Bengaluru (Karnataka) [India], May 25: In a major milestone in Indian oncology care, Immuneel Therapeutics’ Made-In-India CAR T-cell therapy has delivered the country’s first known long-term remission in patients with aggressive blood cancers. Seven patients treated in 2022 have now surpassed two years of progression-free survival (PFS), a first for any made-in-India CAR T-cell therapy. This achievement reinforces the durability of Immuneel’s approach and its potential to transform outcomes for patients with aggressive blood cancers.
- Breakthrough data from Immuneel Therapeutics shows sustained remission in multiple patients treated with Varnimcabtagene autoleucel (IMN-003A)
- Seven patients surpassed two-year progression-free survival (PFS), a national first known for Indian CAR T therapy
- Benchmark response rates recorded with 83% ORR at Day 90 and 50% at Day 365
- Over 100 patients in the real world have been treated to date with improved outcomes and a favorable safety profile
The CAR T-cell therapy, known as Varnimcabtagene autoleucel (IMN-003A), under Immuneel’s IMAGINE Phase 2 clinical trial, aimed at treating adult patients with relapsed or refractory CD19- positive B-cell Non-Hodgkin Lymphoma (B-NHL), which is among the most aggressive forms of blood cancer, and many patients do not respond to standard therapies. In India, access to next-generation treatments like CAR T-cell therapy has been limited by cost and infrastructure, until now.
The encouraging results of the therapy recorded an 83% overall response rate (ORR) at Day 90 and a 50% ORR at Day 365, with a complete response rate of 83%, placing it among the highest reported outcomes in Indian clinical benchmarks for CAR T-cell therapies. The therapy has now been administered to more than 100 patients in India, marking Immuneel’s successful scale-up in delivering this complex therapy with consistent outcomes and a favorable safety profile. The data is backed up by 22+ presentations and publications at global platforms, along with an original article publication in Blood-Immunology & Cellular Therapy.
Ms. Kiran Mazumdar-Shaw, Board Director & Co-Founder, Immuneel Therapeutics, said, “Immuneel was founded with a clear mission to make advanced, life-saving cancer therapies accessible and affordable for patients in India. Seeing our Made-in-India CAR T therapy deliver durable remission outcomes across more than 100 patients, with several patients remaining in remission beyond two years, is a powerful validation of that mission. These encouraging long-term real-world outcomes demonstrate that innovation rooted in India can meet global benchmarks while addressing local healthcare needs at scale. As the clinical evidence continues to mature, Immuneel remains committed to strengthening India’s position in next-generation, transformative cancer therapies.”
Mr. Amit Mookim, Board Director & CEO, Immuneel Therapeutics, added, “This achievement is not just a clinical validation, but a strategic proof point of what’s possible when world-class science is built for India and beyond, in India. Crossing the two-year progression-free survival mark with multiple patients demonstrates that India can lead in delivering durable, next-generation therapies. At Immuneel, our focus remains on scaling access, deepening impact, and continuing to redefine what cancer care can look like for patients and families in India and beyond India.”
Globally, CAR T therapies are considered revolutionary but are often expensive and logistically challenging. Immuneel’s effort marks a turning point in making these advanced treatments accessible to Indian patients, particularly those who have exhausted other options.
Key Clinical Highlights:
- India’s Longest-Known CAR T Therapy Survivors: Seven patients enrolled in the Phase 2 IMAGINE trial have crossed the two-year PFS milestone, a first for any CAR T therapy in India, underscoring durable remission and the potential for improved long-term survival
- Strong and Sustained Response Rates: IMN-003A (clinical trial) showed an 83% ORR at Day 90, a 50% ORR at Day 365, and a Complete Response rate of 83%, setting new standards in treatment for relapsed/refractory CD19+ B-NHL
- 1000-Patients Milestone: Therapy has been successfully administered to more than 100 patients
post commercialization across leading Indian hospitals, demonstrating consistent clinical outcomes, favorable safety profile, and Immuneel’s ability to scale complex cell therapy delivery nationally
- Backed by DBT-BIRAC Grant: The IMAGINE Phase 2 trial was supported by BIRAC (Biotechnology Industry Research Assistance Council) under the Department of Biotechnology’s BIPP scheme, underscoring national recognition of its scientific merit
About the IMAGINE Study
The IMAGINE Phase 2 trial was launched in 2022 to evaluate the safety and efficacy of Varnimcabtagene autoleucel (IMN-003A) in relapsed and refractory CD19-positive B-cell malignancies.
Trial Details:
- Clinical Trial Registry Number: CTRI/2022/03/041162
- Study Sites (Original Trial)
- Narayana Health- Mazumdar Shaw Medical Center, Bangalore
- Apollo Cancer Center, Chennai
- PGIMER, Chandigarh Extended Trial Site
CMC Vellore
Rajiv Gandhi Cancer Institute, New Delhi
The study confirmed the therapy’s favorable safety profile with no severe neurotoxicity, and demonstrated durable responses with significant improvements in patients’ quality of life
About Immuneel Therapeutics (Immuneel)
Immuneel is a pioneering start-up company leading the change in cell & gene therapies and personalized immunotherapy for patients in India. Headquartered in Bengaluru, India – a research-led, fully integrated cell & gene therapies company committed to bringing breakthrough cancer treatments to India, affordably & build a portfolio of next-generation cell therapies.
Additional information about Immuneel is available at www.immuneel.com.
