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BioWorld - Saturday, September 23, 2023
Home » Topics » Regulatory, BioWorld Science

Regulatory, BioWorld Science
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Liver and lungs
Endocrine/Metabolic

Krystal’s KB-408 cleared by FDA to enter phase I trial in α1-antitrypsin deficiency

Sep. 22, 2023
No Comments
Krystal Biotech Inc. has received IND clearance from the FDA for KB-408 for the treatment of α1-antitrypsin deficiency (AATD). KB-408 is a modified, replication-defective, nonintegrating HSV-1-derived vector carrying two full-length copies of the serpin family A member 1 gene (SERPINA1) to enable expression of α1-antitrypsin (AAT).
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Influenza virus
Infection

Via Nova Therapeutics receives FDA clearance of IND for influenza A nucleoprotein inhibitor

Sep. 22, 2023
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Via Nova Therapeutics Inc. has received clearance of its IND application from the FDA for its influenza A nucleoprotein inhibitor, VNT-101. The novel investigational small molecule is directed against a novel target, the influenza A nucleoprotein, and is being developed for treatment of seasonal influenza A infection.
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Gastrointestinal

Genflow receives recommendation from Belgium’s FAHMP regarding trials with GF-1002 in NASH

Sep. 21, 2023
No Comments
Genflow Biosciences plc has received correspondence from Belgium’s Federal Agency for Medicines and Health Products (FAHMP) with a recommendation to initiate a phase I/II trial of GF-1002 in patients with nonalcoholic steatohepatitis (NASH), rather than in healthy volunteers.
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CAR T cell attacking cancer cells
Immuno-oncology

Leucid Bio gets MHRA go-ahead for phase I/II study of NKG2D CAR T-cell therapy LEU-011

Sep. 21, 2023
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Leucid Bio Ltd. has received approval from the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) to commence a phase I/II trial of LEU-011 for the treatment of adults with relapsed or refractory solid tumors.
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Gastrointestinal

Hepagene’s THR-β agonist HPG-7233 cleared to enter clinic for NASH and dyslipidemia

Sep. 21, 2023
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Hepagene Therapeutics Inc. has received FDA clearance of its IND application for HPG-7233 for the treatment of patients with nonalcoholic steatohepatitis (NASH) and dyslipidemia.
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Cytomegalovirus in a human cell
Infection

Spybiotech seeks clearance in UK to begin clinical testing of SPYVLP-01 for human CMV

Sep. 20, 2023
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Spybiotech Ltd. has filed a clinical trial application (CTA) with the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) to evaluate SPYVLP-01, a vaccine targeting human cytomegalovirus (CMV) using its hepatitis B virus-like-particle platform technology.
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Mantle cell lymphoma
Cancer

Lantern’s LP-284 cleared by FDA to enter clinic for NHL

Sep. 19, 2023
No Comments
Lantern Pharma Inc. has received FDA clearance of its IND application for LP-284, being developed for the treatment of relapsed or refractory non-Hodgkin lymphoma (NHL), including mantle cell lymphoma, double hit lymphoma and other high-grade B-cell lymphomas. Enrollment in a first-in-human phase I trial is expected to begin during the fourth quarter of this year. 
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Gastrointestinal

Therapyx’s Fapxil awarded US orphan drug designation for familial adenomatous polyposis

Sep. 19, 2023
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Therapyx Inc.’s Fapxil has been awarded orphan drug designation by the FDA for the treatment of familial adenomatous polyposis (FAP).
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Concept art for adeno-associated viral-based gene therapy.
Neurology/Psychiatric

Atamyo files CTA in Europe for ATA-200 gene therapy for limb-girdle muscular dystrophy type 2C/R5

Sep. 19, 2023
No Comments
Atamyo Therapeutics SAS has filed a clinical trial application (CTA) in Europe for ATA-200, its gene therapy targeting γ-sarcoglycan (SGCG)-related limb-girdle muscular dystrophy type 2C/R5 (LGMD-R5).
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Neurology/Psychiatric

Lapix’s TIM-3/4 receptor agonist cleared to enter clinic for multiple sclerosis

Sep. 19, 2023
No Comments
Lapix Therapeutics Inc. has received IND clearance from the FDA to initiate a phase I trial of its first-in-class, immune tolerance restoration small molecule, LPX-TI641, for the treatment of multiple sclerosis (MS).
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