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Home » Topics » Regulatory » IND

IND
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Antibodies attacking cancer cell
Immuno-oncology

Oncoc4 gains US IND approval for bispecific antibody for advanced solid tumors

Dec. 3, 2024
Oncoc4 Inc. has obtained IND approval from the FDA for AI-081, a PD-1 and VEGF bispecific antibody for the treatment of advanced solid tumors.
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Neurology/psychiatric

Sangamo’s ST-503 receives IND clearance for idiopathic small fiber neuropathy

Nov. 20, 2024
Sangamo Therapeutics Inc. has received IND clearance from the FDA for ST-503, an investigational epigenetic regulator for the treatment of intractable pain due to idiopathic small fiber neuropathy (iSFN).
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Dermatologic

Enveda advances ENV-294 into clinic for atopic dermatitis

Nov. 14, 2024
Enveda Therapeutics Inc. has received U.S. IND clearance and advanced into phase I trials with ENV-294, its naturally derived anti-inflammatory.
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3D illustration showing presence of tumor inside prostate gland
Diagnostics

Antelope Surgical’s AS-1986NS cleared to enter clinic

Nov. 13, 2024
Antelope Surgical Solutions Inc. has received commercial IND approval from the FDA for its novel prostate cancer technology, AS-1986NS. AS1986NS, a fluorescent and lutetium-175 bearing drug, will be evaluated in trials with the aim of addressing prostate cancer identification and surgical margin delineation.
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Transmission electron microscope image of H5N1 virus particles
Immune

Arcturus gains IND clearance for H5N1 influenza sa-RNA vaccine candidate

Nov. 12, 2024
Arcturus Therapeutics Holdings Inc. has received IND clearance from the FDA to begin a phase I study of ARCT-2304, a self-amplifying mRNA (sa-mRNA) vaccine candidate for active immunization to prevent pandemic influenza disease caused by H5N1 virus.
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Monoclonal antibody illustration
Inflammatory

Hifibio Therapeutics’ BTLA agonist antibody gains US IND clearance

Nov. 5, 2024
Hifibio Therapeutics Inc. has gained IND clearance from the FDA for HFB-200604, a potentially best-in-class BTLA agonist monoclonal antibody for inflammatory and immunology diseases.
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Neurology/psychiatric

Damona’s α5-GABAAR-targeting PAM gains IND clearance to treat cognitive deficits in brain disorders

Nov. 5, 2024
Damona Pharmaceuticals Inc. has obtained IND clearance from the FDA for DPX-101 for the treatment of cognitive deficits in brain disorders, including major depressive disorder.
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RNA strand
Ear, nose & throat

Ribox’s RXRG-001 cleared to enter clinic for radiation-induced xerostomia and hyposalivation

Oct. 28, 2024
Ribox Therapeutics Ltd. has obtained IND clearance from the FDA for the company’s circular RNA therapy, RXRG-001.
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3D illustration of cancer in crosshairs
Cancer

WRN inhibitor IDE-275 gains IND clearance for phase I study in MSI-high tumors

Oct. 28, 2024
Ideaya Biosciences Inc. has announced FDA clearance of an IND application for IDE-275 (GSK-959), a small-molecule inhibitor of Werner helicase (WRN) discovered by Ideaya in collaboration with GSK plc.
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Cancer

Accent Therapeutics’ ATX-559 cleared to enter clinic

Oct. 25, 2024
Accent Therapeutics Inc. has gained IND clearance from the FDA for ATX-559, a first-in-class DHX9 inhibitor.
Read More
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