SOTIO start eerste klinische studie bij mensen met IL-15-superagonist SO-C101
PRAAG–(BUSINESS WIRE)–SOTIO en Cytune Pharma, leden van de PPF Group, kondigen vandaag de eerste dosering aan van kankerpatiënten met SO-C101, een superagonist fusie-eiwit van interleukine IL-15. De fase I/Ib-studie (SC103) zal de veiligheid en de voorlopige werkzaamheid van SO-C101 evalueren bij patiënten met geselecteerde geavanceerde/gemetastaseerde solide tumoren.
De eerste patiënt werd behandeld met SO-C101 aan het Instituut Gustave Roussy (Frankrijk). De klinische proef SC103 zal ook patiënten inschrijven in het kankercentrum Vall d’Hebron (Spanje) en, mits alle nodige goedkeuringen worden verkregen, in het Yale Cancer Center in New Haven, CT en MD Anderson Cancer Center in Houston, Texas. Cytune Pharma is verantwoordelijk voor de klinische ontwikkeling van SO-C101, SOTIO is de sponsor van de klinische proef SC103.
SOTIO initiates first-in-human clinical trial with IL-15 superagonist SO-C101
PRAGUE–(BUSINESS WIRE)– SOTIO and Cytune Pharma, members of the PPF Group, announce today the first dosing of cancer patients with SO-C101, a superagonist fusion protein of interleukin IL-15. The phase I/Ib study (SC103) will evaluate the safety and preliminary efficacy of SO-C101 in patients with selected advanced/metastatic solid tumors.
The first patient was treated with SO-C101 at the Institute Gustave Roussy (France). The SC103 clinical trial will also enrol patients in the Vall d’Hebron cancer center (Spain) and, subject to obtaining all the necessary approvals, at the Yale Cancer Center in New Haven, CT and MD Anderson Cancer Center in Houston, TX. Cytune Pharma is responsible for the clinical development of SO-C101, SOTIO is sponsor of the SC103 clinical trial.
Aurélien Marabelle, M.D., Ph.D., coordinating investigator of the phase I/Ib trial said: “I am very pleased that our medical center has enrolled the first patient in this important clinical trial. We believe that SO-C101 has the potential to make a life-changing difference to many patients with difficult-to-treat forms of cancer. I am looking forward to further advancing this innovative therapy.“
“SO-C101 is a very innovative approach which has been validated for its efficacy and safety in preclinical experiments. Since SO-C101 is an ideal combination partner for checkpoint inhibitors, monoclonal antibodies and other well established therapies, the planning for additional combination trials is already ongoing,” said Radek Spisek, M.D., Ph.D., CEO of SOTIO.
“I’m excited that after 12 years of research and development at Cytune Pharma, which was based on previous research from INSERM and the University of Nantes and supported by Bpifrance and Atlanpole Biotherapies, our invention has now entered the clinical development phase. I hope that SO-C101 will become a treatment for cancer patients in the future,” adds David Bechard, Ph.D., President and COO of Cytune Pharma.
Description of clinical trial
SC103 (Eudra CT: 2012-002814-38): A multicenter open-label phase 1/1b study to evaluate the safety and preliminary efficacy of SO-C101 as monotherapy and in combination with pembrolizumab in selected patients with advanced/metastatic solid tumors. SOTIO received a positive decision allowing launch of SC103 clinical trial within the EU Voluntary Harmonisation Procedure (VHP) in February 2019.
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