Pipeline

March 15, 2021

Company	Drug/Device	Medical Condition	Status
COVID-19 Trials and Actions
Kintor Pharmaceutical	proxalutamide	male COVID-19 outpatients	IND approved by the FDA for phase 3 trial
Melior Pharmaceuticals	tolimidone	nonhospitalized patients recently diagnosed with COVID-19	IND approved by the FDA for phase 2 trial
AIM ImmunoTech	intranasal Ampligen	prophylaxis or early-stage treatment for COVID-19 and other respiratory viral diseases	first patient dosed in phase 1 trial
VBI Vaccines	VBI-2902	COVID-19 vaccine	first patients enrolled in phase 1/2 trial
Can-Fite Biopharma	piclidenoson	patients hospitalized with moderate- to-severe COVID-19	first patient enrolled in phase 2 trial
Other Trials and Actions
Alphamab Oncology	KN046	thymic carcinoma	IND approved by the FDA
TissueTech	TTAX03	facet joint pain resulting from osteoarthritis	IND approved by the FDA
Lee’s Pharma	socazolimab	extensive-stage small-cell lung cancer	IND cleared by China’s National Medical Products Administration for a phase 3 trial
Alteogen	Eylea Biosimilar (ALT-L9)	neovascular (wet) age-related macular degeneration	completion of phase 1 trial
BioEclipse Therapeutics	CRX100	refractory solid tumors	first patient dosed in phase 1 trial
American CryoStem	autologous mesenchymal stem cell infusion therapy	postconcussion syndrome	phase 1 trial initiated
Impact Therapeutics	Wee1 Inhibitor IMP7068	patients with advanced solid tumors	first patient dosed in phase 1 trial
Adicet Bio	ADI-001 allogeneic gamma delta T-cell therapy expressing a chimeric antigen receptor	B-cell nonHodgkin lymphoma	phase 1 trial initiated
BeiGene	BGB-15025 hematopoietic progenitor kinase 1 (HPK1) inhibitor	T-cell activated cancer growth	phase 1 trial initiated
Oncoinvent	Radspherin	ovarian cancer patients with peritoneal carcinomatosis	first patients enrolled in third-level dose cohort of phase 1 trial
DemeRx	ibogaine HCl (DMX-1002)	opioid use disorder	phase 1/2a trial authorized in the UK
Aravive	AVB-500	patients with advanced clear- cell renal cell carcinoma that have progressed on front-line treatment	first patients dosed in phase 1b/2 trial
Metacrine	MET642	nonalcoholic steatohepatitis	first patient treated in phase 2a trial
OCON Health	intrauterine drug delivery platform IUB SEAD	abnormal uterine bleeding	patient enrollment complete in phase 2a trial
AEON Biopharma	BP-450 (prabotulinumtoxinA) injection	preventive treatment of migraine	initiation of phase 2 trial
Edesa Biotech	EB01	chronic allergic contact dermatitis	patient enrollment complete in first cohort of phase 2b trial
IRLAB Therapeutics	mesdopetam	levodopa-induced dyskinesias in Parkinson's disease	first patients dosed in Europe in phase 2b/3 trial
Natera	Signatera tumor-informed, personalized molecular residual disease test	muscle-invasive urothelial carcinoma	phase 3 trial initiated to test use of diagnostic tool prior to treatment with Genentech’s atezolizumab (Tecentriq)
Caladrius Biosciences	CLBS12	Buerger’s disease	Orphan Drug designation granted by the FDA
Sigilon Therapeutics	SIG-007	Fabry disease	Orphan Drug designation granted by the FDA
Steba Biotech	Padeliporfin ImPACT	adults with upper-tract urothelial cancer	Orphan Drug designation granted by the FDA
Passage Bio	PBGM01	GM1 gangliosidosis	Fast-Track designation granted by the FDA
Passage Bio	PBFT02	frontotemporal dementia with granulin mutations	Fast-Track designation granted by the FDA
Passage Bio	PBKR03	Krabbe disease	Fast-Track designation granted by the FDA
Rocket Pharmaceuticals	RP-L201	leukocyte adhesion deficiency-I (LAD-I)	Regenerative Medicine Advanced Therapy designation granted by the FDA
Genentech	Actemra (tocilizumab) subcutaneous injection	systemic sclerosis-associated interstitial lung disease	approved by the FDA
Kite Pharma	Yescarta (axicabtagene ciloleucel)	relapsed or refractory follicular lymphoma after two or more lines of systemic therapy	approved by the FDA for expanded indication
Seqirus	Flucelvax	quadrivalent influenza vaccine	approved by the FDA for expanded age indication
Roche	Ventana ALK (D5F3) CDx Assay	companion diagnostic to identify ALK-positive nonsmall-cell lung cancer patients eligible for treatment with Pfizer's Lorbrena (lorlatinib)	approved by the FDA
Able Medical Devices	Valkyrie Thoracic Fixation System	stabilization and fixation of fractures of the chest wall	approved by the FDA
Brain Scientific	next-generation NeuroCap device	electroencephalogram electrode array used to obtain rapid EEGs in routine clinical and research settings	approved by the FDA