Antibody-based therapies continue to play a pivotal role in the treatment of autoimmune diseases, infectious diseases, and cancer. Recent regulatory advancements highlight the progress of multiple investigational and approved therapies across various indications.
Garadacimab (Andembry) by CSL
Garadacimab (ANDEMBRY) is a Factor XIIa-inhibitory monoclonal antibody (anti-FXIIa mAb) developed as a once-monthly treatment for hereditary angioedema (HAE). Factor XIIa is a key initiator of the contact activation pathway, leading to the release of bradykinin, which drives oedema (swelling) in HAE patients. By blocking Factor XIIa, garadacimab prevents the cascade of events responsible for HAE attacks. The drug is newly approved in Australia and is under regulatory review in the U.S. and EU, with the EMA granting a positive opinion on December 13, 2024.
Bentracimab by SERB Pharmaceuticals & SFJ Pharmaceuticals
Bentracimab is a monoclonal antibody fragment (Fab) developed as a reversal agent for ticagrelor (BRILINTA), a P2Y12 receptor antagonist used to prevent cardiovascular events. In patients requiring urgent surgery or experiencing major bleeding, bentracimab binds to ticagrelor and its active metabolite, neutralizing their antiplatelet effects. The drug received Breakthrough Therapy Designation from the FDA in 2019, underscoring its potential to significantly improve outcomes for patients on ticagrelor. The FDA accepted its Biologics License Application (BLA) on August 2, 2024, marking a key regulatory milestone.
Clesrovimab by Merck
Clesrovimab (MK-1654) is an extended half-life monoclonal antibody (mAb) for passive immunization against respiratory syncytial virus (RSV). Unlike traditional RSV vaccines, clesrovimab is designed to provide rapid and durable protection in infants by delivering immediate neutralizing immunity against RSV infection. A single-dose administration, regardless of birth weight, simplifies its use in both healthy preterm, full-term, and at-risk infants. The US accepted its BLA on December 17, 2024, indicating a potential new prophylactic option for RSV prevention in pediatric populations.
Telisotuzumab Vedotin (Teliso-V) by Abbvie
Telisotuzumab vedotin (Teliso-V) is an investigational, first-in-class antibody-drug conjugate (ADC) targeting c-Met, a receptor tyrosine kinase frequently overexpressed in non-small cell lung cancer (NSCLC) and other solid tumors. This ADC delivers a cytotoxic payload to c-Met-positive tumor cells, promoting tumor cell death while minimizing systemic toxicity. Teliso-V remains in clinical trials and has been submitted for regulatory approval in the U.S. on September 27, 2024. Further information on Teliso-V’s clinical studies is available on ClinicalTrials.gov.
Narsoplimab by Omeros
Narsoplimab is a human monoclonal antibody targeting mannan-binding lectin-associated serine protease-2 (MASP-2), the effector enzyme of the lectin pathway of the complement system. MASP-2 inhibition prevents complement-mediated inflammation and endothelial damage while preserving the function of other complement pathways essential for immune defense. By selectively modulating the complement system, narsoplimab aims to address inflammatory and thrombotic disorders. Following regulatory setbacks, Omeros has proposed a BLA resubmission in the U.S. as of November 21, 2024.
Linvoseltamab by Regeneron
Linvoseltamab is a bispecific BCMAxCD3 antibody designed to bridge B-cell maturation antigen (BCMA) on multiple myeloma (MM) cells with CD3-expressing T cells, thereby promoting T-cell activation and targeted cancer-cell killing. As an off-the-shelf immunotherapy, linvoseltamab represents a promising option for relapsed/refractory multiple myeloma (R/R MM) patients who have exhausted prior treatment options. The FDA accepted its BLA for review on February 21, 2024, and regulatory decisions in both the U.S. and EU are anticipated in the coming months.
Bifikafusp Alfa, Onfekafusp Alfa (Nidlegy) by Philogen
Bifikafusp alfa and onfekafusp alfa, collectively known as Daromun (L19-IL2 + L19-TNF), are under investigation for the treatment of metastatic melanoma and various types of skin cancers. The therapy consists of recombinant fusion proteins composed of a single-chain monoclonal antibody fragment (L19) fused to human recombinant interleukin-2 (IL-2) and tumor necrosis factor-alpha (TNF-α). This intratumoral and intralesional therapy targets fibronectin and IL-2 receptor subunit alpha (IL2RA), enhancing localized immune activation. Following positive Phase 3 results, the EMA has validated the submission of the Marketing Authorization Application for Nidlegy as of July 4, 2024.
Patritumab Deruxtecan by Daiichi Sankyo and Merck
Patritumab deruxtecan (HER3-DXd) is an investigational HER3-directed ADC developed using Daiichi Sankyo’s proprietary DXd ADC technology. This therapy consists of a fully human anti-HER3 IgG1 monoclonal antibody conjugated to a topoisomerase I inhibitor payload (DXd) via cleavable linkers. HER3 is overexpressed in various cancers, including non-small cell lung cancer (NSCLC) and breast cancer, and serves as a promising target for ADC-based therapies. Patritumab deruxtecan was studied most recently with positive Phase 3 results as of September 17, 2024.
As monoclonal antibody research continues to expand, these new therapies are shaping the future of autoimmune disease management, infectious disease prevention, and cancer treatment. With multiple regulatory milestones approaching, these next-generation antibody therapeutics have the potential to significantly improve patient outcomes in their respective fields.
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抗体薬物複合体（Antibody-Drug Conjugates, ADC）は、がん治療において革新的なターゲット型治療薬の一つであり、モノクローナル抗体（mA……
第13回抗体産業シンポジウム（Antibody Industrial Symposium 2025）が、2025年6月25日から26日にかけてフランス・トゥール……
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