Lok Sabha Question No. 3533 (UNSTARRED), answered on 2023-03-22
Subject: CAR-T Cell Therapy
Ministry: SCIENCE AND TECHNOLOGY
Asked by: Vishnu Dutt Sharma

## GOVERNMENT OF INDIA MINISTRY OF SCIENCE & TECHNOLOGY DEPARTMENT OF BIOTECHNOLOGY

## LOK SABHA UNSTARRED QUESTION Dy. No. 3533 TO BE ASNWERED ON 22.03.2023

## CAR-T Cell Therapy

## 3533. SHRI VISHNU DATT SHARMA:

Will the Minister of SCIENCE AND TECHNOLOGY िवǒानऔर ŮौȨोिगकी मंũी be pleased to state:

- (a) whether every year 13.9 lakhs new Cancer cases are registered in India and 8.5 lakh people died from Cancer each year, if so, the details thereof;
- (b) whether effectiveness of CAR-T Cell therapy in different types of cancer has been 80 to 90 percent, if so, the details thereof;
- (c) whether efforts are being made  by  the Government  for undertaking  and  promoting  research  and  development  of  CAR-T Cell  therapy  so  as  to  make  it  available  across  the  country  in affordable and cheaper way;
- (d) if so, the details thereof; and
- (e) if not, the reasons therefor?

## ANSWER

MINISTER OF STATE (I/C) FOR SCIENCE AND TECHNOLOGY AND EARTH SCIENCES

(DR. JITENDRA SINGH)

िवǒानऔर ŮौȨोिगकी तथा पृțी िवǒान क े  राǛमंũी ( ˢतंũ Ůभार ) ( डॉ . िजतŐū िसंह )

- (a) As  per  the  Indian  Council  of  Medical  Research's  Cancer Registry Data Report on 'National Cancer Registry Program

Report, 2020', the estimated number of incidence of cancer cases reported in the country during 2020 - 2022 and estimated mortality of cancer cases in India during (2020-2022) is given below.

| Estimated Incidence of cancer cases in India (2020-2022) - Both Sexes   |   Estimated Incidence of cancer cases in India (2020-2022) - Both Sexes |   Estimated Incidence of cancer cases in India (2020-2022) - Both Sexes |   Estimated Incidence of cancer cases in India (2020-2022) - Both Sexes |
|-------------------------------------------------------------------------|-------------------------------------------------------------------------|-------------------------------------------------------------------------|-------------------------------------------------------------------------|
| Year                                                                    |                                                                    2020 |                                                                    2021 |                                                                    2022 |
| Estimated Incidence of cancer Cases -(ICD10:C00-C97)                    |                                                                 1392179 |                                                                 1426447 |                                                                 1461427 |
| Estimated Mortality of cancer Cases -(ICD10:C00-C97)                    |                                                                  770230 |                                                                  789202 |                                                                  808558 |

- (b) Effectiveness of CAR T-cell therapy has been seen maximally in blood cancers- specifically Acute Lymphoblastic Leukemia, NonHodgkin Lymphoma and Multiple Myeloma.

In India, investigators from IIT-B & Tata Memorial Center, Mumbai worked  jointly  since  2015  to  develop  CAR  T-cell  therapy.    They successfully developed CD19-directed CAR T-cell therapy which is effective against a type of blood cancer called B Acute Lymphoblastic Leukemia (B- ALL), and B- Non Hodgkin Lymphoma (B-NHL).  The  therapy  underwent  extensive  testing  in  pre-clinical models and then was successfully manufactured in clinical grade manufacturing facilities. With these efforts they were able to get approval  of  all  relevant  Committees  and  finally  DCGI  approval  in March 2021 for conducting Phase 1 clinical trial at TMC on children and adolescents with B- ALL Adults with B-NHL. Patients included in these trials were those who's disease had relapsed and was not responding to any other known treatment. The Phase 1 trials are over  and  the  therapy  has  been  found  to  be  safe  and  effective matching  results  of  the  best  international  studies  and  data.  This therapy was thus successfully designed, developed and brought to trial  entirely  in  India  with  help  of  large  academic  grants  from Government agencies.

On basis of this, Phase 2 trial have been approved for both children and adults with B- ALL or B- NHL. These trials are being conducted at Tata Memorial Center and few other hospitals. The early work of

TMH  and  IIT-B  were  supported  by  grants  from  Tata  Trusts, Intramural  grants  from  TMC  and  IIT-B,  and  large  grant  by  DBTBIRAC National Biopharma Mission.  IIT- B Investigator has also set up  a  start-up  Company-  ImmunoACT  that  is  now  sponsoring  the Phase- 2 study in adults and will be ready to mass- manufacture it when it is approved.

(c) & (d)  Yes, Sir. The Department of Biotechnology is supporting research projects on CAR-T cell therapy for cancers such as B-cell Acute Lymphocytic Leukemia, Multiple Myeloma, Glioblastoma and Hepatocellular Carcinomas. Besides research projects, the Department  has  recently  recommended  for  the  establishment  of Virtual Network Centres (VNCs) for the Development of Genetically Engineered  'Off-the-shelf'  and  Inducible  CAR-T  Cells  for  Cancer Therapeutics, Network Centre for Research on Glioblastoma Stem cell-targeted T-Cell Immunotherapy using Non-Genetically Engineered Mesenchymal Stromal Cells, and Interdisciplinary Cancer Immunotherapy Network (CIN) for the Design and Development  of  Novel,  Indigenous,  Affordable  Cell  Therapy/Cell Based  Medicinal  Products  (CTMPs/CBMPs)  as  Immunotherapeutic Drugs for Cancers in India.

Biotechnology  Industry  Research  Assistance  Council  (BIRAC),  an industry-academia interface agency of Department of Biotechnology  (DBT),  Government  of  India,  has  supported  the following projects under its different schemes:

|   Sl. No. | Title of the Project                                                                                                                                        | Scheme                                                      |
|-----------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------|
|         1 | Chimeric Antigen Receptor CAR -T cells technology for cancer treatment: Development of a pre-clinical grade manufacturing process as per Industry standards | PACE (Promoting Academic Research Conversion to Enterprise) |

|   2. | Evaluation of Safety and Efficacy of CD19 CAR-T Cell Therapy IMN-003A in B Cell Malignancies                                | BIPP (Biotechnology Industry Partnership Programme)   |
|------|-----------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------|
|    3 | Indigenous Autologous anti CD- 19 CAR-T Cell therapy for CD-19 positive Acute Lymphoblast Leukemia ALL and B-Cell Lymphomas | NBM (National Biopharma Mission)                      |
|    4 | First-In-Human Clinical Trial using an indigenously developed CD-19 targeted CAR T-cells                                    | NBM (National Biopharma Mission)                      |
|    5 | First-in-India GMP-grade plasmid and viral vector manufacturing for CAR-T and other gene therapies                          | NBM (National Biopharma Mission)                      |

(e)Not Applicable

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