Drug & Device Pipeline News

January 16, 2023

Company	Drug/Device	Medical Condition	Status
Trials Authorized
American CryoStem	ATCell	Long COVID/PASC	IND for a phase 1 trial approved by the FDA
Immorna	JCXH-105 shingles vaccine	Shingles	IND for a phase 1 trial approved by the FDA
Minerva Biotechnologies	huMNC2-CAR22 (MUC1*-CAR-1XX)	Metastatic breast cancer	IND for a phase 1 trial approved by the FDA
Transgene	TG6050	Advanced non-small cell lung cancer	Phase 1 trial authorized by France’s regulatory authority
Orchard Therapeutics	OTL-203	Hurler subtype of mucopolysaccharidosis type I	IND for a phase 3 trial approved by the FDA
Trials Initiated
Cellf Bio	BioSphincter implant	Severe passive fecal incontinence	Initiation of a phase 1 trial
Frontera Therapeutics	FT-001	Leber congenital amaurosis 2	Initiation of a phase 1 trial
Theriva Biologics	VCN-01	High-grade brain tumors scheduled for surgical resection	Initiation of a phase 1 trial
Trevena	TRV045	Epilepsy and other CNS disorders	Initiation of a phase 1 trial
VYNE Therapeutics	VYN201	Vitiligo	Initiation of a phase 1a/b trial
Aprea Therapeutics	ATRN-119	Advanced solid tumors with DDR mutations	Initiation of a phase 1/2a trial
Avenge Bio	AVB-001	Relapsed refractory ovarian cancer	Initiation of a phase 1/2 trial
Hemab Therapeutics	HMB-001	Glanzmann thrombasthenia	Initiation of a phase 1/2 trial
Surface Oncology	SRF114	Advanced solid tumors	Initiation of a phase 1/2 trial
Bexion Pharmaceuticals	BXQ-350 plus mFOLFOX7 and bevacizumab	Newly diagnosed metastatic colorectal carcinoma	Initiation of a phase 1b/2 trial
Alterity Therapeutics	ATH434	Multiple system atrophy	Initiation of a phase 2 trial
Compass Therapeutics	CTX-009	Metastatic colorectal cancer	Initiation of a phase 2 trial
Glycomine	GLM101	Phosphomannomutase 2-congenital disorder of glycosylation	Initiation of a phase 2 trial
Panbela Therapeutics	CPP-1X-T (eflornithine tablets)	Recent-onset type 1 diabetes	Initiation of a phase 2 trial
Shanton Pharma	SAP-001	Refractory and tophaceous gout	Initiation of a phase 2b trial
Cyclo Therapeutics	Trappsol Cyclo	Early Alzheimer’s disease	Initiation of a phase 2b trial
Biofrontera Bioscience	Ameluz and BF-RhodoLED XL	Actinic keratosis on the extremities, neck and trunk	Initiation of a phase 3 trial
Maggie’s Pearl	Epalrestat	PMM2-CDG (phosphomannomutase-2-congenital disorder of glycosylation)	Initiation of a phase 3 trial
Ocuphire Pharma	Nyxol and Nyxol plus adjunctive low-dose pilocarpine therapy	Presbyopia	Initiation of a phase 3 trial
Zenas BioPharma	Obexelimab	Prevention of IgG4-related disease flare	Initiation of a phase 3 trial
Innovent Biologics	Mazdutide	Type 2 diabetes	Initiation of a phase 3 trial in China
Approvals
Biogen Eisai	Leqembi (lecanemab-irmb)	Alzheimer’s disease	Accelerated approval granted by the FDA