Pipeline

June 22, 2020

Company	Drug/Device	Medical Condition	Status
COVID-19 Trials and Actions
aTyr Pharma	ATYR1923	COVID-19 patients with severe respiratory complications	dosing of first patient in phase 2 trial
BioSig Tech/ ViralClear Pharma	merimepodib combined with remdesivir	patients with advanced COVID-19 who are hospitalized and require oxygen	initiation of phase 2 trial
Immunic	IMU-838	COVID-19	dosing of first patients in phase 2 trial
Pluristem Therapeutics	PLX cells	severe COVID-19 complicated by Acute Respiratory Distress Syndrome (ARDS)	initiation of patient enrollment in phase 2 trial
PTC Therapeutics	PTC299	adults hospitalized with COVID-19	initiation of phase 2/3 trial
Eli Lilly	baricitinib	hospitalized adults with COVID-19	first patient enrolled in phase 3 trial
Arch Biopartners	Metablok (LSALT peptide)	prevention of acute lung and kidney organ injury due to COVID-19	IND approved by the FDA
SpectronRx	Hymon SARS-CoV-2 Test Kit	detection of SARS-CoV-2	Emergency Use Authorization (EUA) granted by the FDA
Picture Genetics/ Fulgent Genetics	RT-PCR At-Home COVID-19 Test	detection of nucleic acid from SARS-CoV-2	EUA granted by the FDA
Other Trials and Actions
BridgeBio Pharma ML Bio Solutions	BBP-418	limb girdle muscular dystrophy type 2i	first patient dosed in phase 1 trial
Bacainn Therapeutics	BT051	ulcerative colitis	initiation of phase 1 trial
Bionic Sight	BS01	retinitis pigmentosa	first patient dosed in phase 1 trial
Atara Biosciences	ATA188, allogeneic EBV-specific T-cell immunotherapy	progressive forms of multiple sclerosis	first patient enrolled in phase 1b trial
BioXcel Therapeutics	BXCL501	opioid withdrawal symptoms	first patient enrolled in phase 1b/2 trial
Innovent Biologics	IBI362	weight loss in overweight or obese subjects	first patient dosed in phase 1b/2 trial
Ascentage Pharma	APG-1387 in combination with entecavir	chronic hepatitis B	dosing of first patient in phase 2 trial
Exicure	cavrotolimod (AST-008)	advanced or metastatic cancer	dosing of the first patient in phase 2 trial
AriBio	AR1001	Alzheimer’s disease	patient enrollment complete in phase 2 trial
Bayer	finerenone	symptomatic heart failure (NYHA class II-IV) with left ventricular ejection fraction	initiation of phase 3 trial
DARÉ Bioscience	DARE-BV1	bacterial vaginosis	initiation of phase 3 trial
Exelixis	cabozantinib (Cabometyx) in combination with atezolizumab (Tecentriq)	patients with metastatic non-small-cell lung cancer previously treated with an immune checkpoint inhibitor and platinum-containing chemotherapy	initiation of phase 3 trial
Bellicum Pharmaceutical	BPX-603	HER2-expressing solid tumors	IND approved by the FDA
GeneQuantum Healthcare	GQ1001	HER2-positive tumors	IND approved by the FDA
HOOKIPA Pharma	HB-202	HPV 16+ cancers	IND approved by the FDA
Leap Therapeutics	DKN-01	gastric and gastroesophageal junction cancer	Orphan Drug designation granted by the FDA
NeoImmuneTech	NT-I7 (efineptakin alfa)	progressive multifocal leukoencephalopathy	Orphan Drug designation granted by the FDA
Protagonist Therapeutics	PTG-300	polycythemia vera	Orphan Drug designation granted by the FDA
Chi-Med	fruquintinib	patients with metastatic colorectal cancer previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF biological therapy, and, if RAS wild-type, an anti-EGFR therapy	Fast Track designation granted by the FDA
Ipsen	liposomal irinotecan (ONIVYDE) in combination NALIRIFOX	patients with previously untreated, unresectable, locally advanced and metastatic pancreatic ductal adenocarcinoma	Fast Track designation granted by the FDA
Allergan Aesthetics	JUVÉDERM VOLUMA XC	augmentation of the chin region	approved by the FDA
Eli Lilly	Lyumjev (insulin lispro-aabc injection); rapid acting	glycemic control in adults with type 1 and type 2 diabetes	approved by the FDA
Merck	Keytruda (pembrolizumab)	patients with unresectable or metastatic tumor mutational burden-high (TMB-H) [?10 mutations/megabase (mut/Mb)] solid that have progressed following prior treatment and have no alternative treatment options	approved by the FDA for expanded indication
Novartis	Ilaris (canakinumab)	adult-onset Still's Disease	approved by the FDA
Novartis	Cosentyx (secukinumab)	active non-radiographic axial spondyloarthritis	approved by the FDA for expanded indication
Jazz Pharma PharmaMar	Zepzelca (lurbinectedin)	adults with metastatic small-cell lung cancer with disease progression on or after platinum-based chemotherapy	approved by the FDA
Merck	GARDASIL 9	prevention of oropharyngeal and other head and neck cancers caused by HPV Types 16, 18, 31, 33, 45, 52 and 58	approved by the FDA for expanded indication
Mylan Biocon	Semglee (insulin glargine injection)	high blood sugar in adults with type 2 diabetes and adult and pediatric patients with type 1 diabetes	approved by the FDA
ViiV Healthcare	Tivicay (dolutegravir) and Tivicay PD	HIV-1 infection in pediatric patients at least four weeks old and weighing at least 3 kg (6.61 pounds) in combination with other antiretroviral treatments	approved by the FDA for expanded indication