Drug & Device Pipeline News - June 17, 2024

June 17, 2024

This week’s Pipeline features a phase 1 trial approval for FLT3-mutated acute myeloid leukemia, a phase 2 trial start for Alzheimer’s disease and an FDA drug approval for lower-risk myelodysplastic syndromes with transfusion-dependent anemia.

Company	Drug/Device	Medical Condition	Status
Trials Authorized
Eilean Therapeutics	Lomonitinib	FLT3-mutated relapsed/refractory acute myeloid leukemia	IND for a phase 1 trial approved by the FDA
InnoCare	ICP-332	Atopic dermatitis	IND for a phase 2 trial approved by the FDA
Ascentage Pharma	Olverembatinib	Succinate dehydrogenase-deficient gastrointestinal stromal tumor patients who failed prior systemic treatment	Approval for a phase 3 trial granted by China’s regulatory authority
Trials Initiated
Zumutor Biologics	ZM008 plus Keytruda (pembrolizumab)	Advanced solid tumors	Initiation of a phase 1 trial
Ensem Therapeutics	BG-68501	Advanced or metastatic solid tumors potentially associated with CDK2 dependency	Initiation of a phase 1 trial
Hutchmed	HMPL-506	Hematological malignancies	Initiation of a phase 1 trial in China
VYNE Therapeutics	VYN202	Immunoinflammatory diseases	Initiation of a phase 1a trial
Assembly Biosciences	ABI-5366	Recurrent genital herpes	Initiation of a phase 1a/b trial
OBI Pharma	OBI-992	Advanced solid tumors	Initiation of a phase 1/2 trial
KSQ Therapeutics	KSQ-001EX	Melanoma, head and neck squamous cell carcinoma and non-small cell lung cancer	Initiation of a phase 1/2 trial
Palatin Technologies	Bremelanotide plus tirzepatide	Obesity	Initiation of a phase 2 trial
Allyx Therapeutics	ALX-001	Alzheimer’s disease	Initiation of a phase 2 trial
NMD Pharma	NMD670	Generalized myasthenia gravis	Initiation of a phase 2b trial
Akero Therapeutics	Efruxifermin	Compensated cirrhosis fibrosis stage 4 due to metabolic dysfunction-associated steatohepatitis	Initiation of a phase 3 trial
Melt Pharmaceuticals	MELT-300	Sedation in patients undergoing cataract surgery	Initiation of a phase 3 trial
Approvals
Geron	Rytelo (imetelstat)	Lower-risk myelodysplastic syndromes with transfusion-dependent anemia	Approved by the FDA
Almirall	Klisyri (tirbanibulin)	Actinic keratosis of the face or scalp	Approved by the FDA for expanded indication
GSK	Arexvy (respiratory syncytial virus vaccine, adjuvanted)	Prevention of RSV lower respiratory tract disease in adults aged 50 through 59	Approved by the FDA expanded age indication
Regeneron Pharmaceuticals	Kevzara (sarilumab)	Active polyarticular juvenile idiopathic arthritis in patients 139 lbs or more	Approved by the FDA for a new indication