Drug & Device Pipeline News

January 29, 2024

This week’s Pipeline features a phase 1 trial approval for ovarian cancer, a phase 1 trial start for an autism and epilepsy therapy, and an FDA drug approval for soft tissue and orthopedic surgeries that avoid direct exposure to articular cartilage.

Company	Drug/Device	Medical Condition	Status
Trials Authorized
Biosion	BSI-082	Hematologic and solid tumors	IND for a phase 1 trial approved by the FDA
CytomX Therapeutics	CX-2051	EpCAM positive tumors	IND for a phase 1 trial approved by the FDA
CytomX Therapeutics	CX-801	Solid tumors, including melanoma, renal and head and neck squamous cell carcinoma	IND for a phase 1 trial approved by the FDA
Harbour BioMed	HBM9027	Advanced solid tumors	IND for a phase 1 trial approved by the FDA
NK CellTech	NK010	Ovarian cancer	IND for a phase 1 trial approved by the FDA
Strand Therapeutics	STX-001	Solid tumors	IND for a phase 1 trial approved by the FDA
Sensorion	SENS-501 gene therapy	OTOF gene-mediated hearing impairment in pediatric patients	Approval for a phase 1/2 trial granted by France’s regulatory authority
Scholar Rock	Apitegromab	Obesity	IND for a phase 2 trial approved by the FDA
Cybin	CYB004	Generalized anxiety disorder	IND for a phase 2a trial approved by the FDA
Renexxion Ireland	Naronapride	Proton-pump inhibitor nonresponsive symptomatic gastroesophageal reflux disease	IND for a phase 2b trial approved by the FDA
Caliway Biopharmaceuticals	CBL-514	Subcutaneous fat reduction	Approval for a phase 3 trial granted by Australia’s regulatory authority
Trials Initiated
Evommune	EVO756	Chronic spontaneous urticaria	Initiation of a phase 1 trial
IAMA Therapeutics	IAMA-6	Autism and epilepsy	Initiation of a phase 1 trial
Sionna Therapeutics	SION-109	Cystic fibrosis	Initiation of a phase 1 trial
Onward Therapeutics	OT-A201	Hematological malignancies and solid tumors	Initiation of a phase 1 trial in Europe
PharmAbcine	PMC-309 plus Keytruda (pembrolizmab)	Advanced or metastatic solid tumors	Initiation of a phase 1a/1b trial
AIM ImmunoTech	Ampligen (rintatolimod) plus Imfinzi (durvalumab)	Late-stage pancreatic cancer	Initiation of a phase 1b/2 trial
Nectero Medical	Nectero EAST System	Infrarenal abdominal aortic aneurysms	Initiation of a phase 2/3 trial
BioNTech Duality Biologics	BNT323/DB-1303	Chemotherapy-naïve patients with HR+ and HER2-low metastatic breast cancer who have progressed on hormone therapy	Initiation of a phase 3 trial
Ascletis Pharma	ASC40	Moderate-to- severe acne	Initiation of a phase 3 trial in China
Approval
Heron Therapeutics	Zynrelef (bupivacaine and meloxicam) extended release	Soft tissue and orthopedic surgical procedures in which direct exposure to articular cartilage is avoided	Approved by the FDA for expanded indication