Immuneel Therapeutics presents early data from India for Varnimcabtagene autoleucel at ASH Annual Meeting 2022

Immuneel Therapeutics announced early results for Varnimcabtagene autoleucel (IMN-003A) from the Imagine study – India’s first phase-II and industry-sponsored trial for a novel autologous CD19-directed CAR-T cell therapy in patients with relapsed/refractory B-cell malignancies at the 64th American Society of Hematology Annual Meeting & Exposition (ASH) held at New Orleans, US, on 11th and 12th December.

The early results were reported from the first 10 patients of the planned 24 patients to be enrolled. Both adult and children with acute leukemia as well as lymphoma patients post-median two lines of treatment, including in post-transplant setting were enrolled. Eight per cent of patients experienced complete clinical response at day 28. At day 90, the results from Imagine showed an overall response rate of 77 per cent, with six out of nine evaluable patients demonstrating complete responses, a statement from Immuneel Therapeutics said.

It also said that day 28 and day 90 read-outs in the B Acute Lymphoblastic leukemia patients indicate 100 per cent and approximately 83 per cent MRD-negative complete remissions respectively, indicating rapid, deep and sustained responses. The median time to manufacture and release Varnimcabtagene was 12 days, with 100 per cent manufacturing success. The peak expansion of Varnimcabtagene was 10 days and the CAR-T cells persisted beyond 28 days in this early data read-out.

The data set for safety in Imagine was favourable, without severe neurotoxicity and comparable to the cumulative safety data-set for Varnimcabtagene, that now includes 125 patients in Spain and India. Only one subject developed ≥ grade-three cytokine release syndrome. There were no unexpected serious adverse events, the statement notified.

It further mentioned that with this early clinical data, Imagine has demonstrated early outcome for treatment with Varnimcabtagene autoleucel. The responses were fast, deep and sustained, with a favourable safety profile. Varnimcabtagene autoleucel offers a significant benefit over standard treatment options for patients in India for relapsed/refractory B-cell malignancies.

The trial is active and recruiting at multiple centres in India, the statement concluded.