Drug & Device Pipeline News

October 31, 2022

Company	Drug/Device	Medical Condition	Status
Trials Authorized
Cellevolve	CE-VST01-JC	Progressive multifocal leukoencephalopathy	IND approved by the FDA
Cour Pharmaceuticals	CNP-106	Myasthenia gravis	IND approved by the FDA
Nihon Medi-Physics	NMK89	Cancer diagnostic	IND approved by the FDA
Trials Initiated
Anixa Biosciences	Breast cancer vaccine	Breast cancer	Initiation of phase 1b trial
Bio-Path Holdings	BP1002	Refractory/relapsed acute myeloid leukemia	Initiation of phase 1/1b trial
Corvus Pharmaceuticals	Ciforadenant plus ipilimumab and nivolumab	Metastatic renal cell cancer	Initiation of phase 1b/2 trial
Sensorion	SENS-401 (arazasetron)	Cisplatin-induced ototoxicity	Initiation of a phase 2a trial in France
Aphaia Pharma	APH-012	Chronic weight management in people with obesity	Initiation of phase 2 trial
Neurocrine Biosciences	NBI-1117568	Schizophrenia in adults	Initiation of phase 2 trial
Seelos Therapeutics	SLS-005 (trehalose injection)	Spinocerebellar ataxia type 3	Initiation of phase 2/3 trial
HUTCHMED	Fruquintinib plus sintilimab	Second-line treatment for locally advanced or metastatic renal cell carcinoma	Initiation of phase 2/3 trial in China
Boehringer Ingelheim	BI 1015550	Idiopathic pulmonary fibrosis	Initiation of phase 3 trial
Codagenix	CoviLiv COVID-19 vaccine	COVID-19	Initiation of phase 3 trial
Finch Therapeutics	CP101	Recurrent C. difficile infection	Initiation of phase 3 trial
Approvals
AbbVie	Rinvoq (upadacitinib)	Nonradiographic axial spondyloarthritis in adults	Approved by the FDA for new indication
AstraZeneca	Imjudo (tremelimumab) plus Imfinzi (durvalumab)	Unresectable hepatocellular carcinoma in adults	Approved by the FDA
Johnson & Johnson	Tecvayli (teclistamab-cqyv)	Relapsed or refractory multiple myeloma in adults	Approved by the FDA