Pipeline

October 26, 2020

Company	Drug/Device	Medical Condition	Status
COVID-19 Trials and Actions
Edesa Biotech	EB05	hospitalized adults with COVID-19 who have or are at risk of developing acute respiratory distress syndrome	IND approved by the FDA
Reven Pharmaceuticals	Rejuveinix	hospitalized COVID-19 patients at high risk of progressing and developing acute respiratory distress syndrome or who are in hypoxemic respiratory failure	IND approved by the FDA
ImmunityBio NantKwest	hAd5-COVID-19	COVID-19 vaccine	first patient dosed in phase 1 trial
Abpro	ABP 300	monoclonal antibody therapy against COVID-19	patient dosing complete in phase 1 trial
Beyond Air	LungFit system (inhaled, high-dose nitric oxide)	adults hospitalized with acute viral pneumonia, including SARS-CoV-2	approval to commence phase 2 trial in Israel
Arch Biosciences	LSALT peptide (Metablok)	prevention of acute lung injury, acute kidney injury and other complications caused by inflammation in hospitalized patients with moderate to severe cases of COVID-19	first patient dosed in phase 2 trial
Enlivex Therapeutics	Allocetra	severe and critical COVID-19 patients	first patients dosed in phase 2 trial
Dr. Reddy’s Labs	Sputnik V COVID-19 vaccine	COVID-19	approval received from the Drug Controller General of India to conduct an adaptive phase 2/3 trial
Centogene	CentoSure	SARS-CoV-2 RT-PCR test	Emergency Use Authorization (EUA) granted by the FDA
Eurofins U.S. Clinical Diagnostics	at-home COVID-19 nasal PCR test	COVID-19 testing	EUA granted by the FDA
Orasure Technologies	DNA Genotek’s OMNIgene ORAL (OM-505, OME-505) saliva collection and stabilization device	COVID-19 testing	EUA granted by the FDA
Spectrum Solutions	SDNA-1000 saliva collection device	detecting COVID-19 infections	EUA granted by the FDA
Other Trials and Actions
Mereo Biotech	etigilimab	a defined series of tumor types, including biomarker-enriched and rare tumor cohort	IND approved by FDA
Adial Pharmacueticals	AD04	alcohol use disorder	IND reactivated by FDA
Adicet Bio	ADI-001	nonHodgkin’s lymphoma	IND approved by FDA
Intellia Therapeutics	NTLA-2001	hereditary transthyretin amyloidosis with polyneuropathy	CTA approved by the UK Medicines and Healthcare products Regulatory Agency
Daiichi Sankyo	DS-1055	patients with advanced or metastatic solid tumors who have progressed on standard treatment including checkpoint inhibitors	first patient dosed in phase 1 trial
Galera Therapeutics	GC4711 in combination with stereotactic body radiation therapy	non-small-cell lung cancer	first patient dosed in phase 1/2 trial
Onexo	AsiDNA	patients with acquired resistance to niraparib for second-line maintenance treatment of relapsed ovarian cancer	first patient treated in phase 1b/2 trial
Aslan Pharmaceuticals	ASLAN004	moderate to severe atopic dermatitis	initiation of third dose cohort of phase 2 trial
Oxeia Biopharmaceuticals	OXE103	patients within 28 days of injury who are highly symptomatic of concussion	initiation of phase 2 trial
Trevi Therapeutics	Haduvio (nalbuphine ER)	chronic cough in patients with idiopathic pulmonary fibrosis	patient screening resumed in phase 2 trial
Imara	IMR-687	beta-thalassemia	first patient dosed in phase 2b trial
Cyclo Therapeutics	Trappsol Cyclo (Hydroxypropyl-?-cyclodextrin)	Niemann-Pick Disease Type C1	initiation of phase 3 trial
Evofem Biosciences	EVO100	prevention of urogenital chlamydia and gonorrhea in women	first patient enrolled in phase 3 trial
Mycovia Pharmaceuticals	oteseconazole (VT-1161)	recurrent vulvovaginal candidiasis	last patient visit complete in phase 3 trial
Versantis AG	VS-01	urea cycle disorders	Rare Pediatric Disease designation granted by the FDA
Genentech	Venclexta (venetoclax) in combination with azacitidine, or decitabine or low-dose cytarabine	newly diagnosed acute myeloid leukemia in adults 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy	approved by the FDA
Embody	Tapestry Biointegrative Implant	tendon and ligament repair	approved by the FDA