TCR therapy - Pipeline Insight, 2021

Researcher’s, “TCR therapy – Pipeline Insight, 2021,” report provides comprehensive insights about 25+ companies and 35+ 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
T-cell receptor (TCR)-based adoptive therapy employs genetically modified lymphocytes that are directed against specific tumor markers. This therapeutic modality requires a structured and integrated process that involves patient screening (e.g., for HLA-A*02:01 and specific tumor targets), leukapheresis, generation of transduced TCR product, lymphodepletion, and infusion of the TCR-based adoptive therapy. The majority of TCR structures are heterodimers comprised of α- and β-chains that are covalently linked via a disulfide bond between the conserved cysteine residues located within the constant region of each chain. Adoptive cell therapy (ACT), which uses genetically engineered human lymphocytes, is increasingly being investigated in patients with hematologic malignancies and solid tumors. The implementation of TCR therapy will require a shortened time to manufacture TCR products and decreased overall cost associated with the administration of TCR therapy.

"TCR therapy - Pipeline Insight, 2021" report by Researcher 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
• GSK3377794: GlaxoSmithKline
Letetresgene autoleucel (GSK3377794) is the first generation of NY-ESO-1 specific T-cell receptor (TCR) engineered T-cells. GSK has exercised the option to obtain an exclusive global license from Adaptimmune for an investigational SPEAR T-cell receptor therapy targeting NY-ESO-1 (GSK3377794). Upon exercise of this option and transition of the programme, GSK has assumed responsibility for all development, manufacturing and commercialization activities for the asset. GSK3377794 has been granted PRIME designation by the European Medicines agency and Breakthrough Therapy Designation by the US Food and Drug Administration. It is currently being evaluated in Phase II clinical trial to treat non-small cell lung cancer.

• BPX-701: Bellicum Pharmaceuticals
BPX-701 is a CaspaCIDe®-enabled natural high affinity T cell receptor (TCR) product candidate designed to target malignant cells expressing the preferentially-expressed antigen in melanoma (PRAME). Initial planned indications for BPX-701 development are Refractory or Relapsed Acute Myeloid Leukemia (AML) and Myelodysplastic Syndromes (MDS) with an additional study planned for metastatic uveal melanoma. In vitro study data showed that BPX-701 demonstrated strong affinity to panels of cancer cells presenting PRAME peptides and low affinity to non-tumor cells, as well as complete elimination of BPX-701 cells in response to rimiducid. It is being investigated in Phase I/II stage of development.

• MDG1011: Medigene AG
MDG1011 is Medigene’s first proprietary, clinical stage TCR immunotherapy product candidate. The TCR-modified T cell product targeting the tumor antigen PRAME (PReferentially expressed Antigen in MElanoma) is being tested in a Phase I/II clinical trial in approximately 92 blood cancer patients with acute myeloid leukemia (AML), myelodysplastic syndrome (MDS) or multiple myeloma (MM).
Further product details are provided in the report……..

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. 25+ 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 II include, GlaxoSmithKline.
• Phases
Researcher’s report covers around 35+ 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?