CEST to Wednesday, October 30, 5:00 p.m. CEST |
| Theme: | 11. New Therapies and Clinical Trials |
| Title: | LP029 “Lomecel-B inhibition of MMP14 activity predicts Lomecel-B bioactivity in the treatment of mild Alzheimer’s” |
The abstract of the poster will also be included in the special CTAD edition of the Journal of Prevention of Alzheimer’s Disease (JPAD), the official journal of the CTAD conference.
About Lomecel-B™
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.
About Longeveron Inc.
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 (AD), and Aging-related Frailty. Lomecel-B™ development programs have received five distinct and important U.S. FDA designations: for the HLHS program - Orphan Drug designation, Fast Track designation, and Rare Pediatric Disease designation; and, for the AD program - Regenerative Medicine Advanced Therapy (RMAT) designation and Fast Track designation. For more information, visit www.longeveron.com or follow Longeveron on LinkedIn, X, and Instagram.
Forward-Looking Statements
Certain statements in this press release that are not historical facts are forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, which reflect management’s current expectations, assumptions, and estimates of future operations, performance and economic conditions, and involve risks and uncertainties that could cause actual results to differ materially from those anticipated by the statements made herein. Forward-looking statements are generally identifiable by the use of forward-looking terminology such as “believe,” “expects,” “may,” “looks to,” “will,” “should,” “plan,” “intend,” “on condition,” “target,” “see,” “potential,” “estimates,” “preliminary,” or “anticipates” or the negative thereof or comparable terminology, or by discussion of strategy or goals or other future events, circumstances, or effects and include, but are not limited to, the anticipated use of proceeds from recent offerings. Factors that could cause actual results to differ materially from those expressed or implied in any forward-looking statements in this release include, but are not limited to, market and other conditions, our limited operating history and lack of products approved for commercial sale; adverse global conditions, including macroeconomic uncertainty; inability to raise additional capital necessary to continue as a going concern; our history of losses and inability to achieve profitability going forward; the absence of FDA-approved allogenic, cell-based therapies for Aging-related Frailty, Alzheimer’s disease, or other aging-related conditions, or for HLHS or other cardiac-related indications; ethical and other concerns surrounding the use of stem cell therapy or human tissue; our exposure to product liability claims arising from the use of our product candidates or future products in individuals, for which we may not be able to obtain adequate product liability insurance; the adequacy of our trade secret and patent position to protect our product candidates and their uses: others could compete against us more directly, which could harm our business and have a material adverse effect on our business, financial condition, and results of operations; if certain license agreements are terminated, our ability to continue clinical trials and commercially market products could be adversely affected; the inability to protect the confidentiality of our proprietary information, trade secrets, and know-how; third-party claims of intellectual property infringement may prevent or delay our product development efforts; intellectual property rights do not necessarily address all potential threats to our competitive advantage; the inability to successfully develop and commercialize our product candidates and obtain the necessary regulatory approvals; we cannot market and sell our product candidates in the U.S. or in other countries if we fail to obtain the necessary regulatory approvals; final marketing approval of our product candidates by the FDA or other regulatory authorities for commercial use may be delayed, limited, or denied, any of which could adversely affect our ability to generate operating revenues; we may not be able to secure and maintain research institutions to conduct our clinical trials; ongoing healthcare legislative and regulatory reform measures may have a material adverse effect on our business and results of operations; if we receive regulatory approval of Lomecel-B™ or any of our other product candidates, we will be subject to ongoing regulatory requirements and continued regulatory review, which may result in significant additional expense; being subject to penalties if we fail to comply with regulatory requirements or experience unanticipated problems with our therapeutic candidates; reliance on third parties to conduct certain aspects of our preclinical studies and clinical trials; interim, “topline” and preliminary data from our clinical trials that we announce or publish from time to time may change as more data become available and are subject to audit and verification procedures that could result in material changes in the final data; the volatility of the price of our Class A common stock; we could lose our listing on the Nasdaq Capital Market; provisions in our certificate of incorporation and bylaws and Delaware law might discourage, delay or prevent a change in control of our company or changes in our management and, therefore, depress the market price of our Class A common stock; we have never commercialized a product candidate before and may lack the necessary expertise, personnel and resources to successfully commercialize any products on our own or together with suitable collaborators; and in order to successfully implement our plans and strategies, we will need to grow our organization, and we may experience difficulties in managing this growth. Further information relating to factors that may impact the Company’s results and forward-looking statements are disclosed in the Company’s filings with the Securities and Exchange Commission, including Longeveron’s Annual Report on Form 10-K for the year ended December 31, 2023, filed with the Securities and Exchange Commission on February 27, 2024, as amended by the Annual Report on Form 10-K/A filed March 11, 2024, its Quarterly Reports on Form 10-Q, and its Current Reports on Form 8-K. The forward-looking statements contained in this press release are made as of the date of this press release, and the Company disclaims any intention or obligation, other than imposed by law, to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise.
Investor and Media Contact:
Derek Cole
Investor Relations Advisory Solutions
derek.cole@iradvisory.com
A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/f106bde7-972a-4687-a91e-03e924f409fc
FAQ
What were the key findings of Longeveron's Lomecel-B presentation at CTAD24?
How does Lomecel-B (LGVN) work in treating Alzheimer's disease?
What were the results of Longeveron's Phase 2a CLEAR MIND trial for Alzheimer's?
