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Pipeline
January 18, 2021
| Company | Drug/Device | Medical Condition | Status |
|---|---|---|---|
| COVID-19 Trials and Actions | |||
| Codagenix Serum Institute of India |
COVI-VAC | single-dose, intranasal, live attenuated vaccine against SARS-CoV-2 | first patient dosed in phase 1 trial |
| DalCor Pharmaceuticals | dalcetrapib | oral anti-viral treatment for COVID-19 | initiation of phase 2 trial |
| Innovation Pharmaceuticals | Brilacidin | hospitalized COVID-19 patients | Fast-Track designation granted by the FDA for phase 2 trial |
| PerkinElmer | PerkinElmer New Coronavirus Nucleic Acid Detection Kit | testing of individuals without COVID-19 symptoms | Emergency Use Authorization (EUA) granted by the FDA |
| Quanterix | Simoa SARS-CoV-2 N Protein Antigen Test | detection of SARS-CoV-2 virus nucleocapsid protein | EUA granted by the FDA |
| Other Trials and Actions | |||
| Editas Medicine | EDIT-301 | sickle cell disease | IND approved by the FDA |
| Vor Biopharma | VOR33 | acute myeloid leukemia | IND approved by the FDA |
| Chipscreen Biosciences | chiauranib | second-line treatment of small-cell lung cancer | IND approved by China’s National Medical Products Administration (NMPA) |
| Gracell Biotechnologies | GC007g, allogeneic donor-derived anti-CD19 chimeric antigen receptor (CAR)-T cell therapy | B-cell acute lymphoblastic leukemia | IND approved by China’s NMPA |
| aTyr Pharma Kyorin Pharma |
ATYR1923 (KRP-R120) | interstitial lung disease | completed last subject visit in phase 1 trial |
| Jounce Therapeutics | JTX-8064 as a monotherapy and in combination with either JTX-4014 or Keytruda | advanced solid tumors | initiation of phase 1 trial |
| Jupiter Orphan Therapeutics | JOTROL | rare diseases, including ataxias, lysosomal storage disorders and mitochondrial diseases | first patient dosed in phase 1 trial |
| OX2 Therapeutics | immunotherapy | recurrent glioblastoma | first patient dosed in phase 1 trial |
| Rezolute | RZ402 | diabetic macular edema | initiation of phase 1 trial |
| Clearside Biomedical | CLS-AX (axitinib injectable suspension) | neovascular age-related macular degeneration (wet AMD) | first patients enrolled in phase 1/2a trial |
| Felix Biotechnology | YPT-01 | chronic P. aeruginosa infections in cystic fibrosis | initiation of phase 1/2 trial |
| Terns Pharmaceuticals | TERN-101 | nonalcoholic steatohepatitis | patient enrollment complete in phase 2a trial |
| Adverum Biotechnologies | ADVM-022 | diabetic macular edema | patient enrollment complete in phase 2 trial |
| Cytokinetics | CK-274 | hypertrophic cardiomyopathy | first patient dosed in cohort 2 of phase 2 trial |
| Immutep | eftilagimod alpha | head and neck cancer | patient enrollment complete in phase 2 trial |
| Cara Therapeutics | oral Korsuva (difelikefalin) | moderate-to-severe pruritus in patients suffering from notalgia paresthetica | initiation of phase 2 trial |
| OncoSec Medical | TAVO (tavokinogene telseplasmid) plus Opdivo (nivolumab) | neoadjuvant therapy prior to surgery in patients with operable, locally or regionally advanced melanoma | first patient dosed in phase 2 trial |
| Redhill Biopharma Cosmo Pharmaceuticals |
Rifamycin SV-MMX 600mg | diarrhea-predominant irritable bowel syndrome | completion of phase 2 trial |
| REMD Biotherapeutics | volagidemab (REMD-477) | type 1 diabetes | patient enrollment complete in phase 2 trial |
| Mirum Pharmaceuticals | volixibat | primary sclerosing cholangitis | first patient enrolled in phase 2b trial |
| RhoVac | RV001 | advanced prostate cancer | first patient enrolled in phase 2b trial |
| Kintara Therapeutics | VAL-083 | newly diagnosed and recurrent glioblastoma | initiation of patient recruitment in phase 2/3 trial |
| Prilenia Therapeutics | pridopidine | amyotrophic lateral sclerosis | first patient enrolled in phase 2/3 trial |
| Arcutis Biotherapeutics | topical roflumilast cream (ARQ-151) | atopic dermatitis | initiation of two phase 3 trials |
| Blue Earth Diagnostics | 18F-fluciclovine, a positron emission tomography imaging radiopharmaceutical | detecting recurrent brain metastases | first patient dosed in phase 3 trial |
| Denovo Biopharma | DB102 (enzastaurin) | patients with newly diagnosed glioblastoma multiforme | first patient dosed in phase 3 trial |
| Organogenesis | ReNu, cryopreserved amniotic suspension allograft | management of symptoms associated with knee osteoarthritis | first patient enrolled in phase 3 trial |
| Pfizer | PF-06939926 | ambulatory male patients, ages 4 through 7, with Duchenne muscular dystrophy | first patient dosed in phase 3 trial |
| Rockwell Medical Wanbang Biopharmaceuticals |
Triferic Dialysate | patients with chronic kidney disease requiring hemodialysis | first patient dosed in phase 3 trial |
| TauRx Pharmaceuticals | hydromethylthionine | mild cognitive impairment and mild-to-moderate Alzheimer’s disease | patient enrollment complete in phase 3 trial |
| Orchard Therapeutics | OTL-200, ex vivo autologous hematopoietic stem cell gene therapy | early-onset metachromatic leukodystrophy | Regenerative Medicine Advanced Therapy designation granted by the FDA |
| Gemini Therapeutics | GEM103 | age-related macular degeneration | Fast-Track designation granted by the FDA |
| Leading Biosciences | LB1148 | postoperative gastrointestinal dysfunction associated with pediatric heart surgery | Fast-Track designation granted by the FDA |
| Merus | Zenocutuzumab | patients with metastatic solid tumors harboring NRG1 gene fusions (NRG1+ cancers) that have progressed on standard-of-care therapy | Fast-Track designation granted by the FDA |
| Abbott | i-STAT Alinity TBI plasma test | rapid handheld traumatic brain injury blood test | approved by the FDA |
| ClearMind Biomedical | Axonpen System | illumination and visualization of intracranial tissue and fluids and the controlled aspiration of tissue and/or fluid during surgery | approved by the FDA |
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