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Pipeline

October 19, 2020

Company	Drug/Device	Medical Condition	Status
COVID-19 Trials and Actions
ARCA Biopharma	AB201 (rNAPc2)	patients hospitalized with COVID-19	IND approved by the FDA
ImmunityBio	hAd5-COVID-19	COVID-19 vaccine	IND approved by the FDA
CytoAgents	GP1681	COVID-19 cytokine storm (hypercytokinemia)	initiation of phase 1 trial
Taiwan Liposome Company	TLC19 (liposomal suspension of hydroxychloroquine for inhalation)	prophylaxis of COVID-19	first patient enrolled in phase 1 trial
VaxArt	VXA-CoV2-1	oral tablet COVID-19 vaccine	first patient dosed in phase 1 trial
Enlivex	Allocetra	severe and critical COVID-19 patients	initiation of phase 2 trial
Rigel Pharmaceuticals	fostamatinib	hospitalized COVID-19 patients	first patients enrolled in phase 2 trial
National Institutes of Health	remdesivir (Vitrakvy) and hyperimmune intravenous immunoglobulin (hIVIG)	adults hospitalized for COVID-19 with symptoms for 12 days or fewer without life-threatening organ dysfunction or organ failure	initiation of phase 3 trial
The CoVIg-19 Plasma Alliance/National Institute of Allergy and Infectious Diseases	anticoronavirus hyperimmune intravenous immunoglobulin (H-Ig) medicine	hospitalized adults at risk for serious complications of COVID-19 disease	first patients enrolled in phase 3 trial
Abbott	AdviseDx SARS-CoV-2 IgM (Immunoglobulin M) lab-based serology test	diagnosis of COVID-19	Emergency Use Authorization granted by the FDA
Other Trials and Actions
Armata Therapeutics	AP-PA02	pseudomonas aeruginosa infections	IND approved by the FDA
Ascletis Pharma	ASC42	nonalcoholic steatohepatitis	IND approved by the FDA
Nanobiotix	NBTXR3 activated by radiation therapy	lung cancer and esophageal cancer	IND approved by the FDA
Nuvation Bio	NUV-422	patients with high-grade gliomas	IND approved by the FDA
Seattle Gummy Company	allergy gummy medication	allergies	IND approved by the FDA
SoniVie	Therapeutic Intra-Vascular Ultrasound (TIVUS) System	pulmonary arterial hypertension	IDE approved by the FDA
Amolyt Pharma	AZP-3601	hypoparathyroidism	first patient dosed in phase 1 trial
NANOBIOTIX	NBTXR3 activated by radiation therapy	pancreatic cancer	first patient dosed in phase 1 trial
Sumitomo Dainippon Pharma Oncology	TP-1454 administered alone and in combination with ipilimumab and nivolumab	advanced metastatic or progressive solid tumors	first patient dosed in phase 1 trial
Bold Therapeutics	BOLD-100 in combination with FOLFOX	advanced gastric, pancreatic, colorectal and bile duct cancers	phase 1b trial initiated
Celldex Therapeutics	CDX-0159	chronic spontaneous urticaria	first patient dosed in phase 1b trial
Evelo Biosciences	EDP1815	mild to moderate atopic dermatitis	patient enrollment complete in phase 1b trial
Regulus Therapeutics	RGLS4326	autosomal dominant polycystic kidney disease	first patients dosed in phase 1b trial
Castle Creek Biosciences	FCX-013	moderate to severe localized scleroderma	first patient dosed in phase 1/2 trial
Linnaeus Therapeutics	LNS8801 in combination with Keytruda (pembrolizumab)	advanced cancer	first patient dosed in phase 1/2 trial
Alessa Therapeutics	Biolen device	localized sustained delivery of bicalutamide into the prostate of men scheduled for prostate surgery for treatment of nonmetastatic prostate cancer	first patient enrolled in phase 2 trial
Evelo Biosciences	EDP1815	mild to moderate psoriasis	first patient dosed in phase 2 trial
CartiHeal	Agili-C implant	cartilage lesions in arthritic and nonarthritic joints	Breakthrough Device designation granted by the FDA
Inventiva	lanifibranor	nonalcoholic steatohepatitis	Breakthrough Therapy designation granted by the FDA
miR Scientific	miR Sentinel PCC4 Assay (miR Sentinelä Prostate Test)	prostate cancer liquid biopsy test	Breakthrough Device designation granted by the FDA
Axovant Gene Therapies	AXO-AAV-GM2	GM2 gangliosidosis	Rare Pediatric Disease designation granted by the FDA
Curtana Pharma	CT-179	medulloblastoma	Rare Pediatric Disease designation granted by the FDA
Italfarmaco Group	givinostat	Duchenne Muscular Dystrophy	Rare Pediatric Disease designation granted by the FDA
Oxular	OXU-003	retinoblastoma	Rare Pediatric Disease and Orphan Drug designation granted by the FDA
Y-mAbs Therapeutics	nivatrotamab	neuroblastoma	Rare Pediatric Disease and Orphan Drug designation granted by the FDA
Orca Bio	Orca-T	patients with blood cancers who are eligible for a hematopoietic stem-cell transplant	Regenerative Medicine Advanced Therapy designation granted by the FDA
Apexigen	APX005M	esophageal- and gastroesophageal-junction cancer and pancreatic cancer	Orphan Drug designation granted by the FDA
Ascentage Pharma	APG-115	acute myeloid leukemia	Orphan Drug designation granted by the FDA
Ascentage Pharma	APG-1252	small-cell lung cancer	Orphan Drug designation granted by the FDA
Immunomedics	Trodelvy (sacituzumab govitecan-hziy)	adult and pediatric patients with glioblastoma	Orphan Drug designation granted by the FDA
Orca Bio	Orca-T	enhancing cell engraftment in patients who qualify for a hematopoietic stem-cell transplant	Orphan Drug designation granted by the FDA
Redhill Biopharma	RHB-204	nontuberculous mycobacteria disease	Orphan Drug designation granted by the FDA
Alexion Pharma	Ultomiris (ravulizumab-cwvz)	adults with paroxysmal nocturnal hemoglobinuria and for atypical hemolytic uremic syndrome	approved by the FDA for new formulation
BioMarin	Palynziq (pegvaliase-pqpz) Injection	adults with phenylketonuria	approved by the FDA for expanded dosing
CrossBay	CrossGlide ETS Plus, Endometrial Tissue Sampler	endometrial biopsy procedure	approved by the FDA
FH Ortho	Telegraph Evolution, humeral nailing system	proximal and/or mid-shaft humeral fractures	approved by the FDA
Harmony Biosciences	Wakix (pitolisant)	cataplexy in adult patients with narcolepsy	approved by the FDA for expanded indication
Merck	Keytruda (pembrolizumab)	monotherapy for adults with relapsed or refractory classical Hodgkin lymphoma	approved by the FDA for expanded indication
Regeneron Pharmaceuticals	Inmazeb (atoltivimab, maftivimab, and odesivimab-ebgn)	Zaire ebolavirus	approved by the FDA