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OM336 · 2 trials · 5 indications
Incidence and severity of treatment-emergent adverse events (TEAEs)
| Arm | Type | Description |
|---|---|---|
| OM336 Dose Escalation | EXPERIMENTAL | Participants will receive OM336 via subcutaneous injection in ascending dose cohorts |
| Name | Type | Description |
|---|---|---|
| OM336 | DRUG | OM336 is an engineered bispecific antibody directed against BCMA and CD3 |
Key Inclusion Criteria: * Diagnosis of active seropositive autoimmune disease * Relapsed/refractory after ≥2 prior/ongoing treatments * Body weight ≥ 50 kg * Willing to comply with and study requirements and procedures Key Exclusion Criteria: * Previous treatment with a BCMA-targeted therapy * Cl...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Novartis AG Sponsored ADR | NVS | 2 | PHASE3 | Ianalumab |
| Zenas BioPharma, Inc. | ZBIO | 1 | PHASE3 | Obexelimab |
| Rigel Pharmaceuticals, Inc. | RIGL | 1 | PHASE3 | Fostamatinib disodium |
| Johnson & Johnson | JNJ | 1 | PHASE2 | M281 |
| Sanofi SA Sponsored ADR | SNY | 1 | PHASE2 | rilzabrutinib |
| HUTCHMED (China) Limited Sponsored ADR | HCM | 1 | PHASE2 | HMPL-523 |
| Vertex Pharmaceuticals Incorporated | VRTX | 1 | PHASE1 | povetacicept |
| CRISPR Therapeutics AG | CRSP | 1 | PHASE1 | CTX112 |
OM336 is an investigational small molecule being developed for warm autoimmune hemolytic anemia (AIHA) and Sjogren's disease. It is also being studied in related autoimmune conditions including cold AIHA, immune thrombocytopenia, and idiopathic inflammatory myopathy. The drug is in Phase 1 clinical development and has not been approved by regulatory authorities.
OM336 targets BCMA, a protein involved in the survival of plasma cells. By targeting BCMA, the drug is designed to modulate autoimmune responses in conditions such as warm autoimmune hemolytic anemia and Sjogren's disease. The drug is a small molecule, and its mechanism is being evaluated in early-stage clinical trials.
OM336 is being developed by Lakefront Biotherapeutics, a biopharmaceutical company listed under the ticker LKFT. The company is conducting Phase 1 clinical trials for the drug in autoimmune cytopenias and seropositive autoimmune diseases. Lakefront Biotherapeutics is responsible for the drug's clinical development program.
OM336 is in Phase 1 clinical development. It is currently being evaluated in two recruiting clinical trials, one in autoimmune cytopenias and another in seropositive autoimmune diseases. The drug is investigational and has not yet received regulatory approval for any indication.
OM336 is being studied in two Phase 1 clinical trials. NCT07083960 is evaluating the drug in autoimmune cytopenias, including warm and cold AIHA and immune thrombocytopenia, with an enrollment of 32 participants in Australia. NCT07229144 is studying the drug in Sjogren's disease and idiopathic inflammatory myopathy, with 39 participants in New Zealand.
OM336 is a distinct investigational drug developed by Lakefront Biotherapeutics. No alternative names for OM336 have been disclosed. It is a small molecule targeting BCMA, and it is being studied specifically for autoimmune conditions such as warm autoimmune hemolytic anemia and Sjogren's disease.