Drug & Device Pipeline News

May 22, 2023

Company	Drug/Device	Medical Condition	Status
Trials Authorized
Antengene	ATG-031	Advanced solid tumors or B-cell non-Hodgkin's lymphoma	IND for a phase 1 trial approved by the FDA
Flavocure Biotech	Caflanone (FBL-03G)	Pancreatic cancer	IND for a phase 1 trial approved by the FDA
Indapta Therapeutics	IDP-023	Relapsed/refractory multiple myeloma and lymphoma	IND for a phase 1 trial approved by the FDA
Nuvectis Pharma	NXP900	Tumors	IND for a phase 1 trial approved by the FDA
Phio Pharmaceuticals	PH-762	Cutaneous squamous cell carcinoma, melanoma and Merkel cell carcinoma	IND for a phase 1b trial approved by the FDA
Kimera Labs	MSC exosomes	COVID-19 symptoms in adults with mild-to-moderate illness	IND for a phase 1/2a trial approved by the FDA
Decibel Therapeutics	DB-OTO	Profound congenital hearing loss caused by mutations of the otoferlin gene	Approval for a phase 1/2 trial granted by Spain’s regulatory authority
PepGen	PGN-EDO51	Duchenne muscular dystrophy	Approval for a phase 2 trial granted by Canada’s regulatory authority
HiST Pharma	TC Cream	Psoriasis vulgaris	IND for a phase 3 trial approved by the FDA
YS Biopharma	PIKA rabies vaccine	Rabies	Approval for a phase 3 trial granted by Pakistan’s regulatory authority
Trials Initiated
Iterion Therapeutics	Tegavivint	Relapsed/ refractory c-Myc-overexpressing large B-cell lymphomas	Initiation of a phase 1 trial
Therini Bio	THN391	Alzheimer’s disease	Initiation of a phase 1 trial
Numab Therapeutics	NM26-2198	Moderate-to-severe atopic dermatitis	Initiation of a phase 1a/1b trial
TILT Biotherapeutics	Igrelimogene litadenorepvec (TILT-123)	Solid tumors refractory to immune checkpoint inhibitors	Initiation of a phase 1 trial in Finland
ImmunoBrain Checkpoint	IBC-Ab002	Early Alzheimer's disease	Initiation of a phase 1b trial
Protara Therapeutics	TARA-002	High-grade nonmuscle-invasive bladder cancer with carcinoma in situ	Initiation of a phase 1b trial
Debiopharm	Debio 0123 plus temozolomide	Recurrent or progressive glioblastoma	Initiation of a phase 1/2 trial
Novadip Therapeutics	NVD-003	Congenital pseudarthrosis of tibia	Initiation of a phase 1b/2a trial
ASLAN Pharmaceuticals	Farudodstat	Alopecia areata	Initiation of a phase 2a trial
CARsgen Therapeutics	CT041	CLDN18.2-positive advanced gastric cancer/gastroesophageal junction cancer	Initiation of a phase 2 trial
Inhibikase Therapeutics	IkT-148009	Parkinson's disease	Initiation of a phase 2 trial
SOFIE Biosciences	[18F]FAPI-74	Gastrointestinal cancers, including hepatocellular carcinoma, cholangiocarcinoma, gastric, pancreatic and colorectal cancer	Initiation of a phase 2 trial
Approvals
Astellas Pharma	Veozah (fezolinetant)	Moderate-to-severe vasomotor symptoms due to menopause	Approved by the FDA