TCR-Therapy - Pipeline Insight, 2024

This “TCR-Therapy - Pipeline Insight, 2024,” report provides comprehensive insights about 30+ companies and 100+ pipeline drugs in TCR-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

TCR-Therapy Understanding

TCR-Therapy: Overview

The T-cell receptor (TCR) is a molecule found on the surface of T cells, or T lymphocytes, that is responsible for recognizing fragments of antigen as peptides bound to major histocompatibility complex (MHC) molecules. The binding between TCR and antigen peptides is of relatively low affinity and is degenerate, that is, many TCRs recognize the same antigen peptide and many antigen peptides are recognized by the same TCR. The TCR is composed of two different protein chains (that is, it is a heterodimer). In humans, in 95% of T cells the TCR consists of an alpha (a) chain and a beta (ß) chain (encoded by TRA and TRB, respectively), whereas in 5% of T cells the TCR consists of gamma and delta (?/d) chains (encoded by TRG and TRD, respectively). This ratio changes during ontogeny and in diseased states (such as leukemia). It also differs between species. Orthologues of the 4 loci have been mapped in various species. Each locus can produce a variety of polypeptides with constant and variable regions. The TCR is a disulfide-linked membrane-anchored heterodimeric protein normally consisting of the highly variable alpha (a) and beta (ß) chains expressed as part of a complex with the invariant CD3 chain molecules. T cells expressing this receptor are referred to as a:ß (or aß) T cells, though a minority of T cells express an alternate receptor, formed by variable gamma (?) and delta (d) chains, referred as ?d T cells. Each chain is composed of two extracellular domains: Variable (V) region and a Constant (C) region, both of Immunoglobulin superfamily (IgSF) domain forming antiparallel ß-sheets. The Constant region is proximal to the cell membrane, followed by a transmembrane region and a short cytoplasmic tail, while the Variable region binds to the peptide/MHC complex. The TCR is a heterodimer of one a and one ß chain, or one ? and one d chain, which are disulphide-linked. Each TCR chain is composed of a constant and a variable domain, followed by a membrane-spanning region and a short cytosolic tail. The essential function of the TCR complex is to identify specific bound antigen and elicit a distinct and critical response. The signal transduction mechanism by which a T cell elicits this response upon contact with its unique antigen is termed T-cell activation (just as phototransduction is the term given to the signal transduction event by which photoreceptors elicits vision upon exposure to photons). There are myriad molecules involved in the complex biochemical process (called trans-membrane signaling) by which T-cell activation occurs. The most common mechanism for activation and regulation of molecules beneath the lipid bilayer is via reversible tyrosine phosphorylation by protein kinase/phosphatase.

TCR-Therapy - Pipeline Insight, 2024 report outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the TCR-Therapy pipeline landscape is provided which includes the disease overview and TCR-Therapy treatment guidelines. The assessment part of the report embraces, in depth TCR-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, TCR-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 TCR-Therapy R&D. The therapies under development are focused on novel approaches to treat/improve TCR-Therapy.

TCR-Therapy Emerging Drugs Chapters

This segment of the TCR-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.

TCR-Therapy Emerging Drugs

IMC F106C: ImmunocoreIMC-F106C is an ImmTAC targeting PRAME for patients with HLA-A02, which is expressed in approximately 40% of Western populations (United States, Canada, EU). In order to expand the potential of TCR therapy targeting PRAME, the Company is developing IMC-T119C, a first-in-class ImmTAC product candidate targeting a PRAME peptide presented by HLA-A24. HLA-24 is an HLA-type that is estimated to be present in 60% of people in Japan and 15-20% in Western populations. Currently the drug is in Phase III stage of clinical trial evaluation for the treatment of patients with 1L advanced, cutaneous melanoma.

GSK 3377794: GlaxoSmithKlineGSK 3377794 developed by GlaxoSmithKline is an investigational SPEAR T-cell receptor targeting NY-ESO-1. GSK ‘794 is an engineered T-cell therapy, for which a patient’s own cells have been genetically modified to express a T-cell receptor (TCR) recognizing with high affinity the tumor-specific antigen, NY-ESO. When the modified cells are re-infused into the patient, they recognize and kill tumor cells that express the NY-ESO antigen. NY-ESO is expressed at various levels across different tumors and appears to be expressed at high levels in defined sub-types of soft tissue sarcomas, melanoma, multiple myeloma, bladder cancer, non-small cell lung cancer (NSCLC), ovarian cancer and gastrointestinal cancers.GSK3377794 has been granted PRIME designation by the European Medicines Agency and Breakthrough Therapy Designation by the US Food and Drug Administration. The drug was originated by Adaptimmune, and currently being developed by GSK. Currently, the drug is in the Phase II stage of its development for the treatment of gastrointestinal cancer, Liposarcoma, Malignant melanoma, multiple myeloma, non-small cell lung cancer, ovarian cancer, and synovial sarcoma.

MDG 1011: MediGene AGMDG1011 is a TCR-T immunotherapy directed against the tumor antigen PRAME (Preferentially expressed Antigen in Melanoma) and was manufactured to be administered in a single intravenous dose to patients suffering from relapsed or refractory acute myeloid leukemia (AML), myelodysplastic syndrome (MDS) or multiple myeloma (MM) who had previously undergone extensive pre-treatment with standard or experimental therapies. Currently the drug is in Phase I/II stage of clinical trial evaluation for the treatment of patients with High Risk Myeloid and Lymphoid Neoplasms.

TSC-100: TScan TherapeuticsTSC-100 is HA-1 and HA-2 specific TCR-T candidates directed at eliminating native blood cells, including residual cancer cells, in target-positive and HLA-A*02:01-positive patients undergoing hematopoietic cell transplantation (HCT). TSC-100 was identified using ReceptorScan from hundreds of millions of CD8+T cells. The therapies is designed to elicit an anti-tumor response in patients by targeting HA-1 or HA-2 minor antigens, which are present on malignant and normal blood cells of patients but not on any of the new, donor-derived blood cells.

TCR-Therapy: Therapeutic Assessment

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

Major Players in TCR-Therapy

There are approx. 30+ key companies which are developing the therapies for TCR-Therapy. The companies which have their TCR-Therapy drug candidates in the most advanced stage, i.e. phase III include, Immunocore.

Phases

This report covers around 100+ 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

TCR-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
• Parenteral
• intravenous
• Subcutaneous
• Topical.

Molecule Type

Products have been categorized under various Molecule types such as

• Monoclonal Antibody
• Peptides
• Polymer
• Small molecule
• Gene therapy

Product Type

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

TCR-Therapy: Pipeline Development Activities

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

TCR-Therapy Report Insights

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

TCR-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 TCR-Therapy drugs?
• How many TCR-Therapy drugs are developed by each company?
• How many emerging drugs are in mid-stage, and late-stage of development for the treatment of TCR-Therapy?
• What are the key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the TCR-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 TCR-Therapy and their status?
• What are the key designations that have been granted to the emerging drugs?

Key Players

• Immunocore
• GlaxoSmithKline
• Altor BioScience Corporation
• Immatics
• Immunocore
• SCG Cell Therapy
• Baudax Bio
• TScan Therapeutics
• 2seventy bio
• Treadwell Therapeutics
• T-Knife
• Triumvira
• Abata Therapeutics
• Affini-T Therapeutics
• Triumvira
• Lion TCR
• Poseida Therapeutics
• Athenex, Inc.
• Adaptimmune
• Neogene Therapeutics
• Alaunos Therapeutics
• MediGene AG
• Zelluna Immunotherapy

Key Products

• IMC-F106C
• GSK 3377794
• ALT-801
• IMA402
• IMC M113V
• SCG101
• IMA401
• TI-168
• SCG 162
• TSC 201
• MAGE-A4 TCR program
• TCR-BASED CELL THERAPY
• TK 1412
• TAC GUCY2C
• ABA 101
• AFNT-212
• TAC01-HER2 (Allo)

Research Program: Viral antigen- Research Program: Poseida Therapeutics
Research Program: Allogeneic TCR-NKT- TC-520

• NT-112
• mbIL 15 TCR T cell therapy
• MDG10XX

Research Program: Solid Tumors


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