Building on Biotech Heritage, Expanding into Defense and National Security Through Industrial Integrations of Privately Held Specialized Italian CompaniesATC - a Defense-Sector Company: First Industrial IntegrationPraexidia Foundation Joins as a Long-Term Strategic ShareholderCorporate Name Change to Saentra Forge S.p.A.Biotech Clinical Updates and Partnering StrategyCash, Cash Equivalents, and Marketable Securities of approx. $33 million MILAN and NEW YORK, Jan. 27, 2026 (GLOBE NEWSWIRE) -- In response to ...

2026 年 1 月 22 日， Cancer Cell 期刊背靠背发表了两篇 CAR-T 细胞疗法 研究论文，这两项研究均开 发了 表达 IL-12 的靶向 肿瘤相关巨噬细胞 （TAM） 的 CAR-T 细胞疗法 ，通过靶向清除免疫抑制性的 肿瘤相关巨噬细胞， 重塑肿瘤微环境并激发针对实体瘤的抗肿瘤免疫反应，展现了作为不依赖肿瘤抗原的 通用型抗实体瘤 CAR-T 细胞疗法的潜力。 装甲型巨噬细胞靶向的 CAR-T 细胞，重置并重编程肿瘤微环境，控制转移性癌症生长 该研究来自西奈山伊坎医学院， 论文题为： Armored macrophage-targeted CAR-T cells reset and reprogram the tumor microenvironment and control metastatic cancer growth 。 肿瘤相关巨噬细胞 （TAM） 通常表达 FOLR2 或 TREM2 ，其在 实体瘤 中富集，并使肿瘤微环境 （TME） 处于免疫抑制状态。 撰文丨王聪 编辑丨王多鱼 排版丨水成文 在这项研究中，研究团队开发了 表达白细胞介素-12 （IL-12） 的 CAR- ...

Summary of Legend Biotech Conference Call Company Overview - **Company**: Legend Biotech - **Industry**: Biotechnology, specifically focused on cell therapy - **Key Product**: Carvykti, a CAR-T therapy for multiple myeloma - **Market Position**: World's largest standalone cell therapy company, leading in CAR-T therapy for multiple myeloma [2][3] Core Points and Arguments Financial Performance - Carvykti generated approximately **$1.7 billion** in net trade sales over the last 12 months [3] - The company has a cash position of nearly **$1 billion** and has achieved positive operating profit for Carvykti in Q3 [4] - Legend anticipates achieving company-wide profitability in 2026, with Carvykti expected to generate over **$5 billion** in annual peak sales [5][8] Product Efficacy and Market Penetration - Carvykti has treated over **10,000 patients**, demonstrating a **97% manufacturing success rate** [6][8] - The therapy has shown a **median progression-free survival (PFS)** of nearly **35 months** in heavily pretreated patients [10] - In the CARTITUDE-4 trial, the median PFS has not yet been reached after nearly three years of follow-up [10][44] - Carvykti is the only CAR-T therapy to achieve a **five-year remission survival** in one-third of patients after a single infusion [9] Market Expansion and Strategy - The company is expanding its global presence, with **279 treatment sites** in **14 countries** [6] - A partnership with Johnson & Johnson (J&J) is aimed at maximizing Carvykti's potential, with a **50/50 cost-sharing and profit split** in the U.S. [8] - The company is focusing on community settings, where **70%** of relapsed and refractory multiple myeloma patients are treated [15] Clinical Trials and Future Directions - Ongoing trials (CARTITUDE-5 and CARTITUDE-6) are evaluating Carvykti in newly diagnosed patients, with the goal of addressing an additional **50,000 patients** annually [14] - The company is also exploring allogeneic therapies and in vivo CAR-T programs, with a focus on capital efficiency and rapid clinical proof of concept [21][23] Competitive Landscape - Despite competition in the multiple myeloma market, Legend emphasizes Carvykti's superior survival outcomes and unique one-time treatment benefits [30][37] - The current market penetration for BCMA-targeted therapies is low, with less than **10%** in fifth-line treatments and less than **5%** in second to fourth-line treatments, indicating significant growth potential [13][35] Additional Important Insights - The National Comprehensive Cancer Network (NCCN) has updated guidelines recommending Talvey as a bridging therapy to BCMA CAR-T therapy, which is expected to be adopted quickly [19] - The company has improved its manufacturing turnaround time to below **30 days**, supporting increased supply capacity [31] - The collaboration with J&J includes a **30/70** cost-sharing arrangement for the China market, where Legend leads [32] Conclusion Legend Biotech is positioned as a leader in the CAR-T therapy market for multiple myeloma, with strong financial performance, promising clinical outcomes, and a strategic focus on expanding its market presence and pipeline development. The company aims to leverage its successful R&D model to explore new therapeutic areas while maintaining profitability and enhancing patient outcomes.

Core Insights - Lineage Cell Therapeutics has received a novel induced pluripotent stem cell (iPSC) line with hypoimmunity edits from Factor Bioscience, marking a significant milestone in their strategic collaboration [1][2] - The new iPSC line is designed to support non-immune privileged and/or non-HLA matched indications, with specific genetic edits aimed at reducing immunogenicity and enhancing clinical differentiation [1][2] - Lineage plans to leverage this new technology to broaden its cell therapy platform and develop novel product candidates, particularly in the field of retinal cell transplantation [2] Company Overview - Lineage Cell Therapeutics is a clinical-stage biotechnology company focused on developing allogeneic cell therapies for serious medical conditions, utilizing a proprietary cell-based technology platform [3][4] - The company's pipeline includes several therapies, such as OpRegen for age-related macular degeneration, OPC1 for spinal cord injuries, and others targeting auditory neuropathy and Type 1 Diabetes [4] Collaboration Details - The partnership with Factor Bioscience aims to combine manufacturing capabilities with advanced cell engineering technologies to create superior product candidates [2] - The agreement allows Lineage to obtain an exclusive license for the novel gene-edited cell line for preclinical, clinical, and commercial purposes, contingent on further performance criteria and testing outcomes [1][2]

Core Insights - Link Cell Therapies has officially launched from stealth mode with a $60 million Series A financing round [1][2] Group 1: Financing Details - The Series A financing was led by Johnson & Johnson through its corporate venture capital organization, Johnson & Johnson Innovation - JJDC, Inc. [2] - Founding investors include Samsara BioCapital and Sheatree Capital, along with participation from Wing Venture Capital and other new strategic and financial investors [2]

Investment in the Company is subject to significant risks and should only be made after a careful review of the relevant documentation and following the consultation of a legal, tax or other adviser. Investing in the Company is speculative, not suitable for all investors, and intended only for investors who are able to bear the high economic risks of such investment, which can include, but are not limited to, loss of all or a substantial portion of your investment. Each prospective purchaser should carefull ...

Core Insights - Capricor Therapeutics, listed as CAPR, is focused on developing cell therapies for rare diseases, with a recent price target set at $48 by Industrial Alliance Securities, indicating a potential increase of about 72.72% from its current price of $27.79 [1][6] Company Performance - Capricor has achieved significant success in a late-stage study for its cell therapy targeting a heart condition associated with a rare muscular disorder, marking a major milestone after a previous setback with U.S. regulators [2] - The stock price of CAPR has surged by 336.48%, or $21.40, from previous levels, with a year-high of $40.37, reflecting strong investor interest and confidence [3][6] - The company's market capitalization is approximately $1.27 billion, indicating its growing presence in the biotechnology sector, with a trading volume of 48.52 million shares today [4] Future Outlook - The positive developments and outlook from Industrial Alliance Securities suggest a promising future for Capricor as it continues to advance its cell therapy programs, with investors closely monitoring its progress [5]

Summary of Sana Biotechnology FY Conference Call (December 03, 2025) Company Overview - **Company**: Sana Biotechnology (NasdaqGS:SANA) - **Focus**: Development of cell therapies, particularly in vivo CAR T and treatments for Type 1 diabetes Key Points Industry Context - The field of cell therapy, especially in vivo CAR T, is gaining traction with multiple companies entering the space [1][2] - Type 1 diabetes affects approximately 9 million people and is projected to grow to about 15 billion by 2040 [3] Core Product: SC451 - **Objective**: Aiming for a functional cure for Type 1 diabetes through gene-modified islet transplantation [2][6] - **Mechanism**: Gene-modified islets can function without immunosuppression, a significant advancement over traditional methods [5][6] - **Current Status**: IND (Investigational New Drug) application expected in 2026, with hopes to begin clinical studies [6][17] Clinical Insights - Previous studies have shown that gene-modified islets can survive and function without the need for insulin [6][8] - The goal is to achieve normal blood sugar levels and eliminate the need for insulin in patients [15][16] - Current data indicates that a dose of around 1 billion cells may be necessary for achieving euglycemia [15] Manufacturing and Regulatory Pathway - The company is in discussions with global regulators, including the FDA, to ensure compliance for human testing [16][23] - Challenges include ensuring genomic stability and product purity during the manufacturing process [20][21] - The company has made significant progress in developing a master cell bank for consistent product quality [22][23] Competitive Landscape - Other companies, such as Vertex, have reported success with stem cell-derived islet transplants, but often require immunosuppression [12][13] - Sana's approach aims to overcome the need for immunosuppression, potentially offering a more scalable solution [5][6] In Vivo CAR T Development - The in vivo CAR T program focuses on delivering a DNA plasmid specifically to T cells, enhancing manufacturability and safety [31][32] - The company has demonstrated effective B cell depletion in non-human primates, indicating potential for human application [34] Future Outlook - The company is optimistic about achieving breakthrough designation based on upcoming data [27][28] - Phase 1 trials are anticipated to involve 12-15 patients, with preparations underway for manufacturing [29] Additional Considerations - The company acknowledges potential challenges in scaling manufacturing and ensuring consistent cell viability post-transplant [19][24] - T cell fitness and individual patient immune responses may impact the effectiveness of CAR T therapies [36] Conclusion Sana Biotechnology is positioned at the forefront of innovative cell therapies, particularly for Type 1 diabetes and in vivo CAR T applications. The company is making strides in overcoming traditional challenges associated with immunosuppression and manufacturing, with a clear path toward clinical trials and potential market entry.

Summary of Century Therapeutics FY Conference Call Company Overview - **Company**: Century Therapeutics (NasdaqGS: IPSC) - **Focus**: Development of induced pluripotent stem cells (iPSCs) for CAR T cells and natural killer (NK) cells targeting autoimmune diseases and cancer [1][2] Key Developments - **CNTY813**: New program for iPSC-derived beta islet cells aimed at treating type 1 diabetes [1] - **CNTY308**: A CD19 CAR-iT cell therapy that is being developed for autoimmune diseases [1][19] Core Advantages of iPSC-Derived Therapies 1. **Engineerability**: Ability to harness synthetic biology for cell therapy [4] 2. **Characterization and Reproducibility**: High control over the differentiation process of iPSCs [4] 3. **Profitable Scalability**: Pathway to achieve antibody-like scale and cost efficiency [5] Alloevasion Technology - **Definition**: A set of genetic edits that allow iPSC-derived cells to coexist with the patient's immune system [6] - **Key Features**: - Removal of HLAs to prevent T cell engagement [7] - Introduction of a universal NK cell inhibitory ligand for protection against NK cells [8] - IgG degrading protease to mitigate antibody-mediated immunity [9][10] Clinical Development Plans - **CNTY813**: On track for IND-enabling stages by the end of 2025, with tumorigenicity studies underway [18] - **CNTY308**: Clinical trials planned to initiate next year, focusing primarily on autoimmune diseases [23][24] Market Opportunity - **Type 1 Diabetes**: Approximately 2 million patients in the U.S. and 9 million worldwide, presenting a significant unmet medical need [32] - **Autoimmune Diseases**: Over 50 million patients in the U.S., indicating a large potential market for CNTY308 [22] Partnerships and Future Plans - Continuous dialogue with pharmaceutical companies for potential partnerships, especially in Type 1 diabetes and autoimmune disease markets [31][32] - Exploration of regenerative medicine opportunities, including potential applications in Parkinson's disease and cardiac disease [36][38] Financial Position - **Cash Reserves**: Approximately $133 million, expected to fund operations into Q4 2027 [39] - **Upcoming Catalysts**: Clinical data generation for CNTY101 and CNTY308, and IND submission for type 1 diabetes expected in 2026 [39] Conclusion Century Therapeutics is positioned at the forefront of iPSC-derived cell therapies, with innovative approaches to address significant medical needs in autoimmune diseases and type 1 diabetes. The company's focus on Alloevasion technology and scalable manufacturing processes enhances its potential for success in the competitive biotech landscape.

Core Insights - The World Health Organization (WHO) has approved "olastrocel" as the International Non-Proprietary Name (INN) for the active cellular substance in CELZ-201, Creative Medical's lead allogeneic cell therapy [1][2][3] - This milestone enhances international clarity, strengthens regulatory positioning, and supports the advancement of olastrocel in large unmet-need global markets [1][3] Company Overview - Creative Medical Technology Holdings, Inc. is a clinical-stage biotechnology company focused on developing regenerative and immune cell therapies targeting unmet needs in various medical fields, including neurology, urology, orthopedics, and autoimmune diseases [5] - The company utilizes proprietary regenerative medicine platforms and a robust regulatory strategy to accelerate therapeutic innovation [5] Product Development - Olastrocel is an allogeneic, off-the-shelf cellular therapeutic candidate derived from perinatal tissue, developed under the AlloStem® platform [4] - The therapy is currently in clinical development for chronic lower back pain, degenerative disc disease, Type 1 diabetes (new-onset), and biodefense-related indications, representing multi-billion-dollar market opportunities [3][4][6] Strategic Importance - Securing the INN "olastrocel" is seen as foundational for global development, medical adoption, and long-term scalability, providing a cohesive scientific identity for the asset [3][4] - The approval is expected to improve efficiency in global submissions, labeling, and pharmacovigilance, offering a competitive advantage as the therapy progresses toward later-stage development [6]