Drug & Device Pipeline News - April 22, 2024

April 22, 2024

This week’s Pipeline features a phase 1/2 trial approval for advanced solid tumors, a phase 2b trial for mild-to-moderate Alzheimer’s disease and an FDA device approval for bone healing after spinal fusion surgery.

Company	Drug/Device	Medical Condition	Status
Trials Authorized
TransCode Therapeutics	TTX-MC138	Advanced solid tumors	IND for a phase 1/2 trial approved by the FDA
Lamassu Biotech	SA53-OS	Cancers with p53 genetic mutation	IND for a phase 1/2a trial approved by the FDA
Trials Initiated
Artiva Biotherapeutics	AlloNK plus monoclonal antibodies	Lupus nephritis	Initiation of a phase 1 trial
Compass Therapeutics	CTX-8371	Advanced solid tumors in patients who progressed on at least one regimen containing a checkpoint blocker	Initiation of a phase 1 trial
NeuroBo Pharmaceuticals	DA-1726	Obesity	Initiation of a phase 1 trial
NiKang Therapeutics	NKT3447	Cancers with cyclin E amplification or overexpression	Initiation of a phase 1/1b trial
Volastra Therapeutics	Sovilnesib	Platinum-resistant or refractory high-grade serous ovarian cancer	Initiation of a phase 1b trial
AviadoBio	AVB-101 gene therapy	Frontotemporal dementia with GRN gene mutations	Initiation of a phase 1/2 trial
Boundless Bio	BBI-825	Locally advanced/metastatic cancer with resistance gene amplifications	Initiation of a phase 1/2 trial
Aspen Neurosciences	ANPD001	Parkinson's disease	Initiation of a phase 1/2a trial
Actinogen Medical	Xanamem	Mild-to-moderate Alzheimer’s disease in patients with elevated levels of plasma pTau	Initiation of a phase 2b trial
Approvals
AstraZeneca	Fasenra (benralizumab)	Severe asthma in patients age 6 to 11 years with an eosinophilic phenotype	Approved by the FDA for expanded age range
Xstim	Xstim Spine Fusion Stimulator	Bone healing following spinal fusion surgery	Approved by the FDA