FDA approves first cell therapy for solid tumors; Breakthrough in islet cell therapy for diabetes; FDA approval of AMTAGVY for melanoma; Advances in cell and gene therapy manufacturing; Collaboration in immuno-oncology therapeutics; Tau-targeting therapies for Alzheimer's disease
Successful insulin independence achieved in non-human primate with HIP modified islet cells, potentially eliminating insulin injections.
FDA approves AMTAGVY cellular therapy for metastatic melanoma, demonstrating high objective response rate and durable responses.
Deep dives
Potential Revolutionary Treatment for Type 1 Diabetes
Preclinical data showcases insulin independence in a diabetic non-human primate post-transplantation of HIP modified islet cells, without immunosuppression. The study by SANA Biotechnologies reveals effective endocrine function of the modified islets, potentially eliminating the need for insulin injections. The research sets a high immunological benchmark by achieving insulin independence and maintaining stable glucose levels in the recipient without any immune reactions. Clinical trials are awaited to further validate the safety and effectiveness of this transformative approach.
FDA Approval of AMTAGVY for Metastatic Melanoma
The US FDA has approved AMTAGVY, a cellular therapy for metastatic melanoma post-treatment with PD-1 blocking antibodies. This approval marks a milestone in T-cell immunotherapy, with a notable objective response rate among patients and continuing responses without tumor progression. Accelerated Approval allows early access to this promising therapy while further studies confirm its clinical benefits and efficacy in treating advanced solid tumors.
Innovative Approaches in Cell and Gene Therapy
MIP Discovery secures financing to enhance downstream processing of cell and gene therapies, focusing on non-biological affinity reagents. The novel technology aims to improve viral vector characterization and purification for cost-effective production of advanced therapies. Collaboration between Ziphos Biocciences and Kologna Therapeutics targets immuno-oncology therapeutics using Envivo Carti cell therapies, showing promising potential for universal off-the-shelf treatments in cancer patients.
The latest episode of the DDW Highlights podcast is now available to listen to below. DDW’s Megan Thomas narrates five key stories of the week to keep DDW subscribers up-to-date on the latest industry updates.
In a breakthrough for advanced therapies, this week saw the FDA approve the first ever cell therapy for solid tumour cancers, but there were other significant developments in the cell and gene therapy space.