Drug & Device Pipeline News

October 30, 2023

This week’s Pipeline features a phase 1 trial approval for liver cancer, a phase 2 trial start for lymphatic malformations in pediatric patients and an FDA device approval for coronary artery disease.

Company	Drug/Device	Medical Condition	Status
Trials Authorized
Biosyngen	BST02	Liver cancer	IND for a phase 1 trial approved by the FDA
Endogena Therapeutics	EA 2351	Geographic atrophy	IND for a phase 1 trial approved by the FDA
KaliVir Immunotherapeutics	ASP1012	Locally advanced/metastatic solid tumors	IND for a phase 1 trial approved by the FDA
Rise Therapeutics	R-2487	Rheumatoid arthritis	IND for a phase 1 trial approved by the FDA
PHAXIAM Therapeutics	PHAXIAM phages	Endocarditis infections caused by staphylococcus aureus	Approval for a phase 1 trial granted by France’s regulatory authority
Verve Therapeutics	VERVE-101	Heterozygous familial hypercholesterolemia	IND for a phase 1b trial approved by the FDA
ReAlta Life Sciences	RLS-0071	Acute exacerbations of chronic obstructive pulmonary disease	IND for a phase 2 trial approved by the FDA
Lipella Pharmaceuticals	LP-310	Symptomatic oral lichen planus	IND for a phase 2a trial approved by the FDA
MTF Biologics	FlexHD Pliable	Implant-based breast reconstruction	IDE approved by the FDA
Trials Initiated
Iksuda Therapeutics	IKS014	Advanced HER2+ solid tumors	Initiation of a phase 1 trial in Australia
Aurion Biotech	AURN001	Corneal edema secondary to corneal endothelial dysfunction	Initiation of a phase 1/2 trial
Boehringer Ingelheim	BI 764532	Small cell lung cancer and other neuroendocrine cancers	Initiation of a phase 2 trial
Oxular	OXU-001	Diabetic macular edema	Initiation of a phase 2 trial
Protara Therapeutics	TARA-002	Treatment of pediatric patients with lymphatic malformations	Initiation of a phase 2 trial
Sparrow Pharmaceuticals	SPI-62	Autonomous cortisol secretion	Initiation of a phase 2 trial
BioNTech	Autogene cevumeran plus atezolizumab and chemotherapy	Resected pancreatic ductal adenocarcinoma	Initiation of a phase 2 trial
Sabin Vaccine Institute	Marburg virus vaccine	Marburg virus	Initiation of a phase 2 trial in Uganda
Acasti Pharma	GTX-104	Aneurysmal subarachnoid hemorrhage	Initiation of a phase 3 trial
Moderna Therapeutics	mRNA-1083 influenza and COVID-19 combination vaccine	Influenza and COVID-19	Initiation of a phase 3 trial
Renibus Therapeutics	RBT-1	Postoperative complications following cardiothoracic surgery	Initiation of a phase 3 trial
Approvals
Bausch Health	Cabtreo (clindamycin phosphate, adapalene and benzoyl peroxide) topical gel	Acne vulgaris in patients age 12 and older	Approved by the FDA
Pfizer	Penbraya (meningococcal groups A, B, C, W and Y vaccine)	Meningococcal disease in patients age 10 to 25	Approved by the FDA
BioMarin	Voxzogo (vosoritide)	Achondroplasia in children of all ages with open growth plates	Approved by the FDA for expanded age indication
Genentech	Rozlytrek (entrectinib) oral pellet formulation	Treatment of pediatric patients with solid tumors harboring a NTRK gene fusion	Approved by the FDA for new formulation
Celltrion	Zymfentra (infliximab-dyyb) subcutaneous formulation	Moderately-to-severely active ulcerative colitis and Crohn’s disease after treatment with an intravenous infliximab product	Approved by the FDA for new formulation
Servier Pharmaceuticals	Tibsovo (ivosidenib tablets)	Relapsed/ refractory myelodysplastic syndromes with IDH1 mutations	Approved by the FDA for new indication
Medinol	EluNIR-PERL drug-eluting stent	Coronary artery disease	Approved by the FDA