Drug & Device Pipeline News

June 13, 2022

Company	Drug/Device	Medical Condition	Status
Trials Authorized
Alpha Tau Medical	Alpha DaRT	Recurrent cutaneous squamous cell carcinoma	IDE approved by the FDA
EpimAb Biotherapeutics	EMB-01 plus Tagrisso	Nonsmall-cell lung cancer	IND approved by the FDA for phase 1b/2 trial
Legend Biotech	LB1908	Relapsed or refractory gastric, esophageal and pancreatic cancers	IND approved by the FDA
Passage Bio	PBML04	Metachromatic leukodystrophy	IND approved by the FDA
Quoin Pharmaceuticals	QRX003	Netherton syndrome	IND approved by the FDA
Sonoma Biotherapeutics	SBT115301	Autoimmune and inflammatory disease	IND approved by the FDA
AUM Biosciences	AUM001 plus Keytruda	Microsatellite stable colorectal cancer	IND approved by the FDA for a phase 2 trial
Clarity Pharmaceuticals	SAR-Bombesin imaging agent	Prostate cancer	IND approved by the FDA for a phase 2 trial
Gannex Pharma	ASC42	Primary biliary cholangitis	FDA approval for a drug-drug interaction study
Harbour Biomed	HBM7008	Solid tumors	IND approved by China’s regulatory authority
Alimera Sciences	Fluocinolone acetonide intravitreal implant	Diabetic macular edema	IND for a phase 3 trial approved by China’s regulatory authority
Antengene	ATG-018	Advanced solid tumors and hematologic malignancies	Approval for a phase 1 trial granted by Australia’s regulatory authority
Senhwa Biosciences	Pidnarulex plus talazoparib	Prostate cancer	Approval for a phase 1 trial granted by Australia’s regulatory authority
Enlivex Therapeutics	Allocetra	Peritoneal metastases arising from solid cancer	Approval for a phase 1/2 trial approved by Israel’s regulatory authority
Trials Initiated
Assembly Biosciences	ABI-H3733	Chronic hepatitis B infection	Initiation of phase 1b trial
Sorrento Therapeutics	STI-1558	Treatment and prevention of COVID-19	Initiation of phase 1 trial
Arbutus Biopharma Vaccitech	AB-729 plus VTP-300	Virologically suppressed chronic hepatitis B infection	Initiation of phase 2a trial
HMNC Brain Health Develco Pharma	Oral prolonged-release Ketamine (KET01)	Treatment-resistant depression	Initiation of phase 2 trial
Apellis Pharmaceuticals Sobi	Pegcetacoplan	Immune-complex membranoproliferative glomerulonephritis and C3 glomerulopathy	Initiation of phase 3 trial
Moderna Therapeutics	Seasonal influenza vaccine (mRNA-1010)	Seasonal influenza	Initiation of phase 3 trial
Approvals
Regeneron Sanofi	Dupixent (dupilumab)	Moderate-to-severe atopic dermatitis in children age six months to five years	Approved by the FDA for expanded indication
CStone Pharmaceuticals Pfizer	Cejemly (sugemalimab)	Unresectable stage 3 nonsmall-cell lung cancer	Approved in China
Immunocore	Kimmtrak (tebentafusp)	Unresectable or metastatic uveal melanoma	Approved in the UK, Canada and Australia
Novartis	Tabrecta (capmatinib tablets)	Locally advanced unresectable or metastatic nonsmall-cell lung cancer harboring MET exon 14-skipping alterations	Approved in Canada