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BioWorld - Saturday, December 20, 2025
Home » Topics » Drugs » Monoclonal antibody

Monoclonal antibody
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Myelin sheath and neurons in the brain

With strong Guillain-Barré data, Annexon preps for ANX-005 BLA

June 4, 2024
By Karen Carey
Annexon Inc.’s stock (NASDAQ:ANNX) climbed 31% June 4 following news that a single infusion of C1q protein complex inhibitor ANX-005 at the 30-mg/kg dose delivered a statistically significant 2.4-fold improvement in Guillain-Barré syndrome patients. Shares closed at $5.99, up $1.41.
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Immuno-oncology

IND clearance for Fibrogen’s Gal9-targeting monoclonal antibody for solid tumors

June 4, 2024
Fibrogen Inc. has received IND clearance from the FDA allowing the company to initiate a phase I trial of FG-3165, a galectin-9 (Gal9)-targeted monoclonal antibody under development for treatment of solid tumors characterized by high levels of Gal9 expression.
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Illustration of immunoglobulin A with secretory IgA
Dermatologic

JJP Biologics’ CD89 antagonist receives EMA clearance for first-in-human studies

May 29, 2024
JJP Biologics Sp. z o.o. has received clearance from the EMA to conduct a first-in-human study of its CD89 antagonist, JJP-1212, for IgA-mediated autoimmune and fibrotic diseases. A phase I study in healthy participants will be conducted in Poland.
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Red wooden approved stamp

Celltrion’s Omlyclo gets nod as Europe’s first Xolair biosimilar

May 28, 2024
By Marian (YoonJee) Chu
South Korea’s Celltrion Inc. secured May 22 the European Commission’s go-ahead for Omlyclo (CT-P39) to be the first biosimilar to Genentech Inc./Novartis AG’s Xolair (omalizumab) in Europe for three of its major indications.
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Globe showing Asia-Pacific region

Astrazeneca in Asia: $604M Nona deal, $1.5B Singapore ADC plant

May 28, 2024
By Marian (YoonJee) Chu
Cambridge, U.K.-based Astrazeneca plc is looking to Asia, specifically China and Singapore, to build an innovative cancer-focused pipeline filled with antibody-drug conjugates (ADC), monoclonal antibodies (MAbs) and cell therapies.
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Innovent’s picankibart hits phase III plaque psoriasis endpoints

May 28, 2024
By Tamra Sami
Innovent Biologics Inc.’s picankibart (IBI-112) met all primary endpoints and key secondary endpoints in the phase III registrational Clear-1 trial in Chinese subjects with moderate to severe plaque psoriasis.
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Dermatologic

Astria and Ichnos Sciences reveal preclinical profile of new anti-OX40 antibody for atopic dermatitis

May 28, 2024
Inhibition of OX40 is known to induce and maintain responses in moderate to severe atopic dermatitis (AD). Astria Therapeutics Inc. and Ichnos Sciences Inc. are developing STAR-0310, a YTE-modified (M252Y/S254T/T256E) monoclonal antibody targeting OX40.
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Red wooden approved stamp

Celltrion’s Omlyclo gets nod as Europe’s first Xolair biosimilar

May 24, 2024
By Marian (YoonJee) Chu
South Korea’s Celltrion Inc. secured May 22 the European Commission’s go-ahead for Omlyclo (CT-P39) to be the first biosimilar to Genentech Inc./Novartis AG’s Xolair (omalizumab) in Europe for three of its major indications.
Read More
Globe showing Asia-Pacific region

Astrazeneca in Asia: $604M Nona deal, $1.5B Singapore ADC plant

May 24, 2024
By Marian (YoonJee) Chu
Cambridge, U.K.-based Astrazeneca plc is looking to Asia, specifically China and Singapore, to build an innovative cancer-focused pipeline filled with antibody-drug conjugates (ADC), monoclonal antibodies (MAbs) and cell therapies.
Read More
Immuno-oncology

IOMX-0675, a potential best-in-class dual-targeting antibody that repolarizes immunosuppressive tumor microenvironment

May 23, 2024
Researchers from Iomx Therapeutics AG presented the discovery and preclinical evaluation of IOMX-0675, a novel LILRB1 and LILRB2 cross-specific antibody being developed for the treatment of solid tumors.
Read More
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