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BioWorld - Sunday, March 1, 2026
Home » Topics » Drugs » Monoclonal antibody

Monoclonal antibody
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Post-J&J bid, Sensei explores new oncology VISTAs

March 27, 2024
By Randy Osborne
An increasingly popular target across varied cancer types is the immune system regulator V-domain Ig suppressor of T-cell activation (VISTA), where a number of developers have taken early stage aim – among them Sensei Biotherapeutics Inc., with SNS-101, which Wainwright analyst Edward White believes could be the first anti-VISTA monoclonal antibody approved as a therapeutic agent. But there’s plenty of work ahead.
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Green approved stamp

Astellas wins first approval of Vyloy in gastric cancer in Japan

March 27, 2024
By Marian (YoonJee) Chu
Japan’s Ministry of Health, Labor and Welfare approved Astellas Pharma Inc.’s Vyloy (zolbetuximab) to treat a type of advanced gastric cancer on March 26, making it the first anti-claudin 18.2 monoclonal antibody to gain regulatory clearance worldwide.
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Invivyd’s COVID MAb Pemgarda gains US EUA with boxed warning

March 25, 2024
By Karen Carey
The U.S. FDA granted emergency use authorization (EUA) on March 22 for Waltham, Mass.-based Invivyd Inc.’s half-life extended monoclonal antibody (MAb) VYD-222 – making it available to prevent COVID-19 in immunocompromised adults and adolescents – but its use comes with a boxed warning for anaphylaxis.
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Lungs
Respiratory

China NMPA approves IND for Henlius’ anti-GARP/TGF-β1 mAb for IPF

March 14, 2024
Shanghai Henlius Biotech Inc.’s IND application for HLX-6018, a novel anti-glycoprotein-A repetitions predominant (GARP)/transforming growth factor-β1 (TGF-β1) monoclonal antibody (mAb), has received approval by China’s National Medical Products Administration (NMPA) for the treatment of idiopathic pulmonary fibrosis (IPF).
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Celltrion files for US approval of Xolair biosimilar, CT-P39

March 12, 2024
By Marian (YoonJee) Chu
South Korean biopharmaceutical company Celltrion Inc. submitted a BLA to the U.S. FDA on March 10 to gain approval for its Xolair (omalizumab; Novartis AG) biosimilar, CT-P39, across major indications of asthma, food allergy and chronic spontaneous urticaria.
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US FDA includes amyloid in revised Alzheimer’s draft

March 11, 2024
By Mari Serebrov
Reflecting the evolving scientific understanding of Alzheimer’s disease, the U.S. FDA revised its 2018 draft guidance on developing drugs to treat early Alzheimer’s.
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Celltrion files for US approval of Xolair biosimilar, CT-P39

March 11, 2024
By Marian (YoonJee) Chu
South Korean biopharmaceutical company Celltrion Inc. submitted a BLA to the U.S. FDA on March 10 to gain approval for its Xolair (omalizumab; Novartis AG) biosimilar, CT-P39, across major indications of asthma, food allergy and chronic spontaneous urticaria.
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Neurology/Psychiatric

VHB-937, a TREM2-binding MAb with efficacy in a broad range of neurodegenerative disease models

March 11, 2024
It has been previously demonstrated that TREM2 is extensively shed during chronic neuroinflammation, which hiders its function, while TREM2 activation enhances effector functions of microglia.
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Antibodies attacking cancer cell
Immuno-oncology

Ono Pharmaceutical licenses NXI-101 from Nex-I

March 6, 2024
Ono Pharmaceutical Co. Ltd. has entered into a license agreement with Nex-I Inc. to develop and commercialize NXI-101.
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Immuno-oncology

Preclinical data support ongoing clinical development of MAb and ADC for CLDN18.2+ tumors

March 1, 2024
Tumors in the stomach and pancreas are known to express claudin 18.2 (CLDN18.2) and the absence of expression in normal tissues makes it an attractive therapeutic target.
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