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Home » Topics » Regulatory » IND

IND
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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.
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Yuhan nabs Ubix cancer drug for ₩150B; YH-35995 trial cleared

July 1, 2024
By Marian (YoonJee) Chu
Yuhan Corp., of Seoul, South Korea, has inked a ₩150 billion (US$108.6 million) deal with Korean biotech Ubix Therapeutics Inc. to gain exclusive global rights to UBX-103, Ubix’s oral small-molecule androgen receptor degrader for prostate cancer. Yuhan also announced July 1 that it gained the U.S. FDA’s nod to start a phase I study of a Gaucher disease drug candidate called YH-35995.
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Spinal cord
Neurology/psychiatric

Kbio obtains IND clearance for EV68-228-N for acute flaccid myelitis

July 1, 2024
Kbio Inc. has obtained IND clearance from the FDA for EV68-228-N, a human monoclonal IgG1 against the capsid of enterovirus D68 (EV-D68) designed as an intravenous therapeutic for the treatment of acute flaccid myelitis.
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Cancer tumor in breast illustration
Cancer

Circle Pharma files IND application for first-in-class cyclin A/B RxL inhibitor for solid tumors

July 1, 2024
Circle Pharma Inc. has submitted an IND application to the FDA for CID-078, a first-in-class cyclin A/B RxL inhibitor. Pending approval, the company plans to initiate a phase I trial in patients with advanced solid tumor malignancies.
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Illustration of tumor
Immuno-oncology

Kalivir’s oncolytic immunotherapy VET3-TGI cleared by FDA to enter clinic for solid tumors

July 1, 2024
Kalivir Immunotherapeutics Inc. has announced FDA clearance of its IND application for VET3-TGI for patients with incurable, advanced solid tumors.
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