CAR-T Therapy - Pipeline Insight, 2024

This “CAR-T Therapy- Pipeline Insight, 2024” report provides comprehensive insights about 200+ companies and 252+ pipeline drugs in CAR-T Therapy 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.

Geography Covered

• Global coverage

CAR-T Therapy: Understanding

CAR-T Therapy: Overview

Chimeric Antigen Receptors (CARs), also known as chimeric immunoreceptors, chimeric T cell receptors or artificial T cell receptors - are receptor proteins that have been engineered to give T cells the new ability to target a specific antigen. The receptors are chimeric in that they combine both antigen-binding and T cell activating functions into a single receptor. CAR T-cells are the fusion proteins of a selected single-chain fragment variable from a specific monoclonal antibody and one or more T-cell receptor intracellular signaling domains. A CAR combines antigen-binding domains-most commonly, a single-chain variable fragment (scFv) derived from the variable domains of antibodies with the signalling domains of the TCR chain and additional costimulatory domains from receptors, such as CD28, OX40, and CD137.

CAR T cell therapy uses T cells engineered with CARs to treat cancer. The premise of CAR T immunotherapy is to modify T cells to recognize cancer cells in order to more effectively target and destroy them. Scientists harvest T cells from people, genetically alter them, and then infuse the resulting CAR T cells into patients to attack their tumors. Cancer Immunotherapy utilizes and enhances the immune system's standard capacity and is considered one of the most promising approaches for treating various diseases (including cancer, autoimmune diseases, and allergic-hypersensitivity reactions) are severe.

Adoptive T-cell transfer (ACT) is a new area of transfusion medicine that involves the infusion of lymphocytes to mediate antitumor, antiviral, or anti-inflammatory effects. Three forms of ACT are being developed for cancer therapy; these include tumor-infiltrating lymphocytes (TILs), T-cell receptor (TCR) T-cells, and CAR T-cells. Out of these three, CAR T-cells are the most developed ACTs. ACT was developed to treat advanced cancer with a patient's T-cells, and it has been established over many years through the ex vivo manipulation, expansion, and reinfusion of T-cells. A novel method for generating large numbers of autologous lymphoid cells capable of lysing Rosenberg first described new, noncultured, primary, and metastatic cancer cells in 1980.

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

CAR-T Therapy- Pipeline Insight, 2024 report outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the CAR-T Therapy pipeline landscape is provided which includes the disease overview and CAR-T Therapy treatment guidelines. The assessment part of the report embraces, in depth CAR-T Therapy 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 Therapy collaborations, licensing, mergers and acquisition, funding, designations and other product related details.

Report Highlights

The companies and academics are working to assess challenges and seek opportunities that could influence CAR-T Therapy R&D. The therapies under development are focused on novel approaches to treat/improve CAR-T Therapy.

CAR-T Therapy Emerging Drugs Chapters

This segment of the CAR-T Therapy report encloses its detailed analysis of various drugs in different stages of clinical development, including phase II, I, preclinical and Discovery. It also helps to understand clinical trial details, expressive pharmacological action, agreements and collaborations, and the latest news and press releases.

CAR-T Therapy Emerging Drugs

CT053: Carsgen Therapeutics Zevorcabtagene Autoleucel (Zevor-cel, R&D code: CT053) is an autologous fully human CAR T-cell product candidate against B-cell maturation antigen (BCMA) for the treatment of relapsed/refractory multiple myeloma (R/R MM). In October 2022, China National Medical Products Administration (NMPA) accepted the New Drug Application (NDA) and has granted the priority review for zevor-cel. Zevor-cel is expected to be approved by the NMPA for the treatment of R/R MM at the end of 2023 or the beginning of 2024. In January 2023, CARsgen and Huadong Medicine entered into a collaboration agreement for the commercialization of CARsgen's lead drug candidate, zevor-cel, in mainland China. Since reaching the agreement, teams from CARsgen and Huadong Medicine have been working together closely to implement this collaboration and prepare for the approval and commercialization of zevor-cel in China.

Descartes-08: Cartesian Therapeutics Descartes-08 is a CD8+ CAR-T investigational therapy that targets cells expressing B-cell Maturation Antigen (BCMA), a protein expressed by all plasma cells. Descartes-08 is engineered to have a defined and predictable half-life, enabling repeat dosing to maximize potency while minimizing risk of toxicity. Descartes-08's enhanced safety features enable use for of a wide range of diseases, from multiple myeloma and other cancers to autoimmune diseases. Descartes-08 is currently in Phase II clinical trials to treat patients with Systemic Lupus Erythematosus (SLE).

ALLO-501A: Allogene Therapeutics ALLO-501A, a next-generation anti-CD19 Allo CAR T, eliminates the rituximab recognition domains in ALLO-501, which could allow for use in a broader patient population, including NHL patients with recent rituximab exposure. This product candidate is currently being studied in an ongoing potentially pivotal Phase II trial. In June 2022, the US Food and Drug Administration granted Regenerative Medicine Advanced Therapy (RMAT) designation to ALLO-501A in r/rLBCL.

CTX110: CRISPR Therapeutics CTX110 is under development by CRISPR Therapeutics AG. CTX110 is an allogeneic CAR T-cell therapy currently in Phase I/II stage of development for the treatment of CD19 positive malignancies in the US and Europe. The program utilizes CRISPR’s proprietary gene-editing technology to make targeted modifications to the T-cell, thereby enabling an allogeneic, or off-the-shelf product that is applicable to a broader patient population and addresses the challenges of the current generation of autologous therapies.

IMPT 314: Imm PACT Bio IMPT-314 is a CD19/CD20-targeting chimeric antigen receptor (CAR) T-cell therapy that utilizes a potent bispecific CAR and a 4-1BB costimulatory domain. It is the same CAR construct as ImmPACT Bio's IMPT-514, which is under development for systemic lupus erythematosus andlupusnephritis.

IMPT-314 and IMPT-514 are based on work by Yvonne Chen, Ph.D., associate professor, and Sarah Larson, M.D., associate clinical professor, both of the University of California, Los Angeles (UCLA). Initial Phase 1 data from a UCLA investigator-led study evaluating the bispecific CAR construct underlying IMPT-314 demonstrated a 91% (10/11) overall response rate, 73% (8/11) complete response rate, 18.2-month median progression free survival, and a well-tolerated safety profile with no cytokine release syndrome above Grade 1 and no neurotoxicity in patients with relapsed or refractory (R/R) non-Hodgkin lymphoma. IMPT-314 is currently being evaluated in the ongoing Phase I/II, multi-center, open-label trial in participants with R/R aggressive B-cell lymphoma. IMPT-314 has received Fast Track Designation from the US Food and Drug Administration for the treatment of R/R aggressive B-cell lymphoma.

ALLO-715: Allogene Therapeutics ALLO-715 is an allogeneic CAR T-cell therapeutic candidate targeting B-cell maturation antigen (BCMA). ALLO-715 is manufactured to express a CAR that is designed to target BCMA and gene-edited to lack TCRa and CD52 to minimize the risk of Gv HD and avoid being destroyed by the patient’s immune system. ALLO-715 is initially be evaluated for the treatment of adult patients with relapsed/refractory multiple myeloma. ALLO-715 utilizes the TALEN gene-editing technology pioneered and owned by Cellectis. Allogene has an exclusive license to the Cellectis technology for allogeneic products directed at the BCMA target and holds the global development and commercial rights for this investigational candidate. Currently, the drug is in the Phase I stage of its development for the treatment of Multiplemyeloma.

CAR-T Therapy: Therapeutic Assessment

This segment of the report provides insights about the different CAR-T Therapy drugs segregated based on following parameters that define the scope of the report, such as:

Major Players in CAR-T Therapy

• There are approx. 200+ key companies which are developing the therapies for CAR-T Therapy. The companies which have their CAR-T Therapy drug candidates in the most advanced stage, i.e. Registered include, Carsgen Therapeutics.

Phases

This report covers around 252+ products under different phases of clinical development like

• Late stage products (Phase III)
• Mid-stage products (Phase II)
• Early-stage product (Phase I) along with the details of
• Pre-clinical and Discovery stage candidates
• Discontinued & Inactive candidates

Route of Administration

CAR-T Therapy pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs such as

• Oral
• Intravenous
• Subcutaneous
• Parenteral
• Topical

Molecule Type

Products have been categorized under various Molecule types such as

• Recombinant fusion proteins
• Small molecule
• Monoclonal antibody
• Peptide
• Polymer
• Gene therapy

Product Type

Drugs have been categorized under various product types like Mono, Combination and Mono/Combination.

CAR-T Therapy: Pipeline Development Activities

The report provides insights into different therapeutic candidates in phase II, I, preclinical and discovery stage. It also analyses CAR-T Therapy therapeutic drugs key players involved in developing key drugs.

Pipeline Development Activities

The report covers the detailed information of collaborations, acquisition and merger, licensing along with a thorough therapeutic assessment of emerging CAR-T Therapy drugs.

CAR-T Therapy Report Insights

• CAR-T Therapy Pipeline Analysis
• Therapeutic Assessment
• Unmet Needs
• Impact of Drugs

CAR-T Therapy Report Assessment

• Pipeline Product Profiles
• Therapeutic Assessment
• Pipeline Assessment
• Inactive drugs assessment
• Unmet Needs

Key Questions

Current Treatment Scenario and Emerging Therapies:

• How many companies are developing CAR-T Therapy drugs?
• How many CAR-T Therapy drugs are developed by each company?
• How many emerging drugs are in mid-stage, and late-stage of development for the treatment of CAR-T Therapy?
• What are the key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the CAR-T Therapy therapeutics?
• What are the recent trends, drug types and novel technologies developed to overcome the limitation of existing therapies?
• What are the clinical studies going on for CAR-T Therapy and their status?
• What are the key designations that have been granted to the emerging drugs?

Key Players

• CARsgen
• CASI Pharmaceuticals
• Tessa Therapeutics
• Cartesian Therapeutics
• Gracell Bio
• Aurora BioPharma
• Carsgen Therapeutics
• Autolus Limited
• CRISPR Therapeutics
• Allogene Therapeutics
• Verismo Therapeutics
• Arcellx
• Nexcella
• JW Therapeutics
• Janssen Pharmaceuticals
• Chongqing Precision Biotech
• Co Immune,Inc.
• Mustang Bio
• Novartis Pharmaceuticals
• Shanghai Unicar-Therapy Bio-medicine Technology
• Sotio Biotech Inc.
• Beam Therapeutics
• AbCLon
• Nanjing IASO Biotherapeutics
• Autolus
• Beijing Immunochina Medical Science and Technology
• Carsgen Therapeutics
• Orgenesis
• IN8Bio
• Oxford BioMedica

Key Products

• Zevorcabtagene autoleucel
• CNCT19
• TT11
• Descartes-08
• GC007g
• AU101
• AUTO4
• CAR-GPC3
• CTX110
• ALLO-715
• Syn KIR110
• ACLX 003
• NXC-301
• JWCAR029
• Ciltacabtagene autoleucel
• PCAR-19B
• CIK-CAR.CD19
• MB-102
• CART22 Therapy
• Humanized CD19 CAR T-cells
• BOXR 1030
• BEAM-201
• AT101
• CT 103A
• AUTO1/22
• IM21CART
• CAR-GPC3
• ORGCAR19.22 (CD19.22 CAR-T)
• INB-300
• 3rd CAR-T

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