Interim Data from the Phase 1/1b AURELIO-03 Trial of SOT101 Presented at the AACR 2022 Annual Meeting

PRAGUE, Czech Republic and BASEL, Switzerland and CAMBRIDGE, Mass, April 12, 2022 (GLOBE NEWSWIRE) --

• Interim Results of the Phase 1 AURELIO-03 study of SOT101 in combination with pembrolizumab for patients with advanced metastatic tumors were presented at the 2022 AACR Annual Meeting
• Data demonstrates that SOT101 in combination with pembrolizumab was well tolerated and the majority of patients had clinical benefit
• Additional posters outline preclinical findings on immunocytokine, SOT201, and lead BOXR CAR-T platform candidate, BOXR1030

SOTIO Biotech, a clinical stage immuno-oncology companyowned by PPF Group, today announced interim safety and efficacy results from the ongoing Phase 1/1b AURELIO-03 study of SOT101, an IL-15 superagonist, in combination with pembrolizumab in patients with advanced/metastatic solid tumors. The data were presented by Dr. Stephane Champiat from Gustave Roussy Cancer Center in an oral presentation at the American Association for Cancer Research (AACR) Annual Meeting 2022. The company also presented findings from preclinical studies of its immunocytokine candidate SOT201, and of its CAR-T cancer therapy BOXR1030 in two poster presentations at the meeting.

The AURELIO-03 study is an open-label, single-arm, multicenter dose escalation study of the IL-15 superagonist, SOT101, in combination with pembrolizumab. Clinical benefit was observed in 12 out of 16 patients with at least one post-baseline tumor assessment, even in immune-checkpoint blocker relapsed or refractory tumors. To date, trial investigators have observed four partial responses with longest duration of more than 33 weeks, five instances of stable disease lasting up to over 40 weeks and a confirmed complete response in a patient with mesothelioma.

The available safety data from patients treated at five escalating SOT101 dose levels, 1.5 to 12 µg/kg, on combination therapy indicate that SOT101 in combination with pembrolizumab was well tolerated. The majority of treatment emergent adverse events were Grade 2 or less and transient. No added safety signals were observed by combining SOT101 with pembrolizumab compared to SOT101 monotherapy. The recommended Phase 2 dose of SOT101 in combination with pembrolizumab was defined at 12 μg/kg, which is the same as for SOT101 monotherapy treatment. The combination of SOT101 with pembrolizumab will be further evaluated in the phase 2 AURELIO-04 trial in six distinct tumor indications, which is expected to start this calendar quarter.

“Establishing the Phase 2 dosing and interim safety and efficacy for SOT101 in combination with pembrolizumab in the AURELIO-03 trial has been a key milestone for us. We are strongly encouraged by the progress observed since its initiation,” said Radek Spisek, M.D., Ph.D., chief executive officer of SOTIO. “We are also very pleased with the progress we have shared on our immunocytokine SOT201 and our metabolically enhanced CAR-T program BOXR1030. We look forward to advancing both programs to first-in-human studies later this year.”

Dr. Stephane Champiat, Head of the Inpatient Unit at the Drug Development of Gustave Roussy Cancer Center and coordinating investigator of the Phase 1/1b AURELIO-03 study added, “The validation of SOT101’s potential as a combination therapy presented at AACR 2022 and as a monotherapy presented at SITC 2021, underscores the promise that IL-15 modulation can have in the immunotherapy of cancer. Its ability to promote both innate and adaptive immune activation can lead to significant progress for patients in need of novel cancer treatment options, and I look forward to its advancement through clinical development.”

Additional Data Presented

SOTIO also presented preclinical results for its lead immunocytokine candidate, SOT201 and its GPC3 targeting, CAR-T cell therapy candidate, BOXR1030 at AACR as poster presentations.

SOT201 is a novel targeted IL-2/IL-15Rβγ agonist to alleviate PD-1-mediated immune cell suppression and potentiate anti-tumor efficacy. In SOTIO’s preclinical studies of SOT201, the immunocytokine candidate demonstrated strong anti-tumor efficacy in vivo. These data show the promise of synergistic concerted action of anti-PD-1 blockage and simultaneous immune cell activation directed preferentially to the high PD-1⁺ T cell tumor environment.

In its study of glypican-3 (GPC3) immunohistochemistry precision, validation, and prevalence in selected solid tumors, SOTIO demonstrated that GCP3 has a high prevalence in selected tumors with low level expression in some normal tissues, making it an attractive target for CAR T cell therapies such as BOXR1030, its GCP3 targeting CAR-T candidate.

All presentations are available on the SOTIO Biotech website here.

About SOT101:

SOT101 (SO-C101) is a subcutaneously administered IL-15Rβγ superagonist that is fused to the sushi+ domain of the IL-15 receptor α chain. SOT101 has demonstrated strong preclinical in vivo efficacy in various tumor models showing increased long-term survival and tumor regression, as well as a favorable toxicology profile. SOT101 has been shown in pre-clinical models to synergize with checkpoint inhibitors and antibody therapies exerting ADCC.

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. Three programs will enter phase I clinical testing within 2022, including SOT201, and IL-15-based immunocytokine, BOXR1030, a GPC3-targeted CAR-T based on proprietary technology designed to improve on the efficacy of CAR T therapies in the tumor microenvironment and SOT102, a next generation Claudin18.2-targetedantibody-drug conjugate (ADCs). 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.