Category Archives: Regenerative Medicine

$8 million grant funds development of NXC-201 in relapsed/refractory AL Amyloidosis $8 million grant funds development of NXC-201 in relapsed/refractory AL Amyloidosis

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California Institute for Regenerative Medicine Awards Funding for CAR-T NXC-201 U.S. AL Amyloidosis Clinical Trial (NEXICART-2)

Longeveron Inc. announced that the U.S. Food and Drug Administration (FDA) granted Regenerative Medicine Advanced Therapy (RMAT) designation to Lomecel-B for the treatment of mild Alzheimer?s Disease. Lomecel-B is a proprietary, scalable, allogeneic cellular investigational therapy being evaluated across multiple indications, including Alzheimer?s Disease (Phase 2a completed), Aging-related Frailty (Phase 2b completed) and hypoplastic left heart syndrome (HLHS) (Phase 2b on-going). To the Company's knowledge based on publicly available information, Lomecel-B is the first cellular therapeutic candidate to receive RMAT designation for Alzheimer?s Disease.

Longeveron previously announced top-line results for the CLEAR MIND Phase 2a clinical trial on October 5, 2023, and reported additional clinical data and imaging biomarker results on December 20, 2023. Full study results for CLEAR MIND will be reported in a Featured Research Oral Presentation at the 2024 Alzheimer?s Association International Conference (AAIC) on July 28, 2024. Established under the 21st Century Cures Act, RMAT designation is a dedicated program designed to expedite the drug development and review processes for promising pipeline regenerative medicine products, including cell therapies.

A regenerative medicine therapy is eligible for RMAT designation if it is intended to treat, modify, reverse or cure a serious or life-threatening disease or condition, and preliminary clinical evidence indicates that the drug or therapy has the potential to address unmet medical needs for such disease or condition. Similar to Breakthrough Therapy designation, RMAT designation provides the benefits of intensive FDA guidance on efficient drug development, including the ability for early interactions with FDA to discuss surrogate or intermediate endpoints, potential ways to support accelerated approval and satisfy post-approval requirements, and potential priority review of the biologics license application (BLA) if Priority Review designation is granted following BLA submission.

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Longeveron Inc. Announces U.S. FDA Grants Lomecel-B Regenerative Medicine Advanced Therapy Designation for the Treatment of Mild Alzheimer's Disease -...

11 juli, 2024

Swedish Medtech Phase Holographic Imaging is making significant strides in the United States, establishing itself at the forefront of the rapidly growing regenerative medicine field. PHI is now taking an important step by applying for listing its shares in the US OTCQB market to enhance its presence and opportunities in the US. BioStock talked to CEO Patrik Eschricht to learn more about what this means for the company.

The core technology of the Phase Holographic Imaging (PHI) commercial HoloMonitor system is so-called Quantitative Phase Imaging (QPI), capable of assessing cell culture quality and health without influencing or damaging cells like traditional measurement methods. PHIs overarching goal with its technology is to contribute to making cell-based therapies affordable, accessible, and patient-safe.

Since 2022, the company has had a laser focus on regenerative medicine. This growing field involves the repair, replacement, or regeneration of dysfunctional cells, tissues, and organs to amplify our natural healing process in the places where it is needed most. Allowing for precise monitoring and verification of cell quality, the QPI technology is considered a valuable asset in this cutting-edge field. According to PHI, QPI measurements would fit seamlessly into an automated manufacturing workflow, setting it apart from other cell quality control methods that require removing precious cells from the process.

With the US spearheading the field of regenerative medicine, PHI has put a lot of emphasis on establishing itself in this major market. PHI got its first US customer already back in 2014 and has always had a strong academic foothold, collaborating with leading US research institutes, such as Northeastern University, Huntsman Cancer Institute, UCSF and the National Institute of Aging.

In 2019, as part of the ongoing expansion of activities in the US, PHI established its first fully owned subsidiary, PHI Inc., in Boston. Two years ago, the company joined the RegenMed Development Organization (ReMDO) located in Winston-Salem. PHI also joined an alliance for advancing cell-based biomanufacturing with other companies in ReMDO and the pioneering Wake Forest Institute for Regenerative Medicine (WFIRM). Together, they aim to automate the manufacturing process of cell-based therapies using recent technological developments in cell culturing, analytical instrumentation, and artificial intelligence.

In 2022, as a next step in its investment in regenerative medicine, PHI opened a new development office in the Innovation Quarter in Winston-Salem to become present at the epicentre of this rapidly growing field.

Now, the company has decided to push even further into the major US market, applying to list its shares on the US-based OTCQB Venture Market. This dual listing would not only offer PHIs current and prospective shareholders an additional trading platform but also enhance PHIs credibility among US investors and partners. BioStock has talked to PHI CEO Patrik Eschricht to learn more about what the dual listing means for the company and its plans moving forward.

We have thought about it before, but now that everyone is talking about regenerative medicine and AI, the time is right. We are very happy about the possibility of dual-listing on the OTCQB, which would be another significant step in PHIs growth journey as a global company. This dual listing would make it more accessible for international investors to invest in PHI, positively increasing liquidity, boosting shareholder value, and supporting our ongoing growth.

We have the worlds eye on Winston-Salem and the leading institute, WFIRM, for pioneering regenerative medicine and bringing scientific discoveries to the clinic and patients. The time is now, as we see the momentum within regenerative medicine and the, therefore, increasing relevance of PHIs unique technology. We have made a strategic decision to push further into the major US market and react to the growing interest in PHI from the US and regenerative medicine partners.

This dual listing would allow international investors to trade in PHI shares, expanding our investor community and enhancing the liquidity of our shares. I see this as a significant benefit to our current shareholders and PHIs ongoing growth.

Certainly to recap, were spearheading an important Smart Manufacturing project with our technology development alliance with WFIRM, ReMDO, analytics leader SAS, BioSpherix, and QIAGEN. This project focuses on creating new standards for cell therapy quality control. A cornerstone of this project is the Cell Report Card, which integrates QPI cell quality data with omics information.

This card tracks a cell sample throughout the lifetime of the cells and the patient, providing data crucial for ensuring quality and safety in cell therapies. We have finalized another round of experiments and continue to evaluate the HoloMonitor data together with our partners.

We are happy to see the substantial growth of the RegeneratOR test bed, particularly with our partner QIAGENs recent commitment to expanding its contributions. The test bed initiative is at the forefront of regenerative medicine, offering access to cutting-edge technologies and expert resources.

In my eyes, its a must-have to drive novel prototyping in the regenerative medicine field and the right place for PHI to present our unique technology for the development of cell-based therapies. At our latest meeting, it was obvious to everyone that not one company can solve all the problems; we need to work together. And at the RegeneratOR test bed, we have a very strong Starting Eleven, a starting lineup with over 60 companies.

We are still thrilled about the USD 160 million NSF grant, which underscores Winston-Salems role as a global hub for regenerative medicine! With the complexity and number of partners involved in this grant, we patiently await the presentation of details and how this grant will directly impact PHIso we, too, can share the news. So far, the increased focus on the region certainly has boosted our visibility and may create new business opportunities.

Our collaboration with WFIRM places us at the forefront of innovation in regenerative medicine. Being at the epicenter of such significant advancements reinforces our strategic positioning and commitment to establishing our QPI technology as the gold standard in cell quality control.

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PHI aims for US listing - BioStock - Connecting Innovation and Capital

MIAMI, July 08, 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 Roger Hajjar, MD, Director of the Gene and Cell Therapy Institute at Mass General Brigham, has been elected to the Longeveron Board of Directors. Dr. Hajjar is an internationally recognized scientist whose cardiac gene therapy discoveries have spurred clinical trials for heart failure, whose methodologies for cardiac-directed gene transfer are currently utilized by investigators around the world, and who was appointed as the inaugural director of the Gene and Cell Therapy Institute. Dr. Hajjar was elected at the Companys recent Annual Meeting of Stockholders.

I am delighted to welcome Roger, and his tremendous experience as a scientist, academic, and operational executive, to the Board of Directors, said Joshua Hare, Co-founder, Chief Science Officer and Chairman of the Board at Longeveron. His thought leadership in gene and cell therapy will bring significant value to Longeveron as we continue to advance Lomecel-B, our proprietary, scalable, allogeneic cellular therapy being evaluated in multiple indications. I look forward to collaborating with him to advance these important therapeutic development programs.

I am excited to join the Longeveron Board at this important time, both for the Company and in the history of gene therapy, said Dr. Hajjar. Gene and cell therapy is revolutionizing patient care with the potential to cure diseases or halt their progression. The Lomecel-Bdata generated to date in HLHS and Alzheimers disease support broad potential for this novel cellular therapy as a regenerative medical therapy across multiple indications and position the Company to potentially profoundly impact affected patients lives for the better.

Dr. Hajjars addition to the Board is part of the planned Board refreshment process at Longeveron, with a focus on bringing in new, relevant, experienced leaders over time to add to the knowledge base and experience provided by current and departing Board members.

Dr. Hajjar is an internationally renowned scientific leader in the field of cardiac gene therapy. His laboratory had validated a number of cardiac targets that led to the initiation and completion under his guidance of First-in-Human gene therapy trials in patients with heart failure. He has initiated multiple clinical trials in gene therapy for a variety of cardiovascular diseases.

He has authored over 500 publications and has received numerous awards for his achievements in the field of cardiac gene therapy. Dr. Hajjar received his Bachelor of Science in Biomedical Engineering from Johns Hopkins University and his Doctor of Medicine from Harvard Medical School and the Harvard-MIT Division of Health Sciences & Technology. He completed his training in internal medicine, cardiology, heart failure/cardiac transplantation, and research fellowships at Massachusetts General Hospital in Boston where he then directed the Cardiology Laboratory of Integrative Physiology and Imaging. From 2007 to 2018, Dr. Hajjar was the Director of the Cardiovascular Research Center, and the Arthur & Janet C. Ross Professor of Medicine at Mount Sinai School of Medicine in New York. From 2019 to 2022, Dr. Hajjar was involved in the creation of a number of gene therapy companies at Flagship Pioneering, Cambridge, MA and he was the head of R&D at Ring Therapeutics.

About Longeveron Inc.

Longeveron is a clinical stage biotechnology company developing regenerative medicines to address unmet medical needs. The Companys 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), Alzheimers disease, and Aging-related Frailty. The Lomecel-BHLHS program has received three distinct and important FDA designations: Orphan Drug designation, Fast Track designation, and Rare Pediatric Disease designation. For more information, visit http://www.longeveron.com or follow Longeveron on LinkedIn, X, and Instagram.

Investor 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/0ff5c44e-e63d-4909-b8b8-6d71186087ec

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Gene Therapy Pioneer Roger Hajjar, MD, Elected to Longeveron Board of Directors - GlobeNewswire

MIAMI, July 09, 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, including hypoplastic left heart syndrome (HLHS) and Alzheimers disease, today announced that Neha Motwani, a senior healthcare investment banker, has been elected to the Longeveron Board of Directors at the Companys recent Annual Meeting of Stockholders.

I am delighted to welcome Neha, with her tremendous healthcare industry experience, to the Board of Directors, said Joshua Hare, Co-founder, Chief Science Officer and Chairman of the Board at Longeveron. Her extensive knowledge of biopharma company operations, financing and capital markets will bring significant value to Longeveron as we continue to advance Lomecel-B, our proprietary, scalable, allogeneic cellular therapy. With five positive clinical trials across three indications, we believe Lomecel-Bhas the potential to be an important therapy for some of the most difficult diseases and conditions associated with aging.

Neha Motwani has over 25 years of healthcare investment banking experience, most recently serving as Managing Director, Healthcare Investment Banking at William Blair. She previously held investment banking roles of increasing responsibility with Truist Securities, Oppenheimer and Company, Stifel Financial and Cowen and Company, where, collectively, she completed transactions raising approximately $7.0 billion. Ms. Motwani earned her B.A. in political science from Columbia University.

I am delighted to join the Board of Directors of Longeveron at this exciting phase of the Companys clinical development, said Ms. Motwani. I look forward to working with this talented team to continue their mission to advance their novel cellular therapy, Lomecel-Bfor the potential treatment of HLHS, a rare and devastating congenital heart condition, and diseases of the aging.

About Longeveron Inc.

Longeveron is a clinical stage biotechnology company developing regenerative medicines to address unmet medical needs. The Companys 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), Alzheimers disease, and Aging-related Frailty. The Lomecel-BHLHS program has received three distinct and important FDA designations: Orphan Drug designation, Fast Track designation, and Rare Pediatric Disease designation. For more information, visit http://www.longeveron.com or follow Longeveron on LinkedIn, X, and Instagram.

Investor 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/00f0eb5c-76f5-49b1-9994-ee363513547b

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Neha Motwani Elected to Longeveron Board of Directors - GlobeNewswire

SALT LAKE CITY, July 9, 2024 /PRNewswire/ --DiscGenics, Inc., a privately held, late-stage clinical, biopharmaceutical company developing allogeneic, cell-based, regenerative therapies for musculoskeletal degeneration, today announced publication of results in the International Journal of Spine Surgery from the combined Phase I/Phase II, first-in-human clinical study of an allogeneic disc progenitor cell therapy (IDCT or rebonuputemcel) for painful lumbar degenerative disc disease (DDD).

The study met the primary safety and efficacy endpoints, showing that a single intradiscal injection of high-dose IDCT (9,000,000 cells/mL) safely increases disc volume and produces statistically significant, clinically meaningful improvements in back pain, disability, and quality of life out to 2 years post-injection in patients with lumbar disc degeneration.

"The results from this study demonstrate IDCT's potential to safely and effectively reduce pain associated with DDD while also producing a regenerative effect within the degenerating disc. MRI image analysis of disc volume indicated the potential to halt and possibly reverse the progression of the disease," said Matthew F. Gornet, M.D., lead author, Board Certified Spine Surgeon at The Orthopedic Center of St. Louis, and top enroller in the IDCT study. "I have been a practicing spine surgeon for more than 30 years and been involved in over 35 FDA clinical trials, and the patient outcomes from this study are very promising."

In the FDA-allowed, prospective, randomized, double-blinded, vehicle- and placebo-controlled,multicenter study, 60 patients with symptomatic, single-level lumbar DDD were randomized to receive single intradiscal injections of either low-dose cells (n= 20), high-dose cells (n= 20), vehicle alone (n= 10), or placebo (n= 10). The primary endpoint was mean visual analog scale (VAS) pain improvement >30% at 52 weeks. Disability and quality of life were evaluated via Oswestry Disability Index (ODI) and EQ-5D, respectively. Disc volume was radiologically assessed. Adverse events (AEs), regardless of whether they were related to treatment, were reported. Patients were assessed at baseline and at 4, 12, 26, 52, 78, and 104 weeks post treatment.

At Week 52, the primary study period, the high-dose group had a mean VAS percentage decrease from baseline (62.8%, P= 0.0005), achieving the endpoint of back pain improvement >30%; the mean change was also significantly greater than the minimal clinically important difference (MCID) of a 20-point decrease (42.8,P= 0.001). This clinical improvement was maintained at Week 104. In addition, the high-dose group had clinically meaningful, statistically significant improvements in ODI and EQ-5D by 12 weeks. Clinical improvement was sustained at 26 weeks, 52 weeks, 78 weeks, and 104 weeks following a single intradiscal injection. Only the high-dose group had a significant change in disc volume, with mean increases of 249.0 mm3(P= 0.028) at 52 weeks and 402.1 mm3(P= 0.028) at 104 weeks. Overall, a minority of patients (18.3%) reported AEs that were severe, with the highest percentage being reported in the placebo group. During the course of the trial, 6.7% of patients experienced serious AEs, all occurring in the vehicle (n= 1) or placebo (n= 3) groups, none were treatment related.

"Since the inception ofDiscGenics, we have seen consistent evidence of safety and the regenerative potential of the unique disc cell population in IDCT to address disc degeneration," said Kevin T. Foley, MD, Chief Medical Officer of DiscGenics and Chairman of Semmes-Murphey Neurologic & Spine Institute. "Our early basic science studies, our demonstrated ability to safely use human cells in 14 different pre-clinical animal studies conducted in the U.S.and Japan, and recently, data from our first-in-human safety and patient-reported outcomes published in this IJSS manuscript, all support the notion that this cell has the potential to safely regenerate the intervertebral disc from the inside-out."

DDD is a chronic and progressive condition where the intervertebral disc breaks down and causes pain and disability. It accounts for nearly 40% of chronic low back pain cases in the U.S., a serious medical condition that affects 12-30% of U.S. adults at a given time and is estimated to cost the U.S. healthcare system over $100 billion each year, creating a considerable burden on the economy and individual patients.

"The significant and durable results from this study demonstrate the incredible potential ofIDCT to change the paradigm of care for patients with DDD, a condition with limited treatment options," said Flagg Flanagan, Chief Executive Officer and Chairman of the Board for DiscGenics." We are excited by the momentum the publication of these study results offers, as we expect to initiate Phase III clinical study of this novel therapy in the U.S. imminently."

AboutIDCT

IDCT (injectable disc cell therapy, orrebonuputemcel) is a standalone, single-injection biologic treatment designed to halt progression of symptomatic lumbar disc degeneration and regenerate the disc from the inside out. The active ingredient (Drug Substance) in IDCT is a live, manufactured progenitor cell population derived from donated adult human intervertebral disc tissue. These cells are enriched and expanded into Discogenic Cells through a multistep manufacturing process in a highly controlled environment under current good manufacturing practices (cGMP) that results in significant proliferation and phenotypic changes to the cells. At the completion of the manufacturing process, the Discogenic Cells are subjected to extensive testing prior to use, including identity, purity, potency, and safety evaluations. The Discogenic Cells are then mixed with a viscous Sodium Hyaluronate Solution and excipients to generate IDCT, the Final Drug Product. IDCT is cryopreserved and maintained as individual "off-the-shelf" doses for administration viapercutaneous injection into the intervertebral disc in an outpatient setting. IDCT has been granted regenerative medicine advanced therapy (RMAT)and Fast Trackdesignations by the U.S. Food and Drug Administration.

Disclaimer:IDCT is an investigational product that is under development by DiscGenics and has not been approved by the FDA or any other regulatory agency for human use.

AboutDiscGenics

DiscGenics is a privately held, late-stage clinical biopharmaceutical company developingallogeneic, cell-based regenerative therapies for musculoskeletal degeneration. It's lead product candidate, IDCT (injectable disc cell therapy, or rebonuputemcel), is a standalone, single-injection biologic treatment designed to halt progression of lumbar disc degeneration and regenerate the disc from the inside out. DiscGenics is also developing a follow-on allogeneic cell platform to enable new musculoskeletal indications. To further development of these unique therapies, and to maintain control over compliance, cost, and production timelines, DiscGenics has built and validated an in-house scalable, allogeneic cell manufacturing process and cGMP facility at its headquarters in Salt Lake City, Utah. For more information, visitdiscgenics.com.

SOURCE DISCGENICS, INC.

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DiscGenics Announces the International Journal of Spine Surgery Has Published Results from an FDA-Approved Study of an Allogeneic Disc Progenitor Cell...

Longeveron announced that the U.S. FDA granted Regenerative Medicine Advanced Therapy (RMAT) designation to Lomecel-B for treating mild Alzheimers Disease. This makes Lomecel-B the first cellular therapeutic candidate to receive RMAT for Alzheimers. The therapy is being evaluated in multiple conditions, including Alzheimers (Phase 2a completed), Aging-related Frailty (Phase 2b completed), and Hypoplastic Left Heart Syndrome (HLHS) (Phase 2b ongoing). The CLEAR MIND Phase 2a trial indicated that Lomecel-B slowed/prevented disease progression compared to placebo, meeting safety and efficacy endpoints. Full results will be presented in July 2024. RMAT designation aims to expedite the drug development process and offers benefits like FDA guidance and potential priority review.

Positive

Receiving the RMAT designation is a significant advancement in Longeveron's journey, especially since Lomecel-B appears to be the first cellular therapeutic candidate to obtain such recognition for treating Alzheimer's Disease. The RMAT status, akin to the Breakthrough Therapy designation, implies that preliminary clinical data is promising enough to warrant expedited review processes. This designation potentially translates into a faster path to market, provided subsequent trials reinforce the positive outcomes observed in the Phase 2a.

Primarily, the designation underscores early indicators of efficacy. The Phase 2a trial demonstrated the slowing or prevention of disease progression, which is quite notable given the limited therapeutic options currently available for Alzheimer's. If these results hold true in further phases, it could revolutionize treatment paradigms.

For investors, the RMAT designation should be seen as a validation of both the science behind Lomecel-B and the strategic decisions of Longeveron. However, it's essential to remember that while the RMAT can speed up the process, it doesn't guarantee final FDA approval. Therefore, keeping an eye on upcoming clinical results, especially from the CLEAR MIND study, is crucial.

The financial landscape of Longeveron could witness substantial shifts due to the RMAT designation for Lomecel-B. Market sentiment often reacts positively to such regulatory advancements, potentially driving up stock prices in the short term. The RMAT designation also enhances the company's profile, making it more attractive to potential investors and partners who are interested in regenerative medicine and neurodegenerative diseases.

In the long run, successful commercialization of Lomecel-B for Alzheimer's could position Longeveron as a leader in a high-demand yet underserved market. With Alzheimer's Drug sales expected to continue growing due to the aging population, the financial implications of successfully bringing an approved treatment to market could be immense.

However, investors should exercise caution. The road to commercialization is fraught with regulatory and developmental hurdles. While the RMAT designation is a positive step, it's just one part of a longer journey. Upcoming clinical data and FDA interactions will provide more definitive indicators of commercial viability.

While my primary focus is oncology, the implications of Lomecel-B's RMAT designation can be understood from a broader biomedical perspective. The RMAT designation emphasizes the therapy's potential to meet unmet medical needs in Alzheimer's Disease, which is a huge medical challenge with significant overlap in the methodologies used in cancer and regenerative medicine research.

The promising early data showing a slowing of disease progression aligns with what we aim for in oncologydisease modification. From a clinical standpoint, this kind of designation is awarded when early clinical trials show significant promise, which in this case, indicates Lomecel-B might have a substantial impact on disease management.

Given the complexity of Alzheimers and the limited treatment options, any therapy that can demonstrate efficacy in the early stages is worth serious attention. However, it's important for investors to recognize that medical breakthroughs undergo rigorous scrutiny and require consistent, replicable results across larger patient populations before they can be deemed effective and safe for widespread use.

- Lomecel-Bappears to be the first cellular therapeutic candidate to receive RMAT designation for Alzheimers Disease

MIAMI, July 10, 2024 (GLOBE NEWSWIRE) -- Longeveron Inc. (NASDAQ: LGVN), a clinical stage regenerative medicine biotechnology company developing cellular therapies for certain life-threatening and chronic aging-related conditions, today announced that the U.S. Food and Drug Administration (FDA) granted Regenerative Medicine Advanced Therapy (RMAT) designation to Lomecel-Bfor the treatment of mild Alzheimers Disease. Lomecel-Bis a proprietary, scalable, allogeneic cellular investigational therapy being evaluated across multiple indications, including Alzheimers Disease (Phase 2a completed), Aging-related Frailty (Phase 2b completed) and hypoplastic left heart syndrome (HLHS) (Phase 2b on-going). To the Company's knowledge based on publicly available information, Lomecel-Bis the first cellular therapeutic candidate to receive RMAT designation for Alzheimers Disease.

The RMAT designation is an important milestone for Longeveron and the Lomecel-Bprogram that recognizes the potential of our cellular therapy to have a positive impact on patients afflicted with this devastating disease, said Joshua Hare, Co-founder, Chief Science Officer and Chairman of the Board at Longeveron. Alzheimers Disease is a neurodegenerative disorder that leads to progressive memory loss and death and currently has very limited therapeutic options. In the CLEAR MIND Phase 2a clinical trial, Lomecel-Bdemonstrated an overall slowing/prevention of disease worsening compared to placebo. The trial achieved the primary safety and secondary efficacy endpoints and showed statistically significant improvements in pre-specified clinical and biomarker endpoints in specific Lomecel-B groups compared to placebo.

Longeveron previously announced top-line results for the CLEAR MIND Phase 2a clinical trial on October 5, 2023, and reported additional clinical data and imaging biomarker results on December 20, 2023. Full study results for CLEAR MIND will be reported in a Featured Research Oral Presentation at the 2024 Alzheimers Association International Conference (AAIC) on July 28, 2024.

We are thrilled to receive the RMAT designation for Lomecel-Bfor the treatment of mild Alzheimers Disease and we look forward to meeting with the FDA to discuss the path forward and the development plans for Alzheimers Disease in the very near future, said Nataliya Agafonova, M.D., Chief Medical Officer at Longeveron.

The RMAT designation is the fourth special regulatory designation received by Longeveron for Lomecel-B. The Lomecel-BHLHS program has received three separate and distinct FDA designations: Orphan Drug designation, Fast Track designation, and Rare Pediatric Disease designation.

We are happy to receive this important RMAT designation as it continues to validate the work we have done so far and allows us to have the important dialogue with the FDA to advance our work and potentially bring this investigational therapeutic option to the many patients suffering from Alzheimers Disease, said Wael Hashad, Chief Executive Officer and Board Member at Longeveron.

Established under the 21st Century Cures Act, RMAT designation is a dedicated program designed to expedite the drug development and review processes for promising pipeline regenerative medicine products, including cell therapies. A regenerative medicine therapy is eligible for RMAT designation if it is intended to treat, modify, reverse or cure a serious or life-threatening disease or condition, and preliminary clinical evidence indicates that the drug or therapy has the potential to address unmet medical needs for such disease or condition. Similar to Breakthrough Therapy designation, RMAT designation provides the benefits of intensive FDA guidance on efficient drug development, including the ability for early interactions with FDA to discuss surrogate or intermediate endpoints, potential ways to support accelerated approval and satisfy post-approval requirements, and potential priority review of the biologics license application (BLA) if Priority Review designation is granted following BLA submission.

About Longeveron Inc.

Longeveron is a clinical stage biotechnology company developing regenerative medicines to address unmet medical needs. The Companys 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), Alzheimers Disease, and Aging-related Frailty. The Lomecel-BHLHS program has received three separate and distinct FDA designations: Orphan Drug designation, Fast Track designation, and Rare Pediatric Disease designation. For more information, visit http://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 managements 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 potential for Lomecel-Bto be an effective treatment for Alzheimers Disease or achieve U.S. FDA approval as a Regenerative Medicine Advanced Therapy (RMAT). 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 allogeneic, cell-based therapies for Aging-related Frailty, Alzheimers 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 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 Companys results and forward-looking statements are disclosed in the Companys filings with the Securities and Exchange Commission, including Longeverons 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 Contact: Derek Cole Investor Relations Advisory Solutions derek.cole@iradvisory.com

Photos accompanying this announcement are available at

https://www.globenewswire.com/NewsRoom/AttachmentNg/cfb4911d-2b0b-4c52-b2fa-b6982947155d

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https://www.globenewswire.com/NewsRoom/AttachmentNg/f106bde7-972a-4687-a91e-03e924f409fc

Lomecel-B is a proprietary, scalable, allogeneic cellular investigational therapy developed by Longeveron for treating conditions like mild Alzheimers Disease.

The RMAT designation expedites the development and review process of Lomecel-B, providing benefits like FDA guidance and potential priority review, indicating its potential to address unmet medical needs in Alzheimers Disease.

The CLEAR MIND Phase 2a trial showed that Lomecel-B slowed/prevented the worsening of Alzheimers Disease compared to placebo, achieving primary safety and secondary efficacy endpoints.

Lomecel-B demonstrated in clinical trials the ability to slow or prevent the progression of Alzheimers Disease, suggesting it could be a viable therapeutic option for patients.

The full results of the CLEAR MIND Phase 2a trial will be presented at the Alzheimer's Association International Conference (AAIC) on July 28, 2024.

Read more here:
Longeveron Announces U.S. FDA Grants Lomecel-B Regenerative Medicine Advanced Therapy (RMAT) Designation for the Treatment of Mild Alzheimers Disease...

Empowering neonatal intensive care unit (NICU) teams and enhancing parent/caregiver engagement

The success of regenerative medicine trials for NEC hinges significantly on the empowerment of NICU teams and the active engagement of parents and caregivers.29 Comprehensive training for NICU team members that focuses on the informed consent process and includes a trauma-informed approach to addressing concerns of parents/caregivers is pivotal for trial success. Effective training strategies ensure that parents/caregivers are adequately informed and supported, thereby facilitating their engagement and mitigating follow-up losses. Many parents/caregivers learn about NEC after diagnosis. The overwhelming psychological burden may hinder their understanding of intervention benefits/risks, and active participation in the trial. Providing clear, accessible information about NEC, including risk factors and proposed interventions before diagnosis can foster informed decision-making. Technological tools (e.g. animated videos) can help to inform parents/caregivers about regenerative medicine interventions and trial procedures.31 We have partnered with the NEC Society, the only patient-led nonprofit organization working to advance research, advocacy, and education to improve treatment strategies and outcomes for the most vulnerable infants at risk for NEC. The perspectives and lived experiences of parents/caregivers affected by NEC significantly contribute to translational research trial design and improve consent processes.

Building upon the foundation of empowered NICU teams and engaged parents/caregivers, the next logical step is to address the recruitment challenges that frequently impede the progress of pediatric and neonatal trials, especially in NEC.32,33 Slow recruitment is a critical issue that can lead to early discontinuation of pediatric and neonatal trials. This is exacerbated by complicating factors such as rarity of the disease, restrictive eligibility criteria, concerns about stem cell interventions, inadequate risk/benefit assessment, limited partner engagement, and lack of institutional support.31 These factors are especially pertinent in NEC, an acute, rare, life-threatening condition affecting the most vulnerable patients. To navigate these challenges, a stepwise and evidence-based approach is essential. This approach relies on empirical evidence gathered at each of the steps below, which inform and refine the subsequent step(s):

Designing eligibility criteria, adverse events, and outcomes based on historical cohort studies such as the Canadian Neonatal Network34;

Conducting observational studies and trial feasibility studies to refine eligibility criteria, pre-specified adverse events, pilot patient and patient-family inclusion strategies, intervention delivery, and outcome measurements;

Developing protocols for phase I/II safety and feasibility interventional trials;

Developing protocols for phase II/III efficacy trials, which will evaluate the effectiveness of interventions.

Careful planning, resource allocation, and a methodological approach informed by empirical evidence is the key to addressing recruitment challenges, allowing advancement into the critical phases of trial development.

The large heterogeneity in outcome selection, measurement, and reporting in NEC trials hinders successful interpretation and implementation of findings. Following the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) Guidelines for Reporting Outcomes in Trial Protocols,35 outcomes should address five core elements: outcome domain (title or concept), measurement variable and tool, specific metric (unit of measurement), method of aggregation (procedure for estimating treatment effect), and time point of outcome data collection. A harmonized core outcome set for NEC treatment trials involving stem cell-based interventions considering the most relevant outcomes for clinicians, patients, and parents/caregivers is required to guide the development of evidence-based regenerative medicine interventions.

Early involvement of trial statisticians using modern frameworks can address challenges related to small sample sizes and heterogeneous patient populations, minimizing recruitment time and improving trial efficiency through adaptive trial designs and interim data analysis. Adaptive trial designs allow for preplanned modifications to the trial based on interim data analyses, including changes to sample size, treatment allocation, and even the inclusion/exclusion criteria. Techniques like Bayesian statistics36 and response-adaptive randomization37 incorporate prior and accumulating knowledge to adjust trial parameters dynamically, reducing the time required to get effective, safe combination therapies to the most vulnerable patients. Furthermore, adaptive trial designs offer a strategic advantage with the potential for substantial cost savings. The high cost of running trials, driven by the extensive time and resources needed for trial activation and to meet accrual targets, poses a significant barrier to their long-term feasibility and impacts the scope and scale of clinical research undertaken.38 The rarity of NEC necessitates the inclusion of multicenter trials to gather sufficient number of participants, further escalating costs. Moreover, the vulnerability of the patient population, predominantly premature infants, adds layers of complexity in trial design and implementation, requiring rigorous safety protocols and extended monitoring periods. Adaptive designs can mitigate these financial challenges by reducing unnecessary expenditure on ineffective treatments or overly large sample sizes.

The transition from methodologically robust trial designs to the clinical implementation of new treatments, once proven effective through high quality clinical trials, is often delayed or never occurs. This is due to various factors including intervention complexity. Important determinants of implementation include attitudes of medical staff and parents/caregivers towards stem cell-based interventions, and the impact of evidence from evaluative studies on decision-making. A hybrid effectiveness-implementation design could address the delay in implementation by assessing the intervention safety and effectiveness while also exploring implementation barriers.39 Empirically investigating these factors during the safety/efficacy trial phase, especially understanding parent attitudes towards interventions, could be a novel approach.

A multinational consortium is essential for incorporating diverse NEC patients and management practices and evaluating stem cell-based interventions. Our international NEC consortium involving 12 centers across Canada, US, UK, Netherlands, Sweden, and Spain,40 unifies resources, expertise, input from Partners, and patient populations for effective large-scale trial design, conduct, and analysis. The consortium standardizes trial procedures, raises NEC awareness, and advocates for policy and public support, fostering advancement in stem cell-based NEC interventions. Additionally, collaboration with the Neonatal Research Network (NRN), a network of neonatal intensive care units across the United States, will further enhance the capacity for rigorous patient evaluation. Leveraging the NRNs infrastructure and extensive experience in multi-center neonatal trials, including in NEC,41 in combination with the strength of our consortium, will accelerate the development and testing of innovative interventions.

In trials involving small, heterogeneous, and critically ill groups like neonates with NEC, assessing the generalizability of stem cell-based interventions is challenging. Innovative methods like risk and effect score analyses42 can address this by grouping patients based on predicted health outcomes or treatment effects, offering personalized treatment opportunities.43 This novel approach to treatment effect heterogeneity demands multidisciplinary expertise for effective implementation. This nuanced approach underscores the necessity for multidisciplinary expertise and collaboration in overcoming the inherent challenges of neonatal clinical trials, particularly in NEC.

A main task of the dedicated research consortium is the development of NEC-specific adverse event (AE) frameworks and safety endpoints across collaborating centers. These frameworks will categorize AEs by type and severity and link them to stem cell-based interventions, ensuring patient safety, accurate reporting, and effective safety monitoring. Instruments for grading of unexpected AEs44 are essential for quantifying the severity and impact of AEs with enhanced objectivity. A Delphi consensus approach can be employed to develop a comprehensive harmonized AE framework. The Delphi method is a structured communication technique, involving the systematic collection of expert opinions.45 This process involves iterative rounds of questionnaires sent to a panel of selected experts and patient-families. Feedback is aggregated and shared with the panel after each round, allowing for the refinement of opinions and convergence towards a consensus. By gathering insights from key trial Partners (Table1), including parents/caregivers, the Delphi method facilitates the creation of a harmonized AE framework most relevant to neonates with NEC in stem cell trials, enhancing the safety, efficacy, and transparency of interventions in this vulnerable population. Developing these frameworks in the early planning stages of phase I safety trials will allow for consistent safety assessment of these interventions in various trials and settings.

Following the establishment of frameworks to evaluate the safety of interventions, it is crucial to recognize that conducting neonatal stem cell-based intervention trials embodies significant ethical challenges, including minimizing risks and maximizing the value of knowledge gained. Key to both is rigorous preclinical evidence assessment and implementation of a robust consent process to avoid therapeutic misconception and misestimation by the parents/caregivers of these vulnerable, critically ill newborns.

Industry partners are crucial in selecting standardized, clinical-grade stem cell products for NEC treatment. They facilitate the evaluation of product quality standards, scale, costs, labeling, packaging, storage, timely distribution, and regulatory compliance. Furthermore, early involvement of industry partners facilitates the navigation of regulatory compliance with Good Manufacturing Practices.

Early health economic evaluation, which is underutilized in neonatology, is a tool to support product investment decision making, provide guidance in (economic) data collection and support prioritization of future research. Estimation of the economic burden of NEC, as the first step, could highlight its societal and healthcare impact, and guide policy makers in prioritizing treatments. Early engagement of health economics experts to ascertain financial viability is crucial to identify whether and under which conditions, once proven effective, stem cell-based therapies for NEC are economically viable and accessible.

View post:
Translating regenerative medicine therapies in neonatal necrotizing enterocolitis | Pediatric Research - Nature.com

image:

A safer regenerative medicine process that removes the risk of tumor formation.

Credit: Atsushi Intoh

Ikoma, Japan Pluripotent stem cells (PSCs) are a type of stem cells capable of developing into various cell types. Over the past few decades, scientists have been working towards the development of therapies using PSCs. Thanks to their unique ability to self-renew and differentiate (mature) into virtually any given type of tissue, PSCs could be used to repair organs that have been irreversibly damaged by age, trauma, or disease.

However, despite extensive efforts, regenerative therapies involving PSCs still have many hurdles to overcome. One being the formation of tumors (via the process of tumorigenesis) after the transplantation of PSCs. Once the PSCs differentiate into a specific type for stem cell therapy, there is a high probability of tumor formation after differentiated stem cells are introduced to the target organ. For the success of PSC-based therapies, the need of the hour is to minimize the risk of tumorigenesis by identifying potentially problematic cells in cultures, prior to transplantation.

Against this backdrop, a research team led by Atsushi Intoh and Akira Kurisaki from Nara Institute of Science and Technology, Japan, has recently achieved a breakthrough discovery regarding stem cell therapy and tumorigenesis. Our findings present advancements that could bridge the gap between stem cell research and clinical application, says Intoh, talking about the potential of their findings. Their study was published in Stem Cells Translational Medicine and focuses on a membrane protein called EPHA2, which was previously found to be elevated in PSCs prior to differentiation by the team.

Through several experiments involving both mouse and human stem cell cultures, the researchers gained insights into the role of EPHA2 in preserving the potency of PSCs to develop into several cell types. They found that EPHA2 in stem cells is co-expressed with OCT4a transcription factor protein which controls the expression of genes which are critically involved in the differentiation of embryonic stem cells. Interestingly, when the EPHA2 gene was knocked down from the cells, cultured stem cells spontaneously differentiated. These results suggest that EPHA2 plays a central role in keeping stem cells in an undifferentiated state.

The researchers thus theorized that EPHA2-expressing stem cells, which would fail to differentiate, might be responsible for tumorigenesis upon transplantation into the target organ.

To test this hypothesis, the researchers prepared PSC cultures and artificially induced their differentiation into liver cells. Using a magnetic antibody targeting EPHA2, they extracted EPHA2-positive cells from a group of cultures prior to transplantation into mice. Interestingly, the formation of tumors in mice receiving transplants from cultures from which EPHA2 had been removed was vastly suppressed.

Taken together, these results point to the importance of EPHA2 in emerging stem cell-based therapies. EPHA2 conclusively emerges as a potential marker for selecting undifferentiated stem cells, providing a valuable method to decrease tumorigenesis risks after stem cell transplantation in regenerative treatments, remarks Kurisaki.

Further in-depth studies on this protein may lead to the development of protocols that make PSCs safer to use. Luckily, however, these findings pave the way towards a future where we will be able to finally restore damaged organs and even overcome degenerative conditions.

###

Resource

Title: EPHA2 is a novel cell surface marker of OCT4-positive undifferentiated cells during the differentiation of mouse and human pluripotent stem cells.

Authors: Atsushi Intoh, Kanako Watanabe-Susaki, Taku Kato, Hibiki Kiritani, Akira Kurisaki

Journal: Stem Cells Translational Medicine

DOI: 10.1093/stcltm/szae036

Information about Laboratory for Stem Cell Technologies can be found at the following website: https://bsw3.naist.jp/eng/courses/courses215.html

About Nara Institute of Science and Technology (NAIST)

Established in 1991, Nara Institute of Science and Technology (NAIST) is a national university located in Kansai Science City, Japan. In 2018, NAIST underwent an organizational transformation to promote and continue interdisciplinary research in the fields of biological sciences, materials science, and information science. Known as one of the most prestigious research institutions in Japan, NAIST lays a strong emphasis on integrated research and collaborative co-creation with diverse stakeholders. NAIST envisions conducting cutting-edge research in frontier areas and training students to become tomorrow's leaders in science and technology.

Stem Cells Translational Medicine

Experimental study

Animals

EPHA2 is a novel cell surface marker of OCT4-positive undifferentiated cells during the differentiation of mouse and human pluripotent stem cells.

Disclaimer: AAAS and EurekAlert! are not responsible for the accuracy of news releases posted to EurekAlert! by contributing institutions or for the use of any information through the EurekAlert system.

Originally posted here:
Tackling the hurdle of tumor formation in stem cell therapies - EurekAlert

Dublin, June 03, 2024 (GLOBE NEWSWIRE) -- The "Global Biopreservation Market by Product (Media [Cryopreservation, Hypothermic]), Equipment (Freezers, Refrigerators, Incubators, Centrifuge, Accessories), Biospecimen (Tissues, Organs, Stem Cells), Application (Research, Therapeutic) - Forecast to 2029" report has been added to ResearchAndMarkets.com's offering.

The global Biopreservation market is projected to reach USD 7.1 billion by 2029 from USD 4.4 billion in 2024, at a CAGR of 9.8% during the forecast period. The growth of this market is majorly driven by rise in demand for preserving biological materials in healthcare, research, and industrial application, growing prevalence of chronic diseases, and technological advancements. However, technical challenges, quality control, energy consumption and environmental impact could restrain the growth of the Biopreservation market.

Biopreservation Media segment accounted for the highest market share in the Biopreservation market, by product, during the forecast period.

Based on product, the Biopreservation market is segmented into biopreservation media, biopreservation equipment, and accessories. The biopreservation media segment accounted for the largest market share in 2023. This is attributed to the growing advancements in biotechnology and pharmaceutical companies, rise in demand for regenerative medicine, globalization of clinical trials, and expansion of cell & gene therapies.

Human Tissue Samples accounted for the larger market share in the Biopreservation market, by biospecimen, during the forecast period.

The Biopreservation market is segmented into human tissue samples, organs, stem cells, and other biospecimens. The human tissue samples segment accounted for the largest market share in 2023. This can be attributed to the rise in expansion of biobanking initiatives, growth in personalized medicine, and growing investments in biomedical research.

Biobanks accounted for the highest CAGR during the forecast period.

Based on the end user, the Biopreservation market is segmented biobanks, gene banks, hospitals, and other end users such as research institutes and universities, pharmaceutical companies, and contract research organizations. The biobanks segment accounted for the largest share of the biopreservation market in 2023. Growth in clinical research & trials, increasing collaborative research initiatives, and rise in funding from the government are supporting the growth of this end-user segment.

The North America segment accounted for the highest market share in the Biopreservation market, by region, during the forecast period.

Based on the region, the Biopreservation market is divided into North America, Europe, the Asia Pacific, Latin America, the Middle East & Africa, and GCC. North America region accounted for the largest share of the global Biopreservation market in 2023. This large share of North America is due to the strong healthcare system, presence of leading biotech and pharmaceutical companies, and innovation in cryopreservation and cryobanking.

The report provides insights on the following:

Key Attributes:

Key Topics Covered:

Executive Summary

Premium Insights

Key Market Dynamics

Drivers

Restraints

Opportunities

Challenges

Companies Featured

For more information about this report visit https://www.researchandmarkets.com/r/sfoh9k

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Global Biopreservation Market Forecast Report 2024-2029: Advances in Biobanking and Growing Trend of Conserving ... - GlobeNewswire