Last reviewed · How we verify
Unloxcyt (COSIBELIMAB)
Unloxcyt blocks the PD-1/PD-L1 pathway to help the immune system recognize and attack cancer cells.
At a glance
| Generic name | COSIBELIMAB |
|---|---|
| Sponsor | Checkpoint Therapeutics Inc |
| Drug class | Programmed Death Ligand-1 Blocker [EPC] |
| Target | Pd-1 |
| Modality | Monoclonal antibody |
| Therapeutic area | Oncology |
| Phase | FDA-approved |
| First approval | 2024 |
Mechanism of action
. Mechanism of Action PD-L1 may be expressed on tumor cells and tumor-infiltrating immune cells and can contribute to the inhibition of the anti-tumor immune response in the tumor microenvironment. Binding of PD-L1 to the PD-1 and B7.1 receptors found on T cells and antigen presenting cells suppresses cytotoxic T-cell activity, T-cell proliferation, and cytokine production. Cosibelimab-ipdl binds PD-L1 and blocks the interaction between PD-L1 and its receptors PD-1 and B7.1. This interaction releases the inhibitory effects of PD-L1 on the anti-tumor immune response. Cosibelimab-ipdl has also been shown to induce antibody-dependent cell-mediated cytotoxicity (ADCC) in vitro.
Approved indications
- metastatic cutaneous squamous cell carcinoma (mCSCC)
- locally advanced CSCC (laCSCC)
Common side effects
- Fatigue
- Musculoskeletal pain
- Rash
- Edema
- Diarrhea
- Hypothyroidism
- Nausea
- Constipation
- Headache
- Pruritus
- Localized infection
- Urinary tract infection
Key clinical trials
- Cosibelimab for CSCC in Patients With Kidney Transplant or Hematologic Malignancy (PHASE4)
- Phase I Study of Cosibelimab and Balixafortide in Metastatic Pancreatic Ductal Adenocarcinoma (PHASE1)
- Study of Pemetrexed+Platinum Chemotherapy With or Without Cosibelimab in First Line Metastatic Non-squamous NSCLC (PHASE3)
- Phase 1 Study of CK-301 (Cosibelimab) as a Single Agent in Subjects With Advanced Cancers (PHASE1)
- Study of Cosibelimab in Subjects With Relapsed or Refractory Lymphoma (PHASE1)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Unloxcyt CI brief — competitive landscape report
- Unloxcyt updates RSS · CI watch RSS
- Checkpoint Therapeutics Inc portfolio CI