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Pipeline

March 22, 2021

Company	Drug/Device	Medical Condition	Status
COVID-19 Trials and Actions
Cytocom	CYTO-205	COVID-19	IND approved by the FDA
Meissa Vaccines	MV-014-212, COVID-19 vaccine	COVID-19	IND approved by the FDA
CORAT Therapeutics	COR-101	hospitalized patients with moderate-to-severe COVID-19	clinical trial authorized in Germany
Histogen Amerimmune	emricasan	mild symptomatic COVID-19 patients	first patient dosed in phase 1 trial
Moderna	mRNA-1283, COVID-19 vaccine	COVID-19	first patients dosed in phase 1 trial
Sanofi Pasteur Translate Bio	MRT5500, COVID-19 vaccine	COVID-19	initiation of phase 1/2 trial
BioAegis Therapeutics	recombinant human plasma gelsolin (rhu-pGSN)	hospitalized patients with severe COVID-19 pneumonia	patient enrollment complete in phase 2 trial
Rigel Pharmaceuticals	fostamatinib	hospitalized COVID-19 patients	completion of patient enrollment in phase 2 trial
Moderna	mRNA-1273, COVID-19 vaccine	COVID-19	first patients dosed in phase 2/3 pediatric study
Medicago GlaxoSmithKline	adjuvanted COVID-19 vaccine	COVID-19	initiation of phase 3 portion of phase 2/3 trial
Rigel Pharmaceuticals	fostamatinib	hospitalized COVID-19 patients	completion of patient enrollment in phase 3 trial
Persephone Biosciences	noninterventional, observational study	impact of gut microbiome composition and function on the immune system and efficacy of COVID-19 vaccinations	initiation of study
Other Trials and Actions
Check-Cap	C-Scan	detection of polyps before they may transform into colorectal cancer	Investigational Device Exemption (IDE) granted by the FDA
Nouscom	NOUS-PEV	patients with either locally advanced 1L melanoma or 1L nonsmall-cell lung cancer	trial authorized by the Spanish National Agency of Medicines and Medical Devices
Arbutus Biopharma	AB-836	hepatitis B infection	regulatory approval granted for a phase 1a/1b trial in New Zealand
Peptomyc	Omomyc (OMO-103)	advanced solid tumors	authorization from the Spanish National Agency of Medicines and Medical Devices for a phase 1/2 trial
Creative Medical Technologies	ImmCelz	stroke	IND approved by the FDA
Adagene	ADG126	advanced solid tumors	first patient dosed in phase 1 trial
Adicet Bio	ADI-001	B-cell nonHodgkin's lymphoma	initiation of phase 1 trial
Aligos Therapeutics	ALG-010133	chronic hepatitis B	first patient cohort dosed in phase 1 trial
Anokion	KAN-101	celiac disease	first patients dosed in multiple ascending-dose portion of phase 1 trial
Beigene	BGB-15025	advanced solid tumors	initiation of phase 1 trial
Bioventus	MOTYS (PTP-001)	osteoarthritis of the knee	first patients dosed in phase 1 trial
CANbridge Pharmaceuticals	CAN106	complement dysregulation diseases	first patient dosed in phase 1 trial
Diffusion Therapeutics	trans sodium crocetinate (TSC)	hypoxia	first patient dosed in phase 1 trial
Galmed Pharmaceuticals	Amilo-5MER	chronic inflammatory diseases	first patient dosed in phase 1 trial
Impact Therapeutics	IMP7068	advanced solid tumors	first patient dosed in phase 1 trial
Pliant Therapeutics	PLN-1474	nonalcoholic steatohepatitis with liver fibrosis	completion of phase 1 trial
Ventyx Biosciences	VTX-958	autoimmune diseases	first patient dosed in phase 1 trial
Corcept Pharmaceuticals	relacorilant + Keytruda	adrenal cancer with cortisol excess	first patient enrolled in phase 1b trial
Sorrento Therapeutics	STI-6129	advanced relapsed and/or refractory systemic amyloid light-chain amyloidosis	first patient treated in phase 1b trial
Histogen	HST-003	knee cartilage regeneration	initiation of phase 1/2 trial
Aclaris Therapeutics	ATI-1777	moderate-to-severe atopic dermatitis	patient enrollment complete in phase 2a trial
MediPrint Ophthalmics	LLT-BMT1	glaucoma	completion of phase 2a trial
Hovione	minocycline	dry eye caused by Meibomian gland dysfunction	completion of phase 2 trial
OSE Immunotherapeutics	Tedopi	recurrent ovarian cancer	initiation of phase 2 clinical trial
Renibus Therapeutics	RBT-1	acute kidney injury prevention in subjects undergoing coronary artery bypass graft and/or cardiac valve surgery	initiation of phase 2 trial
Retrotrope	RT001	amyotrophic lateral sclerosis	first patients dosed in phase 2 trial
Zenith Epigenetics	ZEN-3694 + Keytruda + Xtandi	metastatic castration-resistant prostate cancer	first patient dosed in phase 2 trial
AzurRx	MS1819	cystic fibrosis patients with exocrine pancreatic insufficiency	patient enrollment complete in phase 2b trial
Chinook Therapeutics	atrasentan	IgA nephropathy	initiation of phase 3 trial
FibroGen	pamrevlumab	ambulatory Duchenne muscular dystrophy	initiation of phase 3 trial
Natara Genentech	Signatera	companion diagnostic to identify muscle-invasive urothelial carcinoma patients eligible for investigational treatment with Genentech's atezolizumab (Tecentriq)	initiation of phase 3 trial
Harbour Biomed	tanfanercept (HBM9036)	patients with moderate-to-severe dry eye disease	first patient dosed in phase 3 trial
Opthea	OPT-302	treatment-naïve patients with wet (neovascular) age-related macular degeneration	first patient dosed in phase 3 trial
Swedish Orphan Biovitrum	avatrombopag	immune thrombocytopenia in pediatric patients	first patient dosed in phase 3 trial
Alkermes	nemvaleukin alfa (ALKS 4230)	mucosal melanoma	Orphan Drug designation granted by the FDA
CiRC Biosciences	chemically induced photoreceptor-like cells (CiPCs)	retinitis pigmentosa	Orphan Drug designation granted by the FDA
Linnaeus Therapeutics	LNS8801	metastatic uveal melanoma	Orphan Drug designation granted by the FDA
Nuvation Bio	NUV-422	malignant gliomas	Orphan Drug designation granted by the FDA
Sagimet Biosciences	TVB-2640	nonalcoholic steatohepatitis	Fast-Track designation granted by the FDA
Spectrum Pharmaceuticals	poziotinib	Nonsmall-cell lung cancer in previously treated patients with HER2 exon 20 mutations	Fast-Track designation granted by the FDA
BioXcel Therapeutics	BXCL501 (orally dissolving thin film formulation of dexmedetomidine)	agitation associated with dementia	Breakthrough Therapy designation granted by the FDA
AVEO Oncology	Fotivda (tivozanib)	adults with relapsed or refractory advanced renal cell carcinoma who have received two or more prior systemic therapies	approved by the FDA
Melinta Therapeutics	Kimyrsa (oritavancin)	adults with acute bacterial skin and skin structure infections caused by susceptible isolates of designated gram-positive microorganisms	approved by the FDA
Baxter	next-generation Artificial Kidney 98 (AK 98) dialysis machine	hemodialysis	approved by the FDA
Boston Scientific	TheraSphereY-90 Glass Microspheres	hepatocellular carcinoma	approved by the FDA
iCAD	ProFound AI Version 3.0 for Digital Breast Tomosynthesis	3D mammography	approved by the FDA
Olympus	Narrow Band Imaging	assessing the neoplastic potential of colorectal polyps	approved by the FDA