Immuneel Therapeutics has achieved a landmark milestone in Indian oncology with seven patients treated with the country's first indigenous CAR-T cell therapy maintaining progression-free survival for over two years. The breakthrough represents India's first known long-term remission using homegrown CAR-T technology for aggressive blood cancers.
Clinical Trial Results Demonstrate Durable Efficacy
The IMAGINE Phase 2 trial evaluated Varnimcabtagene autoleucel (IMN-003A) in adult patients with relapsed or refractory CD19-positive B-cell Non-Hodgkin Lymphoma (B-NHL), one of the most aggressive blood cancers with limited response to standard treatments. Seven trial participants treated in 2022 have now surpassed the two-year progression-free survival milestone without disease progression.
The therapy demonstrated robust clinical outcomes with an 83% overall response rate at Day 90, maintaining a 50% overall response rate at Day 365. Complete response was achieved in 83% of patients, establishing new benchmarks for Indian CAR-T trials. Notably, trial results showed no cases of severe neurotoxicity or requirements for intensive care admission, indicating a favorable safety profile.
National Scale-Up Demonstrates Consistent Outcomes
The success has expanded beyond the initial trial cohort, with more than 50 patients across leading hospitals now treated with consistent outcomes. The multi-center trial was conducted at Narayana Health–Mazumdar Shaw Medical Centre in Bengaluru, Apollo Cancer Centre in Chennai, and the Postgraduate Institute of Medical Education and Research in Chandigarh.
"This achievement validates our mission to make world-class cancer therapies accessible and affordable. Long-term survivors from a Made-in-India CAR T therapy prove the transformative power of local innovation," said Kiran Mazumdar-Shaw, Co-Founder & Board Director of Immuneel Therapeutics.
Government Support Enables Indigenous Innovation
The development received significant government backing through a BIRAC grant under the Department of Biotechnology's BIPP scheme, reflecting strong national endorsement for indigenous therapeutic development. This support has been crucial in demonstrating that advanced, next-generation treatments can be developed and scaled within India while achieving globally comparable outcomes.
Amit Mookim, CEO & Board Director of Immuneel Therapeutics, emphasized the broader implications: "Crossing the two-year survival milestone highlights India's capability to deliver durable, next-generation treatments. Our priority remains expanding access and impact."
Addressing Treatment Accessibility Challenges
CAR-T cell therapy has been globally recognized as a game-changer in cancer treatment but has remained largely inaccessible to Indian patients due to high costs and complex logistics. Immuneel's indigenous development addresses these barriers by creating locally manufactured therapy that maintains international efficacy standards.
The achievement marks a significant step toward making advanced cancer immunotherapies available domestically, potentially transforming treatment options for patients with aggressive blood cancers who previously had limited therapeutic alternatives.