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From Patient to Warrior: The Journey of CAR-T Cells

CAR-T cell therapy is a revolutionary advancement in the field of cell and gene therapy. It empowers a patient’s own immune system to recognize and eliminate cancer cells with remarkable precision.

This therapy involves collecting a patient’s T cells from the blood and reprogramming them in the lab to express special molecules on their surface, chimeric antigen receptors (CARs). These receptors enable the modified T cells to detect and attack cancer cells when reintroduced into the patient’s body.

CAR-T cell therapy has delivered transformative outcomes for patients, particularly in blood cancers, and is being explored across a wide range of solid and hematological malignancies.

Smarter CAR-Construct & Design for Safer Treatment

At the heart of ImmunoACT’s innovation is a next-generation cell and gene therapy platform, purpose-built to deliver affordable efficacy without compromising safety. Our approach blends cutting-edge science with thoughtful design to make these therapies more accessible and tolerable. 

Our CAR-T constructs use fully humanized components, making them more “familiar” to the immune system. This reduces the risk of rejection, minimizes off-target toxicity, and improves patient experience by lowering the need for intensive supportive care.

Each CAR we design includes:

  • A single-chain variable fragment (scFv) tailored for precise tumor targeting
  • A flexible hinge (spacer) to enable optimal antigen engagement
  • A CD8α transmembrane domain for enhanced stability
  • A 4-1BB co-stimulatory domain to support T-cell survival and sustained action
  • A CD3ζ signaling domain to trigger strong and specific immune responses

Our clinical-stage CAR-T therapies integrate humanized sequences and undergo rigorous optimization to ensure potency, persistence, and safety. By reducing the likelihood of severe toxicities, we are not just improving patient safety, we are redefining how cell therapies can be delivered.

The gene sequence of the CAR construct is first integrated into a plasmid, which is then used to produce a lentiviral vector. This vector delivers the CAR gene into T cells, enabling them to recognize and attack cancer cells.

The Backbone of Breakthroughs: Our Plasmid DNA Platform

Our plasmid DNA platform is the foundation of our gene therapy manufacturing ecosystem, enabling scalable, consistent, and GMP-compliant production of high-purity plasmids, critical building blocks for advanced genetic therapies.

From vial thaw to final fill-finish, the platform is designed for reliability and efficiency at clinical and commercial scales. We manufacture:

  • Gene of Interest (GOI) plasmids, tailored for precise therapeutic payloads
  • Backbone plasmids, essential for packaging and expression within our Lentiviral Vector (LVV) platform

End-to-End Process Integration

Our platform seamlessly integrates upstream and downstream operations to ensure high yield, purity, and regulatory compliance:

  • Seed Expansion & Fermentation: High-density biomass generation for robust plasmid yield
  • Cell Lysis & Clarification: Efficient recovery of plasmid-rich lysate under controlled conditions
  • Chromatographic Purification: Advanced purification steps to meet stringent quality benchmarks
  • Sterile Filtration & Fill-Finish: Final processing under GMP conditions to ensure clinical-grade readiness

By combining process control, reproducibility, and scalable design, our plasmid DNA platform ensures a strong foundation for vector development, accelerating the delivery of safe and effective gene and cell therapies.

Lentiviral Vector Platform

Lentiviral Vector Platform

At the core of our CAR-T manufacturing process is ImmunoACT’s proprietary Lentiviral Vector (LVV) platform, designed to deliver genetic payloads with precision, safety, and consistency. This platform seamlessly integrates both the gene of interest (GOI), encoding the CAR construct, and essential backbone plasmids, all manufactured under fully GMP-compliant, tightly controlled conditions.

Key Capabilities of Our LVV Platform

  • End-to-End Manufacturing: From vial thaw to fill-finish
  • Scalable Cell Expansion: Utilizes adherent cell factories
  • Robust Purification Processes: Includes nuclease treatment, diafiltration, and chromatographic purification
  • Sterile Filtration & Fill-Finish: for clinical-grade readiness
1. Vial Thaw
Initiating process by thawing well characterized working cell bank
2. Seeding & Expansion
Culturing cells in flasks to begin biomass growth.
3. Scaled Expansion in Cell Factories
Large-scale adherent growth in multi-layer cell factories.
4. Nuclease Treatment
Breaking down residual host-cell nucleic acids post-harvest.
5. Harvest Clarification
Removing cell debris to isolate viral supernatant.
6. Concentration & Diafiltration
Filtering and concentrating the lentiviral vector product.
7. Chromatographic Purification
Removing cell debris to isolate viral supernatant.
8. Sterile Filtration
Ensuring the final vector product is free from microbial contamination.
9. Fill-Finish
Dispensing the purified vector into vials under aseptic conditions for clinical use.

Designed for Performance and Safety

Our Lentiviral Vectors are:

  • Replication-incompetent and non-pathogenic, ensuring safety in clinical use
  • Engineered for high transduction efficiency, achieving yields of ~1.2 × 10^10 TU per batch
  • Validated for consistency and safety, with stringent in-process controls across production runs

By seamlessly integrating our vector platform into the CAR-T manufacturing process, we enhance operational efficiency and clinical precision, yielding highly potent, target-specific T cells (NexCAR19) with reduced variability and consistently superior therapeutic outcomes.

Our Manufacturing Process

1. Leukapheresis

Peripheral Blood Mononuclear Cells (PBMCs) are collected from the patient using leukapheresis. This forms the foundational starting material for autologous CAR-T cell manufacturing.

2. Monocyte Depletion

Monocytes are removed from the PBMC population to reduce non-T-cell components.This enhances T-cell purity and improves the efficiency of downstream processes.

3. T-Cell Activation

T-lymphocytes are activated using CD3/CD28 costimulatory signals in a controlled environment. This primes the cells for efficient gene transfer during the transduction step.

4: Lentiviral Transduction

Activated T-cells are genetically modified with a lentiviral vector encoding the anti-CD19 CAR. This step equips T-cells to recognize and attack CD19-expressing tumor cells.

5: CAR-T Cell Production

Following transduction, T-cells begin expressing the chimeric antigen receptor on their surface. These cells are now classified as NexCAR19—genetically reprogrammed to target B-cell malignancies.

6: Expansion to Target Dose

The CAR-T cells are cultured under GMP conditions to reach the therapeutic dose. Cell growth is monitored to maintain viability, potency, and phenotype consistency.

7: Formulation & Cryopreservation

The final CAR-T product is formulated with infusion-ready buffer and cryopreserved. Post quality checks, it is stored under ultra-low temperatures until patient infusion.

CAR-T manufacturing process

NexCAR19™ has high manufacturing reproducibility & sustainability, with high transduction efficiency and no dose-limiting toxicities, and can be administered at high doses. NexCAR19™‘s vein-to-vein cycle is robust owing to a highly efficiency supply chain process for apheresis and infusion.

≥ 5×106

Dosage by body weight in CAR+ve cells/kg in a single infusion

~19 days

Average vein-tovein interval

~9 days

Average apheresis to manufacturing interval

~10 days

Average postinfusion hospitalization

120 days

Median postinfusion follow up (peak > 700 days)

98%

Manufacturing & Quality Success Rate

≥ 2×109

Absolute Lymphocyte Count for Manufacturing Success

> 30%

Transduction Efficiency > 30%

The Product Pipeline 

Discover our innovative pipeline of CAR-T cell therapies targeting both hematological cancers and solid tumors. With NexCAR19 leading our portfolio and multiple promising candidates in development, we’re advancing breakthrough treatments for patients worldwide.

Product Pipeline

Product Pipeline

Talicabtagene autoleucel (NexCAR19)

R/R-ALL, R/R-BCL

Target: CD19

Discovery Preclinical Clinical Commercial
2023
Currently available for ex-India out-licensing partnerships

HCAR2

Multiple Myeloma

Target: BCMA

Discovery Preclinical Clinical Commercial
2025

HCAR3

Glioblastoma multiforme, Neuroblastoma

Target: GD2

Discovery Preclinical Clinical Commercial
2027

HCAR4

Gastroesophageal Junction (GEJ) & Gastric Cancer

Target: Undisclosed

Discovery Preclinical Clinical Commercial
2028

Several other assets under discovery for the treatment of solid tumors and haematological malignancies

R/R: Relapsed Refractory
ALL: Acute Lymphoblastic Leukaemia
BCL: B-Cell Lymphoma
Product Pipeline

Product Pipeline

Talicabtagene autoleucel (NexCAR19)

R/R-ALL, R/R-BCL

Target: CD19

Discovery Preclinical Clinical Commercial
2023
Commercial
Currently available for ex-India out-licensing partnerships

HCAR2

Multiple Myeloma

Target: BCMA

Discovery Preclinical Clinical Commercial
2025
Clinical

HCAR3

Glioblastoma multiforme, Neuroblastoma

Target: GD2

Discovery Preclinical Clinical Commercial
2027
Discovery

HCAR4

Gastic Cancer and GEJ Cancer

Target: Undisclosed

Discovery Preclinical Clinical Commercial
2028
Discovery

Several other assets under discovery for the treatment of solid tumors and haematological malignancies

R/R: Relapsed Refractory
ALL: Acute Lymphoblastic Leukaemia
BCL: B-Cell Lymphoma

Publications

Read our publications, showcased in prestigious journals such as Molecular Cancer Therapeutics by AACR and Blood by the American Society of Haematology.

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  • Philanthropic initiatives to support global health equity.
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