CAR T - Cell Therapy - Competitive Landscape, 2022

CAR T - Cell Therapy - Competitive Landscape, 2022

DelveInsight’s, “CAR T - Cell Therapy - Competitive landscape, 2022,” report provides comprehensive insights about 193+ companies and 450+ drugs in CAR T - Cell Therapy Competitive landscape. It 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 - Cell Therapy: Understanding CAR T - Cell Therapy: Overview Chimeric antigen receptors (CARs) are recombinant receptors for antigens which redirect the specificity and function of T lymphocytes and/or other immune cells in a single molecule. Cancer Immunotherapy utilizes and enhances the immune system's standard capacity and is considered one of the most promising approaches for treating various diseases (including cancer, autoimmune diseases, and allergic–hypersensitivity reactions) are severe. CAR T-cells are the fusion proteins of a selected single-chain fragment variable from a specific monoclonal antibody and one or more T-cell receptor intracellular signaling domains. A CAR combines antigen-binding domains-most commonly, a single-chain variable fragment (scFv) derived from the variable domains of antibodies with the signalling domains of the TCR chain and additional costimulatory domains from receptors, such as CD28, OX40, and CD137. CAR T-cell therapy involves genetic modification of a patient's autologous T-cells to express a CAR, specific for a tumor antigen, followed by ex vivo cell expansion and re-infusion back to the patient. As shown in the below figure, the extracellular domain of the CAR consists of the antigen-binding moiety and a spacer. These antigen-binding moieties could be: • an scFv (single-chain fragment variable), derived from antibodies • a human Fab fragment, selected from phage display libraries • nature ligands that engage their cognate receptor Report Highlights • In February 2022, Fully human anti-B-cell maturation antigen (BCMA) chimeric antigen receptor (CAR) T-cell therapy (CT103A) received orphan drug designation (ODD) from the FDA for the treatment of relapsed and/or refractory multiple myeloma (R/R MM), according to a press release by IASO Biotherapeutics. • In March 2022, JW Therapeutics announced that it has received the Investigational New Drug (IND) clearance from the National Medical Products Administration (NMPA) of China for a pivotal clinical trial of its anti-CD19 autologous chimeric antigen receptor T (CAR-T) cell immunotherapy product Carteyva (relmacabtagene autoleucel injection) in the treatment of second-line large B-Cell lymphoma. • In April 2022, the FDA approved axicabtagene ciloleucel (brand name Yescarta) for adult patients with large B-cell lymphoma that is refractory to first-line chemoimmunotherapy or relapses within 12 months of first-line chemoimmunotherapy. It is not indicated for the treatment of patients with primary central nervous system lymphoma. • In May 2022, Novartis announced the US Food and Drug Administration (FDA) has granted accelerated approval for Kymriah (tisagenlecleucel) for the treatment of adult patients with relapsed or refractory (r/r) follicular lymphoma (FL) after two or more lines of systemic therapy. Kymriah is now FDA approved in three indications and remains the only CAR-T cell therapy approved in both adult and pediatric settings • In March 2021, The US Food and Drug Administration approved Abecma (idecabtagene vicleucel), a cell-based CAR T - Cell Therapy to treat adult patients with multiple myeloma who have not responded to, or whose disease has returned after, at least four prior lines (different types) of therapy. Abecma is the first cell-based CAR T - Cell Therapy approved by the FDA for the treatment of multiple myeloma. • In June 2021, based on ZUMA-3 study data, the US FDA has accepted the supplemental Biologics License Application (sBLA) and granted Priority Review designation for Tecartus for the treatment of adult patients with relapsed or refractory B-cell precursor ALL • In April 2021, The Janssen Pharmaceutical Companies of Johnson & Johnson announced that they had submitted a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) seeking approval of cilta-cel for the treatment of patients with relapsed and/or refractory multiple myeloma Company Profiles & their Late-stage Drug Profiles 1. Company Overview: JW Therapeutics JW Therapeutics (HKEx: 2126) is an independent and innovative biotechnology company focusing on developing, manufacturing and commercializing cell immunotherapy products. Founded in 2016, JW Therapeutics is committed to becoming an innovation leader in cell immunotherapy. The company has built a top world-class platform for technology and product development in cell immunotherapy, as well as a promising product pipeline covering both hematologic malignancies and solid tumors, to bring the hope of a cure for Chinese and global patients, and to lead the healthy and standardized development of China’s cell immunotherapy industry. Product Description: JWCAR029 JWCAR029 is a CAR-T cell product targeting CD19, which is intended to treat late-stage lymphoma and leukemia (Second-line therapy or greater). The molecule is in phase-II stage of development. Initially, JWCAR029 is being studied for the treatment of B-cell malignancies focusing on relapsed and refractory DCBCL. In June 2020, the National Medical Products Administration (“NMPA”) accepted for review its NDA relating to relma-cel as a third-line treatment for DLBCL. 2. Company Overview: Gilead Sciences Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. The company strives to transform and simplify care for people with life-threatening illnesses around the world. Gilead has operations in more than 35 countries worldwide, with headquarters in Foster City, California. Product Description: KTE-X19 KTE-X19 is an investigational, autologous, CD19 CAR T-cell therapy. The drug uses the XLP manufacturing process that includes T-cell selection and lymphocyte enrichment. Lymphocyte enrichment is necessary in certain B-cell malignancies for which KTE-X19 in under investigation. KTE-X19 is currently in Phase II clinical evaluation for the treatment of adult acute lymphocytic leukemia and pediatric acute lymphocytic leukemia. The FDA has approved brexucabtagene autoleucel (formerly KTE-X19; Tecartus) for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL). 3. Company Overview: Bristol Myers Squibb Bristol Myers Squibb is inspired by a single vision—transforming patients’ lives through science. The goal of the company’s cancer research is to deliver medicines that offer each patient a better, healthier life and to make cure a possibility. Building on a legacy across a broad range of cancers that have changed survival expectations for many, Bristol Myers Squibb researchers are exploring new frontiers in personalized medicine, and through innovative digital platforms, are turning data into insights that sharpen their focus. Deep scientific expertise, cutting-edge capabilities and discovery platforms enable the company to look at cancer from every angle. Cancer can have a relentless grasp on many parts of a patient’s life, and Bristol Myers Squibb is committed to taking actions to address all aspects of care, from diagnosis to survivorship. Because as a leader in cancer care, Bristol Myers Squibb is working to empower all people with cancer to have a better future. Product Description: Abecma Abecma is the first-in-class B-cell maturation antigen (BCMA)-directed chimeric antigen receptor (CAR) T cell immunotherapy approved in the U.S. for the treatment of adult patients with relapsed or refractory multiple myeloma after four or more prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody. Abecma recognizes and binds to BCMA on the surface of multiple myeloma cells leading to CAR T cell proliferation, cytokine secretion, and subsequent cytolytic killing of BCMA-expressing cells. Abecma was granted Orphan Drug and Breakthrough Therapy designations by the FDA. Orphan Drug designation provides incentives to assist and encourage the development of drugs for rare diseases. 4. Company Overview: Novartis Novartis is reimagining medicine to improve and extend people’s lives. As a leading global medicines company, we use innovative science and digital technologies to create transformative treatments in areas of great medical need. In company quest to find new medicines, consistently rank among the world’s top companies investing in research and development. Novartis products reach nearly 800 million people globally and finding innovative ways to expand access to our latest treatments. About 108,000 people of more than 140 nationalities work at Novartis around the world. Product Description: Kymriah Kymriah is a genetically-modified autologous T-cell immunotherapy. Each dose of Kymriah is a customized treatment created using an individual patient’s own T-cells, a type of white blood cell known as a lymphocyte. The patient’s T-cells are collected and sent to a manufacturing center where they are genetically modified to include a new gene that contains a specific protein (a chimeric antigen receptor or CAR) that directs the T-cells to target and kill leukemia cells that have a specific antigen (CD19) on the surface. Once the cells are modified, they are infused back into the patient to kill the cancer cells. 5. Company Overview: Innovent Biologics Innovent has built an international team of advanced talents in high-end biological drug development and commercialization, including many overseas experts. The company has also entered into strategic collaborations with Eli Lilly and Company, Adimab, Incyte, Hanmi and other international pharmaceutical companies. Innovent strives to work with all relevant parties to help advance China’s biopharmaceutical industry, improve drug availability to ordinary people and enhance the quality of the patients’ lives. Since it was founded, Innovent has developed a fully-integrated platform which includes R&D, CMC (Chemistry, Manufacturing, and Controls), clinical development and commercialization capabilities. Leveraging the platform, the company has built a robust pipeline of 21 innovative assets in the fields of oncology, metabolic diseases and other major therapeutic areas. Sixteen have entered into clinical development, four have entered Phase 3 clinical trials, three monoclonal antibodies have their New Drug Application (NDA) under review and three of them have been granted with priority review status, and one, Tyvyt (sintilimab injection), is now approved for relapsed or refractory classical Hodgkin’s lymphoma (r/r cHL). Product Description: CT 103A CT103A is an innovative therapy co-developed by IASO BIO and Innovent. Previous studies indicate patients with relapsed/refractory multiple myeloma (RRMM) who received high-dose BCMA-targeting CAR-T cells may achieve better remission but have worse adverse events. Moreover, once the disease progresses again, the re-infusion of CAR-T cells is not effective. To solve this dilemma, CT103A has been developed, a lentiviral vector containing a CAR structure with a fully human scFv, CD8a hinger and transmembrane, 4-1BB co-stimulatory and CD3z activation domains. Based on strict selection and screening, utilizing a proprietary in-house optimization platform, the construct of the CT103A CAR-T is potent and persistent. According to the company’s pipeline, the drug is currently in Phase III stage of clinical trial evaluation to treat multiple myeloma. Further product details are provided in the report…….. Future of Competitive Landscape of CAR T - Cell Therapy is estimated to be very strong. Key emerging and approved drugs include Novartis Kymriah and many other. CAR T - Cell Therapy Analytical Perspective by DelveInsight • In-depth CAR T - Cell Therapy analysis: Assessment of Products The Report provides in-depth commercial assessment of drugs that have been included, which comprises collaboration, agreement, licensing and acquisition – deals values trends. The sub-segmentation is described in the report which provide company-company collaboration (licensing/partnering), company academic collaboration and acquisition analysis in tabulated form. • CAR T - Cell Therapy clinical assessment of products The report comprises of comparative clinical assessment of products by development stage, product type, and route of administration, molecule type. CAR T – Cell Therapy Report Assessment • Company Analysis • Therapeutic Assessment • Approved/Pipeline drug Assessment • Inactive drugs assessment • Unmet Needs Key Questions Current Treatment Scenario and Emerging Therapies: • How many companies are developing CAR T - Cell Therapy drugs? • How many CAR T - Cell Therapy 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 - Cell Therapy? • What are the key collaborations (Industry–Industry, Industry–Academia), Mergers and acquisitions, licensing activities related to the CAR T - Cell 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 CAR T - Cell Therapy and their status? • What are the key designations that have been granted to the emerging and approved drugs?   Key Players • Alnylam Pharmaceuticals • JW Therapeutics • Gilead Sciences • Janssen Pharmaceuticals • Innovent Biologics • Sorrento Therapeutics • Cartesian Therapeutics • CASI Pharmaceuticals/Juventas Cell Therapy • Novartis • Poseida Therapeutics • Shanghai Unicar-Therapy Bio-medicine Technology • Sinobioway Cell Therapy Co., Ltd. • Tessa Therapeutics • Wuhan Bio-Raid Biotechnology • Miltenyi Biomedicine • Bristol-Myers Squibb • Autolus Limited • Beijing Immunochina Medical Science and Technology • Carsgen Therapeutics • Cellular Biomedicine Group • Chongqing Precision Biotech • Eureka Therapeutics • Formula Pharmaceuticals • Guangzhou Bio-gene Technology • Hebei Senlang Biotechnology • Mustang Bio • MolMed • Aurora BioPharma • Atara Biotherapeutics • Autolus • Bellicum Pharmaceuticals • Kecellitics Biotech Company Ltd • Yake Biotechnology • Minerva Biotechnologies • Allogene Therapeutics • PersonGen BioTherapeutics (Suzhou) • Precision BioSciences • Pregene (ShenZhen) Biotechnology Company • Shanghai GeneChem • Shanghai Longyao Biotechnology • Shenzhen BinDeBio Key Products • Breyanzi • Kymriah • CT103A • CEA CAR-T • Descartes-11 • CNCT19 • CTL119 • P-BCMA-101 • CD19/CD20/CD22/CD30 CAR T-cell therapy • CD19-targeted CAR T-cells • EPCAM-targeted CAR-T cells • TT11 • CD19+CD22 CAR-T cell sequential therapy • CART-19/22 • MB-CART2019.1 • JCAR017 • AUTO4 • AUTO3 • IM19 CAR-T • CSG-CD19 • CT053 • Descartes-08 • Orvacabtagene autoleucel • CAR-T CD30 • PCAR-19B • BCMA CAR-T cells • CD123 CAR-T cells • CD19 CAR-T cells • ET140202 • CIK-CAR.CD19 • BG-T19 • Autologous CD19-targeting CAR T cells (Senl-001) • MB-102 • Autologous CAR-T CD44v6 cell therapy • AU101 • ATA2271 • AU105 • AUTO1 • BPX-601 • Anti-CD22 CAR • CAR-T cells targeting CD19 and CD22 • huMNC2-CAR44 CAR T-cells • CD19-CART • ALLO-501A • AUTO1/22 • ET 1402L1-CART • BPX-603 • CAR-CD44v6 • MB-106 (CD20 CAR) • Anti-MUC1 CAR-T cells • PCAR-019 • PBCAR0191 • PBCAR20A • PBCAR269A • BCMA CAR T-cells • CAR19 CAR T cells • MG7-CART Cells • GPC3 – CART Cells • Anti-CD19 and Anti-CD20 CAR-T Cells • Humanized CD19 CAR-T cells • Dual Specificity CD19 and CD22 CAR-T Cell Immunotherapy • Mesothelin CAR-T cell therapy

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