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BioWorld - Thursday, March 23, 2023
Home » Topics » FDA, BioWorld Science

FDA, BioWorld Science
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Immuno-oncology

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

Feb. 14, 2023
No Comments
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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Immuno-oncology

Harbour Biomed's HBM-1022 targeting CCR8 cleared to enter clinic for solid tumors

Feb. 7, 2023
No Comments
Harbour Biomed Ltd. has received IND clearance by the FDA to initiate clinical trials in the U.S. with HBM-1022, a monoclonal antibody generated from Harbour's integrated G protein-coupled receptor (GPCR) platform. The antibody can enhance antitumor immunity by depleting CCR8 positive regulatory T cells, activating effector T cells.
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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
No Comments
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
No Comments
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
No Comments
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
No Comments
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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Cancer

Beatica's BEA-17 awarded orphan drug designation for glioblastoma

Feb. 1, 2023
No Comments
The FDA has awarded orphan drug designation to Beactica Therapeutics AB's BEA-17 for the treatment of glioblastoma (GBM).
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Gastrointestinal system with ulcerative colitis.
Gastrointestinal

Rise Therapeutics to advance R-3750 immunotherapy for ulcerative colitis

Feb. 1, 2023
No Comments
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
No Comments
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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Dermatologic

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

Jan. 30, 2023
No Comments
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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