Drug & Device Pipeline News

April 25, 2022

Company	Drug/Device	Medical Condition	Status
Trials Initiated
Black Diamond Therapeutics	BDTX-1535	Nonsmall-cell lung cancer and glioblastoma	Initiation of phase 1 trial
KemPharm	Serdexmethylphenidate	Idiopathic hypersomnia	Initiation of phase 1 trial
Kinnate Biopharma	KIN-3248	Intrahepatic cholangiocarcinoma and urothelial carcinoma	Initiation of phase 1 trial
BioAge Labs	BGE-105	Muscle aging/atrophy	Initiation of phase 1b trial
Processa Pharmaceuticals	PCS6422 and capecitabine	Advanced refractory gastrointestinal cancer	Initiation of phase 1b trial
Cyclacel Pharmaceuticals	CYC140	Advanced solid tumors and lymphomas	Initiation of phase 1/2 trial
INmune Bio	XPro1595	Neuroinflammation caused by Alzheimer’s disease	Initiation of phase 2 trial
Ultragenyx	Setrusumab (UX143)	Osteogenesis imperfecta	Initiation of phase 2/3 trial
Bavarian Nordic	MVA-BN respiratory syncytial virus (RSV) vaccine	RSV	Initiation of phase 3 trial
MaaT Pharma	MaaT013	Acute gastrointestinal graft-vs.-host disease	Initiation of phase 3 trial
Approvals
InspectIR	InspectIR COVID-19 breathalyzer	Detection of COVID-19 infection	Emergency Use Authorization granted by the FDA
Merck	Keytruda (pembrolizumab)	High-risk early-stage triple-negative breast cancer	Approved in Canada
BeiGene	Tislelizumab	Esophageal squamous-cell carcinoma	Approved in China
Takeda	Nuvaxovid COVID-19 vaccine	COVID-19	Approved in Japan