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BioWorld - Monday, December 29, 2025
Home » Topics » Regulatory » IND

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Colorized transmission electron micrograph of SARS-CoV-2.
Infection

Insilico Medicine's 3CLpro inhibitor ISM-3312 cleared to enter clinic in China for COVID-19

Feb. 24, 2023
Insilico Medicine Inc. has received IND clearance from China's National Medical Products Administration (NMPA) for ISM-3312, an orally available 3CLpro inhibitor for the treatment of COVID-19. ISM-3312 has a novel molecular structure and was optimized from compounds designed by Chemistry42, Insilico’s generative chemistry AI platform.
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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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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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Immuno-oncology

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

Feb. 7, 2023
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
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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