Drug & Device Pipeline News

April 3, 2023

Company	Drug/Device	Medical Condition	Status
Trials Authorized
Comanche Biopharma	CBP-4888	Preeclampsia	IND for a phase 1 trial approved by the FDA
Cullinan Oncology	CLN-617	Advanced solid tumors	IND for a phase 1 trial approved by the FDA
PathoVax	HPV16 RG1-VLP	HPV vaccine	IND for a phase 1 trial approved by the FDA
Athos Therapeutics	ATH-063	Inflammatory bowel disease	IND for a phase 1 trial approved by Australia’s regulatory authority
Trials Initiated
Direct Biologics	ExoFlo	Medically refractory ulcerative colitis	Initiation of a phase 1 trial
OliX Pharmaceuticals	OLX10212	Dry and wet age-related macular degeneration	Initiation of a phase 1 trial
Viking Therapeutics	VK2735	Metabolic and endocrine disorders	Initiation of a phase 1 trial
Grey Wolf Therapeutics	GRWD5769	Advanced solid tumors	Initiation of a phase 1/2 trial in Australia
RAPT Therapeutics	RPT193	Moderate-to-severe asthma	Initiation of a phase 2a trial
Cardiff Oncology	Onvansertib	KRAS/NRAS-mutated metastatic colorectal cancer	Initiation of a phase 2 trial
EnteroBiotix	EBX-102	Liver cirrhosis and hepatic encephalopathy	Initiation of a phase 2 trial
Lantern Pharma	LP-300	Treatment of non-smokers with advanced non-small cell lung cancer	Initiation of a phase 2 trial
Imvax	IGV-001	Newly diagnosed glioblastoma	Initiation of a phase 2b trial
Approvals
Pharming	Joenja (leniolisib)	Activated phosphoinositide 3-kinase delta syndrome in patients age 12 years and older	Approved by the FDA
Getinge	iCast covered stent system	Iliac arterial occlusive disease	Approved by the FDA
Incyte	Pemazyre (pemigatinib)	Myeloid/lymphoid neoplasms with FGFR1 fusion	Approved in Japan
Roche	Columvi (glofitamab for injection)	Relapsed/ refractory diffuse large B-cell lymphoma	Approved in Canada