SOTIO Initiates CLAUDIO-01 Trial with Antibody-Drug Conjugate SOT102 in Patients with Gastric and Pancreatic Cancer

• CLAUDIO-01 is the first-in-human trial of SOT102, a CLDN18.2 (Claudin 18.2) targeting antibody-drug conjugate (ADC)
• The trial will enroll up to 109 patients with gastric and pancreatic cancer

PRAGUE, Czech Republic, April 26, 2022 (GLOBE NEWSWIRE) — SOTIO Biotech, a clinical stage immuno-oncology company owned by PPF Group, announced today that it has dosed the first patient in its Phase 1/2 CLAUDIO-01 trial of SOT102 in patients with gastric and pancreatic cancer. SOT102 is the lead program of SOTIO’s growing ADC pipeline built on multiple platforms.

“Antibody-drug conjugates constitute one of the most exciting drug classes in oncology,” said Radek Spisek, M.D., Ph.D., chief executive officer of SOTIO. “The careful design of SOT102, including the use of NBE-Therapeutics’ ADC platform is aimed to provide an efficacious and safe treatment option for patients with CLDN18.2 cancers.”

The phase 1/2 CLAUDIO-01 trial (EudraCT number: 2021-005873-25) is a first in human, open label, multicenter clinical trial to assess the safety and preliminary efficacy of SOT102 in monotherapy and in combination with established standard of care therapies (SoC). The trial will enroll up to 109 patients with gastric adenocarcinoma or adenocarcinoma of the gastroesophageal junction (GEJ) and pancreatic adenocarcinoma across sites in Belgium, the Czech Republic, France, Spain and the USA. The first patient was dosed at the Masaryk Memorial Cancer Institute, Brno, Czech Republic, under the supervision of Radka Obermannova, M.D., Ph.D, principal investigator.

Josep Tabernero, M.D., Ph.D., Head of Medical Oncology at Vall d’Hebron University Hospital and coordinating investigator of the trial added, “CLDN18.2 is a promising target in gastric and pancreatic cancer due to its prevalent expression in cancers of the gastrointestinal tract. Based on its preclinical data SOT102 represents a potentially safer and more effective treatment option for targeting the CLDN18.2 protein in gastric and pancreatic cancers. The initiation of this clinical trial is major milestone in studying its potential benefit for these patients.”

About SOT102

SOT102 is a CLDN18.2 targeting antibody-drug conjugate based on a proprietary, highly specific monoclonal antibody conjugated to a potent cytotoxic drug molecule and is being developed in collaboration with NBE-Therapeutics. Preclinical data from studies of SOT102 have demonstrated potent anti-tumor efficacy in vitro and in vivo and, due to NBE’s proprietary site-specific sortase mediated antibody coupling (SMAC) conjugation platform.

About SOTIO Biotech
SOTIO Biotech is shaping the future of cancer immunotherapies by translating compelling science into patient benefit. The robust SOTIO clinical pipeline includes a differentiated superagonist of the attractive immuno-oncology target IL-15, SOT101, currently being tested in phase II clinical trials. SOT102, a next generation Claudin18.2-targeted antibody-drug conjugate (ADCs) has just entered clinical phase. Two programs will enter phase I clinical testing within 2022, including SOT201, an IL-15-based immunocytokine and BOXR1030, a GPC3-targeted CAR-T based on proprietary technology designed to improve on the efficacy of CAR T therapies in the tumor microenvironment. 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.