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BioWorld - Wednesday, June 3, 2026
Home » Topics » Regulatory » IND

IND
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Cancer cells
Immuno-oncology

Turnstone receives IND clearance for phase I trial of TIDAL-01 for solid tumors

Nov. 2, 2022
Turnstone Biologics Corp. has received IND clearance from the FDA for the company's lead selected tumor-infiltrating lymphocyte (TIL) therapy program, TIDAL-01.
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Cancer

Abbisko cleared to enter clinic with FGFR inhibitor ABSK-121 for solid tumors

Nov. 2, 2022
Abbisko Therapeutics Co. Ltd. has received clearance from the FDA to initiate a phase I...
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Immune checkpoint inhibitors illustration of PD-1, CTLA-4 and PD-L1.
Immuno-oncology

FDA approves IND for bifunctional fusion protein SIM-0237

Oct. 28, 2022
Simcere Pharmaceutical Group announced that the FDA has cleared the company’s IND application for SIM-0237 for the treatment of adult patients with advanced solid tumors.
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Infection

Ascletis files IND application for ASC-10 as treatment of monkeypox virus infection

Oct. 27, 2022
Ascletis Pharma Inc. announces that the company has filed an IND application with the FDA for ASC-10, an oral antiviral drug candidate targeting viral polymerase of monkeypox virus.
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Central nervous system
Neurology/Psychiatric

FDA clears IND application and grants orphan drug designation for CE-VST01-JC

Oct. 26, 2022
Cellevolve Bio Inc. announced that the FDA has cleared its IND application for CE-VST01-JC, an allogeneic, off-the-shelf, JC-specific T-cell therapy (JC-VST) targeting JC polyoma virus (JCV), being studied for the treatment of progressive multifocal leukoencephalopathy (PML).
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Illustration of neuromuscular junction in myasthenia gravis
Neurology/Psychiatric

Cour Pharmaceuticals set to advance CNP-106 for myasthenia gravis

Oct. 26, 2022
Cour Pharmaceuticals Inc. announced that the FDA has cleared an IND application to initiate a phase Ib/IIa proof-of-concept study of its...
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Fallopian tubes, ovaries and uterus
Endocrine/Metabolic

FDA clears Vitti's allogenic exosomal product for primary ovarian insufficiency to enter clinic

Oct. 19, 2022
Vitti Labs LLC has received FDA clearance of its IND for EV-Pure, an allogenic exosomal product, for women with primary ovarian insufficiency.
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Gastrointestinal

Zhiyi Biotech cleared to advance SK-10 into clinic in U.S. for chemotherapy-induced diarrhea

Oct. 19, 2022
Guangzhou Zhiyi Biotechnology Co. Ltd. has received IND approval from the FDA to conduct a phase I study in the U.S. with SK-10 for the treatment of chemotherapy-induced diarrhea.
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Lung cancer illustration
Cancer

Prelude receives clearance for phase I study of SMARCA2 protein degrader PRT-3789 for solid tumors

Oct. 19, 2022
Prelude Therapeutics Inc. has received...
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Antibodies attacking cancer cell
Immuno-oncology

China's NMPA clears IND for anti-GARP monoclonal antibody HLX-60 for solid tumors and lymphomas

Oct. 18, 2022
China's National Medical Products Administration (NMPA) has cleared an IND application for a clinical trial of Shanghai Henlius Biotech Inc.'s HLX-60 for the treatment of solid tumors and lymphomas.
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