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AK101
AK101 is a bispecific antibody that simultaneously engages CD3 on T cells and PSMA on tumor cells to redirect immune attack against PSMA-expressing cancers.
AK101 is a bispecific antibody that simultaneously engages CD3 on T cells and PSMA on tumor cells to redirect immune attack against PSMA-expressing cancers. Used for Metastatic castration-resistant prostate cancer (mCRPC) with PSMA expression.
At a glance
| Generic name | AK101 |
|---|---|
| Sponsor | Akeso |
| Drug class | Bispecific T-cell engager (BiTE) |
| Target | CD3 / PSMA |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
AK101 functions as a T-cell engager by binding CD3 on cytotoxic T lymphocytes while simultaneously targeting prostate-specific membrane antigen (PSMA) on cancer cells. This dual binding brings T cells into close proximity with tumor cells, triggering T-cell activation and cytotoxic killing of PSMA-positive malignancies. The bispecific design enables potent anti-tumor immunity without requiring prior T-cell engineering.
Approved indications
- Metastatic castration-resistant prostate cancer (mCRPC) with PSMA expression
Common side effects
- Cytokine release syndrome
- Fatigue
- Pyrexia
- Infusion-related reactions
Key clinical trials
- A Clinical Study of AK101 in Subjects With Moderate to Severe Plaque Psoriasis (PHASE1, PHASE2)
- Clinical Study of AK101 in Subjects With Moderate to Severe Plaque Psoriasis (PHASE2)
- Open Label Study to Evaluate the Safety and Efficacy of AK101 Injection Subcutaneously in Subjects With Psoriasis (PHASE3)
- A Study of AK101 in Subjects With Moderately to Severely Active Ulcerative Colitis (PHASE1)
- A Phase 3 Study of Efficacy and Safety of AK101 in Subjects With Psoriasis (PHASE3)
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 |
|---|---|
| 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:
- AK101 CI brief — competitive landscape report
- AK101 updates RSS · CI watch RSS
- Akeso portfolio CI