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BioWorld - Monday, December 15, 2025
Home » Topics » Regulatory » IND

IND
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Conceptual image for brain cancer treatment
Cancer

Hemispherian’s GLIX-1 cleared to enter clinic

Aug. 5, 2025
No Comments
Hemispherian AS has received IND clearance for GLIX-1 for the treatment of glioblastoma from the U.S. FDA. GLIX-1 targets DNA repair mechanisms, specifically the enzyme TET2, selectively in tumor cells while sparing healthy tissues.
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Cancer

Mabwell receives IND clearance in US and China

Aug. 4, 2025
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Mabwell (Shanghai) Bioscience Co. Ltd. announced that its Cadherin-17 (CDH17)-targeting antibody-drug conjugate (ADC), 7MW-4911, has received IND clearance to initiate clinical trials from both the U.S. FDA and China's National Medical Products Administration (NMPA).


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Illustration of brain with electrical activity background
Neurology/psychiatric

Actio Biosciences to advance KCNT1 inhibitor into clinic

July 31, 2025
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The U.S. FDA has cleared Actio Biosciences Inc.’s IND application and granted fast track designation to ABS-1230, an expected first-in-class, orally administered small-molecule KCNT1 inhibitor, for the treatment of KCNT1-related epilepsy.
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Art concept for monoclonal antibodies
Immuno-oncology

Radiopharm Theranostics cleared to advance RV-01 into clinic

July 30, 2025
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Radiopharm Theranostics Ltd. announced that the U.S. FDA has cleared the IND application for betabart (RV-01), its Lu177-B7H3 monoclonal antibody designed with strong affinity for the 4Ig isoform of B7-H3 that is highly expressed in tumors and not in healthy tissues.
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Art concept for monoclonal antibodies
Immuno-oncology

Radiopharm Theranostics cleared to advance RV-01 into clinic

July 29, 2025
No Comments
Radiopharm Theranostics Ltd. announced that the U.S. FDA has cleared the IND application for betabart (RV-01), its Lu177-B7H3 monoclonal antibody designed with strong affinity for the 4Ig isoform of B7-H3 that is highly expressed in tumors and not in healthy tissues.
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3D illustration demonstrating antibody-drug conjugate.
Immuno-oncology

Zymeworks’ second ADC with TOPO1 inhibitor payload to enter clinic in US

July 28, 2025
No Comments
The U.S. FDA has cleared Zymeworks Inc.’s IND application for ZW-251, a novel glypican-3 (GPC3)-targeted antibody-drug conjugate (ADC) incorporating the company’s proprietary topoisomerase 1 (TOPO1) inhibitor payload, ZD-06519, for the treatment of hepatocellular carcinoma (HCC).
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Macrophage releasing cytokines as a part of the body's immune response.
Immune

Genetic Leap to advance IL-2 modulator into clinic

July 17, 2025
No Comments
The U.S. FDA has cleared Genetic Leap’s IND application for GL-IL2-138, a small-molecule RNA drug that modulates natural IL-2, allowing for downregulating or upregulating of the immune system to fight diseases.
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Optogenetics illustration
Ocular

Aavantgarde Bio cleared to begin clinical study of Stargardt disease gene therapy in US

July 16, 2025
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The U.S. FDA has cleared Aavantgarde Bio Srl’s IND application for AAVB-039, the company’s gene therapy program for Stargardt disease, the most common inherited form of macular degeneration.
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Circode executives
Newco news

Circode applies circRNA to heart disease drug R&D, in vivo CAR T

July 15, 2025
By Marian (YoonJee) Chu
No Comments
Shanghai Circode Biomed Co. Ltd. is set to begin clinical trials of HM-2002, a circular RNA (circRNA)-based drug for ischemic heart disease, having gained IND clearance in China Jan. 10 and the U.S. on May 30, Circode CEO Chenxiang Tang recently told BioWorld.
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Circode executives
Newco news

Circode applies circRNA to heart disease drug R&D, in vivo CAR T

July 11, 2025
By Marian (YoonJee) Chu
No Comments
Shanghai Circode Biomed Co. Ltd. is set to begin clinical trials of HM-2002, a circular RNA (circRNA)-based drug for ischemic heart disease, having gained IND clearance in China Jan. 10 and the U.S. on May 30, Circode CEO Chenxiang Tang recently told BioWorld.
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