SOTIO Presents Initial Data from VICTORIA-01 Phase 1 Clinical Study of Immunocytokine SOT201 at SITC Annual Meeting

• SOT201, a novel cis-acting immunocytokine, combines IL-15 superagonist and anti-PD-1 activity in order to stimulate tumor specific T cells
• Data show early evidence of durable antitumor activity with SOT201, including responses in patients whose cancer had progressed after checkpoint inhibitor therapy

PRAGUE and BASEL, Switzerland and BOSTON, Nov. 06, 2026 (GLOBE NEWSWIRE) --

SOTIO Biotech, a clinical-stage biopharmaceutical company owned by PPF Group, today announced interim safety and efficacy results from the VICTORIA-01 Phase 1 clinical study of SOT201, a PD-1 targeting IL-15 immunocytokine, at the Society for Immunotherapy of Cancer (SITC) 41^st Annual Meeting taking place November 6-8, 2026, in Phoenix, AZ.

Interim Phase 1 VICTORIA-01 data showed a 59% disease control rate with SOT201 among 22 patients with advanced solid tumors who had received a median of three prior treatment lines. Two patients achieved confirmed partial responses following prior checkpoint inhibitor therapy: an esophageal cancer response lasting 388 days and a cervical cancer response ongoing at 87 days. Most treatment-related adverse events were Grade 1 or 2. The findings supported a recommended dose of 80 µg/kg with a 20 µg/kg priming dose for further evaluation.

“Both IL-15 agonism and PD-1 inhibition have robust clinical validation in immuno-oncology, and SOT201 builds on this foundation by combining PD-1 and IL-15 mechanisms to reinvigorate antitumor T cell activities and to elicit deep antitumor immune responses,” said Vivi Boura, M.D., Ph.D., chief medical officer of SOTIO. “These initial clinical data support continued evaluation of SOT201 in expanded patient cohorts, and we look forward to further characterizing its potential in challenging solid tumor types.”

Presentation details are as follows:

Poster Title: “Interim safety and efficacy results of VICTORIA-01: A phase 1 study to evaluate the safety and preliminary efficacy of SOT201 in patients with advanced/metastatic solid tumors”
Poster Number: 1180
Presenter: Dr. Aung Naing, Department of Investigational Cancer Therapeutics, UT MD Anderson Cancer Center, Houston, Texas
Date: Saturday, Nov. 7, 2026

In additional poster presentations at SITC, SOTIO will share research on the localization of tertiary lymphoid structures (TLS) in immune checkpoint-resistant cancer types, as well as the role of PD-L1⁺ macrophages in shaping TLS organization in ovarian cancer metastases.

Presentation materials will be available upon request.

About SOTIO Biotech

SOTIO Biotech (SOTIO) is a clinical-stage biopharmaceutical company advancing a focused pipeline of next-generation antibody-drug conjugates (ADCs) for solid tumors. The company is pursuing targeted therapies for cancers with significant unmet need and broad expansion potential.

SOTIO’s two lead ADC programs, SOT106 and SOT109, are potential best-in-class therapies designed to rapidly advance to clinical proof of concept. SOT109, currently in a Phase 1/2 study for colorectal cancer, has received Fast Track Designation (FTD) from the U.S. FDA. SOT106, targeting LRRC15 for sarcoma and other solid tumors, has received both Orphan Drug Designation (ODD) and FTD from the U.S. FDA.

The broader pipeline also includes SOT201, a next-generation PD-1-targeting immunocytokine, currently being evaluated in the Phase 1 VICTORIA-01 study in patients with solid tumors.

SOTIO is a member of the PPF Group. For more information, please visit the company’s website at www.sotio.com.

SOTIO is a registered trademark of SOTIO Biotech a.s. in selected countries.