BrightPath Bio (Tokyo Stock Exchange Growth 4594), a leader in iPS cell-derived Natural Killer T (NKT) cell therapy, and Cellistic, a pioneer in advanced iPS cell therapy manufacturing, have announced a new agreement focused on process development and manufacturing. The collaboration aims to advance BrightPath’s innovative allogeneic CAR-T cell therapy platform, which uses iPSC-derived NKT cells for upcoming clinical trials.
BrightPath Bio, a clinical-stage biopharmaceutical company specializing in novel cancer immunotherapies, and Cellistic, an industry leader in iPS cell-based immune cell therapy manufacturing, have announced a strategic collaboration to advance BrightPath’s iPSC-derived BCMA-targeting CAR-NKT cell therapy for a Phase 1 clinical trial in multiple myeloma. This partnership positions BrightPath as a pioneer in the emerging field of allogeneic CAR-T cell therapies.
As part of the agreement, Cellistic will utilize its state-of-the-art 3D bioreactor-based manufacturing platform, Echo, to enable GMP-compliant, clinical-scale production of iPSC-derived CAR-NKT cells. These cells will be used in BrightPath’s upcoming multiple myeloma trial, which is a key step in advancing the clinical potential of this innovative therapy.
Ken Nagai, CEO of BrightPath, highlighted the promising role of NKT cells as effectors in allogeneic CAR-T therapies. NKT cells offer both direct cytotoxicity and indirect anti-tumor activity by priming host CD8+ T cells. This mechanism is expected to help overcome immune rejection and enhance the durability of clinical responses. Despite the potential, large-scale manufacturing of these rare T cells has traditionally been a significant challenge, particularly in maintaining their functionality. However, the use of induced pluripotent stem (iPS) cells has now made large-scale production feasible.
Nagai noted that while BrightPath has successfully established a 2D culture-based manufacturing process, the company recognized the importance of scaling up for commercial production. To meet this demand, BrightPath sought a partner with expertise in scalable manufacturing solutions. Cellistic’s innovative 3D bioreactor platform was identified as the ideal solution, given its proven success in iPSC differentiation and the scaling up of various cell types.
“We are delighted to partner with Cellistic, which has the most experience in culturing iPS cells using 3D bioreactors,” said Nagai. “This collaboration allows us to leverage their cutting-edge development and manufacturing capabilities to accelerate the progress of our BCMA CAR-NKT cell therapy.”
Cellistic’s CEO, Gustavo Mahler, expressed excitement about the collaboration, noting that the Echo platform is specifically designed to address the unique challenges of cell therapy production. “Our platform ensures scalability, quality, and regulatory compliance,” Mahler said. “Together, we are poised to unlock the therapeutic potential of BCMA CAR-NKT cells and bring innovative solutions to patients in need.”
This agreement represents a significant advancement in the cell therapy field, with both companies committed to improving patient outcomes. The partnership will help bring cutting-edge immunotherapies to patients with refractory or progressive cancers, conditions that are difficult to treat with conventional therapies.
About BrightPath Biotherapeutics
BrightPath is a clinical-stage biopharmaceutical company focused on developing innovative cancer immunotherapies for refractory and progressive cancers. The company is actively advancing novel cell therapies and immunomodulatory antibodies through clinical trials.
About Cellistic
Cellistic specializes in process development and manufacturing of immune cell therapies based on human induced pluripotent stem cell (iPSC) technology. With expertise in iPSC reprogramming, gene editing with proprietary STAR-CRISPR™ technology, and differentiation development, Cellistic is a leading partner for advancing iPSC-based cell therapies to the clinic. The company’s Echo® platform is optimized for large-scale production, ensuring quality, scalability, and regulatory compliance.
