Drug & Device Pipeline News - Feb. 12, 2024

February 12, 2024

This week’s Pipeline features a phase 1 trial approval for EGFR-expressing solid tumors, a phase 3 trial start in Japan for stage III/IV non-small cell lung cancer, and the FDA’s first transcatheter therapy approval for tricuspid regurgitation.

Company	Drug/Device	Medical Condition	Status
Trials Authorized
Acepodia	ACE2016	EGFR-expressing solid tumors	IND for a phase 1 trial approved by the FDA
Veru	Enobosarm	Muscle loss associated with weight loss drugs	IND for a phase 2b trial approved by the FDA
Theradaptive	OsteoAdapt SP	Spinal fusion	IDE for a phase 1/2 trial approved by the FDA
Trials Initiated
Tharimmune	TH104	Pruritus in primary biliary cholangitis	Initiation of a phase 1 trial
Vividion Therapeutics	VVD-130850	Advanced solid and hematologic tumors	Initiation of a phase 1 trial
Sirius Therapeutics	SRSD107	Thromboembolic disorders	Initiation of a phase 1 trial in Australia
Prokarium	ZH9	Nonmuscle-invasive bladder cancer	Initiation of a phase 1/1b trial
ProfoundBio	PRO1107	Advanced solid tumors	Initiation of a phase 1/2 trial
ProLynx	PLX038	Primary CNS tumors with MYC or MYCN amplifications	Initiation of a phase 1/2 trial
Triumvira Immunologics	TAC101-CLDN18.2 cell therapy	Claudin 18.2+ solid tumors	Initiation of a phase 1/2 trial
Genprex	Reqorsa Therapy (quaratusugene ozeplasmid) plus Tagrisso (osimertinib)	Late-stage non-small cell lung cancer	Initiation of phase 2a portion of a phase 1/2a trial
Kyowa Kirin	KHK4951 eye drops	Diabetic macular edema	Initiation of a phase 2 trial
Delta-Fly Pharma	DFP-14323 plus afatinib	Stage III/IV non-small cell lung cancer with certain mutations	Initiation of a phase 3 trial in Japan
Approval
Edwards Lifesciences	Evoque valve replacement system	Tricuspid regurgitation	Approved by the FDA