SOTIO Announces First Patient Dosed in Phase 1 Clinical Study of SOT201 for Patients with Solid Tumors

• Novel immunocytokine utilizes dual mechanisms of action to activate immune system to fight solid tumors
• Company has received IND and CTA approval to initiate Phase 1 study in the U.S. and Europe

SOTIO Biotech, a clinical-stage immuno-oncology company owned by PPF Group, today announced the dosing of the first patient in its Phase 1, first-in-human clinical trial evaluating SOT201, a next-generation PD-1-targeting immunocytokine. The VICTORIA-01 study will evaluate the safety, tolerability and initial efficacy of SOT201 monotherapy for the treatment of advanced solid tumors.

“While anti-PD-1 therapeutics have been a great advance in cancer medicine, still only a minority of patients respond to them. Additionally, even patients successfully treated frequently acquire resistance to these therapies, leading to cancer progression. Novel treatments are needed to overcome these therapeutic limitations,” said Richard Sachse, M.D., Ph.D., chief medical officer of SOTIO. “The initiation of the VICTORIA-01 study demonstrates SOTIO’s continued dedication to deliver innovative immunotherapies that can address the challenges of solid tumor treatment. We look forward to further researching the potential that SOT201 holds for patients who have not seen success with other available treatments.”

SOT201 is an antibody-cytokine fusion protein that could improve upon the efficacy of approved checkpoint inhibitors by combining PD-1 targeting with IL-15 immune stimulation in a single therapeutic construct. This combined action of SOT201 makes it promising as a potent standalone therapy that could be especially useful for the treatment of patients with primary or acquired resistance to checkpoint inhibitors (CPIs). The preclinical profile of SOT201 supports its potential to offer best-in-class antitumor activity and broad clinical applicability.

The VICTORIA-01 study is a Phase 1, open-label, dose escalation study of SOT201 which will assess its safety, tolerability, and preliminary efficacy as a monotherapy for patients aged 18 years or above with advanced unresectable or metastatic solid tumors (NCT06163391). The study is now enrolling patients at The University of Texas MD Anderson Cancer Center in Houston, Texas, led by principal investigator Dr. Aung Naing. Additional clinical sites across Europe – including in Belgium, Czech Republic and Spain – will initiate enrollment in the coming months.

About SOTIO Biotech

SOTIO Biotech (SOTIO) is shaping the future of cancer immunotherapies by translating compelling science into patient benefit. The SOTIO pipeline includes three clinical-stage programs: SOT102, a next-generation Claudin-18.2-targeted antibody-drug conjugate which entered the clinic in 2022; BOXR1030, a metabolically-enhanced CAR-T cell therapy targeting GPC3-expressing tumors; and SOT201, a next-generation PD-1-targeting immunocytokine. 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.

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