SAN DIEGO, March 24, 2025 /PRNewswire/ -- Robbins LLP informs stockholders that a class action was filed on behalf of all persons and entities that purchased or otherwise acquired Sana Biotechnology, Inc. (NASDAQ: SANA) securities between March 17, 2023 and November 4, 2024. Sana is a biotechnology company that develops ex vivo and in vivo cell engineering programs to purportedly revolutionize treatment across a broad array of therapeutic areas with unmet treatment needs, including, inter alia, oncology, di ...

ATLANTA, March 24, 2025 (GLOBE NEWSWIRE) -- A shareholder class action lawsuit has been filed against Sana Biotechnology, Inc. (“Sana” or the “Company”) (NASDAQ: SANA). The lawsuit alleges that Defendants made false and/or misleading statements and/or failed to disclose material facts regarding Sana’s business, operations, and prospects, including allegations that: (i) Sana was at significant risk of having insufficient funds to maintain its current operations and advance one or more of its product candidat ...

Product Development and Clinical Trials - The company is developing UP421, a HIP-modified allogeneic primary islet cell product, which was transplanted into a patient with type 1 diabetes (T1D) in December 2024, with positive results showing survival and function of pancreatic beta cells at four weeks post-transplant [27]. - Approximately 9 million people suffer from T1D globally, and the company is developing SC451, a HIP-modified stem cell-derived pancreatic islet cell therapy, aiming for euglycemia without exogenous insulin injections or immunosuppression, with an IND filing expected as early as 2026 [28]. - The GLEAM study, a Phase 1 clinical trial for SC291, has received Fast Track designation from the FDA for relapsed/refractory systemic lupus erythematosus, indicating the potential for expedited development due to unmet medical needs [32]. - Preliminary twelve-week clinical results for UP421 showed that all primary and secondary endpoints were met, with no drug product-related adverse events reported, indicating a significant milestone in cell therapy [28]. - The company has three ongoing clinical trials targeting T1D, B cell mediated autoimmune diseases, and B cell malignancies, demonstrating a broad therapeutic focus [26]. - SC291, targeting B cell mediated autoimmune diseases, is currently in a Phase 1 dose escalation study, with data expected to be shared in 2025 [48]. - SC262, a hypoimmune-modified CD22-directed CAR T program, has received FDA clearance for a Phase 1 clinical study, with data anticipated in 2025 [50]. - The company received IND clearance for SC291, a CD19-directed allogeneic CAR T therapy, in November 2023, with data expected in 2025 [150]. - SC262, a CD22-directed allogeneic CAR T therapy, received IND clearance in January 2024, with data also expected in 2025 [150]. - The GLEAM trial is expected to report progress in 2025, evaluating SC291 for LN, ERL, and ANCA-associated vasculitis [173]. Technology and Innovation - The HIP technology allows for the engineering of allogeneic cells that can evade the immune system, which is crucial for the success of cell therapies [25]. - The company’s hypoimmune technology is designed to enable cells to evade immune detection, which is critical for the success of allogeneic therapies [47]. - The company’s ex vivo cell engineering platform aims to overcome challenges related to engraftment, function, persistence, and manufacturing of desired cells [53]. - The company is developing hypoimmune technology to enable allogeneic cell transplantation without the need for systemic immune suppression [67]. - Current clinical hypoimmune technology involves three gene modifications: disruption of MHC class I and II expression, and overexpression of CD47 [71]. - The hypoimmune technology seeks to address both adaptive and innate immune responses, enhancing the potential for successful allogeneic therapies [65]. - The fusosome technology enables targeted delivery of genetic payloads to specific T cell populations, achieving up to 20% gene delivery in CD8+ T cells at the highest dose level in non-human primate studies [204]. - The fusosome approach allows for in vivo generation of CAR T cells without the complexities and delays associated with ex vivo manufacturing, potentially improving efficacy and safety profiles [201]. - The company is focusing on selecting fusogens that the general population does not have pre-existing immunity to, reducing the risk of immunogenicity [190]. - The fusosome technology has shown the ability to deliver a variety of payloads, including DNA, RNA, and proteins, enhancing flexibility in genome modification [191]. Market Potential and Unmet Needs - The global diabetes population is estimated to be approximately 540 million, highlighting the significant market potential for innovative treatments [43]. - Current T1D treatments, primarily insulin injections, result in a life expectancy approximately 15 years shorter than those without diabetes, highlighting the unmet need for better therapies [114]. - B cell-mediated autoimmune diseases affect over 5 million patients in the U.S., highlighting a significant market opportunity [151]. - Approximately 20% of patients in large trials still experience severe disease flares despite treatment, indicating an unmet need in the market [156]. - Only about 50% of patients treated with approved CD19-directed CAR T therapy achieve a complete response, with one-third relapsing quickly [165]. Manufacturing and Scalability - The company is investing in scalable manufacturing capabilities, including a pilot manufacturing plant in South San Francisco and a long-term lease in Bothell, Washington [56]. - The company is investing in improving manufacturing scale, costs, consistency, and product quality through partnerships with contract development manufacturing organizations (CDMO) [199]. - The non-GMP pilot plant has a bioreactor scale of up to 200L, supporting process development and production for GLP toxicology studies [218]. - The company has established a long-term lease for a GMP manufacturing facility to support the production of allogeneic T cells [218]. - The company aims to enhance patient access to cell and gene therapies by improving manufacturing processes and product characterization [215]. Safety and Efficacy - Hypoimmune primary islets have demonstrated the ability to mediate insulin independence in diabetic NHPs without immunosuppression [73]. - Human hypoimmune cells transplanted into MHC mismatched humanized mice survived without eliciting an immune response, confirming their immune evasion capabilities [77]. - The administration of anti-CD47 antibody resulted in rapid clearance of hypoimmune NHP iPSCs, demonstrating a potential safety mechanism [104]. - In vitro studies showed that hypoimmune NHP iPSCs do not induce NK cell killing, but become susceptible when treated with anti-CD47 antibody [105]. - The preliminary clinical findings from the first-in-human transplantation of UP421 validate that HIP-modified islet cells can function without immunosuppression [101]. - Long-term blood glucose control was maintained for over 64 weeks following transplantation of HIP-modified PSC islet cells, with no observed tumor formation or histological abnormalities [136]. - Positive results from the IST at four weeks post-cell transplantation showed survival and function of pancreatic beta cells, indicated by circulating C-peptide levels [137]. - At twelve weeks, all primary and secondary endpoints were met, with no drug-related adverse events reported, demonstrating the safety of the UP421 transplant [137]. Intellectual Property and Competitive Landscape - As of January 2025, the company holds approximately 45 licensed or owned U.S. issued patents and 57 pending patent applications in the U.S. [221]. - The patent portfolio includes approximately 263 licensed patent applications pending in jurisdictions outside the U.S., primarily in Europe, Canada, China, Japan, and Australia [221]. - The company plans to rely on data exclusivity, market exclusivity, and patent term extensions to protect its proprietary technology [220]. - The expected expiration dates for patents range from 2028 to 2045, depending on the filing dates and regulatory extensions [222]. - The company recognizes the competitive landscape, noting that competitors may have greater financial resources and established marketing capabilities [219].

Sana Biotechnology Reports Fourth Quarter and Full Year 2024 Financial Results and Business Updates Announced positive preliminary 12-week clinical results, building on already released 4-week results, of ongoing type 1 diabetes study showing that hypoimmune-modified pancreatic islet cells transplanted without immunosuppression overcome autoimmune and allogeneic immune recognition, function, and persist with stable C-peptide production post-transplant Enrolling patients in the GLEAM trial for SC291 in B-cel ...

Announced positive preliminary 12-week clinical results, building on already released 4-week results, of ongoing type 1 diabetes study showing that hypoimmune-modified pancreatic islet cells transplanted without immunosuppression overcome autoimmune and allogeneic immune recognition, function, and persist with stable C-peptide production post-transplant Enrolling patients in the GLEAM trial for SC291 in B-cell mediated autoimmune diseases and VIVID trial for SC262 in relapsed/refractory B-cell malignancies; ...

Company Overview - Sana Biotechnology, Inc. focuses on creating and delivering engineered cells as medicines for patients, aiming to repair and control genes, replace missing or damaged cells, and make therapies broadly available [3] Upcoming Event - Sana will webcast its presentation at the Cowen 45 Annual Health Care Conference on March 3, 2025, at 3:10 p.m. ET, featuring a business overview and update by Steve Harr, the President and CEO [1][2] Accessibility of Information - The webcast will be accessible on the Investor Relations page of Sana's website, with a replay available for 30 days following the conference [2]

SEATTLE, Jan. 08, 2025 (GLOBE NEWSWIRE) -- Sana Biotechnology, Inc. (NASDAQ: SANA), a company focused on changing the possible for patients through engineered cells, today announced that it will webcast its presentation at the 43rd Annual J.P. Morgan Healthcare Conference at 9:00 a.m. PT on Wednesday, January 15, 2025. The presentation will feature a business overview and update by Steve Harr, Sana’s President and Chief Executive Officer. The webcast will be accessible on the Investor Relations page of Sana ...

Company Overview - Proactive is a financial news and online broadcast provider delivering fast, accessible, and actionable business and finance news to a global investment audience [1] - The company operates in key finance and investing hubs worldwide, including London, New York, Toronto, Vancouver, Sydney, and Perth [2] - Proactive specializes in medium and small-cap markets while also covering blue-chip companies, commodities, and broader investment stories [2] Industry Coverage - The company reports on a wide range of industries, including energy companies during global crises, aviation and airlines recovering from the pandemic, and economic, social, and governance issues [1] - Proactive delivers news and unique insights across various sectors, including biotech and pharma, mining and natural resources, battery metals, oil and gas, crypto, and emerging digital and EV technologies [3] Technology and Content Production - Proactive is a forward-looking technology adopter, equipping its human content creators with decades of expertise and experience [4] - The company uses automation and software tools, including generative AI, to assist and enhance workflows, but all content is ultimately edited and authored by humans [5] - Proactive follows best practices in content production and search engine optimization [5]

Investment Opportunities - The Haggerston BioHealth marketplace channel offers at least 4 exclusive stock tips weekly, focusing on Pharma, Biotech, and Healthcare sectors [1] - The channel provides access to investment bank-grade financial models, research, and a model portfolio for investors [1] Sana Biotechnology Overview - Sana Biotechnology, Inc (NASDAQ: SANA) completed one of the largest biotech IPOs in history in February 2024 [2] - The company is covered by Edmund Ingham, a biotech consultant with over 5 years of experience in biotech, healthcare, and pharma [2] Research and Analysis Services - Haggerston BioHealth offers detailed reports on over 1,000 companies, including product sales forecasts, integrated financial statements, discounted cash flow analysis, and market-by-market analysis [2] - The group provides catalysts, buy/sell ratings, and forecasts for major pharmaceutical companies, catering to both novice and experienced biotech investors [2]

On Tuesday, Sana Biotechnology Inc SANA released the initial results from a first-in-human study transplanting UP421, an allogeneic primary islet cell therapy engineered with Sana’s hypoimmune (HIP) technology, into a type 1 diabetes patient without the use of any immunosuppression.The study was conducted in partnership with Uppsala University Hospital.Results of the study at four weeks after cell transplantation demonstrate the survival and function of pancreatic beta cells as measured by the presence of c ...