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Pipeline
| Company | Drug/Device | Medical Condition | Status |
|---|---|---|---|
| COVID-19 Trials and Actions | |||
| Aegis Life Entos Pharmaceuticals |
Covigenix VAX-001 | COVID-19 DNA vaccine | first patients dosed in phase 1/2 trial |
| Todos Medical | NLC-V-01 (Tollovir) | treatment of hospitalized COVID-19 patients | initiation of phase 2 trial in Israel |
| SAB Biotherapeutics | SAB-185 | treatment of nonhospitalized adults with mild-to-moderate COVID-19 | first patient dosed in phase 2/3 trial |
| Valneva Dynavax |
VLA2001, using Dynavax's CpG 1018 adjuvant | COVID-19 vaccine | initiation of phase 3 trial |
| Other Trials and Actions | |||
| Chipscreen Biosciences | Chiauranib/CS2164 | small-cell lung cancer | IND approved by the FDA |
| Illuminare Biotechnologies Memorial Sloan Kettering Cancer Center |
Illuminare-1 | fluorescent agent to improve nerve visualization during surgery | IND approved by the FDA |
| Istari Oncology | PVSRIPO with or without PD-1/L1 inhibitors | solid tumors | IND approved by the FDA |
| NeoTx Therapeutics | naptumomab estafenatox | nonsmall-cell lung cancer | IND approved by the FDA |
| Organicell Regenerative Medicine | Zofin | knee osteoarthritis | IND approved by the FDA |
| Stuart Therapeutics | ST-100 | dry eye disease | IND approved by the FDA |
| Transcenta | TST005 | tumors | IND approved by the FDA |
| Vincerx Pharma | VIP152 | relapsed/refractory chronic lymphocytic leukemia and Richter syndrome | IND approved by the FDA |
| XBiotech | ONIVYDE/5-FU combined with XB2001 | pancreatic cancer | IND approved by the FDA |
| Cerus | Contour Neurovascular System | intracranial aneurysms | Investigational Device Exemption (IDE) approved by the FDA |
| Cytosorbents | CytoSorb blood purification technology | removal of ticagrelor during cardiothoracic surgery | IDE approved by the FDA |
| Aligos Therapeutics | ALG-000184 | chronic hepatitis B | first patients dosed in first cohort of phase 1 trial |
| Ayala Pharmaceuticals | AL102 in combination with WVT078 | relapsed and/or refractory multiple myeloma | first patient dosed in phase 1 trial |
| Eden BioCell Ziopharma Oncology TriArm Therapeutics |
CD19-Specific Rapid Personalized Manufacturing CAR-T | relapsed CD19+ leukemias and lymphomas | first patient dosed in phase 1 trial |
| Site One Therapaeutics | ST-2427 | moderate-to-severe pain | first patients dosed in phase 1 trial |
| Transcenta Holding | TST001 in combination with CAPOX | first-line locally advanced unresectable or metastatic gastric cancer | first patient dosed in phase 1 trial |
| The Jerome Canady Research Institute for Advanced Biological and Technological Sciences U.S. Medical Innovations |
Canady Helios Cold Plasma | recurrent and stage 4 solid tumors | completion of phase 1 trial |
| Revolution Medicines | RMC-5552 | advanced relapsed/refractory solid tumors | first patient dosed in phase 1/1b trial |
| CohBar | CB4211 | nonalcoholic steatohepatitis and obesity | completion of last patient final visit in phase 1b trial |
| Kintor Pharmaceutical | pyrilutamide | mild-to-moderate acne vulgaris | patient dosing complete in first patient cohort of phase 1/2 trial |
| Antios Therapeutics | ATI-2173 | chronic hepatitis B | first patients dosed in phase 2a trial |
| Brii Biosciences Vir Biotechnology VBI Vaccines |
BRII-835 (VIR-2218) in combination with BRII-179 (VBI-2601) | chronic HBV infection | first patients dosed in phase 2 trial |
| Checkmate Pharmaceuticals | vidutolimod (CMP-001) in combination with pembrolizumab | head and neck squamous-cell carcinoma | first patients dosed in phase 2 trial |
| Retrotope | RT001 | amyotrophic lateral sclerosis | patient enrollment complete in phase 2 trial |
| Ripple Therapeutics | IBE-814 IVT, (intravitreal dexamethasone implant) | inflammatory retinal diseases | first patient treated in phase 2 trial |
| Sirnaomics | STP705 | keloid scar prevention | initiation of phase 2 trial |
| T3D Therapeutics | T3D-959 | mild-to-moderate Alzheimer's disease | first patients dosed in phase 2 trial |
| AgeneBio | AGB101 | amnestic mild cognitive impairment due to Alzheimer's disease | patient enrollment complete in phase 2b trial |
| Acerta Pharma Veracyte |
acalabrutinib with R-CHOP | treatment of patients with nongerminal-center B-cell (non-GCB) subtype diffuse large B-cell lymphoma identified using Veracyte’s LymphMark genomic test | first patient enrolled in phase 3 trial |
| MorphoSys Incyte |
tafasitamab in combination with lenalidomide and rituximab | treatment of patients with relapsed or refractory follicular lymphoma or marginal-zone lymphoma | first patient dosed in phase 3 trial |
| Novartis | ribociclib with endocrine therapy | HR-positive, HER2-negative early breast cancer | patient enrollment complete in phase 3 trial |
| TG Therapeutics | Ukoniq (umbralisib) in combination with ublituximab and venetoclax | frontline and relapsed or refractory chronic lymphocytic leukemia | initiation of phase 3 trial |
| Amgen | bemarituzumab | first-line treatment for FGFR2b overexpressing and HER2-negative metastatic and locally advanced gastric and gastroesophageal adenocarcinoma in combination with modified FOLFOX6 | Breakthrough Therapy designation granted by the FDA |
| Quadrant Biosciences | Clarifi ASD autism saliva test | assessment of likelihood of autism spectrum disorder | Breakthrough Device designation granted by the FDA |
| ALK | RAGWITEK (Short Ragweed Pollen Allergen Extract) sublingual tablet | short ragweed pollen-induced allergic rhinitis in patients age five through 65 | approved by the FDA |
| Bristol Myers Squibb | Opdivo (nivolumab) plus chemotherapy | advanced or metastatic gastric cancer, gastroesophageal junction cancer and esophageal adenocarcinoma, regardless of PD-L1 expression | approved by the FDA |
| Mayne Pharma | Nextstellis (3 mg drospirenone and estetrol tablets) | contraceptive | approved by the FDA |
| Medtronic | Pipeline Flex Embolization Device with Shield Technology | brain aneurysm | approved by the FDA |
| Orthofix Medical | FORZA Ti TLIF Spacer System | transforaminal lumbar interbody fusion | approved by the FDA |
| Zimmer Biomet | ROSA Partial Knee System | robotically assisted partial knee replacement surgeries | approved by the FDA |
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