The Switzerland headquartered pharma giant is presenting early clinical data from ongoing Phase I clinical trials with YTB323 (anti-CD19) and PHE885 (anti-BCMA), the first Novartis CAR-T cell therapies developed using this platform, at the 63rd American Society of Hematology Annual Meeting & Exposition (ASH) 2021.
The T-Charge platform, which was developed at the Novartis Institutes for BioMedical Research (NIBR), preserves T cell stemness, the ability to self-renew and mature, which results in a product containing greater proliferative potential and fewer exhausted T cells, reported Novartis, a pioneer in CAR-T cell therapies.
With T-Charge, CAR-T cell expansion occurs primarily in-vivo, within the patient’s body, eliminating the need for an extended culture time ex vivo, likely resulting, said the Basel based company, in better and more durable responses, improved long-term outcomes and a reduced risk of severe adverse events.
Initial efficacy data, continued Novartis, show a complete response rate of 73% at month three for the 15 patients with diffuse large B-cell lymphoma (DLBCL) who received dose level two of YTB323.
For the 11 patients with multiple myeloma who received the two highest doses of PHE885, the best overall response was 100%.
“With T-Charge, we aim to build on the vast knowledge gleaned from early investment in CAR-T research and trials. Our ambition now is to go beyond incremental advances, to further reimagine CAR-T cell therapy and give patients a higher likelihood of durable responses with the ultimate potential for a cure,” said Jay Bradner, NIBR president.
“We are encouraged by these promising early clinical data from the first CAR-T cell therapies produced using the T-Charge platform as we look to accelerate their development and delivery to patients,” he added.
The T-Charge platform, will also be rapid, compared with traditional CAR-T, and reliable, through simplified processes and streamlined quality control, claimed Novartis.