BrightPath Bio and Cellistic have entered into a process development and manufacturing agreement to advance BrightPath's allogeneic CAR-T cell therapy platform into clinical trials. The partnership aims to leverage Cellistic’s 3D bioreactor-based manufacturing platform, Echo, to produce induced pluripotent stem cell (iPSC)-derived B-cell maturation antigen (BCMA)-targeting CAR-natural killer T (NKT) cells for Phase I trials of multiple myeloma.
Advancing CAR-T Therapy with iPSC-Derived NKT Cells
The collaboration is designed to enable BrightPath to utilize Cellistic’s development and manufacturing capabilities, potentially accelerating the development of its BCMA CAR-NKT product. Both companies have expressed their commitment to advancing healthcare solutions that improve patient outcomes. BrightPath is focused on developing cancer immunotherapies for refractory or progressive cancers that are unresponsive to standard therapies.
Ken Nagai, CEO of BrightPath, stated, "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-tumour 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."
Overcoming Manufacturing Challenges with iPSC Technology
Nagai further noted the challenges in manufacturing such therapies at scale: "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."
Cellistic's Role in Streamlining Production
Cellistic, with its expertise in iPSC reprogramming, gene editing with STAR-CRISPR technology, and differentiation development, is positioned as a preferred partner for cell therapy developers aiming to enter clinical stages. The company’s Pulse and Echo Platform is at the forefront of the process development and manufacturing of immune cell therapies.
Gustavo Mahler, CEO of Cellistic, commented, "We are excited to partner with BrightPath in the development of their revolutionary iPSC-derived cell therapy. 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 collaboration signifies a step forward in the pursuit of effective cell therapies, with both companies dedicated to advancing healthcare solutions that improve patient outcomes for those with difficult-to-treat cancers.
