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Home » Topics » Regulatory » IND

IND
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Cancer

Immuneering cleared to advance IMM-1-104 into clinic for RAS-mutant solid tumors

Oct. 3, 2022
Immuneering Corp. has received FDA clearance of its IND application for IMM-1-104, paving the way for the company to initiate a phase I/IIa trial of this oral, once-daily small molecule in development for the treatment of advanced RAS-mutant solid tumors.
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Test tube, dropper, DNA illustration
Ear, Nose and Throat

Akouos receives IND clearance for AK-OTOF gene therapy for OTOF-mediated hearing loss

Sep. 14, 2022
Akouos Inc. has received IND clearance from the FDA to initiate a first-in-human phase I/II pediatric trial of AK-OTOF, a gene therapy intended for the treatment of patients with otoferlin gene (OTOF)-mediated hearing loss.
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Antibodies attacking cancer cell
Immuno-oncology

Transcenta cleared to advance gremlin-1-targeting antibody TST-003 into clinic for solid tumors

Sep. 14, 2022
Transcenta Holding Ltd. has received IND clearance from the FDA for TST-003, its first-in-class, high-affinity, humanized monoclonal antibody targeting gremlin-1.
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Non-Hodgkin lymphoma cells in the blood flow
Cancer

Innocare Pharma cleared to begin clinical trials in China with BCL2 inhibitor ICP-248

Sep. 13, 2022
Innocare Pharma Ltd. has received IND approval from China's National Medical Products Administration (NMPA) to begin clinical trials of its B-cell lymphoma-2 (BCL2) inhibitor ICP-248.
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Cardiovascular

Tenaya cleared to begin clinical testing of TN-301 for HFpEF

Sep. 7, 2022
Tenaya Therapeutics Inc. has received FDA clearance of its IND application to begin clinical testing of TN-301, a highly selective small-molecule inhibitor of histone deacetylase 6 (HDAC6) initially being developed for heart failure with preserved ejection fraction (HFpEF).
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Cancer cell destruction by nanoparticles
Cancer

Monte Rosa receives IND clearance for molecular glue degrader MRT-2359 for MYC-driven solid tumors

Sep. 7, 2022
Monte Rosa Therapeutics Inc. has received FDA clearance of its IND application for MRT-2359, a potent and selective GSPT1-directed molecular glue degrader (MGD).
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Test tubes, capsules, dropper
Cancer

Cancer Immuneering submits IND application for IMM-1-104 for advanced RAS-mutant solid tumors

Sep. 5, 2022
Immuneering Corp. has submitted an IND application to the FDA to support a phase I/IIa trial of IMM-1-104, an oral once-daily small molecule in development for the treatment of advanced RAS-mutant solid tumors.
Read More
Endocrine/Metabolic

Immusoft cleared to advance ISP-001 into clinic for MPS I

Sep. 2, 2022
The FDA has cleared Immusoft Corp.'s IND for ISP-001 (iduronicrin genleukocel-T) for the treatment of mucopolysaccharidosis type I (MPS I), allowing initiation of a phase I trial.
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Immune

Stemcyte cleared to study umbilical cord blood stem cell therapy for post-COVID syndrome

Aug. 30, 2022
Stemcyte Inc. has received IND approval from the FDA for a phase II trial using umbilical cord blood stem cell therapy for post-COVID syndrome, or long COVID.
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Pill over molecule structures
Cancer

FDA clears IND for Inhibikase's imatinib prodrug IkT-001Pro for CML

Aug. 29, 2022
The FDA has cleared Inhibikase Therapeutics Inc.'s IND application for IkT-001Pro for the treatment of chronic myelogenous leukemia (CML). IkT-001Pro is a prodrug formulation of imatinib mesylate and has been developed to improve the safety of the first FDA-approved Abelson (Abl) kinase inhibitor, Gleevec (imatinib).
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