Cell therapy weekly: Heart tissue regeneration cell therapy receives green light for Phase III trial
This week: The US Food and Drug Administration (FDA; MD, USA) approved an Investigational New Drug (IND) application for relapsed/refractory non-Hodgkin lymphoma, the China National Medical Products Administration (NMPA; Beijing, China) approved a CAR-T cell therapy for multiple myeloma and a heart regeneration cell therapy has had a positive FDA pre-IND meeting regarding a Phase III trial.
The news highlights:
- US FDA approves IND application for relapsed/refractory non-Hodgkin lymphoma
- NMPA approves CAR-T cell therapy for multiple myeloma
- Positive US FDA pre-IND meeting for heart regeneration therapy
US FDA approves IND application for relapsed/refractory non-Hodgkin lymphoma
The FDA has approved Galapagos’ (Belgium, Germany) IND application for ATALANTA-1, an open-label Phase I/II trial of GLPG5101 in patients with relapsed/refractory non-Hodgkin lymphoma.
Developed using Galapagos’ decentralized platform, GLPG5101 allows for rapid production and administration within 7 days. The ongoing Phase I/II ATALANTA-1 study in Europe is investigating the therapy’s safety, efficacy and feasibility, with Phase I determining the optimal dose and Phase II evaluating treatment response and survival. Early results were promising in patients with relapsed/refractory non-Hodgkin’s lymphoma, with each patient monitored for 24 months.
“We are dedicated to accelerating breakthrough innovation that extends the reach of cell therapies to patients with rapidly progressing cancers,” stated Paul Stoffels, CEO of Galapagos and Chairman of the Board of Directors. “Our innovative, decentralized manufacturing platform is designed to overcome many of the challenges faced by existing CAR-T production methods. The Galapagos platform has the potential for greater speed and scalability, with the delivery of fresh, fit cells with a median vein-to-vein time of 7 days, close to patients. The IND clearance for the Phase I/II study of GLPG5101 marks a significant milestone in our cell therapy clinical program, bringing us one step closer to offering our CD19 CAR-T cell therapy to patients in the US.”
China NMPA approves CAR-T cell therapy for multiple myeloma
Following positive results from the Phase II CARTIFAN-1 study, the China NMPA has approved ciltacabtagene autoleucel (cilta-cel), a B-cell maturation antigen-targeted therapy for patients with relapsed/refractory multiple myeloma.
Cilta-cel has been developed by Legend Biotech to bind to B-cell maturation antigen-expressing myeloma cells and induce activation and proliferation of T cells to eliminate tumors.
“The approval of cilta-cel in [the] China market marks a key milestone and will bring significant benefits to many patients. Moving forward, we will continue to pursue our goal of curing patients, expand our clinical research, and enhance the accessibility of this innovative product to benefit more patients,” said Yong Huang, CEO of Legend Biotech (NJ, USA).
Positive US FDA pre-IND meeting for heart regeneration therapy
Regenerative cell therapy company CellProthera (Mulhouse, France) has announced it has had a positive pre-IND meeting with the FDA regarding a Phase III international clinical trial to investigate ProtheraCytes®, an autologous cell therapy.
ProtheraCytes is designed to regenerate damaged heart tissue and improve outcomes for patients following a heart attack. The therapy will be evaluated in the US and Europe following successful Phase II trials in the UK and France. The anticipated trial will involve a larger patient group with 2 years of follow-up.
“With positive feedback from FDA regulators, we feel we are in a favorable position to launch a pivotal Phase III trial in the US after successful IND filing that will build on the results we have seen thus far,” said Matthieu de Kalbermatten, CEO of CellProthera. “This will run in parallel with our recently launched PERFECT study, which will provide additional long-term safety and efficacy data by following patients from our Phase II study over an additional 10 years.”
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