• Patient enrollment and dosing ongoing in first-in-human study of BOXR1030 enhanced CAR T-cell therapy

SOTIO Biotech, a clinical-stage immuno-oncology company owned by PPF Group, will present on June 1, 2024 (Developmental Therapeutics—Immunotherapy session) a Trial-in-Progress poster on the first-in-human DUET-01 Phase 1/2 study at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting. The study is evaluating the use of BOXR1030, a metabolically enhanced CAR T-cell therapy, for the treatment of patients with solid tumors.

Patient enrollment and dosing in the DUET-01 clinical trial (NCT05120271) are ongoing at three leading cancer care centers across the U.S., with additional sites expected to be imminently initiated in the U.K.

“The arrival of CAR T-cell therapies has profoundly improved the therapeutic outlook for patients with some blood cancers. Unfortunately, the same has not been true for solid tumors, where cell therapies’ success has been stymied by the challenges of overcoming the tumor microenvironment,” said Ecaterina Dumbrava, M.D., Assistant Professor of Investigational Cancer Therapeutics at The University of Texas MD Anderson Cancer Center and primary investigator on the DUET-01 trial. “As a metabolically enhanced GPC3-targeting CAR T-cell therapy, BOXR1030 has shown promising preclinical results in resisting tumor microenvironment-like conditions and improving T cell proliferation compared with standard CAR T cells. GPC3 is a clinically validated tumor-restricted target with a high prevalence in several solid tumor indications with unmet medical need. Given these promising observations thus far, we are looking forward to continuing to evaluate its potential in a clinical setting in the DUET-01 study.”

The DUET-01 clinical trial is a first-in-human, open-label, multicenter, dose escalation study to assess and determine the recommended Phase 2 dose of BOXR1030 in patients with GPC3-positive advanced solid tumors. The trial will enroll up to 98 patients with advanced, unresectable hepatocellular carcinoma, squamous cell lung cancer, myxoid/round cell liposarcoma, and Merkel cell carcinoma.

Presentation materials will be available on June 1, after presentations conclude, here.

About SOTIO Biotech

SOTIO Biotech (SOTIO) is shaping the future of cancer immunotherapies by translating compelling science into patient benefit. The SOTIO pipeline includes 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 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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