Cell and gene therapy start-up NKure Therapeutics and international gene-editing company CRISPR Therapeutics have entered into a partnership to co-develop and co-commercialise CTX112 — a next-generation, off-the-shelf CAR-T therapy, for oncology indications in India.
NKure’s Chief Executive Officer Lalit Pai told businessline, they expect to seek the Central Drugs Standard Control Organisation (CDSCO’s) approval by later in June, to undertake Phase II clinical trials on the product. The company would submit results from CRISPR’s Phase I global trails, he said. Meanwhile, NKure has been looking for sites to conduct the trials in the country and expects to enrol about 25 people for the trial, he said.
The NKure-CRISPR product (CTX112) aims to be among the first off-the-block allogenic products — derived from healthy donor cells and gene-edited using Crispr/Cas9 technology, the companies said. At present, autologous CAR-T therapies have been launched in India — where a patient’s blood is taken, T cells separated, re-engineered over weeks and put back in the person to identify and destroy cancer cells.
The prospective CTX112 product is being evaluated to treat relapsed or refractory B-cell malignancies. (These are a type of white blood cell, critical to the body’s immune system.)
A ready-to-use, off-the-shelf product allows it to be manufactured at scale, the companies said. Though an actual marketable product is at least two years away — it could help make the products more affordable, Pai said, at least one-third of the present cost of the autologous CAR-T’s in India, selling at about ₹40 lakh a dose, which in turn is about one-tenth the global cost. Explaining the gene-editing technology behind the product, the companies said, “They improve treatment durability by enhancing immune evasion, improving cell persistence, and reducing exhaustion — key challenges with current CAR-T treatments.”
Ongoing clinical trials
CTX112 is currently being studied in ongoing clinical trials to evaluate its safety and efficacy in adult patients who have received at least two prior lines of therapy, they added.
CRISPR Therapeutics AG is headquartered in Switzerland, and its wholly-owned US subsidiary, CRISPR Therapeutics Inc, and research and development operations are based in Boston, Massachusetts and San Francisco, California.
According to a note from NKure, B-cell malignancies, such as diffuse large B-cell lymphoma (DLBCL) and other forms of non-Hodgkin’s lymphoma pose a significant health challenge in the country.
“Over 41,000 new cases of non-Hodgkin’s lymphoma are diagnosed annually in India, yet treatment options remain limited, particularly for patients with relapsed or treatment-resistant disease. Although the country has recently approved its first autologous CAR-T therapies, they remain costly and require complex, personalised manufacturing, resulting in long wait times,” the company said.
Published on May 7, 2025