Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
MGD014 · 1 trial · 1 indication
Safety is based on evaluation of adverse events (AEs) and serious adverse events (SAEs) from the time of study drug administration through the End of Study visit.
| Arm | Type | Description |
|---|---|---|
| MGD014 0.1 micrograms/kilogram (mcg/kg) | EXPERIMENTAL | a single 2-hour infusion |
| MGD014 0.3 mcg/kg | EXPERIMENTAL | a single 2-hour infusion |
| MGD014 1.0 mcg/kg | EXPERIMENTAL | a single 2-hour infusion |
| MGD014 3.0 mcg/kg | EXPERIMENTAL | a single 2-hour infusion |
| MGD014 10.0 mcg/kg | EXPERIMENTAL | a single 2-hour infusion |
| MGD014 30.0 mcg/kg | EXPERIMENTAL | a single 2-hour infusion |
| MGD014 100.0 mcg/kg | EXPERIMENTAL | a single 2-hour infusion |
| MGD014 300.0 mcg/kg | EXPERIMENTAL | a single 2-hour infusion |
| MGD014 300.0 mcg/kg multiple doses | EXPERIMENTAL | 2-hour infusion every 2 weeks for 3 infusions |
| Name | Type | Description |
|---|---|---|
| MGD014 | BIOLOGICAL | HIV-1 x CD3 bispecific DART molecule |
Inclusion Criteria: * Ability and willingness of participant to provide written informed consent. * HIV-1 infection, documented by any FDA-approved rapid HIV test or HIV enzyme or chemiluminescence immunoassay (E/CIA) test kit at any time prior to study entry and confirmed by a licensed Western blo...
Top 19 of 30 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Pfizer Inc. | PFE | 7 | PHASE3 | VLA15, Prevenar 20, 13vPnC, ATM-AVI, PG4 |
| Sanofi SA Sponsored ADR | SNY | 1 | PHASE3 | PCV21 |
| GSK plc Sponsored ADR | GSK | 4 | PHASE2 | Penmenvy, iNTS-TCV, Strep A vaccine, Pan-Salmonella vaccine |
| Grifols, S.A. Sponsored ADR Class B | GRFS | 1 | PHASE3 | Xembify |
| CorMedix Inc. | CRMD | 1 | PHASE3 | DefenCath |
| Sinovac Biotech Ltd. | SVA | 4 | PHASE3 | Sinovac PCV24, Group ACYW135X Meningococcal Conjugate Vaccine, Group ACYW135 Meningococcal Conjugate Vaccine |
| Novartis AG Sponsored ADR | NVS | 2 | PHASE2 | EDI048 |
| Innoviva, Inc. | INVA | 3 | PHASE2 | Eravacycline, Sulbactam-durlobactam |
| BiomX Inc. | PHGE | 1 | PHASE2 | BX004 |
| Hoffmann-La Roche | RHHBY | 1 | PHASE3 | Baloxavir Marboxil |
| Merck & Co., Inc. | MRK | 2 | PHASE1 | V118C |
| AstraZeneca PLC | AZN | 1 | PHASE1 | AZD7760 |
| BioNTech SE Sponsored ADR | BNTX | 1 | PHASE1 | BNT163 |
| 60 Degrees Pharmaceuticals, Inc. | SXTP | 1 | PHASE2 | Tafenoquine |
| Tarsus Pharmaceuticals, Inc. | TARS | 1 | PHASE2 | TP-05 |
| Moderna, Inc. | MRNA | 1 | PHASE2 | mRNA-1982 |
| AN2 Therapeutics, Inc. | ANTX | 1 | PHASE2 | Epetraborole |
| Emergent BioSolutions Inc. | EBS | 4 | - | AIGIV/kg |
| Phathom Pharmaceuticals, Inc. | PHAT | 1 | - | Vonoprazan |
MGD014 is an investigational monoclonal antibody being studied for HIV-1 infection. It was evaluated in a Phase 1 clinical trial in HIV-infected individuals who were on suppressive antiretroviral therapy. It is not an approved treatment and remains in clinical development.
MGD014 targets CD3, a protein component of the T-cell receptor complex on T cells. By binding CD3, the antibody is designed to redirect T cells toward HIV-infected cells. CD3 is a protein target, and MGD014 is being developed as a monoclonal antibody therapeutic.
MGD014 is being developed by MacroGenics, Inc., a biopharmaceutical company that trades under the ticker symbol MGNX. MacroGenics is the sponsor of the clinical program evaluating MGD014 for HIV-1 infection.
MGD014 is in Phase 1 clinical development. It has completed one Phase 1 trial and is not currently in any active trials. The drug is investigational and has not been approved by the FDA for any indication.
MGD014 has been studied in one completed Phase 1 trial, NCT03570918, titled MGD014 in HIV-Infected Individuals on Suppressive Antiretroviral Therapy. The trial enrolled 21 participants in the United States and included a controlled design. No active trials of MGD014 are ongoing.