Pipeline

April 27, 2020

Company	Drug/Device	Medical Condition	Status
COVID-19 Trials and Actions
Sinovac Biotech	SARS-CoV-2 vaccine	COVID-19	initiation of phase 1 trial
Theravance Biopharma	TD-0903	hospitalized patients with Acute Lung Injury caused by COVID-19	dosing of first patient in phase 1 trial
BioNTech and Pfizer	BNT162 vaccine	COVID-19	German regulatory authority approval for phase 1/2 trial
Beyond Air	LungFit system	patients hospitalized with COVID-19	initiation of a clinical trial
SaNOtize Research and Development	Nitric Oxide Releasing Solution (NORS)	front-line antiviral prevention and early treatment against COVID-19	Health Canada approval for phase 2 trial
Novartis	hydroxychloroquine	hospitalized patients with COVID-19	initiation of phase 3 trial
Incyte Corp.	ruxolitinib (Jakafi) plus standard-of-care	COVID-19 associated cytokine storm	initiation of phase 3 trial
Oncoimmune	CD24Fc	dampening inflammation caused by COVID-19 virus-induced cellar injuries	initiation of phase 3 trial
aTyr Pharma	ATYR1923	COVID-19 patients with severe respiratory complications	IND approved by the FDA
GenoSensor Corporation	GS COVID-19 RT-PCR KIT	COVID-19	Emergency Use Authorization (EUA) granted by the FDA
ELITechGroup MDx OSANG Healthcare	GeneFinder COVID-19 Plus RealAmp Kit	COVID-19	EUA granted by the FDA
LabCorp	COVID-19 RT-PCR Test	COVID-19 Test home collection kit	EUA granted by the FDA
Shanghai Fosun Pharmaceutical	COVID-19 RT-PCR detection kit	COVID-19	EUA granted by the FDA
Other Trials and Actions
Mind Medicine	18-MC	opioid withdrawal and opioid use disorder	dosing of first patient in phase 1 trial
Harbour BioMed	batoclimab (HBM9161)	neuromyelitis optica spectrum disorder	dosing of first patient in phase 1b/2a trial
Arcutis Biotherapeutics	ARQ-252	adult patients with chronic hand eczema	initiation of phase 1/2b trial
Catalyst Biosciences	SQ dalcinonacog alfa (DalcA)	severe hemophilia B	completion of phase 2b trial
Ionis Pharmaceuticals Roche	tominersen	Huntington's disease	completed enrollment in phase 3 trial
Alphamab Oncology and Jiangsu Alphamab Bio	KN046	refractory or relapsed non-small cell lung cancer	IND approved by the FDA
Autolus Therapeutics	AUTO1	adults with acute lymphoblastic leukemia	IND approved by the FDA
Genome & Company	GEN-001 for combination treatment with avelumab	solid cancers	IND approved by the FDA
Precigen	PRGN-2009	HPV+ solid tumors	IND approved by the FDA
Endospan	NEXUS Aortic Arch Stent Graft System	descending aortic disease and heart disease	Breakthrough Device designation granted by the FDA
CytoSorbents Corp.	CytoSorb blood purification technology	removal of ticagrelor in a cardiopulmonary bypass circuit during emergent and urgent cardiothoracic surgery	Breakthrough Device designation granted by the FDA
Chi-Med	surufatinib	advanced and progressive pancreatic neuroendocrine tumors (NET) and non-pancreatic NET in patients who are not amenable for surgery	Fast Track designation granted by the FDA
Passage Bio	PBGM01	infantile GM1 gangliosidosis	Orphan Drug designation granted by the FDA
Novartis	Kymriah (tisagenlecleucel)	relapsed or refractory follicular lymphoma	Regenerative Medicine Advanced Therapy designation granted by the FDA
Incyte Corp.	Pemazyre (pemigatinib)	adults with certain types of previously treated, advanced cholangiocarcinoma	approved by the FDA
Immunomedics	Trodelvy (sacituzumab govitecan-hziy)	adults with metastatic triple-negative breast cancer who have received at least two prior therapies for metastatic disease	approved by the FDA
Janssen Pharma	Imbruvica (ibrutinib) in combination with rituximab	patients with chronic lymphocytic leukemia or small lymphocytic lymphoma who are new to therapy	approved by the FDA for expanded indication
Seattle Genetics	Tukysa (tucatinib) in combination wiith trastuzumab and capecitabine	adults with HER2+ breast cancer that cannot be surgically removed or has metastasized to other parts of the body	approved by the FDA