Pipeline

December 14, 2020

Company	Drug/Device	Medical Condition	Status
COVID-19 Trials and Actions
Sorrento Therapeutics	intravenous (IV) STI-2020 (COVI-AMG)	healthy volunteers and outpatient COVID-19 patients with mild symptoms	IND approved by the FDA
Cyxone	rabeximod	patients with moderate Covid-19	regulatory authority granted in Poland to initiate phase 2 trial
Puretech	LYT-100 (deupirfenidone)	long COVID respiratory complications and related sequelae	initiation of phase 2 trial
Senhwa Biosciences	silmitasertib	patients with moderate Covid-19	first patient enrolled in phase 2 trial
Inovio Advaccine Biopharmaceuticals Suzhou	INO-4800	COVID-19 vaccine	first patient dosed in phase 2 trial in China
Inovio	INO-4800	COVID-19 vaccine	first patient dosed in phase 2/3 trial
Moderna	mRNA-1273	COVID-19 vaccine	first adolescent patients dosed in phase 2/3 study
NeuroRx Relief Therapeutics	RLF-100 (aviptadil)	respiratory failure in patients with critical COVID-19	patient enrollment complete in phase 2b/3 trial
Rheonix	Rheonix COVID-19 MDx Assay	detection of SARS-CoV-2	expanded Emergency Use Authorization (EUA) to include use of saliva as a sample
LabCorp	PIXEL	home test kit for COVID-19	EUA granted by the FDA
Other Trials and Actions
Alligator Biosciences	mitazalimab	pancreatic cancer	IND approved by the FDA
Antengene	ATG-010 (selinexor) combined with R-GDP (SR-GDP)	relapsed/refractory diffuse large B-cell lymphoma	IND approved by China’s National Medical Products Administration
Cerecor	CERC-007	relapsed or refractory multiple myeloma	IND approved by the FDA
Eyenovia	MicroLine (pilocarpine)	presbyopia	IND approved by the FDA for a phase 3 trial
Altimmune	ALT-801	nonalcoholic steatohepatitis	first patients dosed in phase 1 trial
Cabaletta Bio	DSG3-CAART	mucosal-dominant pemphigus vulgaris	first patients dosed in phase 1 trial
Fusion Pharmaceuticals	[225Ac]-FPI-1434 (FPI-1434)	advanced solid tumors	first patient dosed in multi-dose portion of phase 1 study
Larimar Therapeutics	CTI-1601	Friedreich’s ataxia	patient dosing complete in phase 1 trial
Panbela Therapeutics	SBP-101	first-line treatment of patients with metastatic pancreatic ductal adenocarcinoma	patient enrollment complete in phase 1 trial
Arcturus Therapeutics	ARCT-810	ornithine transcarbamylase deficiency	first patients dosed in phase 1b trial
Celldex	CDX-0159	chronic inducible urticaria	first patients dosed in phase 1b trial
Arch Oncology	AO-176	relapsed/refractory multiple myeloma	first patient dosed in phase 1/2 trial
OSE Immunotherapeutics	FR104	patients undergoing renal transplant	approval from French National Agency for Medicines and Health Products Safety and the French Central Ethics Committee for a phase 1/2 trial
Spero Therapeutics	SPR720	nontuberculous mycobacterial pulmonary disease	first patient dosed in phase 2a trial
CG Oncology	CG0070 in combination with Keytruda (pembrolizumab)	patients with nonmuscle-invasive bladder cancer unresponsive to Bacillus Calmette-Guerin	first patient dosed in phase 2 trial
CytoKinetics	CK-3773274 (CK-274)	hypertrophic cardiomyopathy	first patient dosed in second cohort of phase 2 trial
Magenta Therapeutics	MGTA-145 stem cell mobilization therapy	multiple myeloma	initiation of phase 2 trial
Sojournix	SJX-653	moderate to severe vasomotor symptoms due to menopause	phase 2 trial resumed after pause due to COVID-19
Bellus Health	BLU-5937	refractory chronic cough	first patient dosed in phase 2b trial
Monopar Therapeutics	Validive	prevention of chemoradiotherapy-induced severe oral mucositis in patients with oropharyngeal cancer	initiation of phase 2b/3 trial
Aldeyra Therapeutics	0.25% reproxalap ophthalmic solution	dry eye disease	first patient enrolled in phase 3 trial
Alnylam	lumasiran	advanced primary hyperoxaluria type 1	patient enrollment complete in phase 3 trial
Arcutis Biotherapeutics	roflumilast 0.3% cream	chronic plaque psoriasis	last patient visit complete in both phase 3 trials
Arena Pharmaceuticals	once-daily etrasimod	patients with moderately to severely active ulcerative colitis	patient enrollment complete in phase 3 trial
Brickell Biotech	sofpironium bromide gel, 15%	primary axillary hyperhidrosis	first patient dosed in phase 3 trial
Novaliq	CyclASol (0.1% cyclosporine A in EyeSol)	chronic dry eye disease	first patient enrolled in phase 3 trial
Novocure	Optune concurrent with radiation therapy	newly diagnosed glioblastoma	first patient enrolled in phase 3 trial
Relmada Therapeutics	REL-1017	adjunctive treatment for major depressive disorder	first patient enrolled in phase 3 trial
Ultragenyx	UX701	Wilson disease	Orphan Drug designation granted by the FDA
United Therapeutics	treprostinil	idiopathic pulmonary fibrosis	Orphan Drug designation granted by the FDA
ReGelTec	Hydrafil	low back pain due to degenerative disc disease	Breakthrough Device designation granted by the FDA
Turning Point Therapeutics	repotrectinib	patients with ROS1-positive metastatic nonsmall-cell lung cancer who have not been treated with a ROS1 tyrosine kinase inhibitor	Breakthrough Therapy designation granted by the FDA
Advanced Bionics Phonak	Marvel Cochlear Implant Platform and sound processor	adult and pediatric cochlear implant wearers	approved by the FDA
Biocryst	Orladeyo (berotralstat)	prophylaxis to prevent attacks of hereditary angioedema	approved by the FDA
Novo Nordisk	Saxenda (liraglutide) injection 3 mg	obesity in adolescents (12–17 years)	approved by the FDA for expanded indication