Pipeline

February 15, 2021

Company	Drug/Device	Medical Condition	Status
COVID-19 Trials and Actions
Eli Lilly Junshi Biosciences	bamlanivimab (LY-CoV555) and etesevimab (LY-CoV016)	mild-to-moderate COVID-19 in patients age 12 and older who are at high risk for progressing to severe COVID-19 and/or hospitalization	Emergency Use Authorization (EUA) granted by the FDA
GenScript USA	cPass SARS-CoV-2 Neutralization Antibody Detection Kit in convalescent plasma screening	detection of COVID-19 neutralizing antibodies without the use of live virus	EUA granted by the FDA
Other Trials and Actions
Adaptive Phage Therapeutics	PhageBank therapy	prosthetic joint infections	IND approved by the FDA
Catapult Therapeutics	CAP-100	hematological malignancies	IND approved by the FDA
Ideaya Biosciences	IDE397	solid tumors harboring MTAP deletion	IND approved by the FDA
ImmunoMet Therapeutics	IM156	idiopathic pulmonary fibrosis	IND approved by the FDA
Intrommune Therapeutics	INT301, oral mucosal immunotherapy	peanut allergies	IND approved by the FDA
NeurMedix	NE3107	mild-to-moderate Alzheimer’s disease	IND approved by the FDA for phase 3 trial
Passage Bio	PBKR03	early infantile Krabbe disease (globoid cell leukodystrophy)	IND approved by the FDA
Triastek	T19 3D printed formulation	rheumatoid arthritis	IND approved by the FDA
I-Mab Morphosys	TJ210/MOR210	advanced solid tumors	IND approved by the China National Medical Products Administration
Celon Pharma	CPL’116	autoimmune diseases	completion of phase 1a trial
Cue Biopharma	CUE-101 in combination with Keytruda (pembrolizumab)	first-line treatment for HPV+ recurrent/metastatic head and neck squamous-cell carcinoma	first patient dosed in phase 1 trial
Curis	CA-4948 in combination with ibrutinib	relapsed or refractory hematologic malignancies	first patient dosed in phase 1 trial
Melt Pharmaceuticals	Melt technology (midazolam 3 mg/ketamine 25 mg and midazolam 6 mg/ketamine 50 mg)	sedation and analgesia for patients undergoing cataract surgery	completion of phase 1 trial
Tessa Therapeutics	TT11X – allogeneic CD30-CAR Epstein Barr virus-specific T-cell therapy	CD30+ lymphoma	completion of dosing in first patient cohort in phase 1 trial
Regulus Therapeutics	RGLS4326	autosomal dominant polycystic kidney disease	completion of patient enrollment in first cohort of phase 1b trial
Vaccitech	VTP-300 with and without a low-dose anti-PD-1 antibody	chronic hepatitis B infection	first patient dosed in phase 1b/2a trial
Gemini Therapeutics	GEM103	dry age-related macular degeneration with complement factor H (CFH) and loss-of-function gene variants	completion of patient enrollment in phase 2a trial
Brooklyn Immunotherapeutics	IRX-2 in combination with pembrolizumab (Keytruda) and chemotherapy	triple-negative breast cancer	initiation of phase 2 trial
Trefoil Therapeutics	TTHX1114	Fuchs endothelial corneal dystrophy	initiation of phase 2 trial
Navidea Biopharmaceuticals	NAV3-32	rheumatoid arthritis	initiation of phase 2b trial
Evolve Biologic	PlasmaCap IG (intravenous immunoglobulin)	adults and children with primary immune deficiency disease	completion of phase 3 trial
Innovent Biologics	IBI310 in combination with Tyvyt (sintilimab) injection	first-line treatment of advanced hepatocellular carcinoma	first patient dosed in phase 3 trial
ImmunoMet Therapeutics	IM156	idiopathic pulmonary fibrosis	Orphan Drug designation granted by the FDA
Vascular Perfusion Solutions	VP.S Encore oxygenated perfusion cardiac transport device	preservation of vascularized tissue	Breakthrough Device designation granted by the FDA
Puzzle Medical Devices	minimally invasive transcatheter heart pump	heart failure	Breakthrough Device designation granted by the FDA
Allergan	Botox (onabotulinumtoxinA)	detrusor overactivity associated with a neurologic condition in patients age five and older who have an inadequate response to or are intolerant of anticholinergic medication	approved by the FDA for additional indication
Bristol Myers Squibb/Juno Therapeutics	Breyanzi (lisocabtagene maraleucel)	patients with certain types of large B-cell lymphoma who have not responded to, or who have relapsed after, at least two other types of systemic treatment	approved by the FDA
Regeneron Sanofi	Libtayo (cemiplimab-rwlc)	locally advanced and metastatic basal cell carcinoma	approved by the FDA
Rhizen Pharmaceuticals TG Therapeutics	Ukoniq (umbralisib)	relapsed or refractory marginal-zone lymphoma and follicular lymphoma	accelerated approval granted by the FDA
Signifier Medical Technologies	eXciteOSA daytime intraoral neuromuscular stimulation device	mild obstructive sleep apnea and snoring	approved by the FDA