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Pipeline
May 4, 2020
| Company | Drug/Device | Medical Condition | Status |
|---|---|---|---|
| COVID-19 Trials and Actions | |||
| Inovio | INO-4800 vaccine | COVID-19 | completion of patient enrollment in phase 1 trial |
| BioNTech Pfizer |
BNT162 vaccine | COVID-19 | completion of patient dosing in first cohort of phase 1/2 trial |
| Algernon Pharmaceuticals | NP-120 (Ifenprodil) | COVID-19 patients with severe pneumonia | approval from the Ministry of Food and Drug Safety in South Korea for a phase 2 trial |
| ORYZON Genomics | vafidemstat | prevent progression to Acute Respiratory Distress Syndrome in patients with severe COVID-19 | approval from the Spanish Agency for Medicines and Health Products for a phase 2 trial |
| Innate Pharma | IPH5401 (avdoralimab) | COVID-19 patients with severe pneumonia | first patient dosed in phase 2 trial |
| Moderna | mRNA-1273 vaccine | COVID-19 | second round of dosing in phase 2 trial |
| Chimerix | dociparstat sodium (DSTAT) | COVID-19 patients with acute lung injury | initiation of a phase 2/3 trial |
| Mesoblast | allogeneic mesenchymal stem cell therapy remestemcel-L | moderate/severe acute respiratory distress syndrome due to COVID-19 | initiation of a phase 2/3 trial |
| CTI BioPharma | pacritinib | hospitalized patients with severe COVID-19 | initiation of phase 3 trial |
| Romark Labs | NT-300 (nitazoxanide extended-release tablets) | prevention of COVID-19 in elderly residents of long-term care facilities and healthcare workers | initiation of two phase 3 trials |
| DiaSorin | LIAISON SARS-CoV-2 S1/S2 IgG test | COVID-19 | Emergency Use Authorization (EUA) granted by the FDA |
| Other Trials and Actions | |||
| Adverum Biotechnologies | ADVM-022 | wet age-related macular degeneration | dosing of first patient in cohort 4 of phase 1 trial |
| BioXcel Therapeutics | BXCL701 in combination with pembrolizumab (Keytruda) | treatment of emergent neuroendocrine prostate cancer | initiation of the phase 2 portion of phase 1b/2 trial |
| RhoVac AB | RV001 | advanced prostate cancer | first patient dosed in phase 2b trial |
| Windtree Therapeutics | AEROSURF | premature infants with respiratory distress syndrome | enrollment of first patient in phase 2b bridging trial |
| BioEclipse Therapeutics | CRX100 | therapy-refractory solid tumors | IND approved by the FDA |
| RemeGen | RC48 (disitamab vedotin) | HER2 positive metastatic or unresectable urothelial cancer | IND approved by the FDA |
| Shanghai Green Valley Pharmaceuticals | GV-971 | Alzheimer's disease | IND approved by the FDA |
| Zentalis Pharmaceuticals | ZN-d5 | hematologic malignancies | IND approved by the FDA |
| Neon Therapeutics | neoantigen-targeted T cell therapy (NEO-PTC-01) | patients with metastatic melanoma who are not responsive to checkpoint inhibitors | clinical trial authorization granted by the Dutch Healthcare Authority |
| Takeda Pharmaceuticals | mobocertinib (TAK-788) | patients with metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations whose disease has progressed on or after platinum-based chemotherapy | Breakthrough Therapy designation granted by the FDA |
| AmideBio, LLC | ABG-023 | congenital hyperinsulinism | Orphan Drug designation granted by the FDA |
| Zambon | Liposomal Cyclosporine A for inhalation (L CsA i) | Bronchiolitis Obliterans Syndrome | Fast Track designation granted by the FDA |
| Merck | Keytruda | all adult indications, including monotherapy and combination therapy | approved by the FDA as a new dosage of 400 mg every six weeks |
| Neurocrine Biosciences | Ongentys as add-on to levodopa/carbidopa | patients with Parkinson's disease experiencing "off" episodes | approved by the FDA |
| Sanofi | MenQuadfi Meningococcal (Groups A, C, Y, W) Conjugate Vaccine | prevention of invasive meningococcal disease in persons 2 years of age and older | approved by the FDA |
| GlaxoSmithKline | Zejula (niraparib) | maintenance treatment for women with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in a complete or partial response to first-line platinum-based chemotherapy, regardless of biomarker status | approved by the FDA for expanded indication |
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