List of Immuno-Oncology Companies with Phase 3 Active Clinical Trial - 28
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2seventy Bio Cambridge, Massachusetts, United States | Our name, 2seventy bio, reflects why we do what we do - TIME. Cancer rips time away, and our goal is to work at the maximum speed of translating human thought into action – 270 miles per hour – to give the people we serve more time. We are building the leading immuno-oncology cell therapy company, focused on discovering and developing new therapies that truly disrupt the cancer treatment landscape With a deep understanding of the human body’s immune response to tumor cells and how to translate cell therapies into practice, we’re applying this knowledge to deliver next generation cellular therapies that focus on a broad range of hematologic malignancies, including the first FDA-approved CAR T cell therapy for multiple myeloma, as well as solid tumors. Our research and development is focused on delivering therapies that are designed with the goal to “think” smarter and faster than the disease. Importantly, we remain focused on accomplishing these goals by staying genuine and authentic to our “why” and keeping our people and culture top of mind every day. |
Abcuro Newton, Massachusetts, United States | Abcuro is a clinical stage biotechnology company developing treatments for autoimmune and cancer indications modulated by cytotoxic T and NK cells that express the inhibitory immune checkpoint receptor KLRG1 (killer cell lectin-like receptor G1). The company is advancing ABC008, a first-in-class anti-KLRG1 antibody designed to deplete cytotoxic T cells that attack healthy muscle tissue in patients with inclusion body myositis (IBM), into clinical studies. IBM is a progressive and debilitating inflammatory skeletal muscle condition with no available pharmaceutical therapies. Abcuro has received FDA orphan drug designation for ABC008 in IBM. The company is also advancing ABC015, an anti-KLRG1 blocking antibody capable of reactivating inhibited cytotoxic T and NK cells in the tumor microenvironment. |
Adlai Nortye Biopharma Hangzhou, Zhejiang, China | We are a global clinical-stage biopharmaceutical company focused on innovative oncology drugs, with our R&D and global clinical operation centers in both China and the United States. With a strategic emphasis on oncology, we have built a global pipeline through collaborations and internal discovery with more than 10 drug candidates in development. We have assembled a world-class management team, built our unique immuno-oncology platforms and partnered with multiple top pharmaceutical companies to promote innovation. We are committed to becoming an innovative biopharmaceutical company with global vision and strives to benefit patients worldwide. Our ultimate goal is to transform cancer into manageable conditions. |
Agenus Inc. Lexington, Massachusetts, United States of America | Agenus Inc., a clinical-stage immuno-oncology company, discovers, manufactures, and develops immuno-oncology products in the United States and internationally. The company offers Retrocyte Display, an antibody discovery platform for the identification of fully-human and humanized monoclonal antibodies; and display technologies. It develops vaccine programs, including Prophage vaccine candidate; AutoSynVax, a synthetic neo-antigen; PhosPhoSynVax, a vaccine candidate designed to induce immunity against a class of tumor specific neo-epitopes; and QS-21 Stimulon adjuvant, a saponin-based vaccine adjuvant. The company also develops CTLA-4 and PD-1 antagonists which is in clinical trial phase I for the dose escalation study; AGEN2373, an anti-CD137 monospecific antibody which is in Phase 1 clinical trial; AGEN1223, a novel bispecific antibody designed to deplete regulatory T cells which is in a Phase 1 clinical trial; GS-1423, a tumor microenvironment conditioning anti-CD73/TGFS TRAP bi-functional antibody which is in Phase 1 clinical trial; and TIGIT antibodies. In addition, it engages in the development of INCAGN1876, an anti-GITR monospecific antibody; INCAGN1949, an anti-OX40 monospecific antibody; INCAGN2390, an anti-TIM-3 monospecific antibody; INCAGN2385, an anti-LAG-3 monospecific antibody; and MK-4830, a monospecific antibody targeting ILT4. Agenus Inc. has collaboration agreements with Incyte Corporation, Merck Sharpe & Dohme, and Recepta Biopharma SA.; and collaboration with Gilead Sciences, Inc. to develop immuno-oncology therapies. The company was formerly known as Antigenics Inc. and changed its name to Agenus Inc. in January 2011. Agenus Inc. was founded in 1994 and is headquartered in Lexington, Massachusetts. |
ALX Oncology Holdings Inc South San Francisco, California, United States of America | ALX Oncology Holdings Inc., a clinical-stage immuno-oncology company, focuses on developing therapies for patients fighting cancer. Its lead product candidate is ALX148, a CD47 blocking therapeutic used for the treatment of myelodysplastic syndromes and acute myeloid leukemia, as well as a range of solid tumor indications, including head and neck squamous cell and human epidermal growth factor receptor 2 positive gastric/gastroesophageal junction carcinoma. The company was founded in 2015 and is based in Burlingame, California. |
American Gene Technologies Rockville, Maryland | American Gene Technologies® International Inc. (AGT™) is a private biotechnology company pursuing cures and treatments for infectious diseases, cancers, and monogenic disorders. AGT™'s emerging gene and cell therapeutics programs are designed to: ✅ Create immunotherapy for HIV disease with gene-modified T cells ✅ Activate innate T cell immunity capable of killing all tumor cells with its vector used in immuno-oncology ✅ Treat PKU by bringing a functional gene into cells that express a dysfunctional gene due to mutation ✅ Advance clinically to provide human proof of concept For over a decade, AGT™ has developed, tested, and banked thousands of lentiviral vectors that can be adapted to the specific needs of new target diseases. AGT™ has developed gene therapy for diseases using this rapid gene delivery platform. GENE THERAPIES AGT™’s platform allows it to pursue clinical “cures” for complex diseases. The company has developed patent-protected gene therapeutics that are breakthroughs in medicine. *** See our extensive award winning patents on our website *** HIV/AIDS Immunotherapy for HIV disease with gene-modified T cells IMMUNO-ONCOLOGY Activates innate T cell immunity capable of killing all tumor cells with its vector used in immuno-oncology PHENYLKETONURIA (PKU) Treats PKU by bringing a functional gene into cells that express a dysfunctional gene due to mutation AGT™'s Core Objectives ✔️ Leverage our lentivirus platform to create highly-effective targeted genetic medicines ✔️ Create solutions for patients across a spectrum of infectious diseases, cancers and inherited disorders ✔️ Collaborate with leading medical researchers from around the globe To learn more and get in touch with American Gene Technologies® Inc., contact us today at https://www.americangene.com/contact-us/ |
Arcellx Inc Gaithersburg, Maryland, United States | Arcellx, Inc., a clinical-stage biotechnology company, engages in the development of various immunotherapies for patients with cancer and other incurable diseases. The company’s lead ddCAR product candidate is CART-ddBCMA, which is in phase 1 clinical trial for the treatment of patients with relapsed or refractory (r/r) multiple myeloma (MM). It is also developing ACLX-001, an immunotherapeutic combination composed of ARC-T cells and bi-valent SparX proteins targeting BCMA to treat r/r MM; ACLX-002 and ACLX-003 for treating r/r acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS); and other AML/MDS product candidates, as well as solid tumor programs. The company was formerly known as Encarta Therapeutics, Inc. and changed its name to Arcellx, Inc. in January 2016. Arcellx, Inc. was incorporated in 2014 and is headquartered in Gaithersburg, Maryland. |
Arcus Biosciences Hayward, California, United States of America | Arcus Biosciences is an exciting growth company founded on the vision of creating best-in-class cancer therapies. We are an oncology-focused biopharmaceutical company leveraging its deep cross-discipline expertise to discover highly differentiated therapies and develop a broad portfolio of novel combinations addressing significant unmet needs. We are located in the San Francisco bay area, in the heart of the world’s largest biotechnology research hub. Arcus Biosciences offers a competitive compensation and benefits package, including aggressive participation in the growth of the company in the form of stock option grants. Arcus is an ambitious undertaking, and we fully expect our company to become a force in the discovery, development and commercialization of novel therapies for the treatment of cancer. Our employees enjoy operating in an exceptionally dynamic and cooperative environment in which the “rule book” has not yet been written. |
BeyondSpring Pharmaceuticals New York, New York, United States of America | BeyondSpring Pharmaceuticals is a global biopharmaceutical company focused on developing innovative cancer therapies to improve clinical outcomes. The Company is developing treatments in two of the world’s largest markets, China and the United States. BeyondSpring’s first-in-class lead asset plinabulin, a selective immunomodulating microtubule-binding agent, is being developed as a “pipeline in a drug” with potential to be an anti-cancer agent and to prevent chemotherapy-induced neutropenia (CIN). In the DUBLIN-3 Phase 3 study, the plinabulin and docetaxel combination met the primary endpoint of extending overall survival, compared to docetaxel alone in 2nd/3rd line non-small cell lung cancer (EGFR wild type). In addition, the plinabulin and G-CSF combination for the prevention of CIN has demonstrated positive Phase 3 data, for which it received Breakthrough status in the U.S. and China. Plinabulin is also currently being studied as part of other immuno-oncology (IO) combination regimens that include radiation and/or checkpoint inhibitors for the treatment of a number of cancers. Lastly, BeyondSpring also has three preclinical IO assets and majority ownership in its subsidiary, SEED Therapeutics, which is leveraging a proprietary targeted protein degradation drug discovery platform. |
Bicara Therapeutics Cambridge, Massachusetts, United States | Bicara Therapeutics is a clinical-stage company developing first-in-class biologics engineered to bring together the precision of targeted therapy and the power of tumor modulators. The company's dual-action biologics are designed to deliver an immunomodulatory payload directly to the tumor microenvironment to ramp up immune cell activity, potentially offering long-lasting efficacy |
Bicycle Therapeutics plc Cambridge, United Kingdom | Bicycle Therapeutics (NASDAQ: BCYC) is a clinical-stage biopharmaceutical company that is harnessing the power of bicyclic peptides and leveraging Nobel Prize-winning science to develop a new and differentiated class of medicines to treat cancer and other diseases. Bicycle® molecules are fully synthetic short peptides constrained with small molecule scaffolds to form two loops that stabilize their structural geometry. This constraint facilitates target binding with high affinity and selectivity, making Bicycle molecules attractive candidates for drug development. The company is evaluating zelenectide pevedotin, previously BT8009, a Bicycle® Toxin Conjugate (BTC®) targeting Nectin-4, a well-validated tumor antigen; BT5528, a BTC molecule targeting EphA2, a historically undruggable target; and BT7480, a Bicycle Tumor-Targeted Immune Cell Agonist® (Bicycle TICA®) targeting Nectin-4 and agonizing CD137, in company-sponsored clinical trials. Additionally, the company is developing Bicycle® Radio Conjugates (BRC™) for radiopharmaceutical use and, through various partnerships, is exploring the use of Bicycle® technology to develop therapies for diseases beyond oncology. Bicycle is headquartered in Cambridge, UK, with many key functions and members of its leadership team located in Cambridge, MA. |
Briacell Therapeutics Philadelphia, Pennsylvania, United States | BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW) (TSX: BCT) is a clinical-stage biotechnology company specializing in targeted immunotherapies for cancer. BriaCell achieved positive proof-of-concept in a Phase I/IIa clinical trial for Bria-IMT™ in patients with advanced breast cancer. BriaCell is conducting a Phase I/IIa clinical trial of Bria-IMT™ in combination with a PD-1 inhibitor, retifanlimab (provided by Incyte under a collaboration agreement). Additionally, BriaCell is developing Bria-OTS™, the first “off-the-shelf” personalized immunotherapy for advanced breast cancer. |
Candel Therapeutics Needham, Massachusetts, United States of America | At Candel Therapeutics, we are developing immunotherapies that induce immunogenic cell death in cancer cells at the site of injection, unmasking tumor neo-antigens within an activated microenvironment. This process leads to a systemic, durable immune response against the tumor, with the potential to change disease outcomes across a variety of indications. Candel’s products are designed to improve survival while maintaining quality of life – from early- to late-stage disease. |
CStone Pharmaceuticals Shanghai, China | CStone (HKEX: 2616) is a biopharmaceutical company focused on researching, developing, and commercializing innovative immuno-oncology and precision medicines to address the unmet medical needs of cancer patients in China and worldwide. Established in 2015, CStone has assembled a world-class management team with extensive experience in innovative drug development, clinical research, and commercialization. The company has built an oncology-focused pipeline of 15 drug candidates with a strategic emphasis on immuno-oncology combination therapies. Currently, CStone has received ten NDA approvals for four drugs. Multiple late-stage drug candidates are now under pivotal clinical trials or registration. CStone's vision is to become globally recognized as a world-renowned biopharmaceutical company by bringing innovative oncology therapies to cancer patients worldwide. |
Electra Therapeutics South San Francisco, United States | Electra Therapeutics is a clinical stage biotechnology company developing therapies that target signal regulatory proteins (SIRP) for the treatment of immunological diseases and cancer. |
IDEAYA Biosciences South San Francisco, California, United States | IDEAYA is an oncology-focused precision medicine company. Our teams are committed to the discovery and development of targeted therapeutics for patient populations selected using molecular diagnostics. We are advancing therapeutics that have the potential to be first-in-class and/or best-in-class, with a primary focus in synthetic lethality – an emerging class of precision medicine targets. IDEAYA is headquartered in South San Francisco, California. |
ImaginAb Inglewood, California, United States | ImaginAb is a clinical stage, revenue-generating global biotechnology company developing the next generation of imaging agents and radiopharmaceutical therapy (RPT) products through its proprietary minibody and cys-diabody platforms. The lead candidate 89Zr crefmirlimab berdoxam (CD8 ImmunoPET™) imaging agent is currently in Phase II clinical trials and has been licensed by numerous pharmaceutical and biotech companies for use in imaging within their immunotherapy clinical trials, primarily in oncology. |
IO Biotech Copenhagen, Denmark | IO Biotech is a clinical-stage biopharmaceutical company pioneering the first-in-class investigational dual-action immune-modulating cancer vaccine with the goal of becoming the backbone of combination therapy for people with cancer. The Company’s T-win® vaccine platform is directed against the tumor microenvironment (TME) and is designed to stimulate T cells against tumor cells and the most important immune-suppressive cells in the TME. IO Biotech’s most advanced program for IO102-IO103 is currently in Phase 3 development. IO Biotech is headquartered in Copenhagen, Denmark. IO Biotech has achieved a proven track record of progressing compounds to the clinic, and has two lead immune modulating anti-cancer therapies targeting IDO and PD-L1 in clinical development and several compounds finalizing preclinical phase. IO Biotech has an experienced management team within immuno-oncology fields and a world-class advisory board. |
Iovance Biotherapeutics San Carlos, California, United States, Philadelphia, Pennsylvania, Tampa, Florida | Iovance Biotherapeutics (NASDAQ: IOVA) aims to be the global leader in innovating, developing and delivering tumor infiltrating lymphocyte (TIL) therapies for patients with cancer. We are pioneering a transformational approach to cure cancer by harnessing the human immune system’s ability to recognize and destroy diverse cancer cells in each patient. The Iovance TIL platform has demonstrated promising clinical data across multiple solid tumors. We are committed to continuous innovation in cell therapy, including gene-edited cell therapy, that may extend and improve life for patients with cancer. We are adding to our talented team as we execute our commercial launch, advance our research and development efforts, and build our internal manufacturing capabilities. Iovance is headquartered in the San Francisco Bay Area. Our Iovance Cell Therapy Center (iCTC), a state-of-the-art manufacturing facility, is located in Philadelphia. We also have a research site in Tampa, Florida. Any information expressed by Iovance is subject to the risk factors and information on forward-looking statements contained in its filings with the Securities and Exchange Commission and available here: https://ir.iovance.com/sec-filings |
iTeos Therapeutics Cambridge, Massachusetts, United States | iTeos Therapeutics is a clinical-stage biopharmaceutical company pioneering the discovery and development of a new generation of immuno-oncology therapeutics for patients. iTeos Therapeutics leverages its deep understanding of tumor immunology and immunosuppressive pathways to design novel product candidates with the potential to restore the immune response against cancer. The Company’s innovative pipeline includes three clinical-stage programs targeting novel, validated immuno-oncology pathways designed with optimized pharmacologic properties for improved clinical outcomes, including the TIGIT/CD226 axis and the adenosine pathway. iTeos Therapeutics is headquartered in Watertown, MA with a research center in Gosselies, Belgium. |
LaNova Medicines Shanghai, China | Founded in 2019 in Shanghai, China, LaNova Medicines is a clinical-stage biotechnology company committed to the discovery and development of novel biologic drugs for cancer treatment. Led by industry veterans with a strong passion for innovation, we aim to operate as an R&D engine and deliver transformative medicines to address the unmet clinical needs of cancer patients. Leveraging our proprietary technology platforms and deep understanding of the tumor microenvironment. we have built a differentiated pipeline of products and are striving to progress our programs toward the clinic. |
OncoC4 Rockville, Maryland, United States | Based in Rockville, Maryland, OncoC4 is a privately-held, clinical-stage biopharmaceutical company that is actively engaged in the discovery and development of novel biologicals for cancer treatment. |
OSE Immunotherapeutics Nantes, France | OSE Immunotherapeutics is an integrated biotech company focused on developing first-in-class assets targeting cancer and inflammatory diseases. A current well-balanced first-in-class clinical pipeline including: • Tedopi® (T-cell specific immunotherapy): Company’s most advanced product; positive results for Ph 3 in NSCLC in secondary resistance after CKI failure. Other sponsored combo Ph 2 trials in solid tumors ongoing. • OSE-279 (anti-PD1) advanced preclinical stage • OSE-127 (humanized mAb antagonist of IL-7R); ongoing Ph 2 in Ulcerative Colitis; ongoing preclinical research in leukemia • VEL-101/FR104 (anti-CD28 mAb) developed in partnership with Veloxis in transplantation; ongoing Ph 1/2 in renal transplant (sponsor Nantes University Hospital); Ph 1 ongoing in the US (sponsor Veloxis). • BI 765063 (anti-SIRPα mAb on CD47/SIRPα pathway) developed in partnership with Boehringer Ingelheim in advanced solid tumors; positive Ph 1 dose escalation results in mono and in combo, in particular with anti-PD-1 antibody ezabenlimab; BI sponsored international Ph 1b clinical trial ongoing in combo with ezabenlimab alone or with other drugs in recurrent/metastatic HNSCC and HCC. OSE Immunotherapeutics expects to generate further significant value from its two proprietary drug discovery platforms, which are central to its ambitious goal to deliver next-generation first-in-class immunotherapeutics: • BiCKI® platform focused on immuno-oncology (IO) is a bispecific fusion protein platform built on the key backbone component of anti-PD1 combined with a new immunotherapy target to increase anti-tumor efficacy. Most advanced BiCKI® candidate is targeting anti-PD1xIL-7. • Myeloid platform focused on optimizing the therapeutic potential of myeloid cells in IO & immuno-inflammation (I&I). OSE-230 (ChemR23 agonist mAb), most advanced candidate generated by the platform, with the potential to resolve chronic inflammation. |
Precigen Germantown, Maryland, United States of America | Precigen (Nasdaq: PGEN) is a dedicated discovery and clinical stage biopharmaceutical company advancing the next generation of gene and cell therapies using precision technology to target the most urgent and intractable diseases in immuno-oncology, autoimmune disorders, and infectious diseases. Our technologies enable us to find innovative solutions for affordable biotherapeutics in a controlled manner. Precigen operates as an innovation engine progressing a preclinical and clinical pipeline of well-differentiated unique therapies toward clinical proof-of-concept and commercialization. |
Rakuten Medical San Diego, California, United States | Rakuten Medical, Inc. is a global biotechnology company developing and commercializing precision, cell-targeting investigational therapies on its AlluminoxTM platform, which, in pre-clinical studies have been shown to induce rapid and selective cell killing and tumor necrosis. Outside of Japan, Alluminox therapies have not yet been approved as safe or effective by any regulatory authority. The company’s first drug developed on the Alluminox platform, ASP-1929, has received approval from the Japanese Ministry of Health, Labour, and Welfare, and is currently the subject of a global phase 3 clinical trial for recurrent head and neck cancer. Rakuten Medical is committed to its mission to conquer cancer by delivering our innovative treatments as quickly and safely as possible to as many patients all over the world as possible. The company has locations in 6 countries, including the United States, where it is headquartered, Japan, Taiwan, the Netherlands, Switzerland and India. |
Shanghai Henlius Biotech Shanghai, China | Shanghai Henlius Biotech isabiopharmaceutical company in China that is developing biologics foroncology and autoimmune diseases. |
Sona Nanotech Ltd. Purdy's Wharf Tower II Suite 2001, 1969 Upper Water Street | |
Telix Pharmaceuticals North Melbourne, Victoria | Telix is a biopharmaceutical company focused on the development and commercialisation of therapeutic and diagnostic ('theranostic') radiopharmaceuticals. Telix is headquartered in Melbourne, Australia with commercial operations in the United States, Europe (Belgium and Switzerland) and Japan. Telix is developing a portfolio of radiopharmaceutical products that aims to address significant unmet medical need in oncology and rare diseases. Telix is listed on the Australian Securities Exchange (ASX: TLX). |