CLBS-03

Pictured: 3D illustration of stem cells used for cell therapy iStock, Maksim Tkachenko An autologous and personalized regulatory T cell therapy is safe in patients with type 1 diabetes, but does not help preserve β-cell function. An investigational autologous regulatory T cell therapy being developed by Lisata Therapeutics and Sanford Health is safe and tolerable when used to treat children with type 1 diabetes, but fails to slow or alter disease progression, according to Phase II data published Wednesday in Science Translational Medicine . The mid-stage trial, called The Sanford Project T-Rex Study , enrolled 113 patients aged 8 to 17 years old who had recently been diagnosed with type 1 diabetes mellitus. Study participants were given a high or low dose of the cell therapy or a matching placebo. The goal of the study was to assess the tolerability of the investigational therapy and determine if it could alter disease course. Wednesday’s results, which come from 110 patients, show that the experimental cell therapy was safe. Participants in the high-dose group showed a transient activation of memory regulatory T cells one week after treatment, which suggests that the transfer of the infused cell therapy was effective. However, the treatment did not significantly influence C-peptide levels, a marker of pancreatic β-cell function that is indicative of insulin production. Both high and low doses failed to significantly preserve β-cell function, with p-values of 0.21 and 0.94, respectively. This lack of therapeutic effect was consistent through one year of follow-up and was not influenced by age or baseline C-peptide concentrations. “What is important is that it was demonstrated that this was safe,” Jay Skyler, deputy director at the University of Miami’s Diabetes Research Institute, told STAT News in an interview. The Institute was one of T-Rex’s study sites, but Skyler himself was not involved in the trial. Skyler was not surprised that the investigational cell therapy showed no significant effect on β-cell function, but told STAT that the study’s findings were nevertheless valuable. “It shows us that these cells can be expanded, that you can ship cells that you collect at clinical sites to a central facility and expand them, ship them back, they can be improved. And this can be done safely,” Skyler said. The investigational personalized autologous cell therapy, dubbed CLBS03, was initially developed by Caladrius Biosciences and consists mainly of the patient’s own regulatory T cells. After harvesting, these cells are allowed to expand in vitro and are functionally enhanced using a proprietary method, which in turn allows them to regulate effector T cells. This mechanism of action could prevent the self-targeting mechanism of these T cells, which destroy β-cells in type 1 diabetes, and restore immune balance. In 2022, Caladrius merged with Cend Therapeutics and called the resulting entity Lisata Therapeutics. Tristan Manalac is an independent science writer based in Metro Manila, Philippines. Reach out to him on LinkedIn or email him at tristan@tristanmanalac.com or tristan.manalac@biospace.com .

Summary Caladrius Biosciences Inc Caladrius, formerly NeoStem, Inc., develops and manufactures cell therapy products. Its products are based on its proprietary technologies, Dendritic CellTumor Cell technology; CD34 technology; and T Regulatory technology, for immunooncology, ischemic repair and immunomodulation. The company's developmental pipeline products include CLBS20 NBS20 for the treatment of metastatic melanoma, CLBS10 formerly NBS10 for STelevation myocardial infarction and CLBS03 for type 1 diabetes. It offers services such as product and process development, engineering and automation, GMP manufacturing, cell and tissue processing, storage and distribution, and expert consulting and regulatory support. The company offers products and services to biotechnology, pharmaceutical and medical product companies, and leading academic research institutions. Caladrius is headquartered in Basking Ridge, New Jersey, the US. Caladrius Biosciences Inc CLBS Pharmaceuticals Healthcare Deals and Alliances Profile provides you comprehensive data and trend analysis of the company's Mergers and Acquisitions MAs, partnerships and financings. The report provides detailed information on Mergers and Acquisitions, Equity/Debt Offerings, Private Equity, Venture Financing and Partnership transactions recorded by the company over a five year period. The report offers detailed comparative data on the number of deals and their value categorized into deal types, subsector and regions. GlobalData derived the data presented in this report from proprietary inhouse Pharma eTrack deals database, and primary and secondary research. Scope Financial Deals Analysis of the company's financial deals including Mergers and Acquisitions, Equity/Debt Offerings, Private Equity, Venture Financing and Partnerships. Deals by Year Chart and table displaying information encompassing the number of deals and value reported by the company by year, for a five year period. Deals by Type Chart and table depicting information including the number of deals and value reported by the company by type such as Mergers and Acquisitions, Equity/Debt Offering etc. Deals by Region Chart and table presenting information on the number of deals and value reported by the company by region, which includes North America, Europe, Asia Pacific, the Middle East and Africa and South and Central America. Deals by Subsector Chart and table showing information on the number of deals and value reported by the company, by subsector. Major Deals Information on the company's major financial deals. Each such deal has a brief summary, deal type, deal rationale; and deal financials and target Company's major public companies key financial metrics and ratios. Business Description A brief description of the company's operations. Key Employees A list of the key executives of the company. Important Locations and Subsidiaries A list and contact details of key centers of operation and subsidiaries of the company. Key Competitors A list of the key competitors of the company. Key Recent Developments A brief on recent news about the company. Reasons to Buy Get detailed information on the company's financial deals that enable you to understand the company's expansion/divestiture and fund requirements The profile enables you to analyze the company's financial deals by region, by year, by business segments and by type, for a five year period. Understand the company's business segments' expansion / divestiture strategy The profile presents deals from the company's core business segments' perspective to help you understand its corporate strategy. Access elaborate information on the company's recent financial deals that enable you to understand the key deals which have shaped the company Detailed information on major recent deals includes a summary of each deal, deal type, deal rationale, deal financials and Target Company's key financial metrics and ratios. Equip yourself with detailed information about the company's operations to identify potential customers and suppliers. The profile analyzes the company's business structure, locations and subsidiaries, key executives and key competitors. Stay uptodate on the major developments affecting the company Recent developments concerning the company presented in the profile help you track important events. Gain key insights into the company for academic or business research Key elements such as break up of deals into categories and information on detailed major deals are incorporated into the profile to assist your academic or business research needs. Note*: Some sections may be missing if data is unavailable for the company.