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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 | PHASE4 | Ianalumab |
| Zenas BioPharma, Inc. | ZBIO | 1 | PHASE3 | Obexelimab |
| Rigel Pharmaceuticals, Inc. | RIGL | 1 | PHASE4 | Fostamatinib disodium |
| Johnson & Johnson | JNJ | 1 | PHASE4 | M281 |
| Sanofi SA Sponsored ADR | SNY | 1 | PHASE4 | rilzabrutinib |
| HUTCHMED (China) Limited Sponsored ADR | HCM | 1 | PHASE4 | HMPL-523 |
| Vertex Pharmaceuticals Incorporated | VRTX | 1 | PHASE4 | 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 (ITP), and idiopathic inflammatory myopathy (IIM). The drug is in Phase 1 clinical development and is not yet approved.
OM336 targets BCMA, a protein involved in the survival of plasma cells. By targeting BCMA, the drug aims to modulate autoimmune responses in conditions such as warm autoimmune hemolytic anemia and Sjogren's disease. This mechanism is being evaluated in early-stage clinical trials.
OM336 is being developed by Lakefront Biotherapeutics, a biopharmaceutical company. The company is conducting Phase 1 clinical trials to evaluate the safety and efficacy of OM336 in autoimmune diseases. Lakefront Biotherapeutics is publicly traded under the ticker symbol LKFT.
OM336 is currently in Phase 1 clinical development. It is an investigational drug and has not received regulatory approval. The ongoing Phase 1 trials are recruiting participants to assess the drug's safety, tolerability, and preliminary efficacy in autoimmune conditions.
OM336 is being studied in two Phase 1 clinical trials. The first trial, NCT07083960, is investigating OM336 in autoimmune cytopenias including warm and cold AIHA and ITP, with enrollment of 32 participants in the United States and Australia. The second trial, NCT07229144, is studying OM336 in seropositive autoimmune diseases including Sjogren's disease and IIM, with 39 participants in New Zealand.
OM336 is a distinct investigational small molecule targeting BCMA. No alternative names for OM336 have been disclosed. It is being developed specifically for autoimmune indications and is not known to be identical to any other approved or investigational drug.