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Immuneel Therapeutics (Immuneel), India’s leading clinical stage cell and gene therapy start-up, today announced early results for Varnimcabtagene autoleucel (IMN-003A) from the IMAGINE study—India’s first phase 2 and industry-sponsored trial for a novel autologous CD19 directed CAR-T cell therapy in patients with relapsed/refractory B cell malignancies.
The early results reported findings 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 2 lines of treatment including in post-transplant setting, were enrolled. 80% of patients experienced complete clinical response at day 28. At day 90, the results from IMAGINE showed an overall response rate of 77%, with six out of nine evaluable patients demonstrating complete responses.
Day 28 and day 90 read-outs in the B Acute Lymphoblastic Leukaemia patients indicate 100% and ~83% MRD-negative complete remissions respectively, indicating rapid, deep and sustained responses. The median time to manufacture and release Varnimcabtagene was 12 days, with 100% 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 3 cytokine release syndrome. There were no unexpected serious adverse events.
With this early clinical data, IMAGINE has demonstrated excellent 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 centers in India. These early results were presented on December 11-12, 2022 at the 64th American Society of Hematology Annual Meeting and Exposition (ASH) held in New Orleans. The presented abstracts are available on the ASH website.
"At Immuneel, we believe that India could bring incredibly valuable clinical knowledge to advancing therapeutics," said Dr. Siddhartha Mukherjee, Co-founder and Director of Immuneel Therapeutics. "We are pleased to have presented the abstracts at this year’s ASH Annual Meeting 2022, which showcases data from India for Varnimcabtagene autoleucel indicating the therapy effectiveness. We look forward to sharing the full data at subsequent scientific conferences."
"IMAGINE is an exciting trial for us in India, and that builds onto the excellent global data-set for Varnimcabtagene autoleucel, especially including data both in first relapse and post-transplant setting," added Dr. Arun Anand, Director and Chief Operating Officer of Immuneel Therapeutics. "We are thrilled with the early data, and 70% Complete Response seen in this data-set, is on par with global benchmarks and transformative for Indian patients."
"Varnimcabtagene remains the only global CAR-T cell therapy undergoing advanced Phase-2 study in India in both adult and pediatric setting," said Dr. Sharat Damodar and Dr. Sunil Bhat, Co-Principal Investigators and Senior Hemato-Oncologists of Narayana Health. “With relapse rates of 30 to 40% in adult NHL and 40 to 50% in adult lymphatic leukemia with currently available treatment options in India, the availability of this therapy is transformative for patients in this country, with results which are very comparable to western data".
"Varnimcabtagene autoleucel (IMN-003A) has demonstrated early, deep and durable remission in children and adults with relapsed/refractory B cell malignancies," explained Dr. Anil Kamat, Head, Clinical Development, Immuneel Therapeutics. "IMAGINE is the first multi-center Phase 2 study in cell therapy space in India, and we continue to enroll patients on this trial. This therapy may become the new standard of care for cancer treatment."
About Immuneel Therapeutics
Immuneel is a pioneering clinical stage start-up company leading the change in cell and gene therapies and personalized immunotherapy for patients in India. Headquartered in Bengaluru, India, Immuneel is a research-led, fully integrated cell and gene therapies company committed to bringing affordable breakthrough cancer treatments to India and building a portfolio of next generation cell therapies. Additional information about Immuneel is available at www.immuneel.com.