Pipeline

April 26, 2021

Company	Drug/Device	Medical Condition	Status
COVID-19 Trials and Actions
Aegis Life Entos Pharmaceuticals	Covigenix VAX-001	COVID-19 DNA vaccine	first patients dosed in phase 1/2 trial
Todos Medical	NLC-V-01 (Tollovir)	treatment of hospitalized COVID-19 patients	initiation of phase 2 trial in Israel
SAB Biotherapeutics	SAB-185	treatment of nonhospitalized adults with mild-to-moderate COVID-19	first patient dosed in phase 2/3 trial
Valneva Dynavax	VLA2001, using Dynavax's CpG 1018 adjuvant	COVID-19 vaccine	initiation of phase 3 trial
Other Trials and Actions
Chipscreen Biosciences	Chiauranib/CS2164	small-cell lung cancer	IND approved by the FDA
Illuminare Biotechnologies Memorial Sloan Kettering Cancer Center	Illuminare-1	fluorescent agent to improve nerve visualization during surgery	IND approved by the FDA
Istari Oncology	PVSRIPO with or without PD-1/L1 inhibitors	solid tumors	IND approved by the FDA
NeoTx Therapeutics	naptumomab estafenatox	nonsmall-cell lung cancer	IND approved by the FDA
Organicell Regenerative Medicine	Zofin	knee osteoarthritis	IND approved by the FDA
Stuart Therapeutics	ST-100	dry eye disease	IND approved by the FDA
Transcenta	TST005	tumors	IND approved by the FDA
Vincerx Pharma	VIP152	relapsed/refractory chronic lymphocytic leukemia and Richter syndrome	IND approved by the FDA
XBiotech	ONIVYDE/5-FU combined with XB2001	pancreatic cancer	IND approved by the FDA
Cerus	Contour Neurovascular System	intracranial aneurysms	Investigational Device Exemption (IDE) approved by the FDA
Cytosorbents	CytoSorb blood purification technology	removal of ticagrelor during cardiothoracic surgery	IDE approved by the FDA
Aligos Therapeutics	ALG-000184	chronic hepatitis B	first patients dosed in first cohort of phase 1 trial
Ayala Pharmaceuticals	AL102 in combination with WVT078	relapsed and/or refractory multiple myeloma	first patient dosed in phase 1 trial
Eden BioCell Ziopharma Oncology TriArm Therapeutics	CD19-Specific Rapid Personalized Manufacturing CAR-T	relapsed CD19+ leukemias and lymphomas	first patient dosed in phase 1 trial
Site One Therapaeutics	ST-2427	moderate-to-severe pain	first patients dosed in phase 1 trial
Transcenta Holding	TST001 in combination with CAPOX	first-line locally advanced unresectable or metastatic gastric cancer	first patient dosed in phase 1 trial
The Jerome Canady Research Institute for Advanced Biological and Technological Sciences U.S. Medical Innovations	Canady Helios Cold Plasma	recurrent and stage 4 solid tumors	completion of phase 1 trial
Revolution Medicines	RMC-5552	advanced relapsed/refractory solid tumors	first patient dosed in phase 1/1b trial
CohBar	CB4211	nonalcoholic steatohepatitis and obesity	completion of last patient final visit in phase 1b trial
Kintor Pharmaceutical	pyrilutamide	mild-to-moderate acne vulgaris	patient dosing complete in first patient cohort of phase 1/2 trial
Antios Therapeutics	ATI-2173	chronic hepatitis B	first patients dosed in phase 2a trial
Brii Biosciences Vir Biotechnology VBI Vaccines	BRII-835 (VIR-2218) in combination with BRII-179 (VBI-2601)	chronic HBV infection	first patients dosed in phase 2 trial
Checkmate Pharmaceuticals	vidutolimod (CMP-001) in combination with pembrolizumab	head and neck squamous-cell carcinoma	first patients dosed in phase 2 trial
Retrotope	RT001	amyotrophic lateral sclerosis	patient enrollment complete in phase 2 trial
Ripple Therapeutics	IBE-814 IVT, (intravitreal dexamethasone implant)	inflammatory retinal diseases	first patient treated in phase 2 trial
Sirnaomics	STP705	keloid scar prevention	initiation of phase 2 trial
T3D Therapeutics	T3D-959	mild-to-moderate Alzheimer's disease	first patients dosed in phase 2 trial
AgeneBio	AGB101	amnestic mild cognitive impairment due to Alzheimer's disease	patient enrollment complete in phase 2b trial
Acerta Pharma Veracyte	acalabrutinib with R-CHOP	treatment of patients with nongerminal-center B-cell (non-GCB) subtype diffuse large B-cell lymphoma identified using Veracyte’s LymphMark genomic test	first patient enrolled in phase 3 trial
MorphoSys Incyte	tafasitamab in combination with lenalidomide and rituximab	treatment of patients with relapsed or refractory follicular lymphoma or marginal-zone lymphoma	first patient dosed in phase 3 trial
Novartis	ribociclib with endocrine therapy	HR-positive, HER2-negative early breast cancer	patient enrollment complete in phase 3 trial
TG Therapeutics	Ukoniq (umbralisib) in combination with ublituximab and venetoclax	frontline and relapsed or refractory chronic lymphocytic leukemia	initiation of phase 3 trial
Amgen	bemarituzumab	first-line treatment for FGFR2b overexpressing and HER2-negative metastatic and locally advanced gastric and gastroesophageal adenocarcinoma in combination with modified FOLFOX6	Breakthrough Therapy designation granted by the FDA
Quadrant Biosciences	Clarifi ASD autism saliva test	assessment of likelihood of autism spectrum disorder	Breakthrough Device designation granted by the FDA
ALK	RAGWITEK (Short Ragweed Pollen Allergen Extract) sublingual tablet	short ragweed pollen-induced allergic rhinitis in patients age five through 65	approved by the FDA
Bristol Myers Squibb	Opdivo (nivolumab) plus chemotherapy	advanced or metastatic gastric cancer, gastroesophageal junction cancer and esophageal adenocarcinoma, regardless of PD-L1 expression	approved by the FDA
Mayne Pharma	Nextstellis (3 mg drospirenone and estetrol tablets)	contraceptive	approved by the FDA
Medtronic	Pipeline Flex Embolization Device with Shield Technology	brain aneurysm	approved by the FDA
Orthofix Medical	FORZA Ti TLIF Spacer System	transforaminal lumbar interbody fusion	approved by the FDA
Zimmer Biomet	ROSA Partial Knee System	robotically assisted partial knee replacement surgeries	approved by the FDA