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Pipeline
January 4, 2021
| Company | Drug/Device | Medical Condition | Status |
|---|---|---|---|
| COVID-19 Trials and Actions | |||
| Kentucky BioProcessing | KBP-COVID-19 | COVID-19 vaccine | IND approved by the FDA |
| Hepion Pharmaceuticals | CRV431 | treatment of COVID-19 | IND approved by the FDA |
| Innovation Pharmaceuticals | Brilacidin | hospitalized patients with COVID-19 | IND approved by the FDA |
| Emergent BioSolutions Mount Sinai Health System |
COVID-19 Human Hyperimmune Globulin (COVID-HIG) | postexposure prophylaxis in individuals at high risk of exposure to SARS-CoV-2 | initiation of phase 1 trial |
| Ology Bioservices | ADM03820, anti-SARS-CoV-2 monoclonal antibodies | COVID-19 | patient dosing commenced in phase 1 trial |
| Vasomune | AV-001 | patients hospitalized with COVID-19 | patient dosing commenced in phase 1 trial |
| Serum Institute of India Dynavax |
adjuvanted COVID-19 vaccine with Dynavax’s CpG 1018 | prevention of COVID-19 | first patients dosed in phase 1/2 trial |
| Aldeyra Therapeutics | ADX-629 | COVID-19 | initiation of phase 2 trial |
| Acticor Biotech | glenzocimab | COVID-19-related acute respiratory distress syndrome (ARDS) | first patient enrolled in phase 2 trial |
| Algernon Pharmaceuticals | NP-120 (Ifenprodil) | COVID-19 | last patient treated in phase 2b portion of phase 2b/3 trial |
| NeuroRx Relief Therapeutics |
Zyesami (RLF-100: aviptadil) | respiratory failure in patients with critical COVID-19 | patient enrollment complete in phase 2b/3 trial |
| CureVac | CVnCoV | COVID-19 vaccine | first patient dosed in phase 3 trial |
| EUSA Pharma | siltuximab | hospitalized patients with COVID-19 previously treated with corticosteroids, or another respiratory virus infection-associated case of ARDS | first patient enrolled in phase 3 trial |
| Novavax | NVX-CoV2373 | COVID-19 vaccine candidate | initiation of phase 3 trial |
| Shenyang Tonglian Group | carrimycin | severe COVID-19 in hospitalized patients | approval by the FDA to proceed with phase 3 trial |
| Vir Biotech GlaxoSmithKline |
VIR-7831 (GSK4182136) | hospitalized adults with COVID-19 | first patient dosed in a new subtrial of the NIH Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) program phase 3 trial |
| Moderna | mRNA-1273 | COVID-19 vaccine | Emergency Use Authorization granted by the FDA |
| Other Trials and Actions | |||
| AlloVir | ALVR106 | allogeneic and autologous hematopoietic stem-cell transplant patients with respiratory infections caused by RSV, influenza, PIV or hMPV | IND approved by the FDA |
| Cerecor | CERC-007 | Still’s disease | IND approved by the FDA |
| LyGenesis | novel cell therapy | end-stage liver disease | IND approved by the FDA |
| Moebius Medical | MM-II | pain-in-knee osteoarthritis | IND approved by the FDA |
| Onconova Therapeutics | ON 123300 | patients with relapsed/refractory advanced cancer | IND approved by the FDA |
| Senhwa Biosciences | CX-5461 | solid tumors with BRCA2 or PALB2 mutations | IND approved by the FDA |
| Ziopharm Eden BioCell |
patient-derived CD19-specific CAR-T | patients with relapsed CD19+ leukemias and lymphomas | IND approved in Taiwan |
| BioInvent Transgene |
BT-001 | solid tumors | clinical trial approved to begin in Belgium |
| Polyphor | murepavadin inhaled antibiotic | pseudomonas aeruginosa lung infections in people with cystic fibrosis | clinical trial approved by the UK Medicines and Healthcare products Regulatory Agency |
| Amphivena Therapeutics | AMV564 | selected solid tumors | first patients dosed in phase 1 trial |
| BioEclipse Therapeutics | CRX100 | refractory solid tumors | first patients enrolled in phase 1 trial |
| Ascletis Pharma/Gannex | ASC42 | nonalcoholic steatohepatitis | first patient dosed in phase 1 trial |
| Humanigen | ifabotuzumab | recurrent glioblastoma multiforme | enrollment complete in phase 1 trial |
| Mustang Bio | MB-101 (autologous IL13R?2-CAR T-cells) | leptomeningeal brain tumors | initiation of phase 1 trial |
| Gannex/Ascletis | ASC41 | nonalcoholic steatohepatitis | first patients dosed in phase 1b trial |
| MODAG | anle138b | mild-to-moderate Parkinson´s disease | initiation of phase 1b trial |
| ORIC Pharmaceuticals | ORIC-101 | advanced solid tumors | initiation of second dose expansion portion of phase 1b trial |
| aTyr Pharma | ATYR1923 | pulmonary sarcoidosis | patient enrollment complete in phase 1b/2a trial |
| Evaxion Biotech | EVX-02 | adjuvant therapy in patients with advanced melanoma | first patient dosed in phase 1/2 trial |
| Aldeyra Therapeutics | ADX-629 | adults with mild asthma induced by bronchial asthma challenge | initiation of phase 2 trial |
| Aldeyra Therapeutics | ADX-629 | adults with mild-to-moderate plaque psoriasis | initiation of phase 2 trial |
| Altimmune | HepTcell | chronic hepatitis B | initiation of phase 2 trial |
| Athersys Memorial Hermann-Texas Medical Center |
MultiStem cell therapy | early treatment of traumatic injuries and subsequent complications | first patient enrolled in phase 2 trial |
| Brainstorm Cell Therapeutics | NurOwn (MSC-NTF cells) | progressive multiple sclerosis | patient dosing complete in phase 2 trials |
| Ultimovacs | UV1 universal cancer vaccine | patients with recurrent or metastatic head and neck cancer | initiation of phase 2 trial |
| Annexon | ANX005 | Guillain-Barré syndrome | first patients dosed in phase 2/3 trial |
| Albireo Pharma | odevixibat | Alagille syndrome | initiation of phase 3 trial |
| Fibrogen | pamrevlumab | idiopathic pulmonary fibrosis | first patient dosed in phase 3 trial |
| Neurana Pharmaceutical | tolperisone | symptoms associated with acute and painful muscle spasms of the back | first patient enrolled in phase 3 trial |
| Oncopeptides | melflufen plus dexamethasone and subcutaneous daratumumab | patients with relapsed, refractory multiple myeloma who are refractory to an immunomodulatory agent and a proteasome inhibitor or who have had at least three prior lines of therapy, including these agents | first patients dosed in phase 3 trial |
| Novaremed | NRD135S.E1 | painful diabetic peripheral neuropathy | Fast-Track designation granted by the FDA |
| Moleculin Biotech | annamycin | soft-tissue sarcomas | Orphan Drug designation granted by the FDA |
| Sigilon | SIG-005 | mucopolysaccharidosis type I | Orphan Drug designation granted by the FDA |
| Antengene Karyopharm |
oral Xpovio (selinexor) | patients with multiple myeloma who have received at least one prior therapy | approved by the FDA for expanded indication |
| AstraZeneca | Tagrisso (osimertinib) | adjuvant treatment for patients with nonsmall-cell lung cancer whose tumors have a specific type of genetic mutation | approved by the FDA for expanded indication |
| Almirall Athenex |
Klisyri (tirbanibulin) | topical treatment of actinic keratosis of the face or scalp | approved by the FDA |
| Bracco Diagnostics | ProHance (Gadoteridol) Injection, 279.3 mg/mL for intravenous use with magnetic resonance imaging | children under two years for visualization of areas with disrupted blood-brain barrier and/or abnormal vascularity throughout the brain, spine and associated tissues | approved by the FDA |
| Genentech | Ocrevus (ocrelizumab) | shorter, two-hour infusion time for relapsing and primary progressive multiple sclerosis | approved by the FDA for new formulation |
| Integrum AB | Osseoanchored Prostheses for the Rehabilitation of Amputees (OPRA) Implant System | adults who have transfemoral amputations | approved by the FDA |
| Myovant Sciences | Orgovyx (relugolix) | adults with advanced prostate cancer | approved by the FDA |
| Ridgeback Therapeutics | Ebanga (ansuvimab-zykl) | Zaire ebolavirus infection in adults and children | approved by the FDA |
| Urovant Sciences | Gemtesa (vibegron) | overactive bladder | approved by the FDA |
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