Core Insights - BioRestorative Therapies, Inc. presented promising preliminary data for its BRTX-100 therapy at the ISSCR 2025 Annual Meeting, showing over 50% improvement in pain and function for chronic lumbar disc disease (cLDD) patients [1][4][5] - The number of evaluated subjects in the ongoing Phase 2 clinical trial has more than doubled, indicating significant progress towards full enrollment [1][5] Clinical Trial Data - In the Phase 2 trial, 67.57% of subjects showed over 50% improvement in function (ODI) and 73.82% reported over 50% reduction in pain (VAS) at 12 weeks [4] - By 52 weeks, over 74% of subjects demonstrated over 50% improvement in function and over 72% reported significant pain reduction [5] - The trial aims to enroll up to 99 subjects across 16 U.S. sites, with a randomized, double-blinded, placebo-controlled design [6] Safety and Efficacy - No serious adverse events or dose-limiting toxicities were reported between 26 and 104 weeks at the target dose of 40 million cells, indicating an excellent safety profile [5] - Each new data analysis has shown an upward trend in efficacy markers, enhancing confidence in the therapy's potential to meet FDA thresholds for approval [5][4] Company Overview - BioRestorative focuses on developing stem cell-based therapies for serious musculoskeletal conditions, with BRTX-100 as its lead candidate for treating painful lumbosacral disc degeneration [7] - The company also has a metabolic program targeting obesity and metabolic disorders, and a commercial BioCosmeceutical platform aimed at aesthetic applications [8][9]

Data reported from the ongoing ATALANTA-1 Phase 1/2 study in a heavily pretreated relapsed refractory non-Hodgkin’s Lymphoma (R/R NHL) patient population demonstrate low rates of high-grade toxicities Of the 64 patients enrolled, 61 received treatment, resulting in a 5% attrition rate, significantly lower than industry benchmarks. 95% of patients were infused with fresh, stem-like early memory CD19 CAR-T cells, with 89% receiving treatment within 7 days, avoiding the need for cryopreservation and cytotoxic ...

LONDON, June 12, 2025 (GLOBE NEWSWIRE) -- Autolus Therapeutics plc (Nasdaq: AUTL), an early commercial-stage biopharmaceutical company developing, manufacturing and delivering next-generation programmed T cell therapies, today announces updated long term data (up to approximately three years of follow up) from the FELIX study of obecabtagene autoleucel (obe-cel) in adult patients with relapsed/refractory (r/r) B-cell acute lymphoblastic leukemia (B-ALL), to be presented in an oral presentation at the Europe ...

Iovance Biotherapeutics (IOVA) FY 2025 Conference June 11, 2025 01:20 PM ET Speaker0 Good afternoon everyone. Thanks so much for joining us. I'm really pleased to be joined by Brian Gasman, EVP of Medical Affairs, and Dan Kirby, CCO of Iovance. Thank you both for joining us. Speaker1 Thank you. Speaker0 Dan, maybe I can start with you here. Given Amtagni has been on the market now for over a year, what have been the biggest learnings from this launch? And what has been maybe easier in some ways, or what has ...

Core Viewpoint - MaxCyte and Ori Biotech have formed a strategic collaboration to enhance the efficiency, scalability, and productivity of cell therapy manufacturing by integrating their respective platforms, ExPERT™ and IRO® [1][4]. Group 1: Collaboration Details - The collaboration combines MaxCyte's ExPERT™ platform, known for its efficient transfection capabilities, with Ori's IRO platform, which automates cell therapy manufacturing [2][3]. - The initial evaluation will focus on optimizing the yield and manufacturing timelines of MaxCyte-engineered primary T cells using CD19 CAR expression via CRISPR knock-in [2][3]. Group 2: Technological Integration - MaxCyte's technology provides flexibility and efficiency in transfecting cells at a clinical scale, integrating well with various processes in cell therapy workflows [3]. - Ori's IRO platform enhances cell culture efficiency through automated fluid handling and customizable mixing, contributing to improved scalability [3]. Group 3: Leadership Insights - MaxCyte's CEO expressed excitement about the collaboration, emphasizing the commitment to improving manufacturing processes and accelerating the availability of cell therapies [4]. - Ori's CEO highlighted the partnership as a demonstration of their dedication to providing scalable solutions that address challenges in cell and gene therapy manufacturing [4]. Group 4: Industry Impact - The collaboration aims to enable therapy developers to adopt integrated solutions, thereby accelerating the transition from research to commercialization and increasing patient access to next-generation treatments [4].

CAMBRIDGE, Mass., June 10, 2025 (GLOBE NEWSWIRE) -- Ernexa Therapeutics (Nasdaq: ERNA), developing innovative cell therapies for the treatment of advanced cancer and autoimmune disease, today announced a reverse stock split of its issued and outstanding shares of common stock, par value $0.005 per share (the “Common Stock”), at a ratio of 1-for-15, effective June 12, 2025 at 12:01 a.m. Eastern Time. The Company’s Common Stock is expected to begin trading on a split-adjusted basis when the market opens on Ju ...

Mark J. Bachleda, PharmD, MBA appointed as independent member of the Board of DirectorsDavid Shook, MD appointed as Chief Medical Officer, Mark Meltz, JD as General Counsel and Corporate Secretary, and Jarrad Aguirre, MD, MBA as Senior Vice-President of Medical Affairs SOUTH SAN FRANCISCO, Calif., June 09, 2025 (GLOBE NEWSWIRE) -- Lyell Immunopharma, Inc. (Nasdaq: LYEL), a clinical-stage company advancing a pipeline of next-generation CAR T-cell therapies for patients with cancer, today announced the appoi ...

Core Insights - FibroBiologics has appointed Jason D. Davis as Chief Financial Officer, bringing over 20 years of experience in public company finance and capital markets to support the company's growth [1][2][3] Company Overview - FibroBiologics is a clinical-stage biotechnology company focused on developing therapeutics and potential cures for chronic diseases using fibroblasts and fibroblast-derived materials, holding over 275 patents issued and pending [1][7] - The company is advancing towards its Phase 1/2 clinical trial for diabetic foot ulcers scheduled for the second half of 2025 [2] Leadership and Experience - Jason D. Davis has a proven track record in leading companies through critical growth phases, including IPOs and capital raising initiatives, which is crucial for FibroBiologics as it moves its lead program into clinical trials [2][3] - Prior to joining FibroBiologics, Mr. Davis served as CFO of Virax Biolabs, where he successfully navigated the company through its IPO and managed multiple capital raises [4] Strategic Vision - Mr. Davis emphasized that FibroBiologics' fibroblast-based platform and strong intellectual property portfolio position the company as a high-growth, high-impact enterprise [4] - The company aims to deliver meaningful value not only for shareholders but also for patients globally [4]

– New blinded safety and efficacy data from 30 patients in ongoing Phase 2 trial to be unveiled June 13, 2025 – – ISSCR 2025 is the premier global event for stem cell research, drawing nearly 4,000 leaders from academia, biotech, and pharma – – BioRestorative to release new clinical data to the public prior to market open on June 13th – MELVILLE, N.Y., June 09, 2025 (GLOBE NEWSWIRE) -- BioRestorative Therapies, Inc. (“BioRestorative,” “BRTX” or the “Company”) (NASDAQ: BRTX), a clinical-stage regenerative me ...

2025 年 6 月 5 日，加州大学欧文分校的研究人员在 Cell 子刊 Cell Stem Cell 上发表了题为： Harnessing human iPSC-microglia for CNS-wide delivery of disease-modifying proteins 的研究论文。 该研究利用 CRISPR 基因编辑修饰的 人类诱导多能干细胞来源的小胶质细胞 （iMG） ，实现了 中枢神经系统 （SNS） 范围内的疾病修正蛋白递送，并验证了 撰文丨王聪 编辑丨王多鱼 排版丨水成文 血脑屏障 （Blood-Brain Barrier，BBB）， 是指脑毛细血管壁与神经胶质细胞形成的血浆与脑细胞之间的屏障，和由脉络丛形成的血浆和脑脊液之间的屏障，仅 允许特定类型的分子从血流进入大脑神经元和其他周围细胞。 血脑屏障的存在，对于阻止有害物质由血液进入大脑具有重要意义，但这也同时阻止了绝大部分小分子和大分子药物 （例如多肽，蛋白质和核酸） 的转移，严重 限制了中枢神经系统疾病 （例如神经退行性疾病、脑肿瘤，脑部感染和中风等） 的治疗。 尽管该领域近年来取得了一些进展，但我们仍然迫切需要能够跨越血脑屏 ...