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Home » Topics » Regulatory » IND

IND
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Lung cancer driven by the Kras oncogene shown in purple
Cancer

Erasca’s pan-KRAS inhibitor ERAS-4001 gains IND clearance

June 3, 2025
No Comments
Erasca Inc. has obtained IND clearance by the FDA for ERAS-4001, an oral selective pan-KRAS inhibitor, for the treatment of patients with KRAS-mutant solid tumors.
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Colorful illustration of the heart
Cardiovascular

Circode Biomed’s HM-2002 gains US IND clearance for ischemic heart disease

June 2, 2025
No Comments
Shanghai Circode Biomed Co. Ltd. has obtained IND clearance from the FDA for HM-2002 for ischemic heart disease. It previously received IND clearance in China in January this year.
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Woman receiving chemotherapy
Endocrine/metabolic

Kexing’s GB-18 receives IND clearances in China and US for cancer cachexia

May 29, 2025
No Comments
Kexing Biopharm Co. Ltd. has announced IND clearances this month by China’s National Medical Products Administration (NMPA) and the U.S. FDA for GB-18, a biologic product for the treatment of cancer cachexia.
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Lab glassware and antibodies art concept
Immuno-oncology

Avenzo obtains IND clearance for EGFR/HER3 bispecific ADC AVZO-1418

May 23, 2025
No Comments
Avenzo Therapeutics Inc. has announced IND clearance by the FDA for AVZO-1418 (DB-1418), an EGFR/HER3 bispecific antibody-drug conjugate (ADC). A first-in-human phase I/II study will begin later this year and will evaluate AVZO-1418 as a single agent and in combination therapy in patients with advanced solid tumors.
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Dry, thick and raised patches on the skin of knees and elbows
Dermatologic

Ascletis Pharma’s oral IL-17 inhibitor cleared to enter clinic for plaque psoriasis

May 22, 2025
No Comments
Ascletis Pharma Inc. has announced IND clearance by the FDA for a phase I trial of ASC-50 for the treatment of mild to moderate plaque psoriasis. Dosing is expected to start in the third quarter of this year.
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Cancer cells
Cancer

Avenzo gains IND clearance for CDK4 inhibitor

May 22, 2025
No Comments
Avenzo Therapeutics Inc. has gained IND clearance from the FDA for AVZO-023 (formerly ARTS-023), a CDK4-selective inhibitor. The company also announced it has exercised its exclusive option for AVZO-023 from Allorion Therapeutics Inc., securing global (excluding Greater China) development, manufacturing and commercialization rights.
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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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