Drug & Device Pipeline News

January 31, 2022

Company	Drug/Device	Medical Condition	Status
Trials Authorized
Applied Pharmaceutical Science	APS03118	Cancer	IND approved by the FDA
Compass Therapeutics	CTX-009	Advanced biliary tract cancers	IND approved by the FDA
Hope Medicine	HMI-115	Androgen alopecia	IND approved by the FDA
Lyell Immunopharma	LYL132	NY-ESO-1-expressing solid tumors	IND approved by the FDA
Nanoscope Therapeutics	MCO-010	Stargardt macular degeneration	IND approved by the FDA
Ranok Therapeutics	RNK05047	Advanced solid tumors and lymphomas	IND approved by the FDA
SQZ Biotech	SQZ-eAPC-HPV	HPV16+ solid tumors	IND approved by the FDA
SwanBio Therapeutics	SBT101	Adrenomyeloneuropathy	IND approved by the FDA
Tango Therapeutics	TNG908	Cancers with methylthioadenosine phosphorylase deletions	IND approved by the FDA
TScan Therapeutics	TSC-100	Hematologic malignancies in patients who are undergoing allogeneic hematopoietic cell transplantation	IND approved by the FDA
SELLAS Life Sciences	3D189 (galinpepimut-S)	Hematological malignancies	IND approved by China’s regulatory authority
HCW Biologics Masonic Cancer Center, University of Minnesota	HCW9218	Advanced solid tumors	Phase 1 trial approved by the FDA
ORIC Pharmaceuticals	ORIC-114	Advanced solid tumors with EGFR or HER2 Exon 20 alterations or HER2 amplifications	Clinical trial authorization granted by the Korean regulatory authority
Trials Initiated
Biomea Fusion	BMF-219	Relapsed/refractory acute leukemias	Initiation of phase 1 trial
Biotheryx	BTX-1188	Advanced hematologic and solid tumor malignancies	Initiation of phase 1 trial
Cerevance	CVN766	Psychiatric disorders	Initiation of phase 1 trial
BridgeBio Pharma	BBP-631	Congenital adrenal hyperplasia	Initiation of phase 1/2 trial
Cartesian Therapeutics	Descartes-25	Multiple myeloma	Initiation of phase 1/2 trial
Excision Biotherapeutics	EBT-101	HIV	Initiation of phase 1/2 trial
OBI Pharma	OBI-999	Advanced solid tumors	Initiation of phase 1/2 trial
OBI Pharma	OBI-3424	Advanced solid tumors	Initiation of phase 1/2 trial
Cyclerion Therapeutics	CY6463	Alzheimer’s disease with vascular pathology	Initiation of phase 2a trial
Provention Bio	PRV-3279	Systemic lupus erythematosus	Initiation of phase 2a trial
Athira Pharma	ATH-1017	Parkinson's disease dementia and dementia with Lewy bodies	Initiation of phase 2 trial
BioVie	NE3107	Parkinson’s disease	Initiation of phase 2 trial
Lyra Therapeutics	LYR-220	Chronic rhinosinusitis in patients who have had a prior surgery	Initiation of phase 2 trial
MiNA Therapeutics	MTL-CEBPA	Advanced hepatocellular carcinoma	Initiation of phase 2 trial
Moderna	mRNA-1273.529 Omicron-specific booster	COVID-19	Initiation of phase 2 trial
Opiant Pharmaceuticals	OPNT002 (nasal naltrexone)	Alcohol use disorder	Initiation of phase 2 trial
Panbela Therapeutics	SBP-101	Metastatic pancreatic ductal adenocarcinoma	Initiation of phase 2 trial
Yamo Pharmaceuticals	L1-79	Autism spectrum disorder	Initiation of phase 2 trial
ASLAN Pharmaceuticals	Eblasakimab	Atopic dermatitis	Initiation of phase 2b trial
CalciMedica	Auxora	Critical COVID-19 pneumonia	Initiation of phase 2b trial
Horizon Therapeutics	HZN-825	Idiopathic pulmonary fibrosis	Initiation of phase 2b trial
Achieve Life Sciences	Cytisinicline	Smoking cessation	Initiation of phase 3 trial
Ascletis	ASC40 combined with bevacizumab	Recurrent glioblastoma	Initiation of phase 3 trial
ITM Isotope Technologies	ITM-11 (n.c.a. 177Lu-edotreotide)	Gastroenteropancreatic neuroendocrine tumors	Initiation of phase 3 trial
Lipidor	AKP02 cutaneous spray	Psoriasis	Initiation of phase 3 trial
Lyra Therapeutics	LYR-210	Chronic rhinosinusitis in surgically naïve patients	Initiation of phase 3 trial
Approvals
AbbVie	Skyrizi (risankizumab-rzaa)	Adults with active psoriatic arthritis	Approved by the FDA for new indication
Gilead	Veklury (remdesivir)	COVID-19 in nonhospitalized patients at high risk of progression to severe COVID-19	Approved by the FDA for expanded indication
Immunocore	Kimmtrak (tebentafusp-tebn)	HLA-A*02:01-positive adults with unresectable or metastatic uveal melanoma	Approved by the FDA
Gilead	Veklury (remdesivir)	COVID-19 in nonhospitalized patients younger than 12 years who are at high risk of disease progression	Emergency Use Authorization (EUA) expanded by the FDA
Ipsen	Sohonos (palovarotene capsules)	Fibrodysplasia ossificans progressiva	Approved in Canada