Drug & Device Pipeline News

March 21, 2022

Company	Drug/Device	Medical Condition	Status
Trials Authorized
Adagene	ADG126 plus pembrolizumab	Solid tumors	Approval for a phase 1b/2 trial granted by the FDA
Amolyt Pharma	AZP-3601	Hypoparathyroidism	IND approved by the FDA
Kairos Pharma	KROS 201	Glioblastoma	IND approved by the FDA
Ossium Health	OSSM-001	Perianal fistulizing Crohn’s disease	IND approved by the FDA
Pharmazz	Centhaquine	COVID-19 patients with acute respiratory distress syndrome	IND approved by the FDA
Sonnet BioTherapeutics	SON-1010	Advanced solid tumors	IND approved by the FDA
Maia Biotechnology	THIO	Nonsmall-cell lung cancer	Approval for a phase 2 trial granted by Australia’s regulatory authority
PepGen	PGN-EDO51	Duchenne muscular dystrophy	Clinical trial authorization granted by Canada’s regulatory authority
Trials Initiated
Cocrystal Pharma	CC-42344	Pandemic and seasonal influenza A	Initiation of phase 1 trial in Australia
Emergent BioSolutions	Stabilized isoamyl nitrite	Acute cyanide poisoning	Initiation of phase 1 trial
Entheon Biomedical	N, N-dimethyltryptamine	Addiction disorders	Initiation of phase 1 trial
Gan & Lee Pharmaceuticals	GZR18	Type 2 diabetes	Initiation of phase 1 trial
Immunomic Therapeutics	ITI-3000 DNA vaccine	Merkel cell carcinoma	Initiation of phase 1 trial
Moderna	mRNA-1574 vaccine	HIV	Initiation of phase 1 trial
Inversago Pharma	INV-202	Metabolic syndrome	Initiation of phase 1b trial
Wugen	WU-CART-007	Relapsed or refractory T-cell acute lymphoblastic leukemia / lymphoma	Initiation of phase 1/2 trial
ENA Respiratory	INNA-051	Viral respiratory infections	Initiation of phase 2a trial
Ascentage Pharma	Lisaftoclax (APG-2575)	Relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma	Initiation of phase 2 trial
Glaukos	iLink therapy	Keratoconus	Initiation of phase 2 trial
Shanghai Junshi Biosciences	VV116	Moderate-to-severe COVID-19	Initiation of phase 3 trial in China
Approvals
AbbVie	Rinvoq (upadacitinib)	Moderately-to-severely active ulcerative colitis	Approved by the FDA for new indication
AstraZeneca Merck	Lynparza (olaparib)	BRCA-mutated, HER2-negative high-risk early breast cancer	Approved by the FDA for expanded indication
Corium	Adlarity (donepezil transdermal system)	Alzheimer’s dementia	Approved by the FDA
Shoulder Innovations	InSet stemless humeral system	Shoulder surgery	Approved by the FDA
BeiGene Medison Pharma	Brukinsa (zanubrutinib)	Waldenström’s macroglobulinemia	Approved in Israel