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BioWorld - Monday, April 13, 2026
Home » Topics » Regulatory » IND

IND
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Blood cells and destruction of cancer cell
Cancer

Accutar's chimeric degrader of BTK cleared to enter clinic for B-cell malignancies

Feb. 6, 2023
Accutar Biotechnology Inc. has received FDA clearance of its IND application for AC-0676 for the treatment of patients with relapsed/refractory B-cell malignancies.
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Drug capsule spilling onto brain
Neurology/Psychiatric

FDA clears Egret's EGT-101 to enter clinic for delayed cerebral ischemia after aneurysmal subarachnoid hemorrhage

Feb. 6, 2023
Egret Therapeutics, a portfolio company of Turret Capital Management LP, has announced FDA clearance of its IND application for EGT-101 for the treatment of delayed cerebral ischemia following aneurysmal subarachnoid hemorrhage.
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Macrophage releasing cytokines as a part of the body's immune response.
Inflammatory

Inmagene to advance its long-acting IL-36R monoclonal antibody IMG-008

Feb. 6, 2023
Inmagene Biopharmaceuticals Co. Ltd. has obtained IND approval from the FDA for IMG-008, the company's novel long-acting antagonistic humanized monoclonal antibody that specifically targets human IL-36 receptor (IL-36R) to treat auto-inflammatory diseases.
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Immune checkpoint inhibitors illustration of PD-1, CTLA-4 and PD-L1.
Immuno-oncology

Pliant's integrin inhibitor PLN-101095 cleared to enter clinic for solid tumors

Feb. 3, 2023
Pliant Therapeutics Inc. has received FDA clearance of its IND application for PLN-101095, an oral, small-molecule, dual selective inhibitor of integrins αvβ8 and αvβ1.
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Coronavirus, mRNA and syringe
Infection

Greenlight cleared to begin first-in-human study of mRNA COVID-19 vaccine candidate GLB-COV2-043

Feb. 2, 2023
Greenlight Biosciences Holdings PBC has received regulatory approval from the Rwanda Food and Drugs Authority (Rwanda FDA) to start a first-in-human phase I/II trial of its mRNA vaccine candidate against COVID-19, GLB-COV2-043, as a booster for previously vaccinated individuals.
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Gastrointestinal system with ulcerative colitis.
Gastrointestinal

Rise Therapeutics to advance R-3750 immunotherapy for ulcerative colitis

Feb. 1, 2023
Rise Therapeutics LLC has received FDA clearance for its IND application to proceed with a phase I trial of R-3750, a synthetic biology-based cellular immunotherapy being developed for the treatment of inflammatory bowel disease. The phase I trial will enroll patients with mild to moderate ulcerative.
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The epidermal growth factor receptor in the inactive (left) and active (right) form.
Immuno-oncology

Deka's IND for DK-210 (EGFR) in advanced solid cancer receives FDA clearance

Jan. 31, 2023
Deka Biosciences Inc.'s IND application has been cleared by the FDA allowing the company to proceed with a phase I trial of DK-210 (EGFR) in patients with advanced solid cancer overexpressing epidermal growth factor receptors (EGFR).
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3D heart in chest
Cardiovascular

China's CDE clears IND for Help's iPS cell-derived cardiomyocyte therapy for ischemic heart failure

Jan. 31, 2023
Help Therapeutics Co. Ltd. has received IND approval from China's Center for Drug Evaluation (CDE) for HiCM-188.
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Dermatologic

Escient gains IND clearance for first-in-human study of MRGPRX2 antagonist EP-262

Jan. 30, 2023
Escient Pharmaceuticals Inc. has obtained FDA clearance of its IND application for EP-262, a first-in-class, potent, highly selective small-molecule antagonist of Mas-related G-protein coupled receptor member X2 (MRGPRX2) for mast cell-mediated disorders.
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Antibodies attacking cancer cell
Immuno-oncology

Centessa to advance conditionally tetravalent PD-L1xCD47 bispecific monoclonal antibody

Jan. 27, 2023
Centessa Pharmaceuticals plc has received clearance of its IND application from the FDA to initiate a first-in-human phase I/IIa trial of LB-101 for the treatment of solid tumors.
Read More
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