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Pipeline
March 15, 2021
| Company | Drug/Device | Medical Condition | Status |
|---|---|---|---|
| COVID-19 Trials and Actions | |||
| Kintor Pharmaceutical | proxalutamide | male COVID-19 outpatients | IND approved by the FDA for phase 3 trial |
| Melior Pharmaceuticals | tolimidone | nonhospitalized patients recently diagnosed with COVID-19 | IND approved by the FDA for phase 2 trial |
| AIM ImmunoTech | intranasal Ampligen | prophylaxis or early-stage treatment for COVID-19 and other respiratory viral diseases | first patient dosed in phase 1 trial |
| VBI Vaccines | VBI-2902 | COVID-19 vaccine | first patients enrolled in phase 1/2 trial |
| Can-Fite Biopharma | piclidenoson | patients hospitalized with moderate- to-severe COVID-19 | first patient enrolled in phase 2 trial |
| Other Trials and Actions | |||
| Alphamab Oncology | KN046 | thymic carcinoma | IND approved by the FDA |
| TissueTech | TTAX03 | facet joint pain resulting from osteoarthritis | IND approved by the FDA |
| Lee’s Pharma | socazolimab | extensive-stage small-cell lung cancer | IND cleared by China’s National Medical Products Administration for a phase 3 trial |
| Alteogen | Eylea Biosimilar (ALT-L9) | neovascular (wet) age-related macular degeneration | completion of phase 1 trial |
| BioEclipse Therapeutics | CRX100 | refractory solid tumors | first patient dosed in phase 1 trial |
| American CryoStem | autologous mesenchymal stem cell infusion therapy | postconcussion syndrome | phase 1 trial initiated |
| Impact Therapeutics | Wee1 Inhibitor IMP7068 | patients with advanced solid tumors | first patient dosed in phase 1 trial |
| Adicet Bio | ADI-001 allogeneic gamma delta T-cell therapy expressing a chimeric antigen receptor | B-cell nonHodgkin lymphoma | phase 1 trial initiated |
| BeiGene | BGB-15025 hematopoietic progenitor kinase 1 (HPK1) inhibitor | T-cell activated cancer growth | phase 1 trial initiated |
| Oncoinvent | Radspherin | ovarian cancer patients with peritoneal carcinomatosis | first patients enrolled in third-level dose cohort of phase 1 trial |
| DemeRx | ibogaine HCl (DMX-1002) | opioid use disorder | phase 1/2a trial authorized in the UK |
| Aravive | AVB-500 | patients with advanced clear- cell renal cell carcinoma that have progressed on front-line treatment | first patients dosed in phase 1b/2 trial |
| Metacrine | MET642 | nonalcoholic steatohepatitis | first patient treated in phase 2a trial |
| OCON Health | intrauterine drug delivery platform IUB SEAD | abnormal uterine bleeding | patient enrollment complete in phase 2a trial |
| AEON Biopharma | BP-450 (prabotulinumtoxinA) injection | preventive treatment of migraine | initiation of phase 2 trial |
| Edesa Biotech | EB01 | chronic allergic contact dermatitis | patient enrollment complete in first cohort of phase 2b trial |
| IRLAB Therapeutics | mesdopetam | levodopa-induced dyskinesias in Parkinson's disease | first patients dosed in Europe in phase 2b/3 trial |
| Natera | Signatera tumor-informed, personalized molecular residual disease test | muscle-invasive urothelial carcinoma | phase 3 trial initiated to test use of diagnostic tool prior to treatment with Genentech’s atezolizumab (Tecentriq) |
| Caladrius Biosciences | CLBS12 | Buerger’s disease | Orphan Drug designation granted by the FDA |
| Sigilon Therapeutics | SIG-007 | Fabry disease | Orphan Drug designation granted by the FDA |
| Steba Biotech | Padeliporfin ImPACT | adults with upper-tract urothelial cancer | Orphan Drug designation granted by the FDA |
| Passage Bio | PBGM01 | GM1 gangliosidosis | Fast-Track designation granted by the FDA |
| Passage Bio | PBFT02 | frontotemporal dementia with granulin mutations | Fast-Track designation granted by the FDA |
| Passage Bio | PBKR03 | Krabbe disease | Fast-Track designation granted by the FDA |
| Rocket Pharmaceuticals | RP-L201 | leukocyte adhesion deficiency-I (LAD-I) | Regenerative Medicine Advanced Therapy designation granted by the FDA |
| Genentech | Actemra (tocilizumab) subcutaneous injection | systemic sclerosis-associated interstitial lung disease | approved by the FDA |
| Kite Pharma | Yescarta (axicabtagene ciloleucel) | relapsed or refractory follicular lymphoma after two or more lines of systemic therapy | approved by the FDA for expanded indication |
| Seqirus | Flucelvax | quadrivalent influenza vaccine | approved by the FDA for expanded age indication |
| Roche | Ventana ALK (D5F3) CDx Assay | companion diagnostic to identify ALK-positive nonsmall-cell lung cancer patients eligible for treatment with Pfizer's Lorbrena (lorlatinib) | approved by the FDA |
| Able Medical Devices | Valkyrie Thoracic Fixation System | stabilization and fixation of fractures of the chest wall | approved by the FDA |
| Brain Scientific | next-generation NeuroCap device | electroencephalogram electrode array used to obtain rapid EEGs in routine clinical and research settings | approved by the FDA |
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