Drug & Device Pipeline News

August 14, 2023

This week’s Pipeline features trial authorizations for a Parkinson’s disease therapy and mRNA COVID vaccine, trial starts for limb-girdle muscular dystrophy, phenylketonuria and diabetic retinopathy, and approvals for geographic atrophy, postpartum depression and paroxysmal atrial fibrillation treatments.

Company	Drug/Device	Medical Condition	Status
Trials Authorized
BioCity Biopharma	BC3448	Advanced solid tumors	IND for a phase 1 trial approved by the FDA
ImPact Biotech	Padeliporfin Vascular Targeted Photodynamic (VTP) therapy	Peripheral lung cancer	IND for a phase 1 trial approved by the FDA
Lemonex	LEM-mR203 mRNA COVID-19 vaccine	COVID-19	IND for a phase 1 trial approved by South Korea’s regulatory authority
Aleta Biotherapeutics	ALETA-001	B-cell malignancies that are relapsed/refractory to CD19 CAR T-cell therapy	IND for a phase 1/2 trial approved by the UK’s regulatory authority
Aspen Neuroscience	ANPD001	Parkinson’s disease	IND for a phase 1/2a trial approved by the FDA
Oncternal Therapeutics	ONCT-534	Metastatic castration-resistant prostate cancer	Study May Proceed letter for a phase 1/2 trial issued by the FDA
Puma Biotechnology	Alisertib	Extensive-stage small cell lung cancer	IND for a phase 2 trial approved by the FDA
Ascentage Pharma	Lisaftoclax	Chronic lymphocytic leukemia/small lymphocytic lymphoma	IND for a phase 3 trial approved by the FDA
Venus Medtech	VenusP-Valve	Pulmonary heart valve replacement	IDE approved by the FDA for a pivotal trial
Trials Initiated
Apogee Therapeutics	APG777	Atopic dermatitis	Initiation of a phase 1 trial
Celsius Therapeutics	CEL383	Inflammatory bowel disease	Initiation of a phase 1 trial
Cullinan Oncology	CLN-978	Relapsed/refractory B-cell non-Hodgkin lymphoma	Initiation of a phase 1 trial
LianBio	BBP-398 plus osimertinib	Non-small cell lung cancer with EGFR mutations	Initiation of a phase 1 trial in China
Jnana Therapeutics	JNT-517	Phenylketonuria	Initiation of a phase 1b trial
Asklepios BioPharmaceutical	AB-1003	Limb-girdle muscular dystrophy type 2I/R9	Initiation of a phase 1/2 trial
Sosei Heptares	HTL0039732	Advanced solid tumors	Initiation of a phase 1/2a trial in the UK
Perfuse Therapeutics	PER-001	Diabetic retinopathy	Initiation of a phase 2a trial
Bolt Biotherapeutics	BDC-1001	HER2-positive colorectal, endometrial and gastroesophageal cancers	Initiation of a phase 2 trial
xBiotech	Natrunix	Rheumatoid arthritis	Initiation of a phase 2 trial
Pliant Therapeutics	Bexotegrast	Idiopathic pulmonary fibrosis	Initiation of a phase 2b trial
The Project to Accelerate New Treatments for Tuberculosis (PAN-TB) Collaboration	Bedaquiline, delamanid, pretomanid, quabodepistat and sutezolid combination drug regimens	Tuberculosis	Initiation of a phase 2b/c trial
CymaBay Therapeutics	Seladelpar	Primary biliary cholangitis	Initiation of a phase 3 trial
Pharming Group	Leniolisib	Activated phosphoinositide 3-kinase delta syndrome	Initiation of a phase 3 trial in Japan
Approvals
Astellas	Izervay (avacincaptad pegol intravitreal solution)	Geographic atrophy secondary to age-related macular degeneration	Approved by the FDA
Sage Therapeutics	Zurzuvae (zuranolone)	Postpartum depression	Approved by the FDA
Boston Scientific	POLARx Cryoablation System	Paroxysmal atrial fibrillation	Approved by the FDA