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CAL101
CAL101 is a phosphatidylinositol 3-kinase (PI3K) delta inhibitor that selectively blocks PI3K signaling in immune cells to modulate immune responses.
CAL101 is a phosphatidylinositol 3-kinase (PI3K) delta inhibitor that selectively blocks PI3K signaling in immune cells to modulate immune responses. Used for B-cell malignancies (in development).
At a glance
| Generic name | CAL101 |
|---|---|
| Sponsor | Calluna Pharma AS |
| Drug class | PI3K delta inhibitor |
| Target | PI3K delta (PIK3CD) |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 2 |
Mechanism of action
CAL101 inhibits the delta isoform of PI3K, an enzyme critical for B-cell and T-cell activation and survival. By blocking PI3K delta signaling, the drug reduces proliferation and activation of malignant B cells and modulates immune cell function, making it potentially useful in hematologic malignancies and immune-mediated disorders. This selective inhibition of the delta isoform aims to minimize toxicity compared to pan-PI3K inhibitors.
Approved indications
- B-cell malignancies (in development)
Common side effects
- Diarrhea
- Infections
- Transaminitis
Key clinical trials
- A Study of DZD8586 Versus Investigator's Choice in r/r CLL/SLL (TAI-SHAN6) (PHASE3)
- A Study of Pirtobrutinib (LY3527727) in Participants With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (PHASE4)
- A Study of BGB-16673 Compared to Investigator's Choice in Participants With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Previously Exposed to Both Bruton Tyrosine Kinase (BTK) and B-cell Leukemia/Lymphoma 2 Protein (BCL2) Inhibitors (PHASE3)
- A Study of Idelalisib (GS1101, CAL101) + Ofatumumab in Previously Untreated CLL/SLL (PHASE2)
- A Phase 2 Study of CAL101 in Patients With Idiopathic Pulmonary Fibrosis (PHASE2)
- A Study of Acalabrutinib vs Investigator's Choice of Idelalisib Plus Rituximab or Bendamustine Plus Rituximab in R/R CLL (PHASE3)
- A Study of Oral LOXO-305 in Patients With Previously Treated CLL/SLL or NHL (PHASE1, PHASE2)
- ACY-1215 in Combination With BCR Pathway Inhibitors in Relapsed CLL (PHASE1)
Primary sources
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| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |