SOTIO Begins First Dosing in Phase 1 Study of SOT201 for Solid Tumors

SOTIO Biotech, a clinical-stage immuno-oncology firm backed by PPF Group, has embarked on a significant milestone in cancer treatment with the commencement of its Phase 1 clinical trial for SOT201. This innovative trial, dubbed VICTORIA-01, aims to evaluate the safety, tolerability, and preliminary effectiveness of SOT201 as a standalone therapy for patients suffering from advanced solid tumors.

SOT201 is a cutting-edge immunocytokine designed to enhance the body's immune response against cancer. It combines two mechanisms of action: PD-1 targeting and IL-15 immune stimulation. This dual approach is intended to improve upon the efficacy of existing checkpoint inhibitors, which have shown success in treating cancer but have limitations. Specifically, only a small fraction of patients respond to current anti-PD-1 therapies, and those who do often develop resistance, leading to cancer progression.

Dr. Richard Sachse, SOTIO's Chief Medical Officer, emphasized the necessity for novel treatments to overcome the limitations of current cancer therapies. He stated, "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."

Preclinical studies have shown that SOT201 has the potential to offer best-in-class antitumor activity and broad clinical applicability, making it a promising candidate for treating patients with either primary or acquired resistance to checkpoint inhibitors (CPIs). The VICTORIA-01 trial is an open-label, dose-escalation study designed to assess the safety, tolerability, and initial efficacy of SOT201 in patients aged 18 and above with advanced, unresectable, or metastatic solid tumors.

The first patient has been dosed at The University of Texas MD Anderson Cancer Center in Houston, Texas, under the leadership of principal investigator Dr. Aung Naing. Additional clinical sites across Europe, including in Belgium, the Czech Republic, and Spain, are set to commence patient enrollment in the coming months.

SOTIO Biotech is at the forefront of developing advanced cancer immunotherapies. The company's pipeline features several promising clinical-stage programs. Among these are SOT102, a next-generation Claudin-18.2-targeted antibody-drug conjugate, which entered clinical trials in 2022; BOXR1030, a metabolically-enhanced CAR-T cell therapy targeting GPC3-expressing tumors; and the newly initiated SOT201 immunocytokine.

The strategic advancement of SOTIO's pipeline demonstrates the company's commitment to translating compelling scientific discoveries into tangible patient benefits. By focusing on innovative therapies that target the immune system's mechanisms, SOTIO aims to provide new hope for patients battling advanced and resistant forms of cancer.

In conclusion, the launch of the VICTORIA-01 Phase 1 trial marks a pivotal step in the development of SOT201. This novel immunocytokine has the potential to significantly enhance cancer treatment by overcoming the limitations of current therapies. As SOTIO continues to enroll patients and gather data from this and other studies, the oncology community eagerly anticipates the potential breakthroughs that could emerge from their cutting-edge research.