SOTIO Announces First Patients Dosed in Two Combination Arms of CLAUDIO-01 Study Evaluating SOT102 in First-Line Gastric and Pancreatic Cancer

• Combination arms to treat patients in first-line setting, providing valuable insights on future development potential for this patient population
• Phase 1/2 study is evaluating SOT102, a Claudin 18.2 antibody-drug conjugate, for treatment of gastric and pancreatic cancers

SOTIO Biotech, a clinical-stage immuno-oncology company owned by PPF Group, announced today that it has dosed the first patients in the combination therapy arms of its Phase 1/2 CLAUDIO-01 trial. CLAUDIO-01 is evaluating SOTIO’s potent antibody-drug conjugate SOT102 in patients with gastric and pancreatic cancer. The combination arms will be the first clinical evaluation of SOT102’s potential as a first-line cancer treatment in combination with current standard of care. In the gastric cancer arm, SOT102 will be combined with mFOLFOX plus nivolumab. In the pancreatic cancer arm, SOT102 will be combined with Nab-paclitaxel plus gemcitabine.

“The initiation of the combination arms in our Phase 1/2 CLAUDIO-01 trial represents an exciting clinical milestone in the development of SOT102 and our pursuit to provide novel and improved treatment options for patients suffering from solid tumors. The opportunity to evaluate SOT102 as part of a first-line treatment regimen will provide us valuable insights that could greatly expand the patient population who could benefit from this therapy,” said Radek Spisek, M.D., Ph.D., chief executive officer of SOTIO. “We look forward to collaborating with our clinical sites to carry out these studies, as we work to deliver immunotherapies that can make a meaningful difference in the lives of patients with solid tumors.”

CLAUDIO-01 (EudraCT number: 2021-005873-25) is a Phase 1/2 first-in-human, open-label, multicenter trial to assess the safety and preliminary efficacy of SOT102. SOTIO is progressing dose-finding studies in the trial’s monotherapy arm, in which SOT102 is used as a later-stage treatment. In the trial’s combination arm, by contrast, SOT102 will be dosed in combination with standard-of-care as a first-line treatment for patients with advanced/metastatic gastric/gastroesophageal junction (GEJ) or pancreatic cancers. To date the trial has reported no dose-limiting toxicities.

About SOT102

SOT102 is a potent antibody-drug conjugate that combines the clinically-validated target Claudin 18.2 (CLDN18.2) with a powerful toxin to address gastric, pancreatic and other cancers that have very few targeted treatments available. Preclinical data from studies of SOT102 have demonstrated potent anti-tumor efficacy in vitro and in vivo. SOT102 is currently being studied for the treatment of gastric and pancreatic cancers in the CLAUDIO-01 Phase 1/2 clinical trial at leading centers in Europe and the United States.

About SOTIO Biotech

SOTIO Biotech (SOTIO) is shaping the future of cancer immunotherapies by translating compelling science into patient benefit. The SOTIO pipeline includes a differentiated superagonist of the attractive immuno-oncology target IL-15, nanrilkefusp alfa, currently being tested in Phase 2 clinical trials; 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 as well as other molecules approaching clinical stage such as SOT201, our next-generation PD-1-inhibiting cytokine. 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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