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Home » Topics » Regulatory » IND

IND
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3D illustration showing DNA inside adenovirus
Neurology/psychiatric

IND clearance for Mavrix Bio’s AAV gene therapy for Angelman syndrome

May 13, 2025
No Comments
Mavrix Bio has received IND clearance from the FDA for MVX-220, an investigational AAV gene therapy for the treatment of Angelman syndrome. The company expects to initiate its first-in-human study, ASCEND-AS, in the second half of this year.
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DNA in drug capsules, digital background
Immune

Ensoma gains IND clearance for in vivo HSC-directed therapy for X-linked chronic granulomatous disease

May 13, 2025
No Comments
Ensoma Inc. has obtained IND clearance from the FDA for its lead program EN-374 in X-linked chronic granulomatous disease (X-CGD).
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Pediatric brain illustration
Neurology/psychiatric

Capsida’s gene therapy for STXBP1 developmental and epileptic encephalopathy gains IND clearance

May 13, 2025
No Comments
Capsida Biotherapeutics Inc. has gained IND clearance from the FDA for CAP-002, its first-in-class, intravenously administered gene therapy for syntaxin-binding protein 1 developmental and epileptic encephalopathy (STXBP1-DEE). Dosing in the phase I/IIa SYNRGY trial will begin in the third quarter of this year.
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Illustration of cancer tumor
Cancer

UTR Therapeutics files IND application for UTRxM1-18 for c-MYC-driven cancers

May 9, 2025
No Comments
UTR Therapeutics Inc. has submitted an IND application to the FDA for UTRxM1-18, a novel therapeutic approach for targeting c-MYC-driven cancers. Pending approval, a first-in-human phase I trial is slated to begin next year.
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3D representation of tumor
Cancer

Nutshell gains IND clearance for p53 Y220C reactivator NTS-071

May 5, 2025
No Comments
Nutshell Therapeutics (Shanghai) Co. Ltd. has received IND clearance from the FDA to initiate a phase I trial in the U.S. with NTS-071 for anticipated use in solid tumors with a p53 Y220C mutation. The trial is expected to begin in the second half of this year.
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Immuno-oncology

Obi Pharma gains IND clearance for TROP2-targeting ADC OBI-902

May 2, 2025
No Comments
Obi Pharma Inc. has gained IND clearance from the FDA for OBI-902, a TROP2-targeting cancer therapy for advanced solid tumors.
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Orum halts US study of DAC cancer asset after patient death

April 29, 2025
By Marian (YoonJee) Chu
No Comments
Orum Therapeutics Inc. on April 26 pulled the plug on a U.S.-based phase I study of ORM-5029, its lead oncology degrader antibody conjugate (DAC) asset, a decision that came months after the company first reported a patient death in November 2024.
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Concept art for adeno-associated viral-based gene therapy.
Neurology/psychiatric

Blackfinbio’s AAV gene therapy gains IND clearance

April 28, 2025
Blackfinbio Ltd. has obtained IND clearance from the FDA for its novel AAV gene therapy, BFB-101, for hereditary spastic paraplegia type 47 (SPG47), which is caused by changes in the AP4B1 gene. A phase I/II trial will be conducted in the U.S. at Boston Children’s Hospital.
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Immuno-oncology

Kelun-Biotech′s ADC SKB-518 cleared to enter clinic in US

April 25, 2025
Sichuan Kelun-Biotech Biopharmaceutical Co. Ltd. has been granted IND clearance by the FDA for its antibody-drug conjugate (ADC) drug SKB-518.
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Immuno-oncology

Tagworks advances TGW-101 into phase I following IND clearance

April 25, 2025
Tagworks Pharmaceuticals BV has received IND clearance from the FDA for a phase I trial evaluating its antibody-drug conjugate (ADC) TGW-101 in patients with advanced solid tumors. The company has initiated the first-in-human trial.
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