Drug & Device Pipeline News

January 10, 2022

Company	Drug/Device	Medical Condition	Status
Trials Authorized
Ananda Scientific	Nantheia ATL5	Opioid use disorder	IND approved by the FDA
C-Stone Pharmaceuticals	CS5001	Hematological and solid tumors	IND approved by the FDA
Immunovant	Batoclimab	Myasthenia gravis	Approval granted by the FDA for a phase 3 trial
AB Science	Masitinib	Progressive multiple sclerosis without relapse	Approval for a phase 3 trial granted by France’s regulatory authority
Akeso	Cadonilimab	Locally advanced cervical cancer	Approval for a phase 3 trial granted by China’s regulatory authority
Oryzon	Vafidemstat	Borderline personality disorder	Approval for a phase 2b trial granted by Serbia’s regulatory authority
Trials Initiated
Alentis Therapeutics	ALE.F02	Liver and kidney fibrosis	Initiation of phase 1 trial
Harbor Biomed	HBM4003	Advanced hepatocellular carcinoma, neuroendocrine tumor/neuroendocrine carcinoma and other solid tumors	Initiation of two phase 1 trials
Moderna	mRNA-1189 vaccine	Epstein-Barr virus	Initiation of phase 1 trial
Nuvectis Pharma	NXP800	Solid tumors	Initiation of phase 1 trial
Oncotelic	Ca4P in combination with pembrolizumab	Melanoma	Initiation of phase 1 trial
Samus Therapeutics	Icapamespib	Recurrent malignant glioma	Initiation of phase 1b trial
Longeveron	Lomecel-B	Alzheimer’s disease	Initiation of phase 2a trial
Anebulo Pharmaceuticals	ANEB-001	Acute cannabinoid intoxication	Initiation of phase 2 trial in the Netherlands
Bionomics	BNC210	Social anxiety disorder	Initiation of phase 2 trial
RadioMedix Orano Med	AlphaMedix	Somatostatin receptor-expressing neuroendocrine tumors	Initiation of phase 2 trial
VBI Vaccines Brii Bio	VBI-2601 (BRII-179)	Chronic hepatitis B virus	Initiation of phase 2 trial
Union Therapeutics	Oral orismilast	Moderate-to-severe psoriasis	Initiation of phase 2b trial
InflaRx	Vilobelimab	Hidradenitis suppurativa	Initiation of phase 3 trial
Nanobiotix	NBTXR3	Locally advanced head and neck squamous-cell carcinoma in high-risk elderly patients	Initiation of phase 3 trial
NewAmsterdam Pharma	Obicetrapib	Heterozygous familial hypercholesterolemia and/or established atherosclerotic cardiovascular disease	Initiation of phase 3 trial
Approvals
Xeris Biopharma	Recorlev (levoketoconazole)	Endogenous hypercortisolemia in adults with Cushing’s syndrome for whom surgery is not an option or has not been curative	Approved by the FDA
BeiGene	Tislelizumab	Second- or third-line treatment for locally advanced or metastatic nonsmall-cell lung cancer	Approved in China