Data from SOTIO’s Phase 1/1b AURELIO-03 trial of SOT101 demonstrate clinical benefit in patients with solid tumors

• Data demonstrates that SOT101 monotherapy and SOT101 in combination with pembrolizumab have a favorable safety profile
• Encouraging efficacy signals were observed for both SOT101 monotherapy and SOT101 in combination with pembrolizumab, even in patients with relapsed tumors refractory to checkpoint inhibitors
• 15 of 19 patients receiving SOT101 in combination with pembrolizumab observed clinical benefit at all doses
• The updated results will be presented as an oral presentation at this year’s ASCO meeting by Dr. Elena Garralda from Vall D’Hebron Institute of Oncology, Barcelona, ​​Spain
• AURELIO-04, a global phase 2 study of SOT101 in combination with pembrolizumab in six distinct tumor types is expected to start in the coming weeks

BASEL, Switzerland, May 26, 2022 (GLOBE NEWSWIRE) — SOTIO Biotecha clinical-stage immuno-oncology company owned by PPF Group, Announces Updated Interim Safety and Efficacy Data his Phase 1/1b AURELIO-03 dose escalation study of theIL-2/IL-15 βγ receptor superagonist, SOT101, as monotherapy and in combination with pembrolizumab in patients with advanced solid tumors. Study data shows that SOT101 has a favorable safety profile. The recommended Phase 2 dose has been defined at 12µg/kg SOT101.

The AURELIO-03 study is an open-label, single-arm Phase 1/1b dose-escalation study to determine the recommended Phase 2 dose and to assess the preliminary efficacy of SOT101 in patients with advanced solid tumors, either as monotherapy or in combination with pembrolizumab. SOT101 is administered subcutaneously on days 1, 2, 8, and 9 of each three-week cycle. 30 patients were treated with monotherapy doses of 0.25 to 15 μg/kg and twenty-one patients with combination therapy doses of 1.5 to 12 μg/kg.

Interim results of SOT101 monotherapy demonstrated that four patients were pretreated with a checkpoint inhibitor (CPI) with confirmed stable disease. A partial response was confirmed in a patient with cutaneous squamous cell carcinoma whose tumor was refractory to IPC. Preliminary efficacy is currently being further evaluated in an ongoing monotherapy extension in cutaneous squamous cell carcinoma, melanoma and renal cell cancer.

In 19 patients with at least one post-baseline tumor assessment at all dose levels who were treated with SOT101 in combination with pembrolizumab, one complete response in one patient with mesothelioma, four partial responses and 10 confirmed stable diseases were reported.

The adverse effect profile of SOT101 in combination with pembrolizumab was consistent with the adverse effect profile of either compound as monotherapy. No additive toxicity was observed when combining SOT101 with pembrolizumab. For monotherapy and combination therapy, the recommended phase 2 dose of SOT101 has been established at 12 μg/kg.

These data will be presented by Principal Investigator Dr. Elena Garralda of the Vall D’Hebron Institute of Oncology, Barcelona, ​​Spain, at the 2022 Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago, Illinois on Saturday. June 4, 2022.

“Despite decades of advances in clinical oncology, the difficulty of treating solid tumors has remained a significant challenge for physicians,” said Radek Spisek, MD, Ph.D., CEO of SOTIO. “Given the promising results of our first-in-human study of SOT101, we are very encouraged to have seen excellent preliminary safety and efficacy data both as monotherapy and in combination with pembrolizumab. We look forward to initiating a basket study of SOT101 in combination with KEYTRUDA to evaluate efficacy and safety in patients with selected advanced or refractory solid tumors. This large phase 2 AURELIO-04 trial in collaboration with MSD will be launched in the coming weeks.

Dr. Garralda added: “The patients in this study are among the most difficult to treat, some with up to nine prior lines of treatment, so the clinical benefit observed in the AURELIO-03 study is particularly encouraging. These data highlight the potential impact of SOT101 on the solid tumor treatment landscape.

ASCO’s presentation will be available on the SOTIO Biotech website after presentation time.

About SOT101:

SOT101 (SO-C101) is a subcutaneously administered IL-15R superagonist that is fused to the sushi+ domain of the IL-15 receptor α chain. SOT101 has demonstrated strong preclinical live efficacy in various tumor models showing an increase in long-term survival and tumor regression, as well as a favorable toxicological profile. SOT101 in preclinical models has been shown to act synergistically with checkpoint inhibitors and antibody therapies that exert ADCC.

About SOTIO Biotech

SOTIO Biotech is shaping the future of cancer immunotherapies by translating compelling science into patient benefits. SOTIO’s strong clinical pipeline includes an attractive immuno-oncology target differentiated superagonist IL-15, SOT101, currently being tested in Phase II clinical trials. SOT102, a next-generation Claudin18.2-targeting antibody-drug conjugate (ADC), has recently entered clinical phase. Two programs will enter Phase I clinical testing by 2022, including SOT201, an IL-15-based immunocytokine and BOXR1030, a GPC3-targeted CAR-T based on proprietary technology designed to improve the efficacy of CAR T therapies in the tumor microenvironment. SOTIO is a member of the PPF group. For more information, visit the company’s website at www.sotio.com.

SOTIO is a registered trademark of SOTIO Biotech as in certain countries.