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Home » Topics » Regulatory » IND

IND
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Hepatitis B virus rendering
Infection

Recombinant polyclonal HBV therapy cleared to enter clinic

Aug. 1, 2024
Gigagen Inc., a subsidiary of Grifols SA, has received clearance from the FDA of its IND application to conduct a phase I trial of GIGA-2339 for the treatment of hepatitis B virus (HBV) infections.
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Cancer

FDA clears IND for COM-503

July 30, 2024
The US FDA has cleared an IND application for COM-503, high affinity anti-IL-18 binding protein antibody, in solid tumors.
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Sickle cell illustration
Hematologic

Actinium Pharmaceuticals obtains FDA clearance for trial of Iomab-ACT in sickle cell disease

July 26, 2024
Actinium Pharmaceuticals Inc. has received FDA clearance of an IND application to study Iomab-ACT for targeted conditioning prior to a bone marrow transplant (BMT) in patients with sickle cell disease. 
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Illustration of pancreas, close up of islet
Endocrine/metabolic

FDA grants IND for Tiximed oral antidiabetic

July 24, 2024
Tiximed Inc. has received IND clearance for its inhibitor of thioredoxin-interacting protein (TXNIP), TIX-100, in individuals with type 1 diabetes. TIX-100 is a potent and specific inhibitor of TXNIP.
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3D illustration demonstrating antibody-drug conjugate.
Immuno-oncology

Zymeworks obtains IND clearance for FRα-targeted ADC

July 22, 2024
Zymeworks Inc. has received IND clearance from the FDA for ZW-191, the company’s novel folate receptor-α (FRα)-targeted topoisomerase I (TOPO1) inhibitor antibody-drug conjugate (ADC). Clinical development is set to begin this year, with filings to initiate studies outside the U.S. to be made in the second half of this year.
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3D cross-section illustration of muscle anatomy
Musculoskeletal

FDA approves IND for Myopaxon in Duchenne muscular dystrophy

July 18, 2024
Myogenica Inc., a University of Minnesota startup company, has obtained IND approval from the FDA for Myopaxon, an induced pluripotent stem cell (iPSC)-derived muscle stem cell product to regenerate skeletal muscle. A planned study will evaluate intramuscular injections of Myopaxon in non-ambulatory adult patients with Duchenne muscular dystrophy.
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Neuron
Neurology/psychiatric

Artelo’s FABP5 inhibitor cleared to enter clinic for chemotherapy-induced peripheral neuropathy

July 16, 2024
Artelo Biosciences Inc.’s IND application for ART-26.12, for the treatment of chemotherapy-induced peripheral neuropathy, has been granted clearance by the FDA allowing the company to initiate a first-in-human phase I study. Results are expected in the first half of next year.
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Microscope with laptop displaying histology image.
Cancer

Rgenta’s RGT-61159 cleared by FDA for first-in-human trial in adenoid cystic carcinoma and colorectal cancer

July 11, 2024
Rgenta Therapeutics Inc. has received IND clearance by the FDA for RGT-61159, which is being developed for adenoid cystic carcinoma, colorectal cancer and other solid tumors, as well as acute myeloid leukemia.
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Multiple sclerosis, neurons concept art.
Neurology/psychiatric

Abata obtains IND clearance for autologous TCR-Treg therapy for progressive MS

July 10, 2024
Abata Therapeutics Inc. has obtained FDA clearance for its IND application enabling initiation of a first-in-human study of ABA-101 in patients with progressive multiple sclerosis (MS). A phase I study will open later this year.
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Gastric cancer
Cancer

Signet’s SIGX-1094 receives US IND clearance for diffuse gastric cancer

July 2, 2024
Signet Therapeutics Inc. has received IND clearance from the FDA for SIGX-1094 as a potential treatment for diffuse gastric cancer. A phase I trial is planned in patients with diffuse gastric cancer and other advanced solid tumors.
Read More
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