Pipeline

July 20, 2020

Company	Drug/Device	Medical Condition	Status
COVID-19 Trials and Actions
Dynavax Medicago	Medicago’s Coronavirus Virus-Like Particle (CoVLP) with Dynavax’s CpG 1018	COVID-19 vaccine	first patient dosed in phase 1 study
Junshi Biosciences	JS016	SARS-CoV-2	patient enrollment complete in phase 1 trial
BioSig Technologies/ViralClear Pharmaceutical	merimepodib	advanced COVID-19	enrollment of first patients in phase 2 trial
Bellerophon Therapeutics	INOpulse inhaled nitric oxide (iNO) therapy	COVID-19 patients requiring supplemental oxygen	dosing of first patient in phase 3 trial
NeoImmuneTech	NT-I7 (efineptakin alfa)	adults with mild COVID-19	IND approved by the FDA
BioNTech Pfizer	BNT162b1 and BNT162b2	COVID-19 vaccine	Fast Track designation granted by the FDA
electroCore	gammaCore Sapphire CV noninvasive vagus nerve stimulation	adults with COVID-19 experiencing exacerbation of asthma-related dyspnea and reduced airflow, and for whom approved drug therapies are not tolerated or are insufficient	Emergency Use Authorization (EUA) granted by the FDA
Other Trials and Actions
ESSA Pharma	EPI-7386	metastatic castration-resistant prostate cancer patients who failed standard of care treatments	dosing of first patient in phase 1 trial
JS InnoPharm and Strategia Pharmaceutical	JSI-1187	relapsed, refractory solid tumors with MAPK mutations	dosing of first patient in phase 1 trial
Landos Biopharma	NX-13	inflammatory bowel disease	dosing of first patient in phase 1 trial
Oncorus	ONCR-177 alone and in combination with Keytruda	advanced and/or refractory cutaneous, subcutaneous or metastatic nodal solid tumors	initiation of phase 1 trial
Ribomic	RBM-007	achondroplasia	dosing of first patient in phase 1 trial
Rocket Pharmaceutical	RP-L301, lentiviral vector (LVV)-based gene therapy	pyruvate kinase deficiency	dosing of first patient in phase 1 trial
Ziopharm Oncology	CD19-specific CAR-T, using its Rapid Personalized Manufacturing (RPM) technology	relapsed CD19+ leukemias and lymphomas	initiation of phase 1 trial
Calithera Biosciences	CB-280	adults with cystic fibrosis and chronic airway infection	dosing of first patient in phase 1b trial
Galera Therapeutics	avasopasem manganese (GC4419) in combination with stereotactic body radiation therapy	locally advanced pancreatic cancer	patient enrollment complete in phase 1b/2a trial
Histogen	HST 001	androgenic alopecia in men	patient enrollment complete in phase 1b/2a trial
Adverum Biotechnologies	ADVM-022	diabetic macular edema	enrollment of first patient in phase 2 trial
Arcutis Biotherapeutics	ARQ-252	chronic hand eczema	initiation of phase 2b trial
BridgeBio QED Therapeutics	infigratinib	achondroplasia	first patient dosed in phase 2 trial
Byondis B.V.	[vic-]trastuzumab duocarmazine (SYD985)	HER2-expressing recurrent, advanced or metastatic endometrial cancer	initiation of phase 2 trial
Valbiotis	TOTUM-63	reduction of type 2 diabetes metabolic risk factors	initiation of phase 2/3 trial
Albireo	odevixibat	biliary atresia	enrollment of first patient in phase 3 trial
Biogen Eisai Alzheimer's Clinical Trials Consortium	BAN2401	preclinical Alzheimer's disease	initiation of phase 3 trial
LintonPharm	catumaxomab	advanced gastric cancer with peritoneal carcinomatosis	initiation of phase 3 trial
Tonix Pharmaceutical	TNX-102 SL (cyclobenzaprine HCl sublingual tablets)	management of fibromyalgia	patient enrollment complete in phase 3 trial
Knopp Biosciences	KB-3061	KCNQ2 epileptic encephalopathy	Rare Pediatric Disease designation granted by the FDA
Ascentage Pharma	APG-2575	Waldenström macroglobulinemia	Orphan Drug designation granted by the FDA
Inflazome	Inzomelid	Cryopyrin-Associated Periodic Syndrome	Orphan Drug designation granted by the FDA
Revamp Medical	Doraya device	percutaneous device for the treatment of acute heart failure	Breakthrough Device designation granted by the FDA
Allergan	Botox (onabotulinumtoxinA)	spasticity in pediatric patients 2 years of age and older, including those with lower limb spasticity caused by cerebral palsy	approved by the FDA for expanded indication
Baxter International	Altapore Shape Bioactive Bone Graft	enhance bone growth and help achieve fusion in skeletal surgeries	approved by the FDA
Edward’s Life Sciences	KONECT RESILIA aortic valve conduit	complex aortic valve surgeries	approved by the FDA
Ipsen	Dysport (abobotulinumtoxinA)	upper and lower limb spasticity in pediatric patients two years of age and older, including spasticity caused by cerebral palsy	approved by the FDA for expanded indication
Janssen	Tremfya (guselkumab)	adults with active psoriatic arthritis	approved by the FDA for expanded indication
Paragon 28	APEX 3D	ankle replacement system	approved by the FDA