1. IO Biotech's vaccine shows 25.5 months median progression-free survival. 2. Publication reinforces potential for immune-modulatory treatment in melanoma. 3. Breakthrough Therapy Designation received for novel combination regimen. 4. Study reveals promising long-term outcomes in cancer response. 5. Vaccine is expected to target pan-tumor activity.
FAQ
Why Very Bullish?
The positive clinical results and breakthrough designation suggest increased investor confidence, similar to past successes like Merck's Keytruda, which saw stock appreciation following favorable trial results.
How important is it?
The results from MM1636 and the Breakthrough Therapy Designation significantly enhance IOBT's market position and potential future revenues.
Why Long Term?
With ongoing Phase 3 trials, potential FDA approvals could lead to sustained growth, akin to other biotech firms that benefited post-Phase 3 success.
IO Biotech (Nasdaq: IOBT) Publishes Five-Year Clinical Outcomes of Phase 1/2 Trial in Nature Communications
New York, December 15, 2025 (GLOBE NEWSWIRE) — IO Biotech, a clinical-stage biopharmaceutical company, has announced significant findings from its Phase 1/2 trial, MM1636. The study's five-year analysis reveals promising clinical outcomes for the investigational peptide vaccine, IO102-IO103, used in combination with PD-1 blockade for treating metastatic melanoma.
Key Findings from the MM1636 Trial
The published results demonstrate that the combination of IO102-IO103 and nivolumab yielded a **median progression-free survival (PFS)** of **25.5 months** in patients with first-line metastatic melanoma. This finding is crucial as it reinforces the effectiveness of immune-modulatory vaccination approaches in cancer therapy.
- Median Duration of Response: More than **53 months**.
- Median Overall Survival: An impressive **60 months**.
- Vaccine-Specific Immune Biomarkers: Identification of potential markers suggesting enhanced anti-tumor activity.
Trial Background and Implications
The findings from the MM1636 trial support a **Breakthrough Therapy Designation** for IO Biotech’s approach, facilitating its progression towards regulatory approvals. The results highlight the potential of integrating immune-modulatory vaccination into existing immunotherapy regimens for melanoma patients.
“These are very exciting data... it strengthens our belief in its potential to transform patient care,” stated Mads Hald Andersen, DMSc, PhD, from IO Biotech.
Future Directions for IO Biotech (IOBT)
Following the positive outcomes of the Phase 1/2 trial, IO Biotech has announced the initiation of a pivotal Phase 3 clinical trial (IOB-013/KN-D18). This trial will evaluate the efficacy of Cylembio® (IO102-IO103) in combination with pembrolizumab in patients with previously untreated, unresectable or metastatic melanoma.
Enrollment for this pivotal study was completed by December 2023, with a total of **407 patients** participating across more than **100 clinical sites worldwide**.
About IO Biotech and its Therapeutic Innovations
IO Biotech is committed to advancing the field of immunotherapy through its unique T-win® platform, designed to activate T cells against both tumor and immune-suppressive cells. The company’s flagship candidate, Cylembio® (IO102-IO103), is actively being explored in clinical trials to determine its effectiveness for various cancer types.
For additional information on IO Biotech and their innovative cancer therapies, visit iobiotech.com.
Access the Published Study
The comprehensive article detailing the five-year clinical outcomes from the MM1636 trial is available in Nature Communications at the following link: Five-year clinical outcome and immune biomarkers of durable response from the MM1636 trial.