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CAR-T – Pipeline Insight, 2020

CAR-T – Pipeline Insight, 2020

  • September 2020
  • 105 pages
  • ID: 5968552
  • Format: PDF
  • Delve Insight
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Table of Contents

“CAR-T – Pipeline Insight, 2020,” report provides comprehensive insights about 250+ companies and 250+ 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 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.
Potential Mechanisms of CAR-T Cell-Mediated Toxicity
Significant progress has been made in the field of cancer immunotherapy, and CAR-T cells have shown outstanding efficacy in clinical trials. As with all technologies, CAR-T technologies also need to go through a long process of development, and CAR-T cell therapy has related acute and chronic toxicities that have become a roadblock on the developmental path. If these setbacks are not overcome, it will be difficult to make a more significant breakthrough.
Cytokine Release Syndrome
Cytokine release syndrome (CRS) is the most common toxic side effect in CAR-T cell therapy. CRS is a systemic inflammatory response caused by the significant increase in cytokines accompanied by the rapid in vivo activation and proliferation of CAR-T cells, usually occurring within a few days after the first infusion. CRS is a clinical condition with mild symptoms of fever, fatigue, headache, rash, joint pain, and myalgia. Severe CRS cases are characterized by tachycardia, hypotension, and high fever. Mild to moderate CRS is usually self-limiting and can be managed through close observation and supportive care. Severe CRS must be treated with tocilizumab or steroids alone for intensive treatment.
Advances in Research of CAR-T Cell Therapy for Solid Tumors
Although early CAR-T cell trials of solid tumors did not show the same success as observed in leukemia trials, a better understanding of the multiple barriers seen in solid tumors could promote the design of clinical trials for CAR-T cells. In this early stage of clinical development, CAR-T cells offer much hope. The ability of genetic manipulation techniques to modify CAR-T cells provides almost unlimited opportunities for other changes and improvements, thus providing a strong desire for future success.
Global Landscape of CAR-T Cell Therapy
At present, CAR-T cells are widely used in cellular immunotherapy for various tumors. According to statistics, more than 300 clinical trials of CAR-T cell therapies have been approved by many national drug regulatory agencies, including the FDA of the United States. Statistical data from these clinical trials show that although the effects of various clinical trials vary due to the use of different sources and the preparation techniques of CARs and T cells, as well as differences in pretreatment and combinations of drugs, overall, CAR-T cells are effective in treating tumors with an effective rate of 30% to 70% or even more than 90%. For example, the complete remission rate for r/r ALL treated with the Novartis drug CTL0l9, which the FDA has approved, is 93%. Perhaps CAR-T cell therapy will ultimately remedy the fate of human cancer.

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
• MB-101: Mustang Bio
MB-101 is an IL13R?2-specific CAR T-cell therapy being developed by Mustang (a subsidiary of Fortress Biotech) in the Phase I stage for the treatment of patients with recurrent/refractory malignant glioma. IL13R?2 is an attractive target for CAR T therapy as it has limited expression in normal tissue but is over-expressed on the surface of the majority of GBM. CAR T-cells are designed to express a membrane-tethered IL-13 receptor ligand (IL-13) incorporating a single point mutation that provides high affinity for IL13R?2 and reduces binding to IL13R?1 to reduce healthy tissue targeting. The company is developing MB-101 in collaboration with the City of Hope. Both the companies will assess the T-cell persistence and determine the potential immunogenicity of the cells to determine a recommended Phase II dose.
• JNJ-68284528: Janssen Research & Development, LLC
JNJ-68284528 is an autologous chimeric antigen receptor T-cell (CAR-T) therapy that targets B-cell maturation antigen (BCMA), a molecule expressed on the surface of mature B lymphocytes and malignant plasma cells. Janssen is conducting a phase 3 randomized study comparing JNJ-68284528, a Chimeric Antigen Receptor T Cell (CAR-T) Therapy directed against BCMA, versus Pomalidomide, Bortezomib and Dexamethasone (PVd) or Daratumumab, Pomalidomide and Dexamethasone (DPd) in subjects with relapsed and Lenalidomide-Refractory Multiple Myeloma.

The primary hypothesis for this study is that JNJ-68284528 will significantly improve progression free survival (PFS) compared with standard therapy (PVd or DPd), in participants who have previously received 1 to 3 prior line(s) of therapy, that included a proteasome inhibitor (PI) and an immunomodulatory drug (IMiD) and who are refractory to lenalidomide. This study will be conducted in 3 phases: Screening (up to 28 days before randomization), Treatment, and Follow-Up. Assessment like patient-reported outcome(s) (PROs) assessments, electrocardiogram (ECG), vital signs, pharmacokinetic will be performed during the study. Safety evaluations will include review of adverse events, laboratory test results, vital sign measurements, physical examination findings, and assessments of cardiac function, Immune Effector Cell-associated Encephalopathy (only for Arm B) and Eastern Cooperative Oncology Group performance status. Safety data will be periodically reviewed by an Independent Data Monitoring Committee (IDMC). The duration of the study is approximately 6 years.

• MB-CART20.1: Miltenyi Biomedicine GmbH
A preparation of autologous T lymphocytes that have been genetically modified to express a chimeric antigen receptor (CAR) targeting the tumor-associated antigen (TAA) CD20 (cluster of differentiation 20), and CD4/CD8 enriched, with potential immunostimulating and antineoplastic activities. Upon administration, MB-CART20.1 specifically recognize and kill CD20-expressing tumor cells. The CD20 antigen, a non-glycosylated cell surface phosphoprotein, is a B-cell specific cell surface antigen expressed in B-cell lineage malignancies and certain melanoma cell subpopulations.

Further product details are provided in the report……..

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. 250+ 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 III include, Janssen Research & Development, ViiV Healthcare, Sorrento Therapeutics, Celgene, Novartis, Abbott etc.
This report covers around 250+ products under different phases of clinical development like
• Late-stage products (Phase II and Phase II/III)
• Mid-stage products (Phase II and Phase II/III)
• Early-stage products (Phase I/II and 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
• Intravenous
• Intramuscular
• Subcutaneous
• Intratumoral

• Mechanism of Action
Products have been categorized under various Mechanisms of Action such as
• T lymphocyte replacements
• Immunologic cytotoxicity
• 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.

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.
• On July 24, 2020, FDA approved the third chimeric antigen receptor (CAR) T-cell therapy, this time granting a green light for Kite Pharma’s brexucabtagene autoleucel, the first cell-based gene therapy to treat relapsed or refractory mantle cell lymphoma (MCL).
• September 2020: Sheba Medical Center Treats First Patient with CAR-T Cell Immunotherapy Manufactured Using the Lonza Cocoon Platform
• Lonza and Sheba Medical Center announced the first patient has been treated at Sheba Medical Center with a CD19 CAR-T cell immunotherapy manufactured using Lonza’s Cocoon Platform. The Cocoon Platform is an automated and functionally closed system for patient-scale cell therapy manufacturing, designed to overcome some of the manufacturing challenges of manually producing personalized medicines, including autologous CAR-T cell therapies.
• Atara Biotherapeutics announces FDA clearance of IND for ATA2271, a Next-Generation Autologous Mesothelin-Targeted CAR T with novel PD1DNR and 1XX technologies combined to treat solid tumors

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
• AbbVie Inc.
• Adaptimmune Therapeutics PLC.
• Amgen, Inc.
• Atara Biotherapeutics, Inc.
• Aurora Biopharma, Inc.
• Autolus Therapeutics PLC.
• Bellicum Pharmaceuticals, Inc.
• BioAtla LLC.
• bluebird bio
• Carina Biotech
• CARsgen Therapeutics, Ltd.
• CARTherics
• Celgene
• Cellectis
• Celularity
• Celyad SA
• Creative Biolabs
• DiaCarta, Inc.
• Endocyte, Inc.
• F1 Oncology, Inc.
• Fate Therapeutics Inc.
• Gilead
• Humanigen, Inc.
• Immune Therapeutics, Inc.
• Intrexon, Corp.
• Juno Therapeutics, Inc.
• Kite Pharma, Inc.
• Lion TCR Pte Ltd.
• MaxCyte, Inc.
• Mesoblast, Ltd.
• Minerva Biotechnologies Corp.
• Mustang Bio, Inc.
• Novartis AG
• Oxford BioMedica PLC.
• PeproMene Bio Inc.
• Pfizer, Inc.
• Posedia Therapeutics Inc.
• Precision Biosciences, Inc.
• ProMab Biotechnologies Inc.
• Servier Oncology
• Sorrento Therapeutics, Inc.
• TC Biopharm Ltd.
• Tessa Therapeutics Pte Ltd.
• TILT Biotherapeutics Ltd.
• Tmunity Therapeutics Inc.
• TrakCel Ltd.
• Xyphos
• ZIOPHARM Oncology, Inc.

Key Products
• LCAR-B38M CAR-T Cell
• Anti-CEA CAR-T cells
• CD30.CAR-T
• AUTO CAR T cell therapy
• Defibrotide
• MB-CART2019.1 Dose level 1
• CD19/22 CART
• JNJ-68284528
• CD123 CAR-T cells
• CD19 CAR-T cells
• BCMA CAR-T cells
• CEA CAR-T cells
• CAR-T cell immunotherapy
• Autologous CAR-T cells
• Second generation CAR-T cells
• CAR-T/TCR-T cells immunotherapy
• Allogeneic hematological stem cell transplantation
• Humanized CD19 CAR-T cells
• MB-CART20.1
• MB-CART19.1
• IM19 CAR-T Cells
• Autologous CD19-targeting CAR T cells
• P-BCMA-101 CAR-T cells
• MLM-CAR44.1 T-cells, cyclophosphamide and fludarabine from -5 to -3
• CART-19/22
• Anakinra
• Anti-MUC1 CAR-T cells
• CAR T-cell therapy
• CAR T cells
• CART-19
• CAR-CD19 T Cells
• CAR-BCMA T Cells
• LCAR-B38M CAR-T cell injection
• Gene-modified (GM) T cell therapy
• Descartes-08
• iC9-CAR19 cells
• ALLO-501A

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