Pipeline

September 7, 2020

Company	Drug/Device	Medical Condition	Status
COVID-19 Trials and Actions
Cartesian Therapeutics	Descartes-30, RNA-engineered mesenchymal stem cell therapy	patients with moderate-to-severe ARDS, including that caused by COVID-19	initiation of phase 1/2 trial
Aerpio Pharmaceuticals Quantum Leap Healthcare Collaborative	razuprotafib	acute respiratory distress syndrome (ARDS) in severely ill COVID-19 patients	dosing of first patient in phase 2 trial
Orpheris	OP-101	hospitalized adults with severe COVID-19	enrollment of the first patients in phase 2 trial
Sound Pharmaceuticals	ebselen (SPI-1005)	adults with moderate or severe COVID-19	approval to begin two phase 2 trials granted by the FDA
Vir Biotechnology GlaxoSmithKline	VIR-7831/ GSK4182136	treatment of COVID-19 in patients who are at high risk of hospitalization	dosing of first patients in phase 2/3 trial
AstraZeneca	AZD1222	COVID-19 vaccine	phase 3 trial expanded to the U.S.
Can-Fite Biopharma	piclidenoson	COVID-19	IND approved by the FDA for phase 2 trial
INmune Bio	Quellor	immune mediated complications in COVID-19 patients	IND approved by the FDA for phase 2 trial
Gilead	Veklury (remdesivir)	all hospitalized patients with COVID-19	Emergency Use Authorization (EUA) expanded by the FDA
Other Trials and Actions
Innovent	IBI112	autoimmune disease	dosing of first patient in phase 1 trial
Shattuck Labs	SL-172154	ovarian cancer	dosing of first patient in phase 1 trial
Transcenta Holding	TST001	unresectable or metastatic solid tumors	dosing of first patient in phase 1 trial
Bicycle Therapeutics	BT1718	patients with MT1-MMP-positive squamous non-small-cell lung cancer and a basket of other MT1-MMP-positive solid tumors	first patient dosed in phase 2a expansion portion of phase 1/2a trial
Treadwell Therapeutics	CFI-402411	solid tumors	first patients dosed in phase 1/2 trial
Annovis Bio	ANVS401	patients with early Alzheimer’s disease and Parkinson’s disease	initiation of patient dosing in phase 2a trial
Arena Pharmaceuticals	etrasimod	moderate-to-severe alopecia areata	dosing of first patient in phase 2 trial
Bicycle Therapeutics Oxurion	THR-149	diabetic macular edema	dosing of first patients in phase 2 trial
Embera NeuroTherapeutics	EMB-001	cocaine use disorder	dosing of first patients in phase 2 trial
Chi-Med	HMPL-453	advanced intrahepatic cholangiocarcinoma	initiation of phase 2 trial
POXEL	R-pioglitazone (PXL065)	patients with noncirrhotic biopsy-proven non-alcoholic steatohepatitis (NASH)	initiation of phase 2 trial
NGM Pharmaceuticals	aldafermin	biopsy-confirmed NASH with stage 2 (F2) and F3 liver fibrosis	patient enrollment complete in phase 2b trial
Provention Bio	PRV-015	adult celiac patients not responding to a gluten-free diet	initiation of phase 2b trial
Madrigal Pharmaceuticals	resmetirom	patients with NASH and fibrosis that is diagnosed using noninvasive assessments	enrollment complete in phase 3 trial
Novan	SB206	molluscum contagiosum	initiation of phase 3 trial
AEON Biopharma	ABP-450	cervical dystonia	IND approved by the FDA
CStone Pharmaceuticals	sugemalimab (CS1001)	relapsed or refractory extranodal natural killer (NK)/T-cell lymphoma	IND approved by the FDA
BioCryst Pharmaceuticals	BCX9930	paroxysmal nocturnal hemoglobinuria	Orphan Drug designation granted by the FDA
Plus Therapeutics	Rhenium NanoLiposomes	recurrent glioblastoma	Orphan Drug designation granted by the FDA
Baxter	Theranova	kidney failure dialyzer enabling hemodialysis (HDx) therapy	de novo approval granted by the FDA
Innocoll Holdings	XARACOLL (bupivacaine HCl) Implant	acute postsurgical pain relief for up to 24 hours in adults following open inguinal hernia repair	approved by the FDA
Medtronic	MiniMed 770G hybrid closed loop system	insulin pump system for patients with type 1 diabetes	approved by the FDA
Roche	HIV-1/HIV-2 qualitative test	ability to differentiate between HIV-1 and HIV-2	approved by the FDA