NKure Therapeutics, a Bengaluru-based cell and gene therapy startup, has partnered with Swiss gene-editing pioneer CRISPR Therapeutics to co-develop and co-commercialize CTX112, a next-generation, off-the-shelf CAR-T therapy for oncology indications in India. The collaboration aims to address significant treatment gaps for patients with B-cell malignancies in the country.
The companies plan to seek approval from the Central Drugs Standard Control Organisation (CDSCO) by late June to conduct Phase II clinical trials in India. NKure CEO Lalit Pai indicated they would submit results from CRISPR's global Phase I trials and are currently identifying trial sites with plans to enroll approximately 25 participants.
Addressing a Critical Healthcare Need
B-cell malignancies, including diffuse large B-cell lymphoma (DLBCL) and other forms of non-Hodgkin's lymphoma, represent a substantial health challenge in India. Approximately 41,000 new cases of non-Hodgkin's lymphoma are diagnosed annually in the country, yet treatment options remain limited, particularly for patients with relapsed or treatment-resistant disease.
"India faces a pressing need for advanced yet affordable cancer treatments," said Lalit Pai, CEO of NKure Therapeutics. "This partnership represents a unique opportunity to introduce a next-generation CAR-T therapy that is both cost-effective and readily available, ensuring more patients can access life-saving treatments without long delays."
Innovative Allogeneic Approach
CTX112 represents a significant advancement over current autologous CAR-T therapies available in India. While existing treatments require extracting a patient's own T cells, re-engineering them over several weeks, and reinfusing them—a process that is both time-consuming and expensive—CTX112 takes a fundamentally different approach.
As an allogeneic therapy, CTX112 is derived from healthy donor cells that are gene-edited using CRISPR/Cas9 technology. This creates a "ready-to-use" product that can be manufactured at scale and delivered to patients without the lengthy personalization process required by autologous treatments.
The CRISPR/Cas9 gene-editing technology behind CTX112 makes specific modifications designed to enhance immune evasion, improve cell persistence, and reduce T-cell exhaustion—addressing key challenges with current CAR-T treatments. The therapy targets CD19, a protein expressed on the surface of B cells, for the treatment of relapsed or refractory B-cell malignancies.
Cost and Accessibility Advantages
One of the most significant potential benefits of this partnership is improved affordability and accessibility. Current autologous CAR-T therapies in India cost approximately ₹40 lakh (about $48,000) per dose—already just one-tenth of global prices but still prohibitively expensive for many patients.
According to Pai, the off-the-shelf nature of CTX112 could potentially reduce costs to one-third of current prices in India while eliminating the long manufacturing wait times associated with personalized therapies. Though a marketable product is estimated to be at least two years away, this approach could dramatically expand access to cutting-edge cell therapies.
Clinical Development Status
CTX112 is currently being evaluated in ongoing clinical trials for adult patients who have received at least two prior lines of therapy. The collaboration will leverage data from these global studies as it seeks regulatory approval in India.
Naimish Patel, Chief Medical Officer at CRISPR Therapeutics, emphasized the importance of the partnership: "We collaborate with NKure to expand the reach of CTX112 to India, where there is a clear need for new treatment options for patients with B-cell malignancies. This partnership underscores our commitment to advancing gene-based therapies and providing patients with access to potentially life-changing treatments worldwide."
Regulatory Pathway and Future Outlook
The companies are pursuing a streamlined path to regulatory approval in India, with NKure's local expertise expected to facilitate navigation of the country's healthcare system. If successful, this collaboration could establish a new paradigm for cell therapy development and commercialization in emerging markets.
While significant clinical and regulatory milestones remain ahead, the partnership represents an important step toward expanding access to advanced cell therapies in India and potentially creating a model for other regions where high costs and manufacturing complexities have limited the reach of cellular immunotherapies.
