SOTIO Presents Interim Data from its Phase 1/1b Study of SO-C101 in Patients with Advanced Solid Tumors at SITC 2020

• Late breaking poster demonstrates SO-C101 was well tolerated to date with no dose-limiting toxicities
• Confirmed partial response was observed after SO-C101 monotherapy in a patient with skin squamous cell carcinoma

PRAGUE, Czech Republic, Nov. 11, 2020 (GLOBE NEWSWIRE) — SOTIO, a clinical stage immuno-oncology company, and Cytune Pharma, both owned by PPF Group, today announced new interim data from its Phase 1/1b study of SO-C101, an IL-15 superagonist, as a monotherapy and in combination with pembrolizumab in patients with advanced/metastatic solid tumors. The data are being presented in a late breaking poster at the Society for Immunotherapy of Cancer (SITC) 35^th Annual Meeting, held virtually this year on November 9-14, 2020. Two additional posters are also being presented highlighting the latest preclinical data on SO-C101.

“These interim results present a promising path forward as we continue to evaluate the safety and best Phase 2 dose for SO-C101 as a monotherapy and in combination with pembrolizumab,” said Radek Špíšek, Ph.D., chief executive officer of SOTIO. “With no dose-limiting effects in patients treated to date, we are encouraged that SO-C101 has demonstrated a favorable safety profile. Additionally, we have observed significant, dose dependent activation of NK and T cells and a first confirmed partial response in the SO-C101 monotherapy arm in a patient with skin squamous cell carcinoma refractory to anti-PD-1 therapy. We look forward to progressing in this study and demonstrating SO-C101 as safe a potential potent immunotherapy for patients with advanced solid tumors.”

Data highlights for the late breaking poster titled: “A multicenter open-label phase 1/1b study of SO-C101 as monotherapy and in combination with pembrolizumab in patients with selected advanced/metastatic solid tumors” include:

• SO-C101 has been well tolerated to date, and no dose limiting toxicities have been observed by the cutoff date across Part A (SO-C101 monotherapy dose escalation; n=20, 3 patients ongoing) and Part B (SO-C101 dose escalation in combination with pembrolizumab; n=3, 1 patient ongoing)
• Preliminary results indicate dose proportional pharmacokinetics
• Preliminary pharmacodynamic results demonstrate dose-dependent NK and CD8⁺ T cell activation
• Preliminary efficacy signal, with a confirmed partial response observed after SO-C101 monotherapy in a patient with skin squamous cell carcinoma refractory to anti-PD-1 therapy
  • Patient achieved stable disease after 6 weeks and partial response after 12 weeks of treatment with a tumor volume reduction of 49%

The late breaking poster was presented by trial investigator Aurélien Marabelle, M.D., Ph.D., Clinical Director of the Cancer Immunotherapy Program at Gustave Roussy Cancer Center in Villejuif, France.

SOTIO presented two additional posters highlighting preclinical in vitro and in vivo SO-C101 pharmacokinetic, pharmacodynamic and mechanism of action data. Both poster presentations will be made available on the SOTIO website.

Cytune Pharma is responsible for the clinical development of SO-C101 and SOTIO is a sponsor of the Phase 1 clinical trial.

About SOTIO

SOTIO is shaping the future of cancer immunotherapies by translating compelling science into patient benefit. SOTIO’s robust clinical pipeline includes a differentiated superagonist of the attractive immuno-oncology target IL-15, a platform to streamline personalized active immune cell therapies and a new generation of potent and stable antibody-drug conjugates (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 a.s. in selected countries.