Pipeline

December 21, 2020

Company	Drug/Device	Medical Condition	Status
COVID-19 Trials and Actions
AbbVie	ABBV-47D11	adults hospitalized with COVID-19	initiation of phase 1 trial
Codagenix and the Serum Institute of India	COVI-VAC	single-dose intranasal, live attenuated vaccine against SARS-CoV-2	initiation of phase 1 trial
FSD Pharma	FSD201 (ultramicronized palmitoylethanolamide)	hospitalized patients with COVID-19	first patient dosed in phase 2a trial
ARCA Bio	rNAPc2 (AB201)	patients hospitalized with COVID-19	first patients dosed in phase 2b trial
Abpro	ABP 300	treatment of COVID-19	initiation of phase 2/3 trial
CureVac	CVnCoV	mRNA COVID-19 vaccine	first patient enrolled in phase 2b/3 trial
Pfizer BioNTech	COVID-19 vaccine	COVID-19	Emergency Use Authorization (EUA) granted by the FDA
Abbot	BinaxNOW COVID-19 Ag Card rapid test	detection of COVID-19 infection	EUA granted by the FDA
Applied BioCode	BioCode SARS CoV-2 molecular diagnostic assay with pooled patient samples	pooled COVID-19 testing	EUA granted by the FDA
Ellume	Ellume rapid, at-home COVID-19 antigen test	home use for the detection of active COVID-19 in individuals with or without symptoms, and in adults and children aged 2 years and above	EUA granted by the FDA
Other Trials and Actions
CNS Pharma	Berubicin	glioblastoma multiforme	IND approved by the FDA
Entera Bio	EB613	osteoporosis	IND approved by the FDA
Graphite Bio	GPH101	severe sickle cell disease	IND approved by the FDA
V2ACT Therapeutics	V2ACT	newly diagnosed surgically resectable pancreatic cancer	IND approved by the FDA
Arecor	AT278, ultra-concentrated rapid acting insulin	diabetes	first patient dosed in phase 1 trial
Kineta	KCP506	chronic neuropathic pain	first patient dosed in phase 1 trial
Liminal BioSciences	fezagepras	idiopathic pulmonary fibrosis	first patient dosed in phase 1 trial
Plus Therapeutics	Rhenium NanoLiposome	recurrent glioblastoma	completion of the sixth dosing cohort in phase 1 trial
Protagonist Therapeutics	PN-235 (JNJ-77242113)	inflammation	first patient dosed in phase 1 trial
Synlogic	SYNB1891	intratumoral treatment of solid tumors and lymphoma	initiation of combination therapy stage of ongoing phase 1 trial
Cerecor	CERC-007	relapsed or refractory multiple myeloma	first patient dosed in phase 1b trial
STALICLA	STP1	autism spectrum disorder	first patient enrolled in phase 1b trial
TFF Pharmaceuticals	Voriconazole Inhalation Powder	aspergillosis infections in patients with asthma	first patient dosed in phase 1b trial
Bellicum Pharmaceuticals	BPX-603	tumors that express human epidermal growth factor 2	first patient enrolled in phase 1/2 trial
Nektar Therapeutics	NKTR-255	relapsed or refractory head and neck squamous cell carcinoma or colorectal cancer	first patient dosed in phase 1/2 trial
Prevail Therapeutics	PR006	frontotemporal dementia patients with GRN mutations	first patient dosed in phase 1/2 trial
Hepion Pharmaceuticals	CRV431	nonalcoholic steatohepatitis	first patient dosed in second dosing cohort of phase 2a trial
PureTech Health	LYT-100 (deupirfenidone)	breast cancer-related, upper limb secondary lymphedema	initiation of phase 2a trial
Bellus Health	BLU-5937	chronic pruritus associated with atopic dermatitis	first patient dosed in phase 2 trial
Daiichi Sankyo	datopotamab deruxtecan (DS-1062)	patients with advanced or metastatic nonsmall-cell lung cancer with actionable genomic alterations with progression on or after at least one tyrosine kinase inhibitor and at least one regimen of platinum-based chemotherapy	initiation of phase 2 trial
DiaMedica Therapeutics	DM199	chronic kidney disease	last patient enrolled in phase 2 trial
Elysium Health	BASIS	prevention of acute kidney injury in patients that have undergone a cardiac surgery	initiation of phase 2 trial
Emalex Biosciences	ecopipam	stuttering	first adult patient dosed in phase 2 trial
Harmony Biosciences	pitolisant	excessive daytime sleepiness and other key symptoms in patients with Prader-Willi Syndrome	first patient enrolled in phase 2 trial
Innovent	BI310 in combination with TYVY	patients with second-line or above advanced cervical cancer	first patient dosed in phase 2 trial
REGENXBIO	suprachoroidal delivery of RGX-314 using the SCS Microinjector	diabetic retinopathy	first patient dosed in phase 2 trial
Sanofi	fitusiran	hemophilia A or B	patient dosing resumed in phase 2 trial
Verastem Oncology	VS-6766	KRAS mutant nonsmall-cell lung cancer	initiation of phase 2 trial
Kiniska	vixarelimab	prurigo nodularis	patient dosing initiated in phase 2b trial
Daiichi Sankyo	datopotamab deruxtecan (DS-1062)	patients with advanced or metastatic nonsmall-cell lung cancer without actionable genomic alterations who have previously received platinum-based chemotherapy and immunotherapy	initiation of phase 3 trial
Erytech Pharma	eryaspase	second-line metastatic pancreatic cancer	patient enrollment complete in phase 3 trial
Amgen	sotorasib	patients locally advanced or metastatic nonsmall-cell lung cancer with KRAS G12C mutation	Breakthrough Therapy designation granted by the FDA
Avelas Biosciences	pegloprastide (AVB-620)	intraoperative detection and visualization of positive margins during breast cancer surgery	Breakthrough Therapy designation granted by the FDA
Cyprium Therapeutics	CUTX-101	Menkes disease	Breakthrough Therapy designation granted by the FDA
IO Biotech	IO102 and IO103 with anti-PD-1 mAb	unresectable/ metastatic melanoma	Breakthrough Therapy designation granted by the FDA
Novartis	iptacopan (LNP023)	paroxysmal nocturnal hemoglobinuria	Breakthrough Therapy designation granted by the FDA
Novartis	iptacopan (LNP023)	C3 glomerulopathy	Rare Pediatric Disease designation granted by the FDA
GlaxoSmithKlien	Benlysta	lupus nephritis	approved by the FDA
MacroGenics	Margenza (margetuximab-cmkb)	adults with metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 regimens, at least one of which was for metastatic disease	approved by the FDA