The bispecific antibody pipeline and clinical trial analysis report deliver important insights on ongoing research, clinical strategies, upcoming therapeutics, and commercial analysis.
LAS VEGAS, July 3, 2023 /PRNewswire/ -- DelveInsight's 'Bispecific Antibody Competitive Landscape - 2023' report provides comprehensive global coverage of available, marketed, and pipeline bispecific antibodies in various stages of clinical development, major pharmaceutical companies working to advance the pipeline space, company assessment, comparative assessment, and future growth potential of the bispecific antibody competitive domain.
Key Takeaways from the Bispecific Antibody Competitive Landscape Report
- Over 250+ bispecific antibody companies are evaluating 300+ bispecific antibody drugs in various stages of development, and their anticipated acceptance in the bispecific antibody market would significantly increase market revenue.
- Key bispecific antibody companies such as Janssen, Amgen, Akeso, Zymeworks, Roche, IGM Biosciences, MacroGenics, Provention Bio, Jiangsu Alphamab Biopharmaceuticals, Sichuan Baili Pharmaceutical, Regeneron Pharmaceuticals, Boehringer Ingelheim, and others are evaluating new bispecific antibody drugs to improve the treatment landscape.
- Promising bispecific antibody pipeline drugs such as Amivantamab, Blinatumomab, Ivonescimab, Zanidatamab, Glofitamab, Imvotamab, MGD024, PRV 3279, KN-046, SI-B001, REGN-5458, BI-905711, and others are under different phases of bispecific antibody clinical trials.
- In April 2023, Lonza signed an agreement with ABL Bio focusing on bispecific antibodies for immuno-oncology and neurodegenerative diseases. The collaboration is intended to help in the development and manufacturing of ABL Bio's new bispecific antibody product.
- In March 2023, InvoX Pharma Limited announced that F-star, an invoX company, entered into a second license agreement with Takeda for a novel next-generation immuno-oncology bispecific antibody. Under the terms of the license agreement, F-star will grant Takeda a worldwide, exclusive royalty-bearing license to research, develop, and commercialize a bispecific antibody directed towards an undisclosed immuno-oncology target using F-star's proprietary Fcab and mAb2 platforms. Takeda will be responsible for all research, development, and commercialization activities under the agreement. F-star will receive an undisclosed upfront license fee and is eligible to receive potential future development and commercialization milestone payments, plus royalties on annual net sales.
- In January 2023, Caris Life Sciences and Xencor, Inc. announced an expansion of their collaboration to research, develop and commercialize novel XmAb® bispecific and multi-specific antibodies directed against novel targets, identified and proposed by Caris, for the treatment of patients with cancer.
- In December 2022, Akeso announced a collaboration and license agreement with Summit Therapeutics Inc., to out-license its breakthrough bispecific antibody, ivonescimab (PD-1/VEGF, AK112) for development and commercialization in the United States, Canada, Europe, and Japan. In addition, the Company will co-brand the product in the License Territories.
- In December 2022, Biogen announced that it had reached an agreement with Genentech, a member of the Roche Group, related to the commercialization and sharing of economics for glofitamab. Under the terms of the agreement, Biogen will have no payment obligations and will receive tiered royalties on potential net sales of glofitamab within the United States as part of the companies' long-standing collaboration on antibodies targeting CD20.
- In November 2022, IGM Biosciences and ADC Therapeutics announced that they had entered into a clinical trial collaboration and supply agreement to evaluate the combination of imvotamab, IGM's novel IgM CD20 x CD3 T cell engaging bispecific antibody, and ZYNLONTA® (loncastuximab tesirine-lpyl), ADC Therapeutics' CD19-directed antibody-drug conjugate (ADC), for the treatment of patients with relapsed/refractory (R/R) B cell non-Hodgkin's lymphoma (NHL).
- In November 2022, Nona Biosciences announced that it had entered into a collaboration agreement with Dragonfly Therapeutics based on Nona's proprietary fully human heavy chain only antibody (HCAb) transgenic mice platform to discover and develop fully human heavy chain only antibodies for bispecific/multi-specific therapeutic antibody generation.
- In October 2022, Jazz Pharmaceuticals and Zymeworks Inc. entered into an exclusive licensing agreement under which Jazz will acquire development and commercialization rights to Zymeworks' zanidatamab across all indications in the United States, Europe, Japan, and all other territories except for those Asia/Pacific territories previously licensed by Zymeworks.
- In October 2022, Gilead Sciences and MacroGenics announced an exclusive option and collaboration agreement to develop MGD024, an investigational, bispecific antibody that binds CD123 and CD3 using MacroGenics' DART® platform, and two additional bispecific research programs. The collaboration agreement grants Gilead the option to license MGD024, a potential treatment for certain blood cancers, including acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS).
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Bispecific Antibody Overview
Bispecific antibodies have been developed, with one antigen-binding site directed against the CD3 receptor (which activates cytotoxic T lymphocytes) and the other directed against tumor cell antigens (CD19, CD20, CD33, CD123, HER2, epithelial cell adhesion molecule [EpCAM], BCMA, CEA, and others). The interaction with cytotoxic T lymphocytes and tumor cells caused by Bispecific antibody binding stimulates cytotoxic T cells and enhances tumor cell death. Several bispecific molecules for the treatment of different diseases have been produced in addition to a large spectrum of bispecific antibodies directed against tumors. The osteoporosis bispecific antibody inhibits the Wnt signal-transduction pathway factors (sclerostin and Dkk1), promoting osteoblast development and bone tissue growth.
Bispecific antibodies have various advantages over monospecific antibodies. Bispecific antibodies lead immune system effectors to tumor cells, increasing their cytotoxicity. Bispecific antibodies have higher binding specificity than monospecific antibodies because they engage with two separate surface antigens. When compared to combination therapy with two monospecific medicines, the use of bispecific antibodies allows for cost optimization by lowering the cost of development and clinical trials.
Find out more about bispecific antibody drugs @ Bispecific Antibody Treatment
Bispecific Antibody Pipeline Analysis: Drug Profile
Ivonescimab: Akeso
Ivonescimab, also known as AK112 in China and Australia and SMT112 in the Licence Territories, is a new, potentially first-in-class bispecific antibody that the Company created independently. Ivonescimab combines the immunotherapy benefits of PD-1 blockage with the anti-angiogenesis properties of an anti-VEGF into a single drug. The unique design, we believe, has the potential to lessen side effects and safety concerns. Ivonescimab is thought to be the most advanced PD-1 / VEGF bispecific antibody in the clinic: no known PD-1-based bispecific antibodies have been licensed by the FDA or the EMA.
Akeso is currently running a phase III clinical research comparing ivonescimab monotherapy to pembrolizumab monotherapy as a first-line treatment for NSCLC patients with positive PD-L1 expression. In addition, phase III clinical research comparing Ivonescimab with chemotherapy to chemotherapy in EGFR-mutated advanced non-squamous NSCLC that had previously failed EGFR-TKI therapy is now underway. The NMPA has granted ivonescimab breakthrough therapy designation status in China for three indications: the two aforementioned indications, as well as when combined with docetaxel for the treatment of patients with locally advanced or metastatic NSCLC who have failed prior PD-(L)1 inhibitor combined with platinum-based doublet chemotherapy.
Zanidatamab: Zymeworks
Zanidatamab is a bispecific antibody based on Zymeworks' Azymetric platform that can bind two non-overlapping HER2 epitopes at the same time, a process known as biparatopic binding. This one-of-a-kind design results in a variety of modes of action, including dual HER2 signal blockage, enhanced binding and removal of HER2 protein from the cell surface, and potent effector function, all of which contribute to encouraging anticancer activity in patients. Zymeworks is testing zanidatamab in several Phase I, Phase II, and pivotal clinical trials around the world as a targeted therapeutic option for patients with HER2-positive solid tumors.
A snapshot of the Bispecific Antibody Pipeline Drugs mentioned in the report:
Bispecific Antibody Drugs | Company | Phase | Indication |
Ivonescimab | Akeso | Phase III | Non-small cell lung cancer |
Zanidatamab | Zymeworks | Phase III | Oesophageal cancer |
Erfonrilimab | Alphamab | Phase III | Non-small cell lung cancer; Pancreatic cancer |
SI-B001 | Sichuan Baili Pharmaceutical/SystImmune | Phase II/III | Non-small cell lung cancer |
Glofitamab | Roche | Phase II | Follicular lymphoma; Mantle-cell lymphoma; Non-Hodgkin's lymphoma |
Imvotamab | IGM Biosciences | Phase II | Chronic lymphocytic leukaemia; Diffuse large B cell lymphoma; Follicular lymphoma |
PRV 3279 | Hangzhou Zhongmei Huadong Pharmaceutical/Provention Bio | Phase II | Systemic lupus erythematosus |
Linvoseltamab | Regeneron Pharmaceuticals | Phase II | Multiple myeloma |
MGD024 | MacroGenics | Phase I | Hematological malignancies |
BI-905711 | Boehringer Ingelheim | Phase I | Colorectal cancer; Gastric cancer; Pancreatic cancer |
Learn more about the emerging bispecific antibody pipeline drugs @ Bispecific Antibody Clinical Trials
Scope of the Bispecific Antibody Competitive Landscape Report
- Coverage: Global
- Key Bispecific Antibody Companies: Janssen, Amgen, Akeso, Zymeworks, Roche, IGM Biosciences, MacroGenics, Provention Bio, Jiangsu Alphamab Biopharmaceuticals, Sichuan Baili Pharmaceutical, Regeneron Pharmaceuticals, Boehringer Ingelheim, and others
- Key Bispecific Antibody Pipeline Drugs: Amivantamab, Blinatumomab, Ivonescimab, Zanidatamab, Glofitamab, Imvotamab, MGD024, PRV 3279, KN-046, SI-B001, REGN-5458, BI-905711, and others
- Company Analysis, Therapeutic Assessment, Pipeline Assessment, Inactive drugs assessment, Unmet Needs
Dive deep into rich insights for new bispecific antibody drugs, visit @ Bispecific Antibody Drugs
Table of Contents
1. | Bispecific Antibody Pipeline Report Introduction |
2. | Bispecific Antibody Pipeline Report Executive Summary |
3. | Bispecific Antibody Pipeline: Overview |
4. | Bispecific Antibody Marketed Drugs |
4.1. | Amivantamab: Janssen |
5. | Bispecific Antibody Clinical Trial Therapeutics |
6. | Bispecific Antibody Pipeline: Late-Stage Products (Pre-registration) |
7. | Bispecific Antibody Pipeline: Late-Stage Products (Phase III) |
7.1. | Ivonescimab: Akeso |
8. | Bispecific Antibody Pipeline: Mid-Stage Products (Phase II) |
8.1. | Imvotamab: IGM Biosciences |
9. | Bispecific Antibody Pipeline: Early-Stage Products (Phase I) |
9.1. | MGD024: MacroGenics |
10. | Bispecific Antibody Pipeline Therapeutics Assessment |
11. | Inactive Products in the Bispecific Antibody Pipeline |
12. | Company-University Collaborations (Licensing/Partnering) Analysis |
13. | Unmet Needs |
14. | Bispecific Antibody Market Drivers and Barriers |
15. | Appendix |
For further information on the bispecific antibody pipeline therapeutics, reach out @ Bispecific Antibody Analysis
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