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Who’s Developing Bispecific Antibody Products? Top Companies to Know
Biointron2025-04-02Read time: 9 mins
Bispecific antibodies (BsAbs) are revolutionizing therapeutic strategies by simultaneously targeting two different antigens, offering enhanced efficacy in treating complex diseases like cancer and autoimmune disorders. As of 2025, numerous pharmaceutical and biotechnology companies are at the forefront of BsAb development, driving innovation and expanding clinical applications.
The Rise of Bispecific Antibodies
Mechanism of Action: BsAbs are engineered to bind two distinct targets, facilitating novel therapeutic approaches such as redirecting immune cells to tumor sites or concurrently inhibiting multiple disease pathways.
Clinical Impact: Their dual-targeting capability has shown promise in enhancing treatment specificity and reducing resistance, particularly in oncology and immunology.
DOI:10.20944/preprints202401.1861.v1
Leading Pharmaceutical Companies in BsAb Development
Roche: Roche has developed notable treatments like Hemlibra for hemophilia A and continues to expand its oncology pipeline with BsAb candidates. Columvi, a CD20xCD3 T-cell-engaging bispecific antibody, is part of Roche’s extensive haematology portfolio and is being evaluated in the phase III STARGLO study for DLBCL patients ineligible for stem cell transplant. Roche is also advancing Lunsumio (mosunetuzumab), which received accelerated FDA approval in 2022 for relapsed/refractory follicular lymphoma and is being tested in phase III trials both alone and in combination with other therapies.1
Amgen: Known for its BiTE (Bispecific T-cell Engager) technology, Amgen is advancing BsAb therapies targeting various cancers. The company’s flagship therapy, Blincyto (blinatumomab), was the first BiTE immuno-oncology therapy to receive global approval and recently gained its third FDA indication for use in the consolidation phase of B-ALL treatment, regardless of measurable residual disease status. Amgen’s BiTE molecules are engineered to engage a patient’s own T cells in directly attacking tumor cells, and the company continues to expand the platform’s reach into both hematologic and solid tumors.2
Regeneron: Uses its Veloci-Bi platform to develop BsAbs, focusing on immuno-oncology applications. In addition to CD3 bispecifics and checkpoint inhibitors, Regeneron is advancing a new class of CD28 costimulatory bispecific antibodies aimed at transforming immune-resistant "cold" tumors into "hot" tumors responsive to immunotherapy. Early clinical data, including for REGN7075 in combination with Libtayo, show encouraging activity across solid tumors and blood cancers, reinforcing the potential of their unique costimulatory approach.3
AstraZeneca: Engaged in BsAb research, particularly in respiratory and oncology indications. Developing two lead bispecifics—volrustomig (PD-1/CTLA-4) and rilvegostomig (PD-1/TIGIT)—for NSCLC and other cancers. Volrustomig has shown strong response rates in PD-L1-negative lung cancer when combined with chemo, while rilvegostomig has demonstrated over 60% response in PD-L1-high patients. Both are being studied in Phase III trials, including combinations with AstraZeneca’s ADC, Enhertu.4
Novartis: Actively expanding its BsAb portfolio through strategic collaborations and acquisitions, such as a new $3 billion+ collaboration with Dren Bio, leveraging their Targeted Myeloid Engager platform for cancer. This technology focuses on activating myeloid cells to attack cancer through phagocytosis. Novartis will lead development and commercialization for any resulting drug programs, signaling renewed confidence in bispecifics as part of its streamlined oncology R&D strategy.5
Merck: Investing in BsAb development to complement its existing immunotherapy offerings, with a focus on enhancing anti-tumor responses, e.g. a $700 million upfront deal for global rights to Curon Biopharmaceutical’s CD3xCD19 candidate, CN201, currently in phase 1/2 trials for non-Hodgkin lymphoma (NHL) and acute lymphoblastic leukemia (ALL). This positions Merck as a direct challenger to Amgen’s Blincyto and other CD3xCD19 developers like AstraZeneca and Cullinan. Beyond blood cancers, Merck plans to explore CN201’s potential in autoimmune diseases, aiming to leverage CD19 targeting in indications like lupus and rheumatoid arthritis.6
Pfizer: Pfizer’s Elrexfio (elranatamab), a BCMAxCD3 bispecific, received FDA accelerated approval in 2023 for heavily pretreated multiple myeloma patients. As the first fixed-dose, subcutaneous BCMA bispecific with optional every-other-week dosing, it showed a 58% response rate in Phase 2 trials. Pfizer is expanding its use through the MagnetisMM program in earlier treatment lines and combinations.7
Innovative Biotech Firms Making Strides
Adaptin Bio: Adaptin Bio is developing APTN-101, a bispecific T-cell engager targeting EGFRvIII and CD3, designed for glioblastoma treatment. Utilizing their BRiTE platform, APTN-101 has shown efficacy in preclinical models and is advancing to clinical trials.
Akeso: Akeso has commercialized two bispecific antibodies: cadonilimab (PD-1/CTLA-4) and ivonescimab (PD-1/VEGF). Cadonilimab is approved for recurrent/metastatic cervical cancer, while ivonescimab has shown superiority over pembrolizumab in NSCLC. The company is also exploring bispecifics in autoimmune and inflammatory diseases.
AP Biosciences: AP Biosciences is developing bispecific antibodies with conditional activation to minimize off-target effects. Their T-CUBE platform enables tumor-specific T-cell engagement, aiming to reduce systemic toxicity.
Candid Therapeutics: Candid Therapeutics, launched with $370 million in Series A funding, is developing T-cell engagers for cancer treatment. The company acquired Vignette Bio and TRC 2004, expanding its pipeline of bispecific antibody candidates.
Zenas BioPharma: Zenas BioPharma is advancing bispecific antibodies for autoimmune diseases. Their lead candidate, ZB001, targets CD19 and CD3, aiming to modulate B-cell activity in conditions like systemic lupus erythematosus.
Noteworthy Collaborations
February 12, 2025: AbbVie and Xilio Therapeutics to collaborate on masked T-cell engagers designed to achieve tumor-selective activation for $52M upfront and USD 2.1 billion potential.
March 20, 2025: Sanofi Commits pays $600M upfront for Dren Bio’s bispecific antibody, a myeloid cell engager for deep B-cell depletion, broadening immunology pipeline, and up to $1.9B total.
January 20, 2025: InnoCare and KeyMed Jointly Announce the License Agreement with Prolium for CD20xCD3 Bispecific Antibody ICP-B0.
Global Landscape and Market Outlook
Market Growth: The global BsAb market is projected to grow significantly, driven by clinical successes and increasing investment in R&D. As of 2024, the market is valued at around USD 12 billion and is projected to reach USD 50 billion by 2030.8
Geographical Expansion: Companies across North America, Europe, and Asia are actively participating in BsAb development, reflecting a robust international interest. The US remains a leading hub for bispecific antibody innovation, driven by biotech firms and academic research. Meanwhile, China is rapidly emerging as a key player, with strong investment in biotech and a growing healthcare infrastructure. The success of companies like Akeso highlights China’s rising leadership in this field.
Regulatory Progress: 17 BsAb therapies have received regulatory approvals, with many more in late-stage clinical trials, indicating a maturing therapeutic class.
Conclusion
The development of bispecific antibodies represents a dynamic and rapidly evolving sector within the biopharmaceutical industry. With numerous companies contributing to advancements in this field, BsAbs hold the potential to transform treatment paradigms across various diseases. Continued innovation and collaboration are expected to drive this promising therapeutic area forward.
Roche. (2023, June 15). FDA approves Roche’s Columvi, the first and only bispecific antibody with a fixed-duration treatment for people with relapsed or refractory diffuse large B-cell lymphoma. Roche.com. https://www.roche.com/media/releases/med-cor-2023-06-16
