Pipeline

May 4, 2020

Company	Drug/Device	Medical Condition	Status
COVID-19 Trials and Actions
Inovio	INO-4800 vaccine	COVID-19	completion of patient enrollment in phase 1 trial
BioNTech Pfizer	BNT162 vaccine	COVID-19	completion of patient dosing in first cohort of phase 1/2 trial
Algernon Pharmaceuticals	NP-120 (Ifenprodil)	COVID-19 patients with severe pneumonia	approval from the Ministry of Food and Drug Safety in South Korea for a phase 2 trial
ORYZON Genomics	vafidemstat	prevent progression to Acute Respiratory Distress Syndrome in patients with severe COVID-19	approval from the Spanish Agency for Medicines and Health Products for a phase 2 trial
Innate Pharma	IPH5401 (avdoralimab)	COVID-19 patients with severe pneumonia	first patient dosed in phase 2 trial
Moderna	mRNA-1273 vaccine	COVID-19	second round of dosing in phase 2 trial
Chimerix	dociparstat sodium (DSTAT)	COVID-19 patients with acute lung injury	initiation of a phase 2/3 trial
Mesoblast	allogeneic mesenchymal stem cell therapy remestemcel-L	moderate/severe acute respiratory distress syndrome due to COVID-19	initiation of a phase 2/3 trial
CTI BioPharma	pacritinib	hospitalized patients with severe COVID-19	initiation of phase 3 trial
Romark Labs	NT-300 (nitazoxanide extended-release tablets)	prevention of COVID-19 in elderly residents of long-term care facilities and healthcare workers	initiation of two phase 3 trials
DiaSorin	LIAISON SARS-CoV-2 S1/S2 IgG test	COVID-19	Emergency Use Authorization (EUA) granted by the FDA
Other Trials and Actions
Adverum Biotechnologies	ADVM-022	wet age-related macular degeneration	dosing of first patient in cohort 4 of phase 1 trial
BioXcel Therapeutics	BXCL701 in combination with pembrolizumab (Keytruda)	treatment of emergent neuroendocrine prostate cancer	initiation of the phase 2 portion of phase 1b/2 trial
RhoVac AB	RV001	advanced prostate cancer	first patient dosed in phase 2b trial
Windtree Therapeutics	AEROSURF	premature infants with respiratory distress syndrome	enrollment of first patient in phase 2b bridging trial
BioEclipse Therapeutics	CRX100	therapy-refractory solid tumors	IND approved by the FDA
RemeGen	RC48 (disitamab vedotin)	HER2 positive metastatic or unresectable urothelial cancer	IND approved by the FDA
Shanghai Green Valley Pharmaceuticals	GV-971	Alzheimer's disease	IND approved by the FDA
Zentalis Pharmaceuticals	ZN-d5	hematologic malignancies	IND approved by the FDA
Neon Therapeutics	neoantigen-targeted T cell therapy (NEO-PTC-01)	patients with metastatic melanoma who are not responsive to checkpoint inhibitors	clinical trial authorization granted by the Dutch Healthcare Authority
Takeda Pharmaceuticals	mobocertinib (TAK-788)	patients with metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations whose disease has progressed on or after platinum-based chemotherapy	Breakthrough Therapy designation granted by the FDA
AmideBio, LLC	ABG-023	congenital hyperinsulinism	Orphan Drug designation granted by the FDA
Zambon	Liposomal Cyclosporine A for inhalation (L CsA i)	Bronchiolitis Obliterans Syndrome	Fast Track designation granted by the FDA
Merck	Keytruda	all adult indications, including monotherapy and combination therapy	approved by the FDA as a new dosage of 400 mg every six weeks
Neurocrine Biosciences	Ongentys as add-on to levodopa/carbidopa	patients with Parkinson's disease experiencing "off" episodes	approved by the FDA
Sanofi	MenQuadfi Meningococcal (Groups A, C, Y, W) Conjugate Vaccine	prevention of invasive meningococcal disease in persons 2 years of age and older	approved by the FDA
GlaxoSmithKline	Zejula (niraparib)	maintenance treatment for women with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in a complete or partial response to first-line platinum-based chemotherapy, regardless of biomarker status	approved by the FDA for expanded indication