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

 

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