Pipeline

September 28, 2020

Company	Drug/Device	Medical Condition	Status
COVID-19 Trials and Actions
Ampio Pharmaceuticals	Ampion	respiratory distress due to COVID-19	IND approved by the FDA
DURECT	DUR-928	hospitalized COVID-19 patients with acute liver or kidney injury	first patient dosed in phase 2 trial
Rigel Pharmaceutical	fostamatinib	hospitalized COVID-19 patients	initiation of phase 2 trial
Johnson & Johnson/Janssen	JNJ-78436735 (COVID-19 vaccine)	COVID-19	initiation of phase 3 trial
Vela Diagnostics	ViroKey SARS-CoV-2 RT-PCR Test v2.0	COVID-19 detection	Emergency Use Authorization granted by the FDA
Other Trials and Actions
Advaxis	ADXS-504	prostate cancer	IND approved by the FDA
American Cryostem	ATCell, expanded autologous adipose-derived mesenchymal stem-cell therapy	postconcussion syndrome	IND approved by the FDA
Athenex	TCRT-ESO-A2, autologous T cell receptor - T cell therapy	solid tumors that are NY-ESO-1 positive in HLA-A*02:01 positive patients	IND approved by the FDA
Genocea Biosciences	GEN-011	patients with solid tumors who have failed standard-of-care checkpoint inhibitor therapy	IND approved by the FDA
Morphosys I-Mab	MOR210/TJ210	relapsed or refractory advanced solid tumors	IND approved by the FDA
Cytokinetics	CK-3772271	hypertrophic cardiomyopathy	first patient dosed in phase 1 trial
InMed Pharmaceuticals	INM-755	epidermolysis bullosa	dosing complete in phase 1 trial
Jasper Therapeutics	JSP191	patients with myelodysplastic syndromes and acute myeloid leukemia who are undergoing blood or hematopoietic cell transplantation	first patient dosed in phase 1 trial
Millendo Therapeutics	MLE-301	vasomotor symptoms in menopausal women	first patient dosed in phase 1 trial
Morphic Therapeutic	MORF-057	inflammatory bowel disease	first patient dosed in phase 1 trial
BioMarin	BMN 307	phenylketonuria	first patient dosed in phase 1/2 trial
Neximmune	NEXI-001	acute myeloid leukemia	dosing complete in first cohort of phase 1/2 trial
BridgeBio/Calcilytix Therapeutics	encaleret (CLTX-305)	autosomal dominant hypocalcemia Type 1 (ADH1)	initiation of phase 2 trial
Calithera	elaglenastat (CB-839) in combination with pembrolizumab, carboplatin and pemetrexed	stage IV non-squamous NSCLC whose tumors have a KEAP1 or NRF2 mutation	first patient randomized in phase 2 trial
Frequency Therapeutics	FX-322	sensorineural hearing loss	patient enrollment complete in phase 2a trial
Intensity Therapeutics	INT230-6 in combination with Yervoy (ipilimumab)	breast cancer, liver cancer and sarcoma	first patient dosed in phase 2 trial
Lipocine	LPCN 1144	non-cirrhotic non-alcoholic steatohepatitis	last patient enrolled in phase 2 trial
MiMedx	micronized injectable amniotic tissue	osteoarthritis of the knee	phase 2b trial complete
Nordic Bioscience Clinical Development AKL Research and Development	AAPA	osteoarthritis	first patient enrolled in phase 2 trial
Principia Biopharma	rilzabrutinib	IgG4-related disease	first patient dosed in phase 2a trial
Cortexyme	atuzaginstat (COR388)	mild to moderate Alzheimer’s disease	patient enrollment complete in phase 2/3 trial
MiMedx	micronized dehydrated Human Amnion Chorion Membrane (dHACM) injection	plantar fasciitis	patient enrollment complete in phase 3 trial
Swedish Orphan Biovitrum Selecta Bioscience	SEL-212	chronic refractory gout	first patient randomized in phase 3 trial
Athersys	MultiStem cell therapy	Acute Respiratory Distress Syndrome (ARDS)	Regenerative Medicine Advanced Therapy designation granted by the FDA
Medeor Therapeutics	MDR-101	immune tolerance in kidney transplant recipients	Regenerative Medicine Advanced Therapy designation granted by the FDA
Gyroscope Therapeutics	GT005	geographic atrophy secondary to dry age-related macular degeneration	Fast-Track designation granted by the FDA
Leap Therapeutics	DKN-01	patients with gastric and gastroesophageal junction adenocarcinoma tumors with DKK1 expression, following disease progression on or after prior fluoropyrimidine- and platinum- containing chemotherapy and if appropriate HER2/neu-targeted therapy	Fast-Track designation granted by the FDA
Innova Therapeutics	IVT-8086	osteosarcoma	Rare Pediatric Disease designation granted by the FDA
Mereo Biopharma	setrusumab	osteogenesis imperfecta	Rare Pediatric Disease designation granted by the FDA
Baxter International	Clinimix (amino acids in dextrose) and Clinimix E (amino acids with electrolytes in dextrose and calcium) injections	patients requiring parenteral nutrition	FDA approved for new formulations
Surmodics	Pounce Thrombus Retrieval System	nonsurgical removal of thrombi and emboli from the peripheral arterial vasculature	FDA approved