Pipeline

March 1, 2021

Company	Drug/Device	Medical Condition	Status
COVID-19 Trials and Actions
Pfizer BioNTech	COVID-19 vaccine	COVID-19	first women in the late stages of pregnancy dosed in a clinical trial
AstraZeneca Oxford University	COVID-19 vaccine	COVID-19	initiation of patient enrollment of children age 6 to 17
GlaxoSmithKline Sanofi	recombinant-protein COVID-19 vaccine with new antigen dosages	COVID-19	initiation of phase 2b trial with revamped vaccine
Biophytis	Sarconeos (BIO101)	acute respiratory failure associated with COVID-19	patient enrollment underway in France and Belgium for part 2 of phase 2/3 trial
PTC Therapeutics	PTC299	patients hospitalized with COVID-19	initiation of the second stage of a phase 2/3 trial
Novavax	NVX-CoV2373	COVID-19 vaccine	completion of patient enrollment in phase 3 trial
Pharma Mar	Aplidin (plitidepsin)	hospitalized patients with moderate COVID-19 infection	approval from the Medicines and Healthcare products Regulatory Agency for UK patients to enroll in phase 3 NEPTUNO trial
Other Trials and Actions
NeoImmuneTech	NT-I7	progressive multifocal leukoencephalopathy	IND approved by the FDA
Curocell	CRC01	relapsed/refractory diffuse large B-cell lymphoma	IND approved by the Ministry of Food and Drug Safety of South Korea
Dialco Medical	DIMI renal replacement system	hemodialysis	Investigational Device Exemption (IDE) granted by the FDA
Gala Therapeutics	RheOx Bronchial Rheoplasty System	chronic bronchitis	IDE granted by the FDA
AbFero Pharmaceuticals	SP-420	myelodysplastic and myelofibrosis patients with transfusional iron overload	initiation of phase 1 trial
LG Chem Life Sciences	LG00303174	chronic inflammatory diseases	first patient dosed in phase 1 trial
Longeveron	Lomecel-B	hypoplastic left heart syndrome	completion of phase 1 trial
INOVIO	INO-4500 DNA vaccine	Lassa fever	first patient dosed in phase 1b trial
Locus Bioscience	LBP-EC01, a CRISPR-Cas3-enhanced bacteriophage	Escherichia coli (E. coli) bacteria causing urinary tract infections	completion of phase 1b trial
Salarius Pharmaceuticals	seclidemstat	relapsed and refractory Ewing sarcoma and Ewing-related sarcomas	initiation of expansion stage of ongoing phase 1/2 trial
Cartesian Therapeutics	Descartes-11	newly diagnosed high-risk multiple myeloma	initiation of phase 2a trial
Bridge Biopharma ML Bio Solutions	BBP-418	limb-girdle muscular dystrophy type 2i	first patient dosed in phase 2 trial
Ocuphire Pharma	Nyxol and low-dose pilocarpine	presbyopia	first patients enrolled in phase 2 trial
Stealth Biotherapeutics	elamipretide	dry age-related macular degeneration with geographic atrophy	patient enrollment complete in phase 2 trial
Akero Therapeutics	efruxifermin	nonalcoholic steatohepatitis	initiation of phase 2b trial
The Center for Probe Development and Commercialization	[18F]PSMA-1007	diagnostic imaging product targeting prostate-specific membrane antigens	initiation of phase 3 trial
Immunocore	tebentafusp	uveal melanoma	Breakthrough Therapy designation granted by the FDA
Dascena	GI Bleed Risk Alert System	early prediction of gastrointestinal bleeding in adult patients in a hospital setting	Breakthrough Device designation granted by the FDA
Regeneron Sanofi	Libtayo (cemiplimab-rwlc)	first-line treatment for advanced nonsmall-cell lung cancer with high PD-L1 expression (?50%)	approved by the FDA
EndoClot Plus	EndoClot Polysaccharide Hemostatic System	management of bleeding during GI procedures	approved by the FDA