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Long Story Short - What does CAR-T therapy consist of, what is it?
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CAR-T and the Possibility of Cancer Treatment, Part 1

style="margin: 0in 0in 0.0001pt; font-size: 12pt; font-family: Calibri, sans-serif;">click her for part two of this article series

(Note: companies that could be impacted by the content of this article are listed at the base of the story (desktop version). This article uses third-party references to provide a bullish, bearish and balanced point of view; sources listed in the "Balanced" section)

Chimeric Antigen Receptor T cell therapy (CAR-T) is a gene therapy designed to harness the potency of antibodies and T-lymphocytes into one single medicine for the treatment of cancer. CAR-T therapy could be viewed as a “living anti-cancer drug” as the medicine itself consists of a living cell, which is genetically engineered to find and destroy cancer cells. Dr. Carl H. June pioneered this technology at the University of Pennsylvania, where the first tests were conducted in cancer patients in 2010. Seven years later, the U.S. Food & Drug Administration (FDA) approved this novel gene therapy for the treatment of patients suffering from “B-cell precursor acute lymphoblastic leukemia” (ALL), a type of blood cancer known to be the most common malignant growth in children.

Thus far, anti-cancer antibodies have been one of the most successful drug classes for the treatment of cancer patients. Antibody drugs such as Roche’s Avastin, Herceptin and Rituxan have prolonged survival of many cancer patients. Another class of medicines, known as T-infiltrating lymphocytes (TILs), has been shown to be effective as an anti-cancer treatment. Given the relative success of both therapeutic strategies, the question is, how do you combine both treatments into one potent anti-cancer drug?

CAR-T represents the solution to this riddle. CAR-T consists of two main components: 1) the tumor associated antigen (TAA) domain of an anti-cancer antibody (scFV) linked through a spacer/transmembrane region to 2) the cytoplasmic domain of the receptor of a cancer-killing T lymphocyte. The new anti-cancer drug, CAR-T, is a genetically engineered T-lymphocyte expressing a chimeric T cell receptor on its surface (Figure 1). This chimera consists of the binding domain of the antibody (external domain protruding from the cell surface), fused to the signaling portion CD3 of the T cell receptor (internal domain facing the cellular cytoplasm).

Figure 1 – Structure of a CAR-T construct. The left panel depicts a CAR-T medicine (first generation), whereas the right panel depicts the natural T cell receptor, TCR. In the CAR-T construct (left panel), the binding domain (light blue/purple) of an anti-cancer antibody (scFV) replaces the alpha/beta chain portion (green/red) of the natural TCR (right panel). The transmembrane and cytoplasmic components of CAR-T and TCR, including CD3 domain, are depicted in blue.


 

Source – Oncotarget 2015, 8(52)90521-90531 ?

To generate a CAR-T drug, five main steps are required (Figure 2):

  1. blood from the patient is extracted
  2. T-lymphocytes are purified from extracted blood, and subsequently genetically modified to express the CAR chimeric receptor
  3. CAR-T cells are grown in vitro (ex vivo)
  4. Once CAR-T cells are grown to reach a therapeutic dose, they are injected back into the patient
  5. Injected CAR-T cells are engineered to find and kill cancer cells


Source – The University of Texas Southwestern Medical Center



Success of Gilead and Novartis bodes well for the future of CAR-T approach

In 2017, the U.S. Food and Drug Administration (FDA) approved two CAR-T therapies for the treatment of blood cancers. Novartis Kymriah and Gilead’s Yescarta were approved by the agency for the treatment of pediatric acute lymphoblastic leukemia (ALL) and non-Hodgkin’s lymphoma (NHL), respectively. Patients who have not responded to, or who have relapsed following at least two other conventional treatments, are eligible for CAR-T therapy. The success of these two gene therapies in human clinical trials, followed by FDA endorsement and commercialization clearance have led to heightened enthusiasm on the potential for this cancer treatment. In clinical trials, CAR-T therapy demonstrated a 90% complete remission rate in B-cell acute lymphoblastic leukemia patients (Complete remission corresponds to the disappearance of all signs of cancer in response to treatment. However, it does not mean the cancer is cured).

Diffuse large B-cell lymphoma (DLBCL) is the most common type of NHL in adults. Gilead’s Yescarta is approved for the treatment of adult patients suffering from various types of NHL including DLBCL, primary mediastinal large B-cell lymphoma, high grade B-cell lymphoma and DLBCL arising from follicular lymphoma. In human clinical trials, patients treated with Yescarta showed a complete remission rate of 51 percent. Although not a reality yet, industry experts believe the positive experience seen with CAR-T drugs for the treatment of blood cancers will translate to similar success in solid tumors.  



CAR-T Complexity and High Prices Remain as Significant Challenges

Developing an effective living therapy for the treatment of cancer will not come without significant challenges. To recreate the immunological synapse in cancer patients is difficult, due to the complexity of the interaction of T lymphocytes with cancer cells. Giving that CAR-T cells are alive, they will respond to inhibitory signals from the tumor microenvironment, which could potentially inhibit their function and shut down the killing capacity of these cells. This has been the case with CAR-T drugs developed for the treatment of solid tumors such as lung cancer, breast and prostate cancers. Solid tumors present many barriers to CAR-T cells. The solid mass of a primary tumor creates physical barriers hindering penetration by CAR-T cells. Cancer cells populating a solid tumor can themselves diminish expression of tumor associated antigens (TAAs) on their surfaces, making the target elusive to CAR-T cells. Cancer cells heterogeneity, combined with the release of inhibitory cytokines, have been shown to create a prohibitive environment for CAR-T cells.

At present, CAR-T treatments are very expensive, with Novartis’s Kymriah and Gilead’s Yescarta carrying price tags of $475,000 and $373,000, respectively, just for a one-time treatment per patient. In the opinion of industry experts, the price of CAR-T gene therapy would have to come down before significant market penetration is achieved in oncology markets. At present, another obstacle to widespread adoption of CAR-T therapies is related to the safety of these drugs. CAR-T therapy is often associated with neurotoxicity and cytokine storms (abnormally high levels of pro-inflammatory cytokines), which could be fatal in some treated patients.



How to Engineer Better CAR-Ts for the Treatment of Cancer

The fact that CAR-T drugs are “living cancer treatments” offers the possibility to modulate their functions in vivo. Scientists have designed different approaches to diminish neurotoxicity of CAR-T drugs. Chimeric receptors in CAR-T constructs could be designed to be turned on and off, depending on specific patient needs. Additional domains could be added to the cytoplasmic portion of the chimeric receptor to boost the killing functions of CAR-T cells, increase their longevity, duration of immunological activity, avoid exhaustion, and overcome inhibitory signals from the tumor microenvironment. These improvements are of paramount importance when treating solid tumors with CAR-Ts. Furthermore, CAR-T constructs could be engineered to simultaneously target multiple tumor antigens, and to express specific cytokines which could engage the host immune system, thus amplifying the anti-tumor immune response and improving the treatment’s efficacy.

Significant efforts are being made to develop “off-the-shelf” CAR-T cells, which could lower price tags and simplify the manufacturing process for these complex anti-cancer medicines. Better selection of T cells subsets to prepare the CAR-T product will potentially improve durability and efficacy of the treatment (stem T cells with proliferative/differentiation potential, rather than effector T cells, are better suited as a source to manufacture CAR-T medicines). The advent of gene-editing technologies such as CRISPR allows for more efficient genetic manipulation and engineering of CAR-T constructs. Although these approaches are currently being evaluated in preclinical models and human clinical trials, the consensus view is that there is still ample margin for improvement in CAR-T product design for the treatment of cancer. For a deeper dive into innovations in CAR-T space by emerging industry leaders in read Part 2 of this article series here. 


Sources

Programming CAR-T cells to kill cancer. Nature Biomedical Engineering 2018, Vol 2, June 2018, p377-391

Switching on the green light for chimeric antigen receptor T-cell therapy. Clinical & Translational Immunology 2019, Vol 8, e1046

CAR-T with License to Kill Solid Tumors in Search of a Winning Strategy. International Journal of Molecular Sciences 2019, Vol 20, p1903

Chimeric-antigen receptor T (CAR-T) cell therapy for solid tumors: challenges and opportunities. Oncotarget 2015, Vol 8(52), p90521-90531



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  Research - Dyadic (DYAI) - Another licensing agreement, 05/08/2019
  Research - Entravision (EVC) - Update on full year 2018 results, 05/08/2019
  Research - KeyW (KEYW) - First quarter 2019 results, 05/08/2019
  Research - DLH Holdings (DLHC) - Second quarter 2019 Review, 05/08/2019
  Research - TherapeuticsMD (TXMD) - First quarter 2019 earnings update, 05/07/2019
  Research - Ducommun (DCO) - First quarter 2019 review, 05/07/2019
  Research - Endeavour Silver (EXK) - Rating lowered to Market Perform, 05/07/2019
  Research - Genie Energy (GNE) - Increasing estimates; strong results, 05/07/2019
  Research - Coeur Mining (CDE) - Review of first quarter 2019, 05/03/2019
  Research - ACCO Brands (ACCO) - Raising price target, 05/03/2019
  News - Game of Thrones: Energy Battles, 05/03/2019
  Research - Aurania Resources (ARU.V) - Drilling results analysis, 05/03/2019
  Research - Albany International (AIN) - First quarter 2019 review, 05/02/2019
  Research - Great Lakes Dredge & Dock (GLDD) - Strong third quarter, 05/01/2019
  Research - 1-800-Flowers.com (FLWS) - Fiscal 3Q19 Update, 05/01/2019
  Research - Comtech (CMTL) - Analysis of new contract and acquisition, 04/30/2019
  Research - Scorpio Bulkers (SALT) - First Quarter 2019 Review, 04/30/2019
  Research - Dyadic (DYAI) - Expanding partnership portfolio, 04/30/2019
  Research - TherapeuticsMD (TXMD) - Assumption of Coverage, 04/29/2019
  Research - Coeur Mining (CDE) - Updating estimates, 04/26/2019
  Research - Genprex (GNPX) - Initiation of Coverage, 04/26/2019
  News - Tax Cuts and Jobs Act: Are we better off?, 04/26/2019
  News - Blockchain for Business: Worth the Hype?, 04/25/2019
  Research - KeyW (KEYW) - Announces Definitive Merger Agreement, 04/23/2019
  Research - Aurania Resources (ARU:CA) - Appoints new CFO, 04/23/2019
  News - Uranium Imports: Trade War Goes Nuclear, 04/22/2019
  News - Does A 70% Top Marginal Tax Rate Make Sense?, 04/18/2019
  News - Boeing 737 MAX: Is it safe to fly? , 04/17/2019
  Research - Avino Silver & Gold (ASM) - Mine exploration provides optimism, 04/17/2019
  Research - Sierra Metals (SMTS) - Full year projection estimates, 04/17/2019
  Research - Vectrus (VEC) - Award is a big win, 04/17/2019
  IPO Podcast Series: Drug Disruption, 04/16/2019
  Research - Cumulus Media (CMLS) - , 04/16/2019
  Research - Coeur Mining (CDE) - First quarter production results, 04/15/2019
  Research - Endeavour Silver (EXK) - Waiting for a turnaround, 04/15/2019
  Research - Dyadic (DYAI) - Nasdaq Up-Listing Approved, 04/15/2019
  Research - Scorpio Bulkers (SALT) - Liquidity boost; adjusting estimates, 04/12/2019
  Research - Great Panther Silver (GPL) - Production numbers slightly lower than expected, 04/11/2019
  Research - Aurania Resources (ARU:CA) - Another promising copper target, 04/10/2019
  News - Could renewables supply 50% of all generation? How about 80%?, 04/05/2019
  Research - One Stop Systems (OSS) - Initiation of Research Coverage, 04/04/2019
  News - Stock Buybacks: Good, evil, or maybe something in between?, 04/03/2019
  Research - Prize Mining (PRZ:CA) - Behind the recent deal, 04/03/2019
  Research - Aurania Resources (ARU:CA) - Updates on copper production, 04/03/2019
  News - Macular Edema: The search for the cure continues, 04/02/2019
  Research - Trovagene (TROV) - Update on data readout, 04/02/2019
  Research - Trovagene (TROV) - Updated prostate cancer data, 04/02/2019
  Research - Sierra Metals (SMTS) - 2018 full year recap, 04/01/2019
  Research - Albany International (AIN) - Appoints new CFO, 04/01/2019
  Research - Pyxis Tankers (PXS) - 2018 financial update, 03/29/2019
  Research - Dyadic (DYAI) - 2018 full year update, 03/28/2019
  Podcast Launch: The Science of Investing in Biotechs, 03/28/2019
  A Video Introduction to Enochian Biosciences, 03/28/2019
  Official Trailer: NEW Podcast Series- Icons of Business, Leaders of Emerging Companies, 03/26/2019
  Research - Information Services (III) - Favorable risk/reward moving forward, 03/25/2019
  Research - Torchlight Energy - Strong updates on project estimates, 03/25/2019
  Research - 1-800-Flowers.com (FLWS) - Investor Day Highlights, 03/25/2019
  Research - Prize Mining (PRZ:CA) - Initiation of Research Coverage, 03/25/2019
  News - The Case for Dr. Copper: New Sources of Demand are Positive for Copper, 03/25/2019
  Research - Cumulus Media (CMLS) - Raising Price Target, 03/22/2019
  Research - Pangaea Logistics (PANL) - Business Model/Strategy Shine, 03/22/2019
  Research - Seanergy (SHIP) - What do the results show?, 03/21/2019
  Research - E.W. Scripps - Analysis of recent acquisitions, 03/21/2019
  Research - ProMIS Neurosciences (PMN:CA) - Potential opportunity in Alzheimer's , 03/21/2019
  Research - Genie Energy (GNE) - Initiation Report, 03/20/2019
  Research - E.W. Scripps (SSP) - Acquiring stations, building portfolio, 03/20/2019
  Research - Tegna (TGNA) - Acquisition highlights, 03/20/2019
  Research - Information Services (III) - 2019 growth possibilities, 03/18/2019
  Research - Tribune Publishing (TPCO) - Behind the numbers , 03/18/2019
  Research - Harte-Hanks (HHS) - The focus towards growth, 03/15/2019
  Research - Information Services (III) - Q4 review; the full story, 03/15/2019
  News - Artificial Intelligence: Can an algorithm do what you do?, 03/14/2019
  Research - Townsquare Media (TSQ) - Quarter over delivers, 03/14/2019
  Research - Tribune Publishing (TPCO) - Looking forward into 2019, 03/14/2019
  Research - KeyW (KEYW) - What will drive 2019 performance?, 03/13/2019
  Research - Townsquare Media (TSQ) - Revenues surprise, 03/13/2019
  Research - Salem Media (SALM) - Looking past the first quarter 2019, 03/13/2019
  Research - Energy Fuels (UUUU) - Updating estimates, 03/13/2019
  News - CRISPR-Cas9: Editing away sickness, 03/13/2019
  Research - Gannett (GCI) - Favorable risk/reward, 03/12/2019
  Research - Comtech Telecommunications (CMTL) - Deeper dive in 2Q19 results, 03/12/2019
  Research - Euroseas (ESEA) - Lowering Price Target, 03/12/2019
  Research - Aurania Resources (ARU:CA) - New drilling has commenced, Funding secured, 03/11/2019
  Research - Great Lakes Dredge (GLDD) - Investor Meeting Highlights, 03/11/2019
  News - Green New Deal: Environment Savior or Economy Destroyer?, 03/08/2019
  Research - McClatchy (MNI) - Outlook for 2019, 03/08/2019
  Research - Trovagene (TROV) - 2018 full year update, 03/08/2019
  News - Do We Need to Prepare for War in Space?, 03/07/2019
  Research - Eagle Shipping (EGLE) - Long-term outlook positive, 03/07/2019
  Research - Comtech (CMTL) - Exceeds 2Q quarterly expectations, 03/07/2019
  Research - Kratos Defense (KTOS) - Drone prospect takes flight, 03/07/2019
  News - DNA Data Storage: The Future of Informatics, 03/06/2019
  Research - Genco Shipping (GNK) - 4Q18 Results Surprise , 03/06/2019
  Research - E.W. Scripps (SSP) - Raising Price Target, 03/05/2019
  NobleConXV Panel - Marketing Early-Stage Natural Resource Companies to Investors, 03/05/2019
  Research - Tegna (TGNA) - Looking towards subscriber growth in 2019, 03/04/2019
  Research - Great Panther Silver (GPL) - Expectations in line, 03/04/2019
  Research - Kratos Defense (KTOS) - Acquisition announced, 03/01/2019
  Research - Gray Television (GTN) - 2018 full year results, 03/01/2019
  Research - Avino Silver (ASM) - Increasing 2019 estimates, 03/01/2019
  Research - Ducommun (DCO) - 2018, the inflection year, 03/01/2019
  News - Merger Mania Hits the Mining Space, 03/01/2019
  News - Electric Cars: Time to plug in?, 02/28/2019
  News - Could the US Have More Oil than the Saudis?!, 02/27/2019
  News - Cannabiz: Growing Like a Weed, 02/26/2019
  Research - Cumulus Media (CMLS) - Earnings preview, 02/26/2019
  News - Legalizing Sports Gambling: Place Your Bets, 02/25/2019
  News - Alzheimer’s, Cannibals, and the Scientist Who Saw the Connection, 02/22/2019
  Research - Cumulus Media (CMLS) - Raising price target, 02/14/2019
  News - High-yield bonds: Trash or Treasure?, 02/13/2019
  News - Trump vs Obama: Who did the first two years better?, 02/12/2019
  A MUST WATCH - panel of key opinion leaders - a cure for diabetes, 02/11/2019
  The business of cannabis - WATCH an industry panel break it all down, 02/11/2019
  WORTH READING - Electric Cars, OPEC Today, FED Impact, 02/11/2019
  Channelchek in Forbes - referenced as a gatekeeper for emerging growth companies, 02/11/2019
  NobleConXV Keynote Address, 02/05/2019
  NobleConXV Webcasts, 02/04/2019
  News - The Great Wall of America, 01/24/2019
  News - Is OPEC still king of oil?, 01/24/2019
  News - End of an Era: Sears Struggles to Survive, 01/23/2019
  News - Buybacks: Who benefits?, 01/21/2019
  News - Robinhood: Could it steal customers from the banks?, 12/31/2018
  News - Holiday Havoc: Why December turned into a tough time for investors, 12/27/2018
  News - The Fed raised its rates, now what?, 12/19/2018
  News - Polo-like kinases inhibitors are novel drug targets of cancer therapeutics, 12/14/2018
  News - Can manufacturing keep up with demand for biologic drugs?, 12/04/2018
  News - HIV - Could there be a cure?, 12/01/2018
  News - Gold - Trending Up?, 11/27/2018
  Welcome to Channelchek video, 11/20/2018
  News - Cancer - Harnessing the power of immune system, 11/15/2018
  News - Cancer - Gene therapy, what the future holds, 11/15/2018
  News - Alzheimer’s - The race to a better treatment, 11/15/2018
  News - Trump – Is he right to withdraw from INF?, 11/15/2018
  News - Cancer – Is combination therapy the answer?, 11/15/2018
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