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

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Immuno-oncology

Tscan receives IND clearance for TSC-200-A0201 TCR T-cell therapy targeting HPV16

June 7, 2023
Tscan Therapeutics Inc. has received IND clearance by the FDA for TSC-200-A0201, a T-cell receptor (TCR) T-cell therapy targeting human papillomavirus 16 (HPV16), an oncogenic virus responsible for some cervical cancers and head and neck squamous cell carcinomas.
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Gastrointestinal

Onquality’s CDK4/6 inhibitor cleared to enter clinic for chemotherapy-induced diarrhea

June 7, 2023
Onquality Pharmaceuticals LLC has received FDA clearance of its IND application for OQL-051 for the prophylaxis of chemotherapy-induced diarrhea.
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Tumor necrosis factor (TNF), a cytokine involved in inflammation processes
Immuno-oncology

Bioinvent's anti-TNFR2 antibody BI-1910 cleared to enter clinic

June 2, 2023
Bioinvent International AB has received IND...
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Ocular

Pharmabcine’s TIE2 agonistic antibody PMC-403 cleared to enter clinic in Korea for wet AMD

May 24, 2023
Pharmabcine Inc. has received IND approval from the Korean Ministry of Food and Drug Safety (MFDS) to initiate a phase I trial of PMC-403 in Korea in subjects with neovascular (wet) age-related macular degeneration (AMD).
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Antibody-drug conjugate
Immuno-oncology

Bioray receives IND clearance in China for BRY-812 ADC targeting LIV-1

May 24, 2023
Bioray Pharmaceutical Co. Ltd.’s IND application for BRY-812, a novel antibody-drug conjugate (ADC) targeting human LIV-1 for the treatment of advanced malignant tumors, has been accepted by the China National Medical Products Administration (NMPA).
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Antibodies attacking cancer cell
Immuno-oncology

Laekna's monoclonal antibody LAE-102 cleared by FDA to enter clinic for solid tumors

May 22, 2023
Laekna Therapeutics Shanghai Co. Ltd. has received FDA clearance of its IND application to initiate clinical development with LAE-102 in the U.S.
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Natural killer cell attacking cancer cell
Immuno-oncology

Indapta’s NK cell therapy IDP-023 cleared to enter clinic for multiple myeloma and lymphoma

May 18, 2023
Indapta Therapeutics Inc. has gained IND clearance from the FDA to commence a first-in-human phase I trial of IDP-023, an allogeneic natural killer (NK) cell therapy, in patients with relapsed or refractory multiple myeloma and lymphoma, anticipated to begin in the second half of this year. The study will explore three different dose levels of Indapta’s G-NK cells alone and in combination with IL-2 and the monoclonal antibodies rituximab and daratumumab.
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3D illustration of B-cell lymphoma
Immuno-oncology

Antengene’s anti-CD24 antibody ATG-031 cleared by FDA to enter clinic for solid tumors and B-NHL

May 18, 2023
Antengene Corp. Ltd. has received FDA clearance of its IND for a phase I study of the first-in-class...
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Infection

Kimera receives IND approval to study mesenchymal stem cell exosomes to treat COVID-19

May 17, 2023
Kimera Labs Inc. has received IND approval from the FDA to study the company’s exosomes in a phase I/IIa trial, which is set to begin next month.
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Scientist, microscope and dropper
Cancer

Nuvectis cleared to advance SRC/YES1 kinase inhibitor NXP-900 into clinic

May 16, 2023
Nuvectis Pharma Inc. has received IND clearance from the FDA for NXP-900, a novel inhibitor of...
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