CAR-T Pipeline Insight, 2022

DelveInsight's CAR-T Pipeline Insights 2022 report provides comprehensive insights about 120+ companies and 460+ pipeline drugs in CAR-T pipeline landscape. It covers the pipeline drug profiles, including clinical and nonclinical stage products. It also covers the therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.

CAR-T: An Overview

CAR-T is a type of treatment in which a patient's T cells (a type of immune system cell) are changed in the laboratory so they will attack cancer cells. T cells are taken from a patient's blood. Then the gene for a special receptor that binds to a certain protein on the patient's cancer cells is added to the T cells in the laboratory. The special receptor is called a chimeric antigen receptor (CAR). Large numbers of the CAR T cells are grown in the laboratory and given to the patient by infusion. CAR T-cell therapy is used to treat certain blood cancers, and it is being studied in the treatment of other types of cancer. Also called chimeric antigen receptor T-cell therapy.

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CAR-T Pipeline Insights

CAR-T Pipeline Insight report by DelveInsight outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the CAR-T pipeline landscape is provided which includes the disease overview and CAR-T treatment guidelines. The assessment part of the report embraces, in depth CAR-T commercial assessment and clinical assessment of the pipeline products under development. In the report, detailed description of the drug is given which includes mechanism of action of the drug, clinical studies, NDA approvals (if any), and product development activities comprising the technology, CAR-T collaborations, licensing, mergers and acquisition, funding, designations and other product related details.

CAR-T Cells Advantages
• HLA (Human Leukocyte Antigen) independent antigen recognition
• Minimal risk of generating undesired autoimmunity or GvHD (Graft-versus-host disease)
• Significant quantities of tumor-specific T-cells are rapidly generated
• CARs active in both CD4 + and CD8 + T-cells
• Target antigens include proteins, carbohydrates, and glycolipids

Adverse Events with CAR T-cell Therapy
• Acute Infusion Reactions
• On-target Toxicities
• Organ-specific toxicities

Limitations of Existing Technologies for CAR T-Cells

Several limitations are being observed with the use of existing technologies for developing CAR T-cells. Thesetechnologies are used for developing CAR T-cells to target one protein present in tumor cells. Therefore, a new CAR T-cellis required to be developed for targeting another protein in tumor cells. Toxicity related to use of CAR T-cells areobserved. It is not possible to block the functioning of CAR T-cells after removal of tumor cells. Off-target toxicity is alsoobserved. Use of second-generation CAR-Cells has caused cytokine release syndrome. Therefore, researcher's aredeveloping an organic bi-specific adaptor molecule that has the potential to serve as a bridge between a CAR T-cell and acancer cell.

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CAR-T Emerging Drugs

JWCAR029: JW Therapeutics
JWCAR029 is a CAR-T cell product targeting CD19, which is intended to treat late-stage lymphoma and leukemia (Second-line therapy or greater). The molecule is in phase-II stage of development. Initially, JWCAR029 is being studied for the treatment of B-cell malignancies focusing on relapsed and refractory DCBCL. In June 2020, the National Medical Products Administration ("NMPA") accepted for review its NDA relating to relma-cel as a third-line treatment for DLBCL.

CT 103A: Innovent Biologics
CT103A is an innovative therapy co-developed by IASO BIO and Innovent. Previous studies indicate patients with relapsed/refractory multiple myeloma (RRMM) who received high-dose BCMA-targeting CAR-T cells may achieve better remission but have worse adverse events. Moreover, once the disease progresses again, the re-infusion of CAR-T cells is not effective. To solve this dilemma, CT103A has been developed, a lentiviral vector containing a CAR structure with a fully human scFv, CD8a hinger and transmembrane, 4-1BB co-stimulatory and CD3z activation domains. Based on strict selection and screening, utilizing a proprietary in-house optimization platform, the construct of the CT103A CAR-T is potent and persistent. According to the company's pipeline, the drug is currently in Phase III stage of clinical trial evaluation to treat multiple myeloma.

CEA CAR T: Sorrento Therapeutics
Sorrento Therapeutics through its wholly-owned subsidiary TNK Therapeutics is developing CEA CAR T. It is a CAR T-cells targeting carcinoembryonic antigen (CEA). The drug is in phase II/III stage of development.

Descartes-11: Cartesian TherapeuticsDescartes-011 are autologous CD8+ T-cells expressing an anti-BCMA chimeric antigen receptor. Descartes-11 is currently in phase II clinical trials to treat patients with multiple myeloma in an outpatient setting.

CTL119: Novartis
CTL119 (CD19 CAR) is a humanized CD19 CAR under development by Novartis in collaboration with the University of Pennsylvania and currently is in Phase II stage for the treatment of Acute Lymphoid Leukemia. CTL119 is produced with a patient's T-cells, some of which are removed and then reprogrammed in Penn's Clinical Cell and Vaccine Production Facility with a gene transfer technique designed to demonstrate the T cells to target and kill tumor cells. The engineered cells contain an antibody-like protein known as a CAR, which is designed to bind to CD19 protein on the surface of cancerous B cells. The modified "hunter" cells are then infused back into the patient's body, where they multiply and are believed to attack the cancer cells.

TT11: Tessa Therapeutics
Tessa Therapeutics is developing TT11 (CD30-CAR-Tcells) in phase II stage of clinical development for the treatment of Relapsed/Refractory Hodgkin Lymphoma. The immunotherapy is CD30 targeted CAR-T cell therapy.

CD19-targeted CAR-T cells: Sinobioway Cell Therapy
CD19-targeted CAR T-cells is under development by Sinobioway Cell Therapy Co., Ltd. The therapeutic candidate is in Phase II stage of development for the treatment of Recurrent or Refractory Diffuse Large B-cell Lymphoma and Recurrent or Refractory Acute Non-T Lymphocyte Leukemia. The therapeutic candidate targets CD-19.

MB-CART2019.1: Miltenyi Biomedicine
MB-CART2019.1 is an autologous pLTG1497-transduced CAR T-cells. Miltenyi Biomedicine is developing MB-CART2019.1 for the treatment of Diffuse Large B Cell Lymphoma and B-cell Non Hodgkin Lymphoma. Zamtocabtagene autoleucel is a proposed International Nonproprietary Name of MB-CART2019.1.

EPCAM-targeted CAR T-cells: Sinobioway Cell Therapy
EPCAM-targeted CAR T-cells is under development by Sinobioway Cell Therapy Co., Ltd. The therapeutic candidate is in Phase II stage of development for the treatment of Liver Cancer and Stomach Cancer. The therapeutic candidate targets Epithelial Cell Adhesion Molecule (EPCAM). It acts by inducing lysis of tumor cells expressing Epithelial Cell Adhesion Molecule (EPCAM).

CAR-T Pipeline Therapeutic Assessment
• Assessment by Product Type
• Assessment of CAR T-cell Therapy by Stage and Product Type
• Assessment by Route of Administration
• Assessment of CAR T-cell Therapy by Stage and Route of Administration
• Assessment by Targets
• Assessment of CAR T-cell Therapy by Stage and Targets

CAR-T Pipeline Companies
• Ziopharm Oncology Inc. and Intrexon
• Yake Biotechnology
• Xyphos Biosciences
• Xi'An Yufan Biotechnology
• Wuhan Sian Medical Technology
• Wuhan Bio-Raid Biotechnology
• Wugen
• WindMIL Therapeutics
• Wellington Zhaotai Therapies
• VorBio
• VCANBIO Cell & Gene Engineering Corporation, Ltd
• UWELL Biopharma
• Transgene, and several others

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Table of Content
1. Introduction
2. Executive Summary
3. CAR-T: Overview
4. Pipeline Therapeutics
5. Therapeutic Assessment
6. Late Stage Products (Preregistration)
7. JWCAR029: JW therapeutics
8. Mid Stage Products (Phase II)
9. Descartes-11: Cartesian Therapeutics
10. Early stage products (Phase I/II)
11. CSG-CD19: Carsgen therapeutics
12. Inactive Products
13. CAR-T Key Companies
14. CAR-T Key Products
15. CAR-T- Unmet Needs
16. CAR-T- Market Drivers and Barriers
17. CAR-T- Future Perspectives and Conclusion
18. CAR-T Analyst Views
19. CAR-T Key Companies
20. Appendix

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