Drug & Device Pipeline News

August 28, 2023

This week's Pipeline features phase 1 trial approvals for ALS, acute myeloid leukemia and non-Hodgkin's lymphomas, a phase 3 trial start for locally advanced or metastatic squamous non-small cell lung cancer, and drug approvals for CHAPLE disease and Huntington's disease-associated chorea.

Company	Drug/Device	Medical Condition	Status
Trials Authorized
Akava Therapeutics	AKV9	Amyotrophic lateral sclerosis	IND for a phase 1 trial approved by the FDA
Boston Immune Technologies and Therapeutics	BITT2101	Relapsed/refractory non-Hodgkin’s lymphomas	IND for a phase 1 trial approved by the FDA
Vincerx Pharma	VIP943	Acute myeloid leukemia	IND for a phase 1 trial approved by the FDA
GlaxoSmithKline	GSK101 plus niraparib	BRCA, HR and HRD-mutated solid tumors	IND for a phase 1/2 trial approved by the FDA
Nascent Biotech	Pritumumab	Brain tumors including glioblastoma	IND for a phase 2 trial approved by the FDA
Aquedeon Medical	Duett Vascular Graft System	Open surgical thoracic aortic repair procedure	IDE approved by the FDA
Trials Initiated
Eilean Therapeutics	ZE46-0134	FLT3-mutated acute myeloid leukemia	Initiation of a phase 1 trial
Ventus Therapeutics	VENT-02	Neuroinflammatory diseases	Initiation of a phase 1 trial
Neurophth Therapeutics	NFS-02	Leber hereditary optic neuropathy caused by ND1 mutation	Initiation of a phase 1/2 trial
AI Therapeutics	Inhaled form of sirolimus (LAM-001)	Bronchiolitis obliterans syndrome in patients post-lung transplant	Initiation of a phase 2 trial
Amber Ophthalmics	Nexagon (lufepirsen ophthalmic gel)	Persistent corneal epithelial defects	Initiation of a phase 2/3 trial
Akeso	Ivonescimab	Locally advanced or metastatic squamous non-small cell lung cancer	Initiation of a phase 3 trial
Minghui Pharmaceutical	MH004 cream	Mild-to-moderate atopic dermatitis	Initiation of a phase 3 trial
Approvals
Pfizer	Abrysvo (respiratory syncytial virus vaccine)	Treatment of pregnant women to prevent RSV-associated lower respiratory tract disease in infants	Approved by the FDA
Regeneron Pharmaceuticals	Veopoz (pozelimab-bbfg)	Treatment of patients age one year and older with CHAPLE disease	Approved by the FDA
Sentient	Tixel	Periorbital wrinkles	Approved by the FDA
Neurocrine Biosciences	Ingrezza (valbenazine)	Chorea associated with Huntington’s disease	Approved by the FDA for new indication
Regeneron Pharmaceuticals	Eylea (aflibercept)	Diabetic retinopathy, wet age-related macular degeneration and diabetic macular edema	Approved by the FDA for new dosing regimen