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BioWorld - Monday, March 23, 2026
Home » Topics » Regulatory » IND

IND
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Cancer

Onkure's PI3Kα H1047R inhibitor OKI-219 cleared to enter clinic for solid tumors

Jan. 5, 2024
Onkure Inc. has received FDA clearance of its IND application for OKI-219, a mutant selective PI3Kα H1047R inhibitor, for solid tumors.
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Cancer

Quanta advances KRAS inhibitor pipeline with IND, candidate selection

Jan. 5, 2024
Quanta Therapeutics Inc. has announced progression of its pipeline of KRAS-directed drug candidates, with the receipt of IND approval from the FDA for QTX-3034.
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Cancer

FDA clears BBO-8520 for clinic in KRAS G12C mutant lung cancer

Jan. 4, 2024
Bridgebio Pharma Inc. has obtained FDA clearance for its IND application for BBO-8520, a first-in-class orally bioavailable and potent small-molecule direct inhibitor of KRAS G12C (ON) state. The company expects to begin enrolling patients with KRAS G12C mutant non-small-cell lung cancer (NSCLC) in the first half of this year.
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Cancer

Pasithea’s macrocyclic MEK inhibitor cleared by FDA to enter clinic for advanced solid tumors

Jan. 3, 2024
Pasithea Therapeutics Corp. has received IND clearance by the FDA to evaluate PAS-004, a small-molecule allosteric inhibitor of MEK 1/2.
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Antibody-drug conjugate illustration
Immuno-oncology

Obi Pharma to advance TROP2-targeted ADC into clinic in US

Jan. 3, 2024
Obi Pharma Inc. has received FDA clearance for its IND application to conduct a phase I/II study of OBI-992, a novel antibody-drug conjugate (ADC) cancer therapy targeting TROP2. The trial will open shortly and aims to enroll patients with advanced solid tumors, including non-small-cell lung cancer, small-cell lung cancer and gastric cancer, although several other cancers are also potential targets.
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Inflammatory

Atom Bioscience’s ABP-745 cleared to enter clinic in US for acute gout

Jan. 2, 2024
Jiangsu Atom Bioscience and Pharmaceutical Co. Ltd. has received FDA clearance of its IND application for a phase I trial in the U.S. of ABP-745, an anti-inflammatory oral small-molecule drug, for the treatment of acute gout.
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Endocrine/Metabolic

Neurobo Pharmaceuticals submits IND in US for DA-1726

Dec. 29, 2023
Neurobo Pharmaceuticals Inc. has submitted an IND application to the U.S. FDA for DA-1726.
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Kidneys
Nephrology

Jemincare obtains approvals to advance five drugs into clinical trials

Dec. 28, 2023
Jiangxi Jemincare Group Co. Ltd. has reported that its wholly owned subsidiary company, Shanghai Jemincare Pharmaceutical Co. Ltd., recently received approvals for clinical trials of five of its drugs in the fields of cancer, kidney and infectious diseases.
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Photomicrograph of bone marrow aspirate showing myeloblasts of acute myeloid leukemia
Cancer

FDA clears Senti Biosciences’ IND for SENTI-202

Dec. 27, 2023
Senti Biosciences Inc. has received clearance of its IND application from the FDA for SENTI-202, an off-the-shelf chimeric antigen receptor natural killer (CAR-NK) cell therapy product candidate designed to selectively target and eliminate CD33- and/or FLT3-expressing hematologic malignancies, such as acute myeloid leukemia (AML) and myelodysplastic syndrome, while sparing healthy bone marrow cells.
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Musculoskeletal

Aurinia submits IND for AUR-200 for autoimmune diseases

Dec. 22, 2023
Aurinia Pharmaceuticals Inc. has submitted an IND application to the FDA for AUR-200, a potential next-generation therapy for B-cell-mediated autoimmune diseases.
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