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BioWorld - Wednesday, December 24, 2025
Home » Topics » Regulatory, BioWorld Science

Regulatory, BioWorld Science
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Test tubes, dropper and capsules
Cancer

Aprea files IND for WEE1 kinase inhibitor

Feb. 7, 2024
Aprea Therapeutics Inc. has submitted an IND application to the FDA to initiate clinical trials of APR-1051, an oral next-generation small-molecule inhibitor of WEE1 kinase.
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Test tube, dropper
Dermatologic

Fermion’s TYK2 JH2 inhibitor cleared by China NMPA to advance into clinic

Feb. 6, 2024
Guangzhou Fermion Technology Co. Ltd. has received IND approval by China’s National Medical Products Administration (NMPA) for its TYK2 JH2 inhibitor, FZ-007-119.
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Art concept for gene therapy research
Neurology/Psychiatric

Encoded Therapeutics’ gene therapy for SCN1A+ Dravet syndrome gets clinical green light in US and Australia

Feb. 6, 2024
Encoded Therapeutics Inc. is advancing its lead gene therapy candidate, ETX-101, for the treatment of SCN1A+ Dravet syndrome into the clinic.
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3D illustration of T cells fighting cancer
Immuno-oncology

Acepodia’s allogeneic γδ2 T-cell therapy for EGFR-expressing solid tumors cleared to enter clinic

Feb. 5, 2024
Acepodia Inc. has obtained FDA clearance of its IND application for ACE-2016, an allogeneic γδ2 T-cell therapy for the treatment of epidermal growth factor receptor (EGFR)-expressing malignancies in patients with solid tumors.
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Brain clay model
Neurology/Psychiatric

FDA clears IND for Jaguar’s JAG-201 for genetic form of ASD and Phelan-McDermid syndrome

Feb. 1, 2024
Jaguar Gene Therapy LLC’s IND application for JAG-201, a gene therapy for a genetic form of autism spectrum disorder (ASD) and Phelan-McDermid syndrome (PMS; 22q13.3 deletion syndrome), has been cleared by the FDA.
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Human NK cell
Immuno-oncology

23andme’s NK cell activator cleared to enter clinic for solid tumors

Feb. 1, 2024
23andme Holding Co. has received FDA clearance of its IND application for 23ME-01473 (‘1473), a dual mechanism antibody and natural killer (NK) cell activator intended to treat cancer.
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Illustration of the inside of an eye with macular degeneration
Ocular

Ascidian’s RNA exon editor cleared to enter clinic for Stargardt disease

Jan. 30, 2024
Ascidian Therapeutics Inc. has received FDA clearance of its IND application for ACDN-01, an RNA exon editor targeting the genetic cause of Stargardt disease.
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Cancer cells
Immuno-oncology

Cytomx receives IND clearances for CX-2051 and CX-801

Jan. 25, 2024
Cytomx Therapeutics Inc. has received clearances from the FDA for IND applications for two conditionally activated Probody therapeutics.
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Immuno-oncology

Harbour’s bispecific antibody HBM-9027 cleared to enter clinic in US for solid tumors

Jan. 24, 2024
Harbour Biomed Ltd. has obtained FDA clearance of its IND application to initiate a first-in-human...
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Neurology/Psychiatric

Vanda receives IND clearance for ASO for Charcot-Marie-Tooth disease type 2S

Jan. 24, 2024
Vanda Pharmaceuticals Inc. has announced FDA approval of its IND application to evaluate VCA...
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