Drug & Device Pipeline News

April 18, 2022

Company	Drug/Device	Medical Condition	Status
Trials Authorized
Aprinoia Therapeutics	APNmAb005	Tau-related diseases	Study May Proceed letter issued by the FDA
Blue Earth Therapeutics	177Lu-rhPSMA-10.1	Metastatic castration-resistant prostate cancer	IND approved by the FDA
MediLink Therapeutics	YL201	Multiple tumor types	IND approved by the FDA
Triastek	T20	Cardiovascular and clotting disorders	IND approved by the FDA
Ilias Biologics	ILB-202	Cardiac surgery-associated acute kidney injury	Approval for a phase 1 trial granted by Australia’s regulatory authority
Jiangsu Recbio Technology	ReCOV COVID-19 vaccine	COVID-19	Phase 2/3 trial approved by the United Arab Emirates regulatory authority
Trials Initiated
Asana Biosciences	ASN004	5T4-expressing advanced solid tumors	Initiation of phase 1 trial
Chinook Therapeutics	CHK-336	Hyperoxalurias	Initiation of phase 1 trial
Exelixis	XL114	Non-Hodgkin’s lymphoma	Initiation of phase 1 trial
Immune-Onc Therapeutics	IO-202	Advanced solid tumors	Initiation of phase 1 trial
Nabriva Therapeutics	Xenleta (lefamulin)	Cystic fibrosis in adults	Initiation of phase 1 trial
Sonnet BioTherapeutics	SON-1010	Advanced solid tumors	Initiation of phase 1 trial
Sciwind Biosciences	XW004	Metabolic disease	Initiation of phase 1 trial in Australia
Caladrius Biosciences	CLBS201	Diabetic kidney disease	Initiation of phase 1b trial
Daré Bioscience	DARE-HRT1	Symptoms of menopause	Initiation of phase 1/2 trial
Imcyse	Imotope IMCY-0141	Relapsing-remitting multiple sclerosis	Initiation of phase 1/2 trial
Inozyme Pharma	INZ-701	ABCC6 deficiency	Initiation of phase 1/2 trial
Moderna Therapeutics	mRNA-1020 and mRNA-1030 seasonal influenza vaccines	Seasonal influenza	Initiation of phase 1/2 trial
MaaT Pharma	MaaT013 in combination with immune checkpoint inhibitors	Metastatic melanoma	Initiation of phase 2a trial in France
Gannex Pharma	ASC42	Primary biliary cholangitis	Initiation of phase 2 trial
IO Biotech	IO102-IO103 plus Keytruda	Nonsmall-cell lung cancer, squamous-cell carcinoma of the head and neck, and urothelial bladder cancer	Initiation of phase 2 trial
Phosplatin Therapeutics	PT-112	Recurrent thymic epithelial tumors	Initiation of phase 2 trial
Surface Oncology	SRF388 plus atezolizumab and bevacizumab	Hepatocellular carcinoma	Initiation of phase 2 trial
Surface Oncology	SRF388	Nonsmall-cell lung cancer	Initiation of phase 2 trial
Akston Biosciences	AKS-452 COVID-19 vaccine	COVID-19	Initiation of phase 2/3 trial in India
Approvals
Transit Scientific	XO Cross support catheter platform	Coronary and peripheral vasculature procedures	Approved by the FDA for expanded use
Astellas Seagen	Padcev (enfortumab vedotin)	Locally advanced or metastatic urothelial cancer	Approved by the European Union
AffaMed Therapeutics	Dextenza	Ocular inflammation and pain following ophthalmic surgery	Approved in China
Novavax	Nuvaxovid COVID-19 vaccine	COVID-19	Conditional marketing authorization in Switzerland