DelveInsight’s, “CAR-T Pipeline Insights 2023” report provides comprehensive insights about 120+ companies and 460+ pipeline drugs in the 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.
In the CAR-T Pipeline 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.
Key Takeaways from the CAR-T Pipeline Report
- Over 120+ CAR T companies are evaluating 460+ CAR T-cell therapies in various stages of development, and their anticipated acceptance in the CAR T-cell therapy market would significantly increase market revenue.
- The leading CAR-T Pipeline Companies are working to develop drug candidates to improve CAR-T treatment landscape include 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, TrakCel, ToolGen, Tmunity Therapeutics, Timmune Biotech, TILT Biotherapeutics, Tianjin Mycure Medical Technology, The Beijing Pregene Science and Technology Company, Tessa Therapeutics Ltd., TC BioPharm, Targazyme, and others.
- Promising CAR-T Pipeline Therapies in various stages of development include Breyanzi, Kymriah, CT103A, CEA CAR-T, Descartes-11, CNCT19, CTL119, P-BCMA-101, CD19/CD20/CD22/CD30 CAR T-cell therapy, CD19-targeted CAR T-cells, EPCAM-targeted CAR-T cells, TT11, CD19+CD22 CAR-T cell sequential therapy, CART-19/22, MB-CART2019.1, JCAR017, AUTO4, AUTO3, IM19 CAR-T, CSG-CD19, CT053, Descartes-08, Orvacabtagene autoleucel, CAR-T CD30, PCAR-19B, BCMA CAR-T cells, CD123 CAR-T cells, CD19 CAR-T cells, ET140202, CIK-CAR.CD19, BG-T19, Autologous CD19-targeting CAR T cells (Senl-001), MB-102, Autologous CAR-T CD44v6 cell therapy, AU101, ATA2271, AU105, AUTO1, BPX-601, Anti-CD22 CAR, CAR-T cells targeting CD19 and CD22, huMNC2-CAR44 CAR T-cells, CD19-CART, ALLO-501A, AUTO1/22, ET 1402L1-CART, BPX-603, CAR-CD44v6, MB-106 (CD20 CAR), Anti-MUC1 CAR-T cells, PCAR-019, PBCAR0191, PBCAR20A, PBCAR269A, BCMA CAR T-cells, CAR19 CAR T cells, MG7-CART Cells, GPC3 – CART Cells, Anti-CD19 and Anti-CD20 CAR-T Cells, Humanized CD19 CAR-T cells, Dual Specificity CD19 and CD22 CAR-T Cell Immunotherapy, Mesothelin CAR-T cell therapy, and others.
- The CAR-T Companies and academics are working to assess challenges and seek opportunities that could influence CAR-T R&D. The CAR-T pipeline therapies under development are focused on novel approaches to treat/improve CAR-T.
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CAR-T 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).
Recent Developmental Activities in the CAR-T Treatment Landscape
- In May 2022, Novartis announced the US Food and Drug Administration (FDA) had granted accelerated approval for Kymriah (tisagenlecleucel) for the treatment of adult patients with relapsed or refractory (r/r) follicular lymphoma (FL) after two or more lines of systemic therapy. Kymriah is now FDA-approved in three indications and remains the only CAR-T cell therapy approved in both adult and pediatric settings.
- In April 2022, the FDA approved axicabtagene ciloleucel (brand name Yescarta) for adult patients with large B-cell lymphoma that is refractory to first-line chemoimmunotherapy or relapses within 12 months of first-line chemoimmunotherapy. It is not indicated for treating patients with primary central nervous system lymphoma.
- In March 2022, JW Therapeutics announced that it had received the Investigational New Drug (IND) clearance from the National Medical Products Administration (NMPA) of China for a pivotal clinical trial of its anti-CD19 autologous chimeric antigen receptor T (CAR-T) cell immunotherapy product Carteyva (relmacabtagene autoleucel injection) in the treatment of second-line large B-Cell lymphoma.
- In February 2022, Fully human anti-B-cell maturation antigen (BCMA) chimeric antigen receptor (CAR) T-cell therapy (CT103A) received orphan drug designation (ODD) from the FDA for the treatment of relapsed and/or refractory multiple myeloma (R/R MM), according to a press release by IASO Biotherapeutics.
- In June 2021, based on ZUMA-3 study data, the US FDA accepted the supplemental Biologics License Application (sBLA) and granted Priority Review designation for Tecartus for the treatment of adult patients with relapsed or refractory B-cell precursor ALL.
- In April 2021, the Janssen Pharmaceutical Companies of Johnson & Johnson announced that they had submitted a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) seeking approval of cilta-cel for the treatment of patients with relapsed and refractory multiple myeloma.
- In March 2021, the FDA approved Abecma (idecabtagene vicleucel), a cell-based CAR T – Cell Therapy to treat adult patients with multiple myeloma who have not responded to or whose disease has returned after at least four prior lines (different types) of therapy. Abecma is the first cell-based CAR T – Cell Therapy approved by the FDA for treating multiple myeloma.
For further information, refer to the detailed CAR-T Drugs Launch, CAR-T Developmental Activities, and CAR-T News, click here for CAR-T Ongoing Clinical Trial Analysis
CAR-T Emerging Drugs Profile
- 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 Therapeutics
Descartes-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 Therapeutics Assessment
There are approx. 120+ key companies which are developing the therapies for CAR-T. The CAR-T Companies which have their CAR-T drug candidates in the most advanced stage, i.e. Preregistration include, JW Therapeutics.
Find out more about the CAR-T Pipeline Segmentation, Therapeutics Assessment, and CAR-T Emerging Drugs @ CAR-T Treatment Landscape
Scope of the CAR-T Pipeline Report
- Coverage- Global
- CAR-T 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, TrakCel, ToolGen, Tmunity Therapeutics, Timmune Biotech, TILT Biotherapeutics, Tianjin Mycure Medical Technology, The Beijing Pregene Science and Technology Company, Tessa Therapeutics Ltd., TC BioPharm, Targazyme, and others.
- CAR-T Pipeline Therapies- Breyanzi, Kymriah, CT103A, CEA CAR-T, Descartes-11, CNCT19, CTL119, P-BCMA-101, CD19/CD20/CD22/CD30 CAR T-cell therapy, CD19-targeted CAR T-cells, EPCAM-targeted CAR-T cells, TT11, CD19+CD22 CAR-T cell sequential therapy, CART-19/22, MB-CART2019.1, JCAR017, AUTO4, AUTO3, IM19 CAR-T, CSG-CD19, CT053, Descartes-08, Orvacabtagene autoleucel, CAR-T CD30, PCAR-19B, BCMA CAR-T cells, CD123 CAR-T cells, CD19 CAR-T cells, ET140202, CIK-CAR.CD19, BG-T19, Autologous CD19-targeting CAR T cells (Senl-001), MB-102, Autologous CAR-T CD44v6 cell therapy, AU101, ATA2271, AU105, AUTO1, BPX-601, Anti-CD22 CAR, CAR-T cells targeting CD19 and CD22, huMNC2-CAR44 CAR T-cells, CD19-CART, ALLO-501A, AUTO1/22, ET 1402L1-CART, BPX-603, CAR-CD44v6, MB-106 (CD20 CAR), Anti-MUC1 CAR-T cells, PCAR-019, PBCAR0191, PBCAR20A, PBCAR269A, BCMA CAR T-cells, CAR19 CAR T cells, MG7-CART Cells, GPC3 – CART Cells, Anti-CD19 and Anti-CD20 CAR-T Cells, Humanized CD19 CAR-T cells, Dual Specificity CD19 and CD22 CAR-T Cell Immunotherapy, Mesothelin CAR-T cell therapy, and others.
- CAR-T Pipeline Segmentation: Product Type, Mechanism of Action, Route of Administration, Molecule Type
Dive deep into rich insights for drugs for CAR-T Pipeline Companies and Therapies, click here @ CAR-T Unmet Needs and Analyst Views
Table of Content
- Introduction
- CAR-T Executive Summary
- CAR-T: Overview
- CAR-T Pipeline Therapeutics
- CAR-T Therapeutic Assessment
- Late Stage Products (Preregistration)
- JWCAR029: JW therapeutics
- Drug profiles in the detailed report…..
- Mid Stage Products (Phase II)
- Descartes-11: Cartesian Therapeutics
- Drug profiles in the detailed report…..
- Early stage products (Phase I/II)
- CSG-CD19: Carsgen therapeutics
- Drug profiles in the detailed report…..
- Inactive Products
- CAR-T Key Companies
- CAR-T Key Products
- CAR-T- Unmet Needs
- CAR-T- Market Drivers and Barriers
- CAR-T- Future Perspectives and Conclusion
- CAR-T Analyst Views
- CAR-T Key Companies
- Appendix
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