CAR-T - Pipeline Insight, 2024

This “CAR-T - Pipeline Insight, 2024” report provides comprehensive insights about 180+ companies and 200+ 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.

Geography Covered

• Global coverage

CAR-T: Understanding

CAR-T: Overview

CAR-T cell therapy represents a revolutionary approach in cancer treatment, harnessing the power of the immune system to combat cancer. This cutting-edge therapy involves a meticulous process where a patient's own T cells, a vital component of the immune system responsible for identifying and eliminating foreign invaders, are genetically engineered to specifically target and destroy cancer cells. The process begins by extracting T cells from the patient's blood through a process called leukapheresis. Once isolated, these T cells undergo genetic modification in the laboratory. Specifically, scientists introduce a gene encoding a chimeric antigen receptor (CAR) into the T cells. This CAR is designed to recognize and bind to a specific protein expressed on the surface of cancer cells. This customization ensures that the engineered T cells can specifically target and attack cancerous cells while sparing healthy cells.

After the genetic modification, the CAR T cells undergo extensive expansion in the laboratory, multiplying into large numbers. This amplification phase is crucial to generating a sufficient number of modified T cells for effective treatment. Once the CAR T cells reach the desired quantity, they are infused back into the patient's bloodstream through intravenous infusion. Upon infusion, these engineered T cells circulate throughout the body, seeking out cancer cells that express the target protein recognized by the CAR.

Upon encountering cancer cells, the CAR T cells bind to the specific protein expressed on their surface, triggering a cascade of immune responses that ultimately lead to the destruction of the cancerous cells. This includes the activation of cytotoxic pathways within the CAR T cells, resulting in the targeted killing of cancer cells. CAR-T cell therapy has demonstrated remarkable success in the treatment of certain blood cancers, such as leukemia and lymphoma, particularly in patients who have not responded to conventional treatments like chemotherapy or stem cell transplantation. Moreover, ongoing research is exploring the potential of CAR-T cell therapy in treating other types of cancers, including solid tumors. While CAR-T cell therapy offers tremendous promise, it also comes with unique challenges and potential side effects, including cytokine release syndrome (CRS) and neurotoxicity, which require careful management and monitoring by healthcare professionals. CAR-T cell therapy represents a groundbreaking advancement in cancer treatment, offering a personalized and targeted approach to fighting cancer by harnessing the body's own immune system. With continued research and refinement, CAR-T cell therapy holds the potential to revolutionize the treatment landscape for various types of cancer, offering hope to patients who previously had limited treatment options.

"CAR-T- Pipeline Insight, 2024" report 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.

Report Highlights

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

CAR-T Emerging Drugs Chapters

This segment of the CAR-T 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 Emerging Drugs

Descartes-08: Cartesian Therapeutics

Descartes-08 is an autologous anti-B cell maturation antigen (BCMA) mRNA CAR-T. Compared to conventional DNA-based CAR T-cell therapies, mRNA CAR-T is designed not to require preconditioning chemotherapy, has been observed to have predictable and controllable pharmacokinetics, and is designed to avoid the risk of genomic integration. Descartes-08 has been granted Orphan Drug Designation by the US FDA for the treatment of MG, a chronic autoimmune disorder that causes disabling muscle weakness and fatigue. Currently, the drug is in Phase II stage of clinical trial for the treatment of autoimmune disorders.

KYV-101: Kyverna Therapeutics

KYV-101 is an autologous, fully human CD19 CAR T-cell product candidate for use in B cell-driven autoimmune diseases. The CAR in KYV-101 was designed by the National Institutes of Health (NIH) to improve tolerability and tested in a 20-patient Phase 1 trial in oncology. Results were published by the NIH in Nature Medicine3. KYV-101 is currently being evaluated in sponsored, open-label, Phase 1/2 trials of KYV-101 in patients with lupus nephritis, an autoimmune disease in which more than half of patients do not achieve a complete response to current therapies and are at risk of developing kidney failure. Additionally, FDA's IND clearance has been obtained for Phase 2 trials of KYV-101 for multiple sclerosis and myasthenia gravis, and a Phase I/II trial for systemic sclerosis.

TX200: Sangamo Therapeutics

TX200 is composed of the patient’s own (autologous) regulatory T cells (Tregs) engineered to express a chimeric antigen receptor (CAR) designed to recognize the HLA-A2 protein present on a transplanted kidney and bind to it. TX200 is in development for the prevention of immune-mediated rejection in HLA-A2 mismatched kidney transplantation from a living donor. It is in Phase I/II stage of its clinical trial.

ALLO-605: Allogene Therapeutics

ALLO-605, a next-generation AlloCAR T™ known as a TurboCAR™, is an investigational product that targets the B-cell maturation antigen (BCMA) for the treatment of patients with relapsed/refractory multiple myeloma and other BCMA-positive malignancies. This study uses ALLO-647, Allogene's proprietary monoclonal antibody (mAb), as a part of its differentiated lymphodepletion regimen. ALLO-605 incorporates Allogene’s proprietary TurboCAR technology, which allows for cytokine activation signaling to be engineered selectively into CAR T cells. In June 2021, ALLO-605 was granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for the potential treatment of relapsed/refractory multiple myeloma. The Phase 1 study evaluating ALLO-605 is underway. Currently, the drug is in Phase I/II stage of its clinical trial for the treatment of Multiple Myeloma.

ATA3219: Atara Biotherapeutics

ATA3219 combines the natural biology of unedited T cells with the benefits of an allogeneic therapy. It consists of allogeneic Epstein-Barr virus (EBV)-sensitized T cells that express a CD19 CAR construct for the treatment of CD19+ relapsed or refractory B-cell malignancies, including B-cell non-Hodgkin’s lymphoma and B-cell mediated autoimmune diseases including systemic lupus erythematosus (SLE) with kidney involvement (lupus nephritis [LN]). ATA3219 has been optimized to offer a potential best-in-class profile, featuring off-the-shelf availability. Currently, the drug is in Phase I stage of its clinical trial.

CB-010 : Caribou Biosciences

CB-010 is an allogeneic anti-CD19 CAR-T cell therapy for the treatment of patients with relapsed or refractory B cell non-Hodgkin lymphoma (r/r B-NHL). CB-010 is the first allogeneic CAR-T cell therapy, to our knowledge, in a clinical trial with a PD-1 knockout, a genome-editing strategy designed to improve antitumor activity by limiting premature CAR-T cell exhaustion. CB-010 is being evaluated in the ongoing, open-label, multicenter ANTLER Phase I clinical trial in adults with r/r B-NHL.

CAR-T: Therapeutic Assessment

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

Major Players in CAR-T

• There are approx. 180+ key companies which are developing the therapies for CAR-T. The companies which have their CAR-T drug candidates in the most advanced stage, i.e. Phase II include, Cartesian Therapeutics.

Phases

This report covers around 200+ 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 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: Pipeline Development Activities

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

CAR-T Report Insights

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

CAR-T 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 drugs?
• How many CAR-T 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?
• What are the key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the CAR-T 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 and their status?
• What are the key designations that have been granted to the emerging drugs?

Key Players

• Caribou Biosciences
• Allogene Therapeutics
• Synthekine
• Shanghai Simnova Biotechnology
• Sana Biotechnology
• Zhejiang University
• Janssen Research & Development
• Beijing Immunochina Medical Science & Technology
• M.D. Anderson Cancer Center
• SecuraBio
• CARsgen Therapeutics
• Caribou Biosciences
• Atara Bio therapeutics
• Wugen
• Vor Biopharma
• Juventas Cell Therapy
• Hebei Senlang Biotechnology
• Cellular Biomedicine Group
• Oncternal Therapeutics
• Autolus Limited
• Lyell Immunopharma
• Gracell Biopharmaceuticals

Key Products

• CB-010
• ALLO-715
• SYNCAR-001
• SNC-109
• SC291
• NKG2D CAR T-cells
• JNJ-90009530
• IM96 CAR-T cells
• Emapalumab
• Duvelisib
• CT048
• CB-012
• ATA3219
• WU-CART-007
• VCAR33
• CNCT19
• Senl-T7
• Prizloncabtagene autoleucel
• ONCT-808
• Obecabtagene autoleucel
• LYL797
• GC012F

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