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TCR Engineered T-Cell Therapy, Potential Market Opportunity & Clinical Pipeline Insights 2019

  • OI-99
  • |
  • Published date: Apr, 2019
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  • Life Sciences & Healthcare
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  • 0 Pages

T cell trials are based on the expression of cloned T cell receptors (TCR) with better targeting affinity. TCR are going to recognize either intracellular or extracellular antigen in the factors of major histocompatibility complex (MHC). Chimeric Antigen Receptors (CAR) and T-Cell Receptors (TCR) are said to be the most advanced ones in developing adoptive T-cell therapy. Both of these receptors use the T-cells to target the tumor with CAR T-cells (CAR-T) limiting to cell surface antigen binding, while TCR T-cells (TCR-T) recognizing peptides that are presented on the cell surface by MHC class I. The TCR cell therapy was improved by using Dominant TCR technology to provide a more effective treatment for patients with solid tumors who otherwise are having a very poor prognosis.


Market Overview


The growing incidence of different types of cancers and autoimmune diseases are driving the growth of the market. Besides this, advantages offered by engineered T cell therapies above traditional cancer treatments such as chemotherapy are the major factors that are going to boost the market growth. Additionally, increase approach to medical insurance fuels the demand for Engineered T cells market. On the contrary, the potential risk of engineered T cell treatments and the high cost of treatments obstruct the growth of this market.


Adoptive transfer of T cells that are gene-engineered with T cell receptors (TCRs) has shown its feasibility and therapeutic potential for treating malignant tumors. CD19-specific CAR-Ts was first approved for treating hematologic malignancies, but they have shown less success against solid tumors.   Working with TCR-engineered T cells has started more than two decades ago, conducting multiple preclinical studies. The success shown by these trials has given the foundation for clinical trials, which includes recent clinical successes of using TCR-engineered T cells for targeting New York esophageal squamous cell carcinoma (NY-ESO-1) and demonstrated the potential of this approach to treat tumors. The clinical TCRs mostly tested so far include HLA-A2-restricted and directed towards either carcinoembryonic antigen (CEA), melanoma-associated antigen recognized by T cells 1 (MART-1), glycoprotein (gp) 100, p53, melanoma-associated antigen (MAGE-) A3 or New York esophageal squamous cell carcinoma antigen (NY- ESO-1). One more TCR that was tested clinically was HLA-A1-restricted and directed against MAGE-A3.  These trials have collectively demonstrated the feasibility and significant clinical responses in patients with metastatic melanoma, synovial sarcoma, and colorectal carcinoma.


To add further clinical development of TCR gene therapy, it should be necessary to select accurate TCRs producing antigen-selective responses that are restricted to the tumor cells and, along with this it should include strategies restoring or enhancing the entry, migration and local accumulation of T cells in cancerous tissues. Thus, TCR-engineered T cells therapy is highly potent but its reactivity outside the tumor is to be minimized, and T cell trafficking inside the tumor tissues is to be maximized.


Treatment-related toxicity has been shown from TCRs studies, selectively those of high-affinity, directed against antigens that are over-expressed on tumor cells and also expressed on the healthy cells. Strategies developing to prevent or limit toxicities and tumor recurrences have already been advanced, some of them need further preclinical testing, and some of them are already implemented in clinical trials. These strategies are categorized along with three renewed challenges of choice of the target antigen, fitness of T cells and sensitization of micromilieu for T cell therapy. We present and will argue that optimizations along with each or combinations of these challenges will significantly contribute to the advancement of clinical TCR gene therapy.


Key Developments



  • US FDA approves IND application for TCR 210 in Non-small cell lung cancer, ovarian cancer, Mesothelioma and Cholangiocarcinoma before December 2018.

  • In Dec 2018, GSK-3377794 by Adaptimmune was in Phase-II clinical trials for treating Non-small cell lung cancer (Late-stage disease, Metastatic disease, Second-line therapy or greater, Combination therapy) in the USA.


Segmentation


This pipeline analysis report segments the TCR engineered T-cell therapy based on therapies employed (monotherapy and undisclosed), RoA (oral and undisclosed), therapeutic modalities (small molecules and disclosed), drugs under development (discovery, pre-clinical, phase I, phase I/II, phase II, and phase III), and recruitment status (recruiting, active not recruiting, enrolling by invitation, and undisclosed).


By application, the TCR engineered T cell therapy market is categorized into lung cancer, breast cancer, colorectal cancer, melanoma, leukemia, and others.


The key players in developing the TCR engineered T cell therapy pipeline include Autolus, Precision Biosciences, Pfizer Inc., Bellicum Pharmaceuticals, Inc., Cell Medica., Oxford BioMedica, Elli Lilly and Company, Novartis AG, Gilead, and Juno Therapeutics, Inc.

Report Description: The report covers in-depth analysis on TCR Engineered T-Cell Therapy Pipeline Insights, 2019. The report assesses the TCR Engineered T-Cell Therapy pipeline by stage of development (early development, pre-clinical, clinical and in approval), by application (lung cancer, breast cancer, colorectal cancer, and others). In addition, the report includes key insights on other development activities, including (but not limited to) – licensing (In and Out), collaborations, acquisitions, reimbursement, patent, and regulatory designations.


The report includes in-depth company profiles of key players in TCR Engineered T-Cell Therapy Pipeline. The company profile includes key information on overview, financial highlights, product portfolio, business strategies, and key recent developments.


The report highlights information on emerging companies with potentially disruptive technologies and new market entrants.


Scope:



  • Provides detailed analysis of the product pipeline structure along with forecast of the various segments and sub-segments of the TCR Engineered T-Cell TherapyPipeline.

  • Provides a comparative analysis of key marketed products and pipeline TCR Engineered T-Cell Therapy 

  • Provides key information on players involved on the TCR Engineered T-Cell Therapy Pipeline.

  • Provides a complete overview of market segments and the regional outlook of TCR Engineered T-Cell Therapy Pipeline.

  • Provides in-depth coverage of key news related toTCR Engineered T-Cell Therapy Pipeline, including major mergers and acquisitions and product development updates such as clinical trial progression updates and regulatory updates

Our research works on a holistic 360° approach to deliver high quality, validated and reliable information in our market reports. The Market estimation and forecasting involve the following steps:




  • Data Collation (Primary & Secondary)




  • In-house Estimation (Based on proprietary databases and Models)




  • Market Triangulation




  • Forecasting




  • Market-related information is assembled from both primary and secondary sources. 






  • Primary sources involved participants from all global stakeholders such as experts from several related industries and suppliers that have been interviewed to obtain and verify critical information as well as to assess prospects of the market. The participants included are CXOs, VPs, and managers. Plus, our in-house industry experts having decades of industry experience contribute their consulting and advisory services. 





  • Secondary sources include public sources such as regulatory frameworks, government IT spending, government demographic indicators, industry association statistics, and company publications annual reports press releases along with paid sources such as Factiva, OneSource, Bloomberg among others. 





  • Top-down and bottom-up approaches: The overall market size was used in the top-down approach to estimate the sizes of other individual submarkets (mentioned in the market segmentation by product, type of manufacturing, and disease) through percentage splits from secondary and primary research. The bottom-up approach was also implemented (wherever applicable) for data extracted from secondary research to validate the market segment revenues obtained. 




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