European Patent Office Confirms Patent Protection for SOT201, SOTIO’s Clinical-Stage Immunocytokine Showing Promising Anti-Tumor Activity

On July 21, 2026 SOTIO Biotech, a clinical-stage biopharmaceutical company owned by PPF Group, reported that the Boards of Appeal of the European Patent Office (EPO) have upheld European Patent EP 3 444 271 B1, reinforcing intellectual property protection for SOT201, the company’s next-generation PD-1-targeting immunocytokine currently being evaluated in a Phase 1 clinical trial. The decision strengthens the intellectual property foundation supporting a program that has already demonstrated a high disease control rate, including objective responses in heavily pre-treated cancer patients.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

During oral proceedings held in the beginning of July, the Boards of Appeal confirmed the validity of the patent and upheld the earlier Opposition Division decision maintaining the patent as granted. The patent is co-owned by Cytune Pharma (an affiliate of SOTIO Biotech), AP-HP (Assistance Publique – Hôpitaux de Paris), and INSERM (Institut National de la Santé et de la Recherche Médicale). Opposition proceedings were initiated by Sanofi and Strawman Limited, and the subsequent appeal was filed by Sanofi.

The patent covers immunocytokines comprising a conjugate of interleukin-15 (IL-15) with the sushi domain of the IL-15 receptor alpha and an immunomodulatory antibody, including PD-1 antagonists. The decision further strengthens protection of SOTIO’s proprietary immunocytokine platform and the SOT201 program.

"We are pleased that the Boards of Appeal have upheld this important patent," said Radek Spisek, M.D., Ph.D., chief executive officer of SOTIO. "The decision validates the strength of the underlying invention and reinforces the intellectual property supporting SOT201. Importantly, this milestone comes as the program continues to generate encouraging clinical data, including objective responses in heavily pre-treated patients, underscoring the potential of this novel immunocytokine approach."

SOT201 is a PD-1-targeted, cis-acting attenuated IL-15 agonist designed to preferentially activate PD-1+CD8+ T cells and enhance anti-tumor immune responses. The investigational therapy is currently being evaluated in the international Phase 1 VICTORIA-01 study in patients with advanced unresectable or metastatic solid tumors.

(Press release, SOTIO, JUL 21, 2026, View Source [SID1234669357])