Cell therapy weekly: RMAT for mantle cell lymphoma CAR-T therapy
This week: Two strategic partnerships have formed, both aimed at advancing CAR-T therapy delivery for relapsed/refractory blood cancers. Plus, the US Food and Drug Administration (MD, USA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation to a second-generation anti-CD19/4-1BB CAR-T therapy for relapsed/refractory mantle cell lymphoma.
The news highlights:
- Partnership advancing acute myeloid leukemia CAR-T therapy
- RMAT for relapsed/refractory mantle cell lymphoma CAR-T therapy
- Non-viral cell therapy manufacturing collaboration
Partnership advancing acute myeloid leukemia CAR-T therapy
Contract development and manufacturing organization (CDMO) Made Scientific (NJ, USA) has formed a strategic manufacturing partnership with clinical-stage biopharmaceutical company Hemogenyx Pharmaceuticals (London, UK). This collaboration will leverage Made Scientific’s specialized expertise in CAR-T cell therapy technology transfer, and manufacturing at its GMP facilities to support the advancement of HG-CT-1. HG-CT-1 is a CAR-T therapy and lead clinical program developed by Hemogenyx, designed for treating relapsed/refractory acute myeloid leukemia (AML) in adult patients.
“Partnering with a trusted CDMO like Made Scientific is essential to the success of HG-CT-1, our lead CAR-T therapy,” said Vladislav Sandler, CEO and co-founder of Hemogenyx Pharmaceuticals. “Made’s expertise in cell therapy manufacturing will be instrumental in driving the continued progress of this potential breakthrough therapy for patients with relapsed or refractory AML.”
Non-viral cell therapy manufacturing collaboration
Kytopen Corp. (MA, USA) and BlueWhale Bio (PA, USA) have partnered to develop a non-viral cell therapy manufacturing workflow aimed at accelerating the delivery of cell therapies to patients. The companies will streamline BlueWhale Bio’s Synecta™ cell-derived nanoparticles (CDNPs) with Kytopen’s Flowfect® continuous flow cellular engineering technology, which is capable of maximizing transfection efficiency, cell health and cell yield, while processing large quantities of engineer cells in minutes.
“We believe this partnership represents a pivotal step forward in personalized cell therapy – bringing us significantly closer to drastically reduced vein-to-vein times for lifesaving treatments,” expressed Kytopen’s Chief Commercial Officer Kevin Gutshall.
Synecta™ CDNPs is a technology that mimics natural T-cells and offers a scalable alternative to synthetic activators. This technology is being used to produce huCART19-IL18 cells, which are currently for patients with relapsed or refractory CD19+ cancers.
RMAT for relapsed/refractory mantle cell lymphoma CAR-T therapy
Galapagos NV’s (Mechelen, Belgium) anti-CD19/4-1BB CAR-T therapy, GLPG5101, has received FDA RMAT designation for the treatment of relapsed/refractory mantle cell lymphoma. Mantle cell lymphoma, a rare and aggressive subtype of non-Hodgkin lymphoma originating from B cells, has limited treatment options and reduce survival rates. GLPG5101 is currently being evaluated in a PHASE I/II trial, ATALANTA-1, for safety, efficacy and feasibility of decentralized manufactured GLPG5101.
“This designation reflects the promising clinical activity and safety profile observed in our ongoing Phase I/II study and supports our commitment to delivering an effective and timely treatment option to patients in need,” said Omotayo Fasan, Clinical Development Program Head at Galapagos. “With RMAT status allowing for closer collaboration with the FDA, this will enable additional opportunities for accelerated development and assessment timelines.”