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BioWorld - Wednesday, December 17, 2025
Home » Topics » Drugs » Monoclonal antibody

Monoclonal antibody
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Sanofi’s BTK inhibitor hits phase III thrombocytopenia endpoint

April 23, 2024
By Karen Carey
An oral Bruton’s tyrosine kinase (BTK) inhibitor that Sanofi SA acquired in 2020 through its $3.68 billion buyout of Principia Biopharma Inc. is headed toward regulatory filings in the U.S and EU by the end of the year, following phase III data in immune thrombocytopenia.
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3D rendered illustration of the anatomy of a cancer cell
Immuno-oncology

Specific and selective anti-ILT4 MAb, CHS-1000, reverses ILT4-mediated immunosuppressive functions in vitro

April 17, 2024
The leukocyte immunoglobulin-like receptor B2 (LILRB2), also known as ILT4, is an immunoreceptor tyrosine-based inhibitory motif (ITIM)-containing receptor that is widely expressed on immunosuppressive myeloid cells in the tumor microenvironment.
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Monoclonal antibody illustration
Infection

Spikimm signs collaboration and license option agreement for anti-BKV monoclonal antibodies

April 17, 2024
Spikimm SAS has signed an exclusive collaboration and license option agreement with SATT Conectus Alsace SAS for monoclonal antibodies targeting the BK virus. Reactivation of the BK virus (BKV) in patients receiving kidney transplant, bone marrow or stem cell grafts has potential serious consequences.
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Essential gaining neuroblastoma candidate in Renaissance buy

April 9, 2024
By Nuala Moran
Essential Pharma Ltd. is paying up to £70 million (US$88.7 million) to acquire Renaissance Pharma Ltd., taking ownership of Hu14.18, a treatment for high-risk neuroblastoma. The antibody has completed a 64-patient phase II trial conducted by St Jude’s Children’s Research Hospital, in which it showed an improvement in overall survival of around 50% compared to currently available therapies.
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Adel CEO Seung-Yong Yoon at company headquarters in Seoul, South Korea

After amyloid beta, Adel seeks next big target for Alzheimer’s

April 2, 2024
By Marian (YoonJee) Chu
Alzheimer’s disease (AD) is recognized worldwide for its debilitating symptoms of declining cognitive function and gradual memory loss. What remains less clear is exactly what causes the neurodegenerative disease, and how to treat it. “Alzheimer’s disease is characterized by two key pathologies – beta-amyloid plaques and tau neurofibrillary tangles.” Seung-Yong Yoon, CEO of Adel Inc., told BioWorld. “Adel is looking to develop a tau-targeting drug, considering tau has been more correlated with AD symptom progression, and the industry’s need for tau pipelines.”
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Green approved stamp

Astellas wins first approval of Vyloy in gastric cancer in Japan

April 2, 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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Cancer cells being destroyed by immunotherapy

Xilio inks $648M IL-12 deal with Gilead, reprioritizes pipeline

March 28, 2024
By Karen Carey
Xilio Therapeutics Inc. retreated with its lead oncology IL-2 drug, XTX-202, after phase II data indicated stable disease was the best response, prompting the company to reprioritize its pipeline and cut its workforce by 21% – but investors focused more on a $647.5 million IL-12 program deal the company signed with Gilead Sciences Inc., as well as an $11.3 million private placement financing.
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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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