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BioWorld - Friday, January 2, 2026
Home » Topics » Monoclonal antibody, BioWorld Science

Monoclonal antibody, BioWorld Science
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Kidneys
Immune

Tonix receives IND clearance to study TNX-1500 to prevent organ rejection in kidney transplant patients

May 5, 2023
Tonix Pharmaceuticals Holding Corp. has received FDA clearance of its IND application to support a phase I trial with TNX-1500, an anti-CD40L monoclonal antibody. The first indication Tonix is seeking for TNX-1500 is the prevention of organ rejection in patients receiving a kidney transplant. Enrollment in the phase I study is expected to open in the third quarter of this year.
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Immuno-oncology

Henlius’ agonistic anti-OX40 humanized monoclonal antibody HLX-51 cleared to enter clinic in China

March 16, 2023
Shanghai Henlius Biotech Inc. has received...
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Coronavirus and antibodies
Infection

Invivyd selects VYD-222 to advance as monoclonal antibody therapeutic option for COVID-19

March 7, 2023
Invivyd Inc. has selected VYD-222 to advance into the clinic as a novel monoclonal antibody therapeutic option for COVID-19. VYD-222...
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Drug vial and syringe
Immuno-oncology

Mabwell's IL-11-targeting monoclonal antibody 9MW3811 cleared to enter clinic

March 1, 2023
Mabwell (Shanghai) Bioscience Co. Ltd. has received approval of its IND application from Australia's Therapeutic Goods Administration (TGA) for 9MW3811 injection for tumors and pulmonary fibrosis.
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Gloved hand holding powder substance in bag
Substance Use & Poisoning

CSX-1004 blocks fentanyl-induced respiratory depression in nonhuman primates

March 1, 2023
Cessation Therapeutics Inc. has announced outcomes of a new study demonstrating that its anti-fentanyl monoclonal antibody treatment, CSX-1004, may provide robust and durable protection from life-threatening respiratory depression caused by high doses of fentanyl. The findings come from the company’s ongoing series of proof-of-concept studies in nonhuman primates.
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Immuno-oncology

Fapon receives IND clearance from FDA for anti-CD47 IgG4 monoclonal antibody FP-002

Feb. 23, 2023
Fapon Biopharma, a subsidiary of Guangdong Fapon Biotech Co. Ltd., has received IND clearance by the FDA for clinical trials of FP-002...
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Liver illustration
Cancer

Preclinical data on NILK-2501 and NILK-3801 bispecific antibody combination presented

Feb. 21, 2023
Glypican 3 (GPC3) is overexpressed in hepatocellular cancers (HCC), even at very early stages. In contrast, GPC3 is not expressed in normal adult organs. One strategy in place for HCC consists in co-targeting GPC3 and CD3 with bispecific antibodies to activate the latter in order to attack GPC3-positive cancer cells.
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Coronavirus and antibodies
Infection

Tonix exercises option to license anti-SARS-CoV-2 monoclonal antibodies from Columbia University

Feb. 14, 2023
Tonix Pharmaceuticals Holding Corp. has exercised an option to obtain an exclusive license from Columbia University for the development of a portfolio of fully human (TNX-3600) and murine (TNX-4100) monoclonal antibodies for the treatment or prophylaxis of SARS-CoV-2 infection.
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Immuno-oncology

FDA clears IND for SIRPα-targeting ADU-1805 in advanced solid tumors

Feb. 14, 2023
The FDA has cleared Sairopa BV's IND application for a phase I trial of ADU-1805 in adults with advanced solid tumors.
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Antibody-drug conjugate illustration
Immuno-oncology

Legochem to develop first-in-class ADC using antibody licensed from Elthera

Feb. 13, 2023
Legochem Biosciences Inc. has entered into a license agreement with Elthera AG to develop and commercialize a novel antibody-drug conjugate (ADC) therapy using a monoclonal antibody developed by Elthera.
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