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

 

Upcoming Events

Featured Products

Featured Stories

Standard Operating Procedures for Risk-Based Monitoring of Clinical Trials

The information you need to adapt your monitoring plan to changing times.

Learn More Here