Drug & Device Pipeline News

November 14, 2022

Company	Drug/Device	Medical Condition	Status
Trials Authorized
Creative Medical Technology	AlloStem	Type 1 diabetes	IND approved by the FDA
Eccogene	ECC5004	Type 2 diabetes	IND approved by the FDA
Pacylex	PCLX-001	Acute myeloid leukemia	IND approved by the FDA for a phase 1/2 trial
ORYZON Genomics	Iadademstat (ORY-1001)	Relapsed/refractory high-grade neuroendocrine carcinomas	IND approved by the FDA for a phase 2 trial
Ascentage Pharma	APG-5918	Advanced solid tumors or hematologic malignancies	Approval for a phase 1 trial granted by China’s regulatory authority
Trials Initiated
DynamiCure	DCBY02	Metastatic solid tumors	Initiation of phase 1 trial
InflaRx	INF904	Complement-mediated chronic diseases	Initiation of phase 1 trial
Pfizer BioNTech	Single dose mRNA-based combination vaccine	Influenza and COVID-19	Initiation of phase 1 trial
Sirnaomics	STP705	Fat reduction in adults undergoing abdominoplasty	Initiation of phase 1 trial
LianBio	BBP-398	Advanced solid tumors	Initiation of phase 1 trial in China
Inventprise	25-valent pneumococcal conjugate vaccine (IVT PCV-25)	Pneumococcal diseases	Initiation of phase 1/2 trial in Canada
Bridge Biotherapeutics	BBT-877	Idiopathic pulmonary fibrosis	Initiation of phase 2a trial
Intercept Pharmaceuticals	INT-787	Severe alcohol-associated hepatitis	Initiation of phase 2a trial
Enanta Pharmaceuticals	EDP-235	Treatment of nonhospitalized, symptomatic adults with mild or moderate COVID-19	Initiation of phase 2 trial
MediPrint Ophthalmics	LL-BMT1 drug-eluting contact lens	Glaucoma	Initiation of phase 2b trial
MedinCell	F14 (mdc-CWM)	Pain after total knee replacement surgery	Initiation of phase 3 trial
PaxMedica	PAX-101 (intravenous suramin)	Stage 1 of African sleeping sickness	Initiation of phase 3 trial in Africa
Xenon Pharmaceuticals	XEN1101	Adults with focal epilepsy	Initiation of phase 3 trial
Approvals
Regeneron Pharmaceuticals	Libtayo (cemiplimab-rwlc) in combination with chemotherapy	Adults with advanced non-small cell lung cancer with no EGFR, ALK or ROS1 aberrations	Approved by the FDA for expanded indication
Sanofi AstraZeneca	Beyfortus (nirsevimab)	Prevention of respiratory syncytial virus in infants	Approved in the EU