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BioWorld - Wednesday, February 25, 2026
Home » Topics » Regulatory » IND

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Ocular

Inflammasome Therapeutics’ inflammasome inhibitor cleared to enter clinic for geographic atrophy

Nov. 14, 2023
Inflammasome Therapeutics Inc. has received FDA clearance to begin a phase I/II trial of the company’s inflammasome inhibitor for the treatment of geographic atrophy, the most severe form of dry age-related macular degeneration. This is the first clinical trial of an inflammasome inhibitor to treat geographic atrophy. The company’s sustained-release implant contains the first of a new class of inflammasome inhibitor drugs, Kamuvudines, developed by the company and designed to halt the multiple processes that cause geographic atrophy.
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Thrombus in bloodstream with platelets and fibrin
Hematologic

Sirius files to begin first-in-human study of candidate for thromboembolic disorders

Nov. 10, 2023
Sirius Therapeutics Inc. has submitted an application in Australia to begin a first-in-human trial of SRSD-107 for the prevention and treatment of thromboembolic disorders.
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Scientist, microscope and dropper
Immuno-oncology

Abbisko's CD73 inhibitor ABSK-051 cleared for clinic in China

Nov. 9, 2023
Abbisko Therapeutics Co. Ltd. has received clearance from China's National Medical Products Administration (NMPA) to conduct clinical trials in China of ABSK-051, a novel small-molecule CD73 inhibitor, for advanced solid tumors.
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Genetic/Congenital

Grace Science’s gene therapy for NGLY1 deficiency cleared to enter clinic in US

Nov. 8, 2023
Grace Science LLC has received FDA clearance of its IND application for GS-100, an AAV9 gene replacement therapy for the treatment of NGLY1 deficiency.
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Cancer

Abbisko’s FGFR4 inhibitor ABSK-012 receives FDA clearance for phase I trials

Nov. 8, 2023
Abbisko Therapeutics Co. Ltd. has received FDA clearance of its IND application for ABSK-012, a highly selective small-molecule inhibitor of fibroblast growth factor receptor 4 (FGFR4), for advanced solid tumors.
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Breast cancer cells.
Immuno-oncology

FDA clears Briacell’s personalized cellular immunotherapy to enter clinic

Nov. 6, 2023
Briacell Therapeutics Corp. has received IND clearance from the FDA to begin clinical studies with Bria-OTS, the first generation of the company’s personalized off-the-shelf cellular immunotherapy for breast cancer.
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Immuno-oncology

Prokarium’s ZH-9 cleared to enter clinic in US for bladder cancer

Nov. 3, 2023
Prokarium Ltd. has obtained FDA clearance of its IND application for ZH-9 for patients with non-muscle invasive bladder cancer.
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Antibody-drug conjugate
Immuno-oncology

Angiex cleared to begin phase I study of TM4SF1-directed ADC

Nov. 3, 2023
Angiex Inc. has received FDA clearance of its IND application for AGX-101, a novel TM4SF1-directed antibody-drug conjugate (ADC) being developed for the treatment of solid cancers.
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Immuno-oncology

Chimeric's CHM-2101 gains IND clearance for GI cancers

Oct. 31, 2023
Chimeric Therapeutics Ltd. has received FDA clearance of its IND application for CHM-2101, a first-in-class CDH17 chimeric antigen receptor (CAR) T cell therapy for gastrointestinal (GI) cancers.
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Cancer

HLX-42 is EGFR-targeting ADC with activity in several cancer models

Oct. 31, 2023
Researchers from Shanghai Henlius Biotech Inc. presented the discovery and preclinical characterization of HLX-42, a next-generation EGFR-targeting antibody-drug conjugate (ADC) being developed for the treatment of cancer.
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