Drug & Device Pipeline News

October 16, 2023

This week’s Pipeline features a phase 2 trial authorization for a type 1 diabetes treatment, a phase 2 gene therapy trial initiation for frontotemporal dementia and an FDA drug approval for plaque psoriasis in children age 6 to 11.

Company	Drug/Device	Medical Condition	Status
Trials Authorized
Aethlon Medical	Hemopurifier	Solid tumors in patients who have stable or progressive disease during anti-PD-1 monotherapy treatment	IND for a phase 1 trial approved by India’s regulatory authority
Radiopharm Theranostics	RAD204	PDL1-positive non-small cell lung cancer	IND for a phase 1 trial approved by Australia’s regulatory authority
Jasper Therapeutics	Briquilimab	Chronic spontaneous urticaria	IND for a phase 1b/2a trial approved by the FDA
Biomea Fusion	BMF-219	Type 1 diabetes in adults	IND for a phase 2 trial approved by the FDA
Acousia Therapeutics	ACOU085	Cisplatin-induced hearing loss	IND for a phase 2 trial approved by Germany’s regulatory authority
Kintor Pharmaceutical	GT1708F	Idiopathic pulmonary fibrosis	IND for a phase 2 trial approved by China’s regulatory authority
Trials Initiated
Tenaya Therapeutics	TN-201 gene therapy	MYBPC3-associated hypertrophic cardiomyopathy	Initiation of a phase 1b trial
AviadoBio	AVB-101 gene therapy	Frontotemporal dementia with GRN mutations	Initiation of a phase 1/2 trial
MBX Biosciences	MBX 1416	Post-bariatric hypoglycemia	Initiation of a phase 1/2 trial
Oncternal Therapeutics	ONCT-534	Metastatic castration-resistant prostate cancer	Initiation of a phase 1/2 trial
Scorpion Therapeutics Pierre Fabre Laboratories	STX-721	Locally advanced/metastatic non-small cell lung cancer with EGFR ex20ins mutations	Initiation of a phase 1/2 trial
GenFleet Therapeutics	GFH009	Relapsed/refractory peripheral T-cell lymphomas	Initiation of a phase 1b/2 trial
Approvals
Arcutis Biotherapeutics	Zoryve (roflumilast) cream	Plaque psoriasis in children age 6 to 11 years, including intertriginous psoriasis	Expanded age indication approved by the FDA
Novartis	Cosentyx (secukinumab) intravenous	Ankylosing spondylitis, psoriatic arthritis and nonradiographic axial spondyloarthritis	New formulation approved by the FDA