BrightPath Biotherapeutics Co., Ltd.

DUBLIN--( BUSINESS WIRE )--The "CD39 Targeted Therapies Clinical Trials, Therapeutic Approaches & Market Opportunity Insight 2025" report has been added to ResearchAndMarkets.com's offering. CD39 targeting therapies are emerging as a promising strategy for modulating immune responses in a range of diseases. CD39 serves as a vital ectonucleotidase that influences the purinergic signaling pathway, thereby regulating the equilibrium between immune activation and suppression. By converting ATP into AMP, which is further transformed into adenosine by CD73, CD39 is instrumental in establishing an immunosuppressive microenvironment. This environment is particularly advantageous for tumors but also plays a role in chronic infections and autoimmune diseases. Inhibiting CD39 activity may restore immune functionality and enhance patient outcomes in these contexts. Report Highlights: First CD39 Targeted Therapy Approval Expected By 2029 CD39 Targeted Therapies In Clinical Trials: > 15 Therapies CD39 Inhibitors Clinical Trials Insight By Company, Country, Indication and Phase CD39 Targeted Therapy Research and Development Trends By Indication CD39 Targeted Therapies Proprietary Technologies Platforms By Company In the realm of oncology, the contribution of CD39 to immune suppression within the tumor microenvironment (TME) is well-established. Tumors frequently utilize the CD39-CD73-adenosine axis to evade immune surveillance, resulting in immune cell exhaustion and diminished anti-tumor responses. Elevated levels of CD39 on regulatory T cells (Tregs) and CD8+ T cells have been associated with unfavorable prognoses in various malignancies. By employing monoclonal antibodies that target CD39, such as IPH5201, it is possible to reactivate the immune system to more effectively combat tumor cells. IPH5201, which is being developed by Innate Pharma and AstraZeneca, is currently under investigation in conjunction with immune checkpoint inhibitors (ICIs) to enhance the immune response in patients with solid tumors. In addition to cancer, CD39-targeting therapies show considerable potential for addressing other diseases, particularly chronic viral infections, autoimmune disorders, and sepsis. In the context of chronic infections like HIV, tuberculosis, and Chagas disease, CD39 is implicated in immune exhaustion and suppression, which obstructs effective immune responses. By inhibiting CD39, there is a possibility of reversing immune dysfunction and improving the body's capacity to eliminate pathogens. In autoimmune disorders, where there is an overactivation of the immune system, the targeting of CD39 may aid in reestablishing equilibrium by enhancing the inhibitory function of regulatory T cells, which are vital for averting tissue damage. The therapeutic promise of targeting CD39 also encompasses sepsis, as CD39 expression on monocytes and macrophages is instrumental in regulating inflammation. In the context of sepsis, achieving a balanced immune response is crucial to mitigate tissue injury while effectively managing infection. By inhibiting the activity of CD39, therapeutic interventions could diminish excessive inflammation and restore immune homeostasis, presenting a novel strategy for addressing this critical condition. The clinical advancement of therapies aimed at CD39 is still in its nascent phase, with several candidates progressing through clinical trials, particularly in Phase 2. Among these, IPH5201 stands out as a leading candidate, demonstrating encouraging outcomes in both preclinical and early-phase clinical investigations. These antibodies are being assessed not only in oncology but also across a range of chronic conditions where CD39 plays a significant role in immune regulation. By focusing on CD39, these therapies seek to bolster immune responses in scenarios characterized by immune suppression or dysfunction. Looking forward, the potential uses of CD39-targeting therapies are extensive. The integration of anti-CD39 antibodies with other treatment modalities, such as immune checkpoint inhibitors or antiviral therapies, presents the opportunity for synergistic effects, thereby enhancing the immune response. Nonetheless, challenges persist, particularly concerning the context-dependent function of CD39 across various diseases and patient demographics. Achieving a precise balance between immune activation and suppression will be essential for the safe and effective implementation of these therapies. As clinical trials advance and additional data is collected, therapies targeting CD39 may emerge as a fundamental component of personalized medicine, effectively addressing various diseases through the precise and controlled modulation of immune responses. Key Topics Covered: Introduction To CD39 Targeting Therapies Role of CD39 & Emergence As Therapeutic Target Discovery of CD39 & Development Of Targeting Therapies CD39 Targeting Therapies Mechanism Of Action CD39 Inhibition CD39 Agonism Current CD39 Targeting Therapy Approaches Antibodies Nucleic Acid Therapeutics Small Molecule Inhibitors Global CD39 Targeted Therapies Clinical Trials Overview By Company By Indication By Country By Phase CD39 Targeted Therapies Clinical Trials Insight By Company, Country, Indication & Phase Research Preclinical Phase I Phase II Global CD39 Targeting Therapy Market Trends & Developments Current Market Outline Future Market Opportunities Role Of CD39 Targeting Therapies By Indication: Clinical Development & Collaborations Cancer Autoimmune & Inflammatory Diseases Cardiovascular Diseases Infections CD39 Targeted Therapies Technology Platforms OligoCreator & LNAplus Platforms - Secarna Pharmaceuticals Unnamed Platforms - Biotheus Unnamed Platform - Adimab OriAb Antibody Discovery Platform - Oricell Therapeutics TMAb Platform - Sensei Biotherapeutics Global CD39 Targeted Therapies Market Dynamics Market Drivers & Opportunities Market Challenges & Restraints Competitive Landscape Adimab Arcus Biosciences Biotheus BrightPath Biotherapeutics Elpiscience Biopharmaceuticals Innate Pharma Orega Biotech OriCell Therapeutics Secarna Pharmaceuticals Trishula Therapeutics For more information about this report visit https://www.researchandmarkets.com/r/pftdih About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. 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TOKYO & MONT-SAINT-GUIBERT, Belgium--( BUSINESS WIRE )--BrightPath Bio (Tokyo Stock Exchange Growth 4594, “BrightPath”), a pioneer in iPS cell-derived Natural Killer T (“NKT”) cell therapy, and Cellistic, a leader in advanced iPS cell therapy manufacturing, today announced a process development and manufacturing agreement to advance BrightPath’s novel allogeneic CAR-T cell therapy platform, utilizing iPSC-derived NKT cells for clinical trials. The strategic collaboration includes the use of Cellistic's innovative 3D bioreactor-based manufacturing platform, Echo, to enable GMP-compliant, clinical-scale manufacturing of iPSC-derived BCMA-targeting CAR-NKT cells for Phase 1 multiple myeloma trial; establishing BrightPath as a first mover in this emerging field. “The use of NKT cells as effectors in allogeneic CAR-T therapy represents a promising strategy, offering not only direct cytotoxicity but also indirect anti-tumor activity through the priming of host CD8 + T cells—a mechanism expected to evade host immune rejection and to enhance the durability of clinical responses. However, achieving clinical-scale manufacturing of such a rare subset of T cells while preserving their original functionality has conventionally been a significant challenge. Induced pluripotent stem (iPS) cell technology has overcome this barrier, making large-scale production feasible,” stated Ken Nagai, CEO of BrightPath. “While we have established a robust 2D culture-based manufacturing process, we have recognized the importance of anticipating the full scalability potential of the iPS cells from commercial perspective at an early stage. To address this need, we are committed to implement more scalable manufacturing solutions. Cellistic is well-positioned to meet this critical requirement with their unique 3D platform and extensive experiences in iPSC differentiation and scale-up of a variety of cell types,” Ken Nagai further noted. “We are delighted to partner with Cellistic, which has the most experience in culturing iPS cells using 3D bioreactors. This collaboration with Cellistic allows us to leverage their state-of-the-art development and manufacturing capabilities to accelerate the development of our BCMA CAR-NKT product.” “We are excited to partner with BrightPath in the development of their revolutionary iPSC derived cell therapy,” said Gustavo Mahler, CEO of Cellistic. “Our Echo manufacturing platform is designed to meet the unique challenges of cell therapy production, ensuring scalability, quality, and regulatory compliance. Together, we can advance the therapeutic potential of BCMA CAR-NKT cells and help BrightPath to bring innovative solutions to patients in need.” The agreement marks a significant step forward in the industry’s pursuit of innovative and effective cell therapies, with both companies committed to advancing healthcare solutions that improve patient outcomes. About BrightPath Biotherapeutics BrightPath is a clinical stage biopharmaceutical company focused on the development of novel cancer immuno-therapies to transform cancer treatment for refractory or progressive cancers that cannot be treated with conventional standard therapies. BrightPath is actively involved in developing cell therapies, currently in clinical trials, and immunomodulatory antibodies. For more information, visit www.brightpathbio.com/English About Cellistic Cellistic® specializes in process development and manufacture of immune cell therapies based on human induced pluripotent stem cell (iPSC) technology using their Pulse® and Echo® Platform. Its focus and expertise in iPSC reprogramming, gene editing using its proprietary STAR-CRISPR ™ technology and differentiation development, positions the company to be the partner of choice for innovative cell therapy developers to advance into clinic. Leveraging more than a decade of scientific and technical knowledge and experience, Cellistic possesses unique capabilities for the design and optimization of proprietary manufacturing platforms for iPSC- based cell therapies. For more information, visit www.cellistic.com .

BrightPath will receive rights to Artisan Bio’s STAR-CRISPR editing platform. Credit: Herney Gómez from Pixabay. BrightPath Biotherapeutics and Artisan Bio have signed a research and licensing agreement to expedite the former’s allogeneic next-generation invariant natural killer T (iNKT) cell therapies to clinic. BrightPath will obtain non-exclusive rights to the STAR-CRISPR editing platform of Artisan Bio for accelerating the development of BrightPath’s iNKT cells. BrightPath Biotherapeutics CEO Kenichi Nagai stated: “This collaboration with Artisan provides us with the potential to create highly engineered allogeneic iNKT cellular therapy programmes for a range of indications, including solid tumours. “Artisan’s STAR-CRISPR system, and their leading editing efficiencies in iPSC cells, will enable our iNKT cell therapies to solve the persistence and efficacy problems faced by first-generation allogeneic CAR-T programmes.” Artisan will receive an upfront payment and research milestone payments, along with licence fees and development milestones from BrightPath. The company will also receive net sales milestones and royalties on future products. Artisan Bio CEO Ryan Gill stated: “We are excited for the BrightPath collaboration and the development of highly engineered iPS cells for cell therapy. “The BrightPath products will build upon our leading STAR-CRISPR platform, our highly optimised guides for allogeneic and proprietary target genes, and our rigorous off-target safety profiling.” Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva. Editorial content is independently produced and follows the highest standards of journalistic integrity. Topic sponsors are not involved in the creation of editorial content. Free Whitepaper Optimise your cell therapy process: a guide to cell thawing Typically carried out at the point of care, errors in cell therapy thawing could compromise treatment efficacy, leading to significant patient impact as well as high costs and a compromised reputation for the product’s developer. This guide addresses how cell thawing has historically developed into the new techniques used today, along with the physical and biological implications of key metrics and components such as warming rate and ice structure. Also included are reviews of key studies from scientific literature and a consideration of the interactions between cooling and warming rates, as applicable to cell and gene therapies. By Cytiva Thematic By downloading this case study, you acknowledge that GlobalData may share your information with Cytiva Thematic and that your personal data will be used as described in their Privacy Policy