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BioWorld - Thursday, December 25, 2025
Home » Topics » Regulatory » IND

IND
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Immuno-oncology

Pyxis provides update on ADC and immunotherapy candidates for solid tumors

Dec. 2, 2022
Pyxis Oncology Inc. has received FDA clearance for its two IND applications to initiate phase I trials...
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Hepatitis B virus
Infection

Bluejay set to advance BJT-778 for chronic hepatitis B and chronic hepatitis D

Dec. 2, 2022
Bluejay Therapeutics Inc. has received approval from the New Zealand Medicines and Medical...
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Microscopic view of of high grade urothelial carcinoma of the ureter in a man.
Immuno-oncology

CSPC's antibody-drug conjugate CPO-204 cleared to enter clinic in US for urothelial cancer

Nov. 30, 2022
CSPC Pharmaceutical Group Ltd. has received IND approval from the FDA for a phase I study in the U.S. of its antibody-drug conjugate CPO-204 in patients with locally advanced or metastatic urothelial cancer.
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Kidneys
Nephrology

Gmax cleared to enter clinic with GMA-131 for diabetic kidney disease

Nov. 15, 2022
Gmax Biopharm LLC has received FDA clearance of its IND filing for GMA-131 injection, an ETa receptor-specific monoclonal antibody, for a phase Ib study in diabetic kidney disease (DKD).
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Gastrointestinal system with ulcerative colitis.
Gastrointestinal

Asieris receives FDA clearance to enter clinic with APL-1401 for ulcerative colitis

Nov. 11, 2022
Asieris Pharmaceuticals Co. Ltd. has received FDA clearance of its IND for APL-1401 for the treatment of moderate to severely active ulcerative colitis.
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Endocrine/Metabolic

FDA clears allogenic cellular therapy Allostem to enter clinic for type 1 diabetes

Nov. 4, 2022
Creative Medical Technology Holdings Inc. has received FDA clearance of its IND application for a clinical trial of Allostem in type 1 diabetes.
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Dermatologic

Brexogen receives FDA clearance for phase I trial of exosome-based therapy for atopic dermatitis

Nov. 3, 2022
The FDA has cleared Brexogen Inc. to initiate a phase I trial of BRE-AD01, an exosome-based therapy for atopic dermatitis.
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Endocrine/Metabolic

Eccogene cleared by FDA to begin phase I study of oral GLP-1 receptor agonist

Nov. 3, 2022
Eccogene (Shanghai) Co. Ltd. has received FDA clearance to begin a phase I study of its glucagon-like peptide 1 (GLP-1) receptor agonist ECC-5004 for type 2 diabetes.
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Cancer cells
Immuno-oncology

Turnstone receives IND clearance for phase I trial of TIDAL-01 for solid tumors

Nov. 2, 2022
Turnstone Biologics Corp. has received IND clearance from the FDA for the company's lead selected tumor-infiltrating lymphocyte (TIL) therapy program, TIDAL-01.
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Cancer

Abbisko cleared to enter clinic with FGFR inhibitor ABSK-121 for solid tumors

Nov. 2, 2022
Abbisko Therapeutics Co. Ltd. has received clearance from the FDA to initiate a phase I...
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