Learn more about innovative CAR-T cell therapy companies and the technologies they use to fight cancer. This article lists 100+ of the leading CAR-T therapy companies worldwide.
In this article:
The Leaders of the CAR-T Industry
An Introduction to CAR-T Companies
Chimeric antigen receptor T-cell therapy (CAR-T) is an approach that is now being explored as an alternative to conventional treatments for several forms of cancer. Thus, CAR-T companies are on the rise, supported by a growing investment flowing into CAR-T research, landmark approvals of CAR-T cell therapies Kymriah and Yescarta, and major acquisitions within the CAR-T space. Most notably, Celgene snagged Juno Therapeutics for a shocking $9 billion in January 2018, and Gilead acquired Kite Pharma for an astounding $11.9 billion in August 2017.
Ranging from small to large, CAR-T companies are emerging in healthcare markets worldwide.
Chimeric Antigen Receptors
Chimeric antigen receptors (CARs) are defined as genetically engineered allogeneic cells that are developed in the laboratory and infused into a patient to help in detecting and fighting cancer cells. The protein constructs stimulate anti-cancer T-cells, which in turn boost a patient’s immune system.
Increase in CAR-T Biotech Companies
Medicine continues to be greatly revolutionized by the continuous advancements in both treatment and technology. What is capable of being done today would have been previously unfathomable. An example of this is the rise of CAR-T cell therapies, as biotechnology companies seek ways to revolutionize cancer treatments and resolve basic challenges that have restricted patient care for years.
List of CAR-T Cell Therapy Companies
Below are 100+ of the leading CAR-T immunotherapy companies involved with chimeric antigen receptor (CAR-T) cell technologies. Some of the companies are developing CAR-T therapies in-house, while others have invested in, acquired, or partnered with companies developing CAR-T therapies.
AbbVie (NYSE: ABBV) and Calibr, a nonprofit drug discovery division of Scripps Research, are co-developing CAR-T therapies aimed at solid tumors and other cancers. Under the terms of the license agreement, AbbVie will pay Calibr an undisclosed upfront license fee and gain exclusive access to Calibr’s switchable CAR-T platform. Calibr’s novel cell therapy program is designed to enhance safety, versatility and efficacy through a proprietary modular “switchable” CAR-T cell that uses antibody-based switch molecules to control the activation and antigen specificity of CAR-T cells. Calibr’s proprietary technology may enable the development of universal CAR-T-based treatments across several types of hematological and solid tumor indications.
Adaptimmune Therapeutics PLC
Adaptimmune’s proprietary SPEAR T-cell platform has produced a robust pipeline of affinity-enhanced T-cell therapies, with multiple INDs open. The company uses these therapies to harness the body’s own immune system to find and destroy cancer cells.
Agios is focused on developing small-molecule anticancer therapeutics targeting cancer cell metabolism through the growth factor pathway. Agios had a broad parternship with Celgene that assisted its ability to have a July 2013 IPO in which it become a publicly traded company (NASDAQ: AGIO). In May 2016, Agios then entered a $200 million deal with Celgene to to develop therapeutics that impact cellular metabolism and explore immuno-oncology drug prospects. Celgene previously entered into a $1 billion deal with Juno involving CAR-T and T-cell receptor technologies and is now supporting Agios within these realms.
Allife Medical Science and Technology Co., Ltd.
ALLIFE has the world leading reprogramming, differentiating and NK based CAR engineering technologies. The company’s cancer immunotherapy program covers a pipeline of CAR-NK therapies for different cancer types from blood cancers to solid malignant tumors. NK cells are a type of innate immune cells that is uniquely responsible for killing and removing diseased cells such as cancer cells.
Launched April 2018, Allogene Therapeutics was formed by two former Kite Pharma executives and raised $300 million in investor funds to acquire and advance a portfolio of cell therapies previously controlled by Pfizer. Allogene will receive from Pfizer the rights to 16 preclinical CAR-T assets licensed from Cellectis and Servier and one clinical asset licensed from Servier, UCART19, an allogeneic CAR T therapy that is being developed for treatment of CD19-expressing hematological malignancies. In partnership with Servier, UCART19 is initially being developed in acute lymphoblastic leukemia (ALL) and is currently in Phase I. UCART19 utilizes TALEN® gene editing technology pioneered and owned by Cellectis. As a result of the deal, Pfizer will have a 25% ownership stake in Allogene.
Since January 2015, Amgen and Kite Pharma have strategic partners in the development and commercialize CAR-T cell therapies based on Kite’s engineered autologous cell therapy (eACT™) platform and Amgen’s broad array of cancer targets. The collaboration combines Amgen’s immuno-oncology assets with Kite’s industry dominance in CAR T cell therapy sector.
Anixa Biosciences, Inc.
Anixa’s therapeutics portfolio includes a cancer immunotherapy program, which uses chimeric endocrine receptor t-cell (CER-T) technology, a novel type of CAR-T, and a cancer vaccine technology focused specifically on triple negative breast cancer (TNBC), the most lethal form of the disease.
In 2015, Anke acquired 15% share of PersonGen, becoming involved with immunoncology and securing co-development rights to PersonGen’s CAR-T projects. The company develops CAR-T therapies for well known targets, such as CD19, and solid tumor markers, such as MUC1. PersonGen has a 2,000 sq. meter GMP CAR-T cell production plant.
Current engineered immune cell therapies often target tumors through a mono-specific receptor that is constitutively expressed and active. In contrast, Arcellx has developed Antigen Receptor Complex T cells (ARC-T) that are readily silenced, activated, and reprogrammed in vivo by administration of a tumor-targeting antigen protein called a sparX. It controls the activity of ARC-T cells by replacing the scFv binding domain found in conventional chimeric antigen receptors (CARs) with a proprietary binding domain specific for a universal “TAG”.
Atara Biotherapeutics (Nasdaq: ATRA) is an off-the-shelf, allogeneic T-cell immunotherapy company developing treatments for patients with cancer, autoimmune and viral diseases. Originating from clinical experience at Memorial Sloan Kettering and QIMR Berghofer, Atara’s off-the-shelf, allogeneic, T cells are bioengineered from donors with healthy immune function and allow for rapid delivery from inventory to patients without a requirement for pretreatment. Atara Biotherapeutics is building a $55M, 90,000-sq-ft CAR-T manufacturing facility in Thousand Oaks, California.
Aurora Biopharma, Inc.
Aurora has a clinical trial collaboration to conduct CAR-T trials with Baylor College of Medicine, Texas Children’s Hospital and Baptist Methodist Hospital in Houston, Texas. The company’s pre-clinical and clinical trials have been supported by financial contributions from the National Institute of Health, Cancer Prevention & Research Institute of Texas, Alliance for Cancer Gene Therapy, American Brain Tumor Association, and other foundations.
Autolus is a leader in cutting-edge T-cell therapies. Utilising advanced cell programming and manufacturing technologies, it has established a development-stage pipeline of CAR-T products for the treatment of haematological malignancies and solid tumors. Autolus uses powerful Chimeric Antigen Receptors (CARs) or T-cell receptors (TCRs) to reprogramme T cells to recognise and kill tumour cells. It is participating in a LibrA T1 trial, a single-arm, open label, multi-center trial evaluating the safety and efficacy of AUTO4, a single dose intravenous CAR T cell treatment for for Peripheral T Cell Lymphoma (PTCL).
Beam Therapeutics is applying base editing across a wide range of serious genetic diseases using both ex vivo and in vivo delivery approaches. It has released data on one of the emerging applications of base editing technology, which is to enable multiplex editing of CAR-T cells without genomic rearrangements. As stated by the company, for advanced cellular therapies requiring a large number of simultaneous edits, base editing represents an important new technology that could open up new options for patients with cancer and other immune-mediated diseases.
Beijing Biohealthcare Biotechnology Co.,Ltd
Beijing Kangai Ruihao Biotechnology Co., Ltd. is carrying out R&D related to the industrialization of CAR-T and immune cell technology. The company has a cell-based drug preparation center designed and managed by the GMP standard, which will provide a pharmaceutical-grade CAR-T and immune cell preparation. The GMP standard cell drug preparation center has a drug-grade CAR-T production line, a drug-level lentivirus production line, a plasmid preparation production line, a stem cell production line, and an immune cell production line.
Beijing Doing Biomedical Co., Ltd.
Beijing Doing Biomedical Co., Ltd. is sponsor of a multi-centre, non-randomised, open label Phase I clinical trial of an Advanced Therapy Investigational Medicinal Product named CD19 CD20 Chimeric Antigen Receptor (CAR) T-cells (CD19 CAR T-cells) in patients with high risk, relapsed CD19+ and CD20+haematological malignancies (leukemia and lymphoma).
Beijing Immunochina Medical Science & Technology Co., Ltd.
Beijing Immunochina is developing CAR-T technology and CAR-T cell products for the treatment of malignant tumors. Founders of Immunochina, Dr. He Ting, Dr. Lu Xin’an and Dr. Qi Feifei, graduated from School of Life Sciences, Tsinghua University. They have been devoted to the basic and translational research in cancer and immunology, and have mastered multiple CAR-T core techniques.
Beijing Sanwater Biological Technology Co., Ltd.
Beijing Sanwater Biological Technology Co., Ltd. is sponsor of a single arm, open-label, multi-center, phase I study which will determine the efficacy of CTL019 in patients with r/r B-cell ALL.
Located near the Houston Medical Center in Texas, Bellicum Pharmaceuticals focuses on developing innovative cellular immunotherapies for cancers and blood disorders. Its GoCAR-T technology incorporates a switch that activates CAR-T cells when triggered by both rimiducid and the targeted antigen expressed on the surface of the cancer cells. GoCAR-T cells are designed to only be fully activated when exposed to both the cancer cells and rimiducid, a system designed to control the degree of activation of the CAR-T cells through adjustments in rimiducid administration.
BioAtla’s partner, Shanghai Sinobioway Sunterra Biotechnology, is undertaking a clinical trial for two novel, conditionally active chimeric antigen receptor T cell (CAB-CAR-T) product candidates targeting Axl and Ror2 for the treatment of metastatic renal cell carcinoma. The precision medicine-driven clinical trial will enroll patients in China with multi-organ, recurrent/refractory metastatic renal cell carcinoma.
F1 Oncology, BioAtla’s partner in CAB technology applications for adoptive cellular therapies (ACTs), combines BioAtla’s CAB technology with F1 Oncology’s proprietary technologies with the goal of developing and commercializing CAB-CAR-T therapies for the treatment of solid tumor malignancies. CAB-CAR-T cell therapies are designed to be conditionally active only in the tumor microenvironment and may help reduce potential adverse events associated with on-target, off-tumor effects of CAR-T therapies.
Bioceltech Therapeutics, Ltd.
Bioceltech Therapeutics is developing allogenic and autologous CAR-T treatments for hematologic neoplasms like leukemia and lymphoma, as well as autologous CAR-T therapies for solid tumors such as ovarian cancer, pancreatic cancer, gastric cancer and glioma etc. Additionally, it is developing nonspecific NK cell therapies for solid tumors.
BioNTech is developing second-generation CAR-T therapy designed to overcome the shortcomings of CAR-T therapy in solid tumors.Its mechanism relies on T cells with CARs engineered to target cancer-specific antigens, including novel antigens selected from its proprietary antigen library and administered with a FixVac immune booster.
bluebird bio has an integrated product platform encompassing cancer immunotherapy, gene therapy and gene editing. In partnership with Celgene, it is developing bb2121, a CAR-T therapy targeting b-cell maturation antigen (BCMA) in previously treated patients with multiple myeloma. bb2121 has Breakthrough Therapy Designation with the FDA and PRIME (PRIority MEdicines) eligibility by the EMA.
In June 2018, Calibr announced a collaboration to develop CAR-T therapies in partnership with Abbvie. Calibr’s novel cell therapy program, led by Travis Young, Ph.D., Director of Protein Sciences at Calibr, is designed to “enhance safety, versatility and efficacy through a proprietary modular ‘switchable’ CAR-T cell that uses antibody-based switch molecules to control the activation and antigen specificity of CAR-T cells.” Calibr’s proprietary technology may be capable of enabling universal CAR-T-based treatments across a variety of hematological and solid tumor indications.
Carina Biotech is an Australian biotech company researching and developing chimeric antigen receptor T cell (CAR-T) technologies to treat solid cancers including pediatric and rare cancers. Carina has produced a pan-cancer CAR-T cell (CNA1003) that can kill a wide range of solid cancers in vitro including high incidence cancers and rare and paediatric cancers.CNA1003 has shown dose-responsive in vitro cytotoxicity against 21 different cancer cell lines across 13 cancer types. Pilot in vivo data has so far demonstrated significant anti-cancer activity of CNA1003 against a number of human cancers.
CARsgen Therapeutics is commercializing CAR-T cell therapies for solid tumors and and hematology malignancies. Its pioneering CAR-T cell therapies include: anti-GPC3 CAR-T for hepatocellular carcinoma (HCC), anti-GPC3 CAR-T for squamous lung cancer (SLC), cancer-specific anti-EGFR CAR-T for glioblastoma multiforme (GBM) and first-in-class anti-Claudin18.2-CAR-T for gastric and pancreatic cancer. Its anti-Claudin18.2 CAR-T cell therapy is being tested within a clinical trial at Changhai Hospital of Shanghai, a Chinese hospital with a specialty in gastroesophageal and related cancers.
Cartesian is developing potent yet safer cell and gene therapies designed to benefit the broadest range of patients with cancer and autoimmune diseases. Unlike conventional CAR-T cells, which have the potential for uncontrolled proliferation and ensuing severe toxicity, Cartesian’s Descartes CAR T-cells are engineered to have a defined and predictable half-life, enabling repeat dosing to maximize potency while minimizing risk of toxicity. The products’ enhanced safety features are intended to enable convenient, outpatient treatment of potentially the widest range of diseases for any CAR-T therapy, from multiple myeloma (relapsed/refractory or early-stage disease), other cancers, and a spectrum of autoimmune conditions such as generalized myasthenia gravis.
Cartherics Pty Ltd
Cartherics Pty Ltd is developing next generation immunotherapies for adenocarcinomas, with an initial primary focus on ovarian, gastric cancers and cutaneous T cell lymphomas. The products in development include potential chimeric antigen receptor (CAR-T) enhanced killer T cells for autologous and allogeneic (‘off-the-shelf’) cancer therapies. In May 2018, Mesoblast partnered with Cartherics to develop allogeneic ‘off-the-shelf’ CAR-T cells armed with multiple targeting receptors for use in solid cancers.
An American biotechnology company, Celgene grabbed the spotlight when it acquired Juno Therapeutics for $9 billion in January 2018 in a strategic move to acquire full rights to the bluebird bio’s CAR-T program. In December 2017, Celgene’s research partner bluebird bio also released promising results for its CAR-T product bb2121 in multiple myeloma patients.
Cell Design Labs (Acquired by Gilead Sciences)
Cell Design Labs was acquired by Gilead Sciences in December 2017. In the deal, Gilead acquired all of the outstanding shares of Cell Design Labs, including the 12.2% of shares held by Gilead subsidiary Kite Therapeutics, for up to approximately $567 million. Cell Design Labs is a biotherapeutics company on a mission to discover and build the next generation of anti-cancer therapies, using two unique technology platforms: Throttle™ (an “on/off” switch that allows the control of CAR T-cell activity using small molecules) and synNotch™ (a synthetic gene expression system that can be deployed to engineer CAR-T cells that require dual antigen recognition for activation).
Cell Medica is developing off-the-shelf engineered T cell therapies. It is harnessing the natural properties of a specific subset of cytotoxic T cells, Natural Killer T cells (NKT cells), and engineering them with features to enhance their anti-tumor efficacy. It CAR-NKT candidates are being developed in collaboration with Baylor College of Medicine and University of North Carolina. The first CAR-NKT product (CMD-501) is being investigated in a trial in pediatric patients with relapsed/refractory neuroblastoma. CMD-501 is an autologous CAR-NKT cell product that targets GD2, a tumor-associated antigen frequently expressed in neuroblastoma.Its second CAR-NKT cell candidate (CMD-502) is an allogeneic product targeting CD19+ B-cell malignancies that is in late stage pre-clinical development and undergoing IND-enabling studies.
Cellectis develops genome-edited chimeric antigen receptor T-cell technologies for cancer immunotherapy. It is creating “off-the-shelf” allogeneic products it calls UCART (Universal Chimeric Antigen Receptor T-cells). UCART19 is its allogeneic anti-CD19 CAR T-cell product being developed by Servier and Pfizer. UCART123 is its product candidate for acute myeloid leukemia (AML) and blastic plasmacytoid dendritic cell neoplasm (BPDCN).
Cellular Biomedicine Group, Inc. (CBMG)
Cellular Biomedicine Group (NASDAQ: CBMG) develops proprietary cell therapies for cancer and degenerative diseases. Its pipeline includes preclinical compounds targeting CD20-, CD22- and B-cell maturation antigen (BCMA)-specific CAR-T compounds, and T-cell receptor (TCR) and tumor infiltrating lymphocyte (TIL) technologies. It conducts immuno-oncology and stem cell clinical trials in China using products from its GMP laboratory. Its GMP facilities in China, consisting of 12 independent cell production lines, are designed and managed according to China and U.S. GMP standards. In September 2017, CBMG entered into a strategic licensing and collaboration agreement with Novartis to manufacture and supply the CAR-T cell therapy Kymriah® (tisagenlecleucel) in China.
Celularity is looking to solve the bottleneck in the CAR-T industry by deriving T-cells from a single (allogeneic) cell line, potentially positioning itself to slash the price point for CAR-T treatments. Celularity’s medicine asset portfolio consists of more than 200 issued or pending patents, as well as pre-clinical and clinical assets, including CAR constructs for allogeneic CAR-T/NK products and licenses of 100+ immunotherapy assets.
Celyad is a clinical-stage biopharmaceutical that is developing CAR-T NK cell-based immunotherapies for cancer treatment. The Belgium-based company holds U.S. Patent No. 9,181,527 relating to allogeneic human primary T-Cells that are engineered to be T-Cell Receptor (TCR)-deficient and express a Chimeric Antigen Receptor (CAR). Its unique immunotherapy approach emerged from research conducted by Professor Charles Sentman and his team at Dartmouth College, called the NKR-T platform. Celyad is now sponsoring and a trial called “Therapeutic Immunotherapy Using NKR-2 T cells” (THINK).
CRISPR Therapeutics AG
CRISPR Therapeutics is developing a portfolio of CAR-T cell product candidates based on its gene-editing technology. The company believes the precision and efficiency of multiplexed editing with CRISPR/Cas9 may ultimately allow it to overcome the primary challenges with the current generation of CAR-T therapies. For one, with CRISPR/Cas9, it can generate off-the-shelf (allogeneic) CAR-T cells, which have distinct advantages over the autologous (patient-derived) products currently on the market. In addition, it can use CRISPR/Cas9 to eliminate or insert genes to create new classes of CAR-T products with improved applicability to solid tumors.
CytoMed Therapeutics Pte Ltd
CytoMed is sponsoring a clinical trial that is an open-label, single-centre, dose escalation, phase I study designed to investigate the safety and tolerability of haploidentical / allogeneic NKG2DL-targeting chimeric antigen receptor (CAR) grafted Gamma Delta (γδ) T Cells (CTM-N2D) in subjects with relapsed or refractory solid tumour. The study objectives of this phase I study are to determine the safety, activity and the safe dose of haploidentical or allogeneic NKG2DL-targeting CAR-grafted γδ T cells in patients with relapsed or refractory solid tumors of different types.
Endocyte is pursuing an Investigational New Drug application for its adaptor-controlled CAR T-cell therapy, which will be studied initially in osteosarcoma.
Eureka Therapeutics Inc.
Eureka Therapeutics has relesaed preliminary safety and clinical results from its ongoing proof-of-concept study of ET140202 T-cell therapy in AFP-positive patients with hepatocellular carcinoma (HCC), the most prevalent form of liver cancer. The data was presented in the late-breaking abstracts session of the CAR-TCR Summit in Boston, Massachusetts. The ET140202 clinical proof-of-concept study was sponsored by Aeon Therapeutics (Shanghai) Co.
F1 Oncology, Inc.
BioAlta LLC and F1 Oncology, Inc. signed a global license agreement to combine BioAtla’s CAB technology with F1 Oncology’s proprietary technologies to develop and commercialize CAR-T therapies and other ACTs for the treatment of cancer.
Fate Therapeutics is developing FT819 as an off-the-shelf CAR T-cell product candidate produced from a master induced pluripotent stem cell (iPSC) line. FT819 has two targeting receptors, a chimeric antigen receptor (CAR) targeting CD19-positive tumor cells and a CD16 Fc receptor that can engage other proven cancer therapies, such as tumor antigen-targeting monoclonal antibody (mAb)-based treatments, to overcome antigen escape.
Fortress Bio got involved in the CAR-T space through its subsidiary Mustang Bio, a clinical-stage biopharmaceutical company that is developing CAR-T technologies with a strategy that is heavy on in-licensing, acquiring an ownership interest, funding third-party R&D, or outlicensing its technologies to bring them to market. In September 2017, Mustang Bioannounced the expansion of its pipeline of CAR T therapies into CD20-directed immunotherapies via an exclusive, worldwide licensing agreement with Fred Hutchinson Cancer Research Center for the use of a CAR T therapy related to autologous T cells engineered to express a CD20-specific chimeric antigen receptor (“CD20 Technology”).
One of the best capitalized and most aggressive players in the CAR-T space, Gilead acquired Kite Pharma for an astounding $12 billion in August 2017. Shortly thereafter in October 2017, Gilead Sciences company Kite Pharma became the second company to achieve a CAR-T cell therapy approval by the U.S. FDA (Yescarta), getting Yescarta approved for the treatment of relapsed or refractory large B-cell lymphoma in adult patients. More recently, Gilead acquired Cell Design Labs in a deal valued at $567 million to further expand its CAR-T product development portfolio.
Guangzhou Anjie Biomedical Technology Co., Ltd.
Guangzhou Anjie Biomedical Technology Co., Ltd. is collaborator in clinical trials exploring CAR T and PD-1 knockout engineered T cells for esophageal cancer.This is a combined phase 1 and 2 clinical study. The aim of its Phase II study is to assess the safety and efficacy of the immunotherapies using anti- MUC1 CAR T cells alone, anti- MUC1 CAR T combining PD-1 knockout engineered T cells, and PD-1 knockout engineered T cell only for the treatment of patients with advanced esophageal cancer.
Hebei Senlang Biotechnology Inc., Ltd.
Hebei Senlang Biotechnology Co., Ltd together Second Hospital of Hebei Medical University, is developing a CAR-T cell immunotherapy clinical study using the CD19 as target for CD19+ patients with relapsed or refractory blood malignant tumors (mainly including ALL and B-cell Lymphoma). This is an open, single-arm, phase I clinical study to evaluate efficacy and safety of chimeric antigen receptor T cell immunotherapy (CAR-T) in the treatment of hematopoietic and lymphoid malignancies. A total of 30 patients are planned to be enrolled over a period of 2 years.
Roche’s RoActemra gains positive CHMP opinion for CAR T-cell-induced cytokine release syndrome. Cytokine release syndrome (CRS), a severe and life-threatening condition, is caused by an overactive immune response and is often associated with the use of chimeric antigen receptor (CAR) T-cell therapy for certain blood cancers. RoActemra would be the first approved treatment for CRS in Europe.
Hrain Biotechnology Co., Ltd.
Hrain Biotechnology has several CAR-T clinical trials registered on ClinicalTrials.gov, an authoritative platform for exchanges of clinical experience in America, as well as multiple clinical centers located in Beijing, Chongqing, Jiangsu, Zhejiang, Henan, and Jiangxi.
Humanigen, Inc. is a biopharmaceutical company developing cutting-edge CAR-T optimization and oncology treatments. Derived from the company’s Humaneered® platform, lenzilumab and ifabotuzumab are monoclonal antibodies with first-in-class mechanisms. Lenzilumab, which targets GM-CSF, is in development as a potential medicine to make CAR-T therapy safer and more effective, as well as a potential treatment for rare hematologic cancers such as chronic myelomonocytic leukemia (CMML) and juvenile myelomonoctyic leukemia (JMML).
iCell Gene Therapeutics
CAR engineered cells expressing single-chain variable fragments (ScFvs) which target a unique surface marker on T cell malignancies. iCell has first-mover technology in this area and a robust patent portfolio. The leading therapeutic in this class is its CD4 targeted CAR, which has an effective IND with US FDA. A clinical trial in conjunction with the University of Louisville and Stony Brook University is enrolling.
Immune Cell, Inc.
Immunotherapy offers an extremely precise approach with the potential to eliminate cancer cells specifically. Immune CEll’s newly designed CD19 targeted ICAR19 T cells can specifically kill CD19+ tumor cells. The company is pursuing a clinical study in which the participants will receive several doses of autologous ICAR19 T cells and the investigators will determine the safety and therapeutic effects of these cells.
Immune Therapeutics is developing CAR-T cell therapies for various applications. It recently acquired the Chinese Chimeric Super Antigen Receptor T cell (CAR-T) cocktail therapy, Immuno-Oncology patents (pending), manufacturing technology, and therapeutic clinical data from Super-T Cell Cancer Company (“STCC”) a newly formed corporation.
Immunochina Pharmaceuticals is developing CAR-T cell therapies and a lentiviral manufacturing platform for the treatment of malignant tumors. As Immunochina expects to receive two IND approvals within China by the end of 2019, the company is accelerating construction of its new commercial-scale, GMP-grade manufacturing facility – supported by recent partnerships with German biopharmaceutical manufacturing and equipment supplier Sartorius and American biotechnology product development company Thermo Fisher Scientific.
The Janssen Pharmaceutical Companies of Johnson & Johnson was granted a PRIME (PRIority MEdicines) designation for the companys investigational B-cell maturation antigen (BCMA) CAR-T therapy, JNJ-68284528 (JNJ-4528), by the European Medicines Agency (EMA). PRIME offers enhanced interaction and early dialogue to optimise development plans and speed up evaluation of cutting-edge, scientific advances that target a high unmet medical need.
Founded in 2013, Juno Therapeutics was acquired by Celgene Corporation for an astounding $9 billion in January 2018. Juno Therapeutics is a clinical-stage immunotherapy company that is revolutionizing medicine by re-engaging the body’s immune system to treat cancer. Juno’s pipeline of investigation CAR T cell product candidates applies its CAR and TCR technologies against a variety of cancer targets.
Juventas Cell Therapy Ltd.
Juventas Cell Therapy is a China-based domestic company located in Tianjin City, China engaged in cell therapy. The company’s lead product, CNCT19, devolved from the CD19 CAR-T, was originally created at the Institute of Hematology, Chinese Academy of Medical Sciences, one of the top hematology centers in China. CD19 CAR-T is used to treat cancer patients with acute lymphoblastic leukemia and relapsed non-Hodgkin lymphoma. Through its commercial collaboration with CASI, Juventas intends to be the first domestic company to launch a CD19 CAR-T in China.
Headquartered in Shanghai, China, JW Therapeutics was founded in 2016 as an innovative CAR-T start-up. It was named “JW” Therapeutics to reflect that it was formed through collaboration by Juno Therapeutics (now owned by Celgene) and WuXi AppTec, combining Juno’s CAR-T platform with WuXi AppTec Group’s R&D and manufacturing. Its first CD19-directed investigational therapy, JWCAR029, is a CAR-T therapy focused on B-cell malignancies, namely relapsed and refractory DCBCL. In March 2018, JW Therapeutics announced it had secured in $90 million in Series A financing to support its progress toward a CAR-T clinical trial. It boasts an impressive investor list that includes: Temasek, Sequoia Capital China, YuanMing Capital, as well as Oriza Seed Capital, Yipu Capital, AVICT Global Holdings, and existing investors WuXi and Juno.
Kecellitics Biotech Company Ltd
Kecellitics Biotech is developing an autologous chimeric antigen receptor T (CAR-T) cell therapy targetting CD 19.
A Gilead Sciences company, Kite Pharma was the second company to achieve a CAR-T cell therapy approval by the U.S. FDA (Yescarta). Priced at $373,000 per patient, Yescarta is for relapsed or refractory large B-cell lymphoma adult patients. Since January 2015, Amgen and Kite Pharma have also had a strategic partnership to develop CAR-T cell therapies based on Kite’s engineered autologous cell therapy (eACT™) platform and Amgen’s broad array of cancer targets.
Leucid Bio is a a spin-out of the UK’s King’s College. Lead by Dr John Maher, a clinical immunologist and immunopathologist who heads the “CAR Mechanics” research group at King’s College London, Leucid Bio is exploring intra tumour applications of CAR-T therapy to treat solid head and neck cancer. The company has a Phase I clinical trial underway (NCT01818323).
Lion TCR Pte. Ltd.
Lion TCR is a Singapore-based clinical stage biotech company developing engineered T-cell immunotherapy against viral-related cancer and chronic hepatitis B with manufacturing and clinical trial operations in China and Singapore. It is world’s first to develop HBV-specific TCR T cell therapy against HCC. Lion TCR’s engineer T cell technologies are exclusively licensed initially from A*STAR, Singapore (TCR-T cell therapy developed by Prof. Antonio Bertoletti’s lab) and the Technical University of Munich (CAR-T cell therapy developed by Prof. Urlike Protzer’s lab).
Luminary Therapeutics takes a non-viral autologous cell therapy approach to cancer and autoimmune disorders. It is developing a broad pipeline of non-viral cell therapies via in-licensed advancements from notable academic institutions’ cell therapy teams. Its leading product candidate is LMY-920, is a CAR-T product for the treatment of B-cell malignancies and autoimmune disorders.
Luye Pharma Group Ltd.
Luye Pharma Group Ltd. has a partnership with the U.S. biotech firm Elpis Biopharmaceuticals Corp. to work on dual target based therapies for cancer patients who fail to respond to current treatment. The companies have a license agreement to jointly develop CAR-R therapies and biologic drug candidates in immuno-oncology.” This is a global collaboration in which Luye will be in charge of the development and commercialization of the co-developed products in China and will have the exclusive rights in the Chinese market.
Marino Biotechnology Co., Ltd.
Marino Biotechnology is developing anti-mesothelin chimeric antigen receptor T (CAR-T) cells for the treatment of patients with mesothelin-positive, recurrent or metastatic malignant tumours.
MaxCyte, Inc. signed a strategic collaboration with Washington University in St. Louis in 2016 for developing unique immunotherapy and CAR-T drug candidates, based on MaxCyte’s proprietary cell engineering platform technology, CARMA.
Medisix Therapeutics Pte Ltd.
Medisix is a Singapore-based immune engineering start-up developing novel cellular therapies to address T cell malignancies. Its technology platform originates from world expert in translational immunology, Professor Dario Campana, MD, PhD, a physician scientist who pioneered CAR-T biology. Its programs utilize proprietary immune engineering approaches that enable T cell leukemias and lymphomas to be targeted with cell therapy. It announced the close of a USD $20 million Series A financing on May 14, 2018.
Mesoblast has combined its technology platform with Cartherics’ technology to facilitate large scale production of allogeneic CAR-T cells produced from induced pluripotent stem cells (iPSCs). Clinical-grade manufacturing and banking methods will be used to convert gene-edited iPSCs to potentially limitless numbers of killer T cells, eliminating costly resources required to produce autologous (patient’s own) CAR-T cells. This could provide large numbers of cancer patients with access to cost-effective ‘off-the-shelf’ CAR-T therapies.
Miltenyi Biotec GmbH
The CliniMACS Prodigy® simplifies the manufacturing processes and enables the automated production of CAR T cells. The instrument is able to perform cell enrichment, activation, genetic manipulation, and expansion with minimal involvement from the user. All steps take place in a closed system, providing a sterile solution for the challenges associated with clinical-grade CAR-T cell production. All reagents for cell enrichment and activation as well as cytokines and media are available in MACS® GMP quality.
Minerva Biotechnologies Corp.
Minerva Biotechnologies’ lead program is a CAR-T targeting MUC1* positive solid tumors that is expected to start a first-in-human clinical trial with the world leading Fred Hutchinson Cancer Research Center. The first targeted indication will be breast cancer.
MolMed’s CAR-T CD44v6 involves isolating the patient’s T cells and modifying them ex vivo with a viral vector. T cells are engineered to express the CAR and the HSV-TK suicide gene already used in Zalmoxis®. Thanks to the presence of CAR, the lymphocytes recognize and kill the tumor cells, while the suicide gene allows to eliminate the T lymphocytes in case of toxic reaction against the patient’s healthy tissues.
MolMed is also the coordinator of the EURE-CART project (EURopean Endeavor for Chimeric Antigen Receptor Therapies) which has obtained a European funding of 5,903,146 euros, as part of Horizon; aimed at demonstrating the safety and efficacy of immunotherapy based on CART-CD44v6 lymphocytes in acute myeloid leukemia and multiple myeloma. Thanks to the experience gained in the development of autologous CD44v6 CAR-T, MolMed is developing autologous CAR-T products against different antigens selectively expressed by tumor cells.
Mustang Bio (NASDAQ:MBIO) is a Fortress Biotech (NASDAQ:FBIO) company that specializes in the development of novel immunotherapies based on proprietary CAR-T technology. In October 2017, it entered into a lease agreement with the UMass Medicine Science Park in Worcester, MA, for a manufacturing facility to develop its CAR-T product candidates. In addition to its CAR-T pipeline, Mustang partnered with the City of Hope National Medical Center and the Fred Hutchinson Cancer Research Center to develop CAR-T therapies for various cancers, and with Harvard Medical School’s Beth Israel Deaconess Medical Center and the Harvard Stem Cell Institute (HSCI) to support the development of CRISPR/Cas9-enhanced CAR T therapies for hematologic malignancies and solid tumors.
Nanjing Legend Biotech
Chinese Firm Nanjing Legend Biotech has developing a strong pipeline of CAR-T products to treat solid and liquid tumors. Johnson & Johnson agreed to pay $350 million to partner with the firm after it released promising CAR-T data at an ASCO annual meeting. Specifically, Janssen Biotech, a Janssen Pharmaceutical Company of Johnson & Johnson, announced it entered into a worldwide collaboration and license agreement with Legend Biotech USA Inc. and Legend Biotech Ireland Limited (“Legend”), subsidiaries of Genscript Biotech Corporation, to develop, manufacture and commercialize a chimeric antigen receptor (CAR) T-cell drug candidate, LCAR-B38M, which targets the B-cell maturation antigen (BCMA). LCAR-B38M is accepted for review by the China Food and Drug Administration (CFDA) and in the planning phase of clinical studies in the United States for multiple myeloma.
In oncoloy, Nektar Therapeutic’s lead product, NKTR-255, is being evaluated in combination with T cell redirection therapies, novel CAR-Ts, anti-HER2 antibodies and anti-CD20 antibodies. For example, effects of NKTR-255, a polymer conjugated human IL-15, are being explored for their efficacy of CAR T cell immunotherapy in a preclinical lymphoma model.
Noile-Immune Biotech is a clinical stage biotechnology company focused on the development and commercialization of next generation CAR-T cells to eradicate solid cancers.Its goals is to discover and develop innovative cancer immunotherapies through partnerships with experts in academia including National Cancer Center (NCC) and Yamaguchi University.
Novartis (NYSE:NVS), a global leader in integrated cancer solutions, achieved a world-first Kymriah became the first CAR-T cell therapy to be approved by the U.S. FDA. With a price tag of $475,000, Kymriah is a treatment for B-cell acute lymphoblastic leukemia that uses autologous (self-derived) T cells. The Swiss multinational pharmaceutical is noted to be one of the largest pharmaceutical companies by both market cap and sales.
Oxford BioMedica PLC
Oxford BioMedica plc signed an agreement with Novartis for the commercial and clinical supply of lentiviral vectors used to generate CTL019 (tisagenlecleucel) and other undisclosed Chimeric Antigen Receptor T cell (CART) products.
PeproMene Bio Inc.
PeproMene signed a mutual investment deal with Binex for developing a CAR-T therapy for patients with recurrence. Around 30% of patients treated with existing CD19-specific CAR-T therapies, like Kymriah and Yescarta are experiencing recurrence. PeproMene Bio is using a newly-discovered antigen, called BAFF-R (B-cell activating factor receptor), to develop the CAR-T therapy for patients with recurrence.
PersonGen BioTherapeutics (Suzhou) Co., Ltd.
PersonGen BioTherapeutics is sponsoring a study designed to explore the safety and efficacy of CD7 CAR-T Cells for patients with relapse/refractory CD7+ NK/T cell lymphoma and T-lymphoblastic lymphoma, and to evaluate the pharmacokinetics of CD7 CAR-T cells in patients.
Pfizer (NYSE:PFE) has partnered with Cellectis and Servier to co-develop allogeneic CAR-T cell therapies for multiple indications. Cellectis’ CAR-T platform technology is an allogeneic approach to CAR-T cell therapies that aims to produce genetically engineered immunotherapy treatments. Through a partnership with Servier, Pfizer is co-developing UCART19 in the U.S., an investigational allogeneic CAR-T cell therapy involving T cells from healthy donors. UCART19 appears bind to the CD19 antigen on the surface of B cells and is believed to elimiante CD19 positive cells through T-cell mediated pro-inflammatory cytokine production and cytotoxicity. In April 2018, Pfizer transferred the bulk of its CAR-T assets to Allogene Therapeutics in exchange for a 25% ownership stake in the company.
Pinze Lifetechnology Co. Ltd.
The aim of Pinze’s research is to assess the feasibility, safety and effectiveness of CD19 CAR-T Cell Therapy for Relapsed/ Refractory Acute Lymphoblastic Leukemia/ B cell Lymphoma patients who have applied it.
Poseida’s pipeline is composed of six preclinical and clinical programs involving gene therapy and CAR-T product candidates for orphan diseases and cancer. P-PSMA-101 is the company’s PSMA-specific stem cell memory CAR-T drug candidate for the treatment of prostate cancer, which is the most common cancer among men in the United States.
Precigen Inc. (Subsidiary of Intrexon Corporation)
The German drugmaker Precigen has reached an agreement to transfer all rights to its CAR-T technology and development programmes to US biotech company Intrexon in return for a $150 million equity stake in the Maryland-based firm, plus a note for another $25 million in stock. Merck is also giving Intrexon $25 million in cash to help get the CAR-T programmes going, and says the handover will allow it to focus on its other R&D activities but still maintain an interest in the rapidly advancing oncology field of CAR-T.
Baxalta and Precision BioSciences are partnering to develop allogeneic CAR-T therapies in a collaboration that could generate up to $1.6 billion for Precision. Under the terms of the agreement, the companies will develop CAR-T therapies for up to six unique targets, with Precision BioSciences responsible for performing early-stage research activities up to Phase 2, following which Baxalta has the exclusive right to opt in for late-stage development and commercialization. Precision BioSciences’ proprietary ARCUS genome editing technology enables the production of CAR-T cells derived from healthy donors rather than relying on a patient with a disease, a strategy that could overcome manufacturing limitations associated with existing CAR T therapies.
Prescient Therapeutics Limited (ASX: PTX)is a clinical stage company developing personalised medicine approaches to cancer. It has a collaboration with private CAR-T company Carina Biotech to develop new targeted cell therapies for cancer patients with solid tumours.
A French pharmaceutical company, Servier entered the CAR-T market in 2015 when it acquired the rights to UCART19 from Cellectis.
Shanghai Bioray Laboratory Inc.
Founded in 2013, the company is headquartered in Shanghai Zizhu Science Park. It has received angel round financing from Oriental Fuhai and the Pre-A round of nearly RMB 100 million from China Resources Leadership for the development of new drug declarations and registrations for the development of UCART for the treatment of B cell hematologic malignancies. Thes funds will help the company to achieve new breakthroughs in the CAR-T field. It has applied for more than 40 patents.
Shanghai GeneChem Co., Ltd.
In 2016, Genechem established Shanghai Genbase Biotechnology Co., Ltd. to develop new drugs for diseases with high incidences in China, including cancer, diabetes and cardiovascular diseases. Working closely with physicians, Genbase has access to clinical samples and databases which facilitates its development of antibodies and cell or gene therapies.One effort is the collaboration with Tianjin First Central Hospital and other hospitals to develop anti-CD19 chimeric antigen receptor (CAR) T-cell therapy. Genechem is also exploring the use of CAR-T therapy for solid tumours. Genechem has helped the FMMU team to convert the MG7 antibody to MG7-CART cells.
Shanghai Sinobioway Sunterra Biotech
Sinobioway Sunterra Biotechnology focuses on cutting-edge biotechnology, specifically field of adoptive cellular therapies. The core business of the company is to sublicense the CAB-CAR-T technology in Greater China from F1 Oncology. By investing in and building the GMP facility for virus packaging and cell processing related to CAB-CAR-T cell therapy, PerHum Therapeutics Biotechnology supports the CAB-CAR-T clinical trials in solid tumors, cooperating with some of the leading hospitals in China. Shanghai PerHum Therapeutics vision is to overcome the challenge of solid tumors, thereby bringing benefit to society as a whole.
Shenzhen BinDeBio Ltd.
Binder Bio Group was established in 2015 and Shenzhen Binder Biotechnology Co., Ltd. is the holding company. Binder Biotech has received strong support from the Shenzhen Municipal Government and has established extensive and in-depth cooperation with the Chinese Academy of Sciences and a number of authoritative hospitals across the country. It is a biotechnology group company that focuses on the treatment of cancer with immune cells. Based on the internationally leading CAR-T and TCR-T immune cell technologies, Binder Biotech is committed to the development and marketing of immunotherapy.
In June 2016, Shire completed a $32 billion merger with Baxalta. Only months before in February 2016, Baxalta and Precision BioSciences entered an agreement to develop allogeneic CAR-T therapies in a collaboration worth up to $1.6 billion. Precision BioSciences’ proprietary ARCUS genome editing technology enables the production of CAR T cells derived from healthy donors rather than relying on a patient with a disease.
Sinobioway Cell Therapy Co., Ltd.
Sinobioway Cell Therapy is a Chinese private company focused on research and development of chimeric antigen receptor T-cell (CER-T) technology in immunotherapy for potential cancer treatment.
Sorrento is developing a proprietary non-viral chimeric antigen receptor (CAR) T technology that could impact the way that CAR constructs are integrated into T cells. Its anti-CEA CAR-T has shown promising clinical activity and safety in phase 1b clinical trial.
Takeda Pharmaceutical Company Limited (“Takeda”)
Takeda is making multiple moves within the immuno-oncology space. It has a collaboration with Memorial Sloan Kettering Cancer Center to develop novel CAR-T products for the treatment of multiple myeloma, acute myeloid leukemia and other solid tumors. It is commercializing CAR-T products in partnership with Noile-Immune Biotech and secured exclusive license rights to NIB-102 and NIB-103 for the treatment of solid tumor indications. It also exercised an option from Crescendo Biologics for an exclusive oncology-targeted Humabody® license, allowing it to evaluate Humabody® VHs for the development of novel CAR-T therapeutics.
Takara Bio Inc.
In Japan, Takara Bio is conducting clinical trials of CD19 CAR gene therapy targeting adult acute lymphocytic leukemia. As in the NY-ESO-1 siTCRTM gene therapy project, it is addressing unmet medical needs in collaboration with our partner Otsuka Pharmaceutical Co., Ltd.
TC BioPharm is conducting Phase II/III clinical studies of its lead product, ImmuniCell®, in renal cell cancinoma, non-small cell lung cancer and melanoma patients. It is developing the next-generation of safer CAR-T products based on proprietary processes using the clinically proven ImmniCell backbone. In December 2017, bluebird bio and TC BioPharm announced a strategic collaboration to research and develop gamma delta CAR-T cell product candidates for cancer immunotherapy.
Tessa Therapeutics Pte Ltd.
Tessa Therapeutics is a clinical-stage cell therapy company focused on autologous and allogeneic therapies for a wide range of cancers. It has released‘proof-of-concept’ data from the preclinical study of TT16, a first-of-its-kind combination immunotherapy that integrates CAR-T cell therapy and oncolytic adenovirus expressing immunomodulatory molecules for the treatment of Human Epidermal Growth Factor Receptor 2 (HER2)-positive solid tumors.
The Pregene (ShenZhen) Biotechnology Company, Ltd.
Pregene ShenZhen Biotechnology is developing a CAR-T cell therapy targeting B-cell maturation antigen (BCMA), for the treatment of multiple myeloma.
Tianjin Mycure Medical Technology Co., Ltd
Tianjin Mycure Medical Technology Co., Ltd is a sponsor of a single center, single arm, open-lable phase 1 study which will determine the safety and efficacy of CD19-CAR-T cells in patients with relapsed or refractory acute B-cell lymphoblastic leukemia (R/R B-ALL).
Timmune Biotech Inc.
Timmune has developed an innovative CAR-T technology, called TriCAR-T, for adoptive T cell cancer therapy.Timmune’s TriCAR-T utilizes a part of the proprietary TriTE construct as a multi-functional binding domain.
Tmunity Therapeutics, Inc.
In 2018, Abzena, plc signed an antibody humanization agreement with Tmunity Therapeutics for the development of new Chimeric Antigen Receptor T Cell (CAR-T) therapies for the treatment of solid and hematological cancers.
ToolGen, Inc. (KONEX, 199800) is a biotechnology company specializing in genome editing. It is exploring the capacity of its CRISPR/cas9 gene editing platform to improve anti-tumor activity of human CAR-T cells. The company has demonstrated that blocking a molecular pathway that down-regulates T-cell activity with the Company’s CRISPR/Cas9 gene editing platform results in increased T-cell receptor signaling, in vitro, and in improved anti-tumor activity when tested against in a mouse glioblastoma tumor model.
UniCAR Therapy is pioneering cancer immunotherapies. In 2018, UniCAR submitted four applications for CAR T-cell drug candidates as investigational new drugs (INDs) to China’s National Medical Products Administration (NMPA). The company collaborates with top-ranked hospitals specializing in hematological malignancies, including leukemia, lymphoma and multiple myeloma. 400+ patients have benefitted from UniCAR’s immunotherapeutic products and the company holds 30+ patents for CAR T-cell technology. It is dedicated to the extended application of the next generation of CAR T-cell therapies with enhanced efficacy and safety profiles.
Unum Therapeutics’ Antibody-Coupled T cell Receptor is a chimeric protein that binds to tumor-targeting antibodies. When ACTR T cells are administered into a patient, they target and attack tumors by co-administering cancer-specific antibodies. Previously at St. Jude Children’s Research Hospital, the company’s Scientific Founder, Dario Campana, created the CD19 CAR that was subsequently shown to be highly effective in treating patients with Acute Lymphoblastic Leukemia (ALL).
UWELL Biopharma is focused on reducing CAR-T manufacturing cost and strengthening market segmentation with European and American products. The company is sponsoring a clinical study designed to evaluate safety and feasibility of administering Welgenaleucel (UWC19) transduced with anti-CD19 lentiviral vector to patients with advanced refractory hematologic malignancies, including DLBCL and ALL.
Wuhan Sian Medical Technology Co., Ltd
Up to now, the company’s CAR-T product targeting CD19 has completed 34 clinical trials of relapsed and refractory acute B-lymphocytic leukemia in Wuhan Union Hospital. The complete remission rate reached 81%, and completed two cases of allogeneic CAR-T clinical. In the study, the longest case has been continuously relieved for nearly 3 years.
Xyphos is developing a best-in-class CAR-T therapy platform based on convertibleCAR™ technology. convertibleCAR technology is based on a unique receptor-antibody control system engineered from protein components of the human NKG2D receptor/MIC ligand immune surveillance pathway. Through minimal mutation of the natural NKG2D receptor and directed evolution of small modular MIC domains that selectively bind the mutated NKG2D, Xyphos created an inert NKG2D CAR (iNKG2D CAR) that can only be activated using bispecific MIC-Antibody fusions (MicAbodies).
Yake Biotechnology Ltd.
Shanghai YaKe Biotechnology Ltd. is developing a humanised CAR-T cell therapy targeting CD19 and CD22. It is a collaborator in a clinical trial exploring the efficacy of CD19-targeted CAR-T cell therapy for minimal residual disease (MRD) in B-cell Malignancies after autologous stem cell transplantation.
Ziopharm’s immunooncology programs, in collaboration with Intrexon Corporation (NYSE:XON) and the MD Anderson Cancer Center, include CAR-T and other adoptive cell-based approaches that leverage non-viral gene transfer methods. ZIOPHARM is advancing its non-viral Sleeping Beauty (SB) platform towards point-of-care (P-O-C) for rapid manufacturing of genetically modified CAR+ T cells, with data from 1st and 2nd generation SB clinical trials indicatng safety, tolerability, disease response, long-term survival, and persistence of CD19-specific CAR+ T cells. The Sleeping Beauty process involves extracting CAR-T cells, injecting them with a kill switch, and genetically modifying them ex vivo for reinsertion into the patient.
Swell of CAR-T Companies
At first, the trend was subtle, but the tide has swelled and created a craze for promising CAR-T product candidates, as two CAR-T products (Kymriah and Yescarta) have been approved by regulatory agencies worldwide.
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