News

SOTIO Provides Update on Interim Data from Clinical Trials of Nanrilkefusp Alfa

• Ongoing clinical trials of nanrilkefusp alfa will be discontinued due to insufficient efficacy;
• SOTIO plans to explore combinations of nanrilkefusp alfa with other modalities;
• SOTIO to continue to advance its immunocytokine platform including next-generation SOT201 program.

SOTIO Doses First Patient in AURELIO-05 Phase 2 Trial of Nanrilkefusp Alfa in Combination with Cetuximab

SOTIO Biotech, a clinical stage immuno-oncology company owned by PPF Group, announced today that the first patient was dosed in its Phase 2 AURELIO-05 combination trial of nanrilkefusp alfa (previously known as SOT101), an IL-15 superagonist, and cetuximab in patients with colorectal cancer.

SOTIO Presents Preclinical Data from BOXR CAR-T Program and Trial Design of Phase 2 AURELIO-04 Study at SITC Annual Meeting

• Findings on the mechanism of action from the BOXR CAR-T platform indicate improved metabolic function and preservation of early memory subsets of T cells. 
• SOTIO anticipates initiating first-in-human DUET-01 trial for lead CAR-T cell therapy candidate, BOXR1030, in coming months.
• Phase 2 AURELIO-04 combination study of SOT101 and KEYTRUDA® is enrolling patients across multiple solid tumor indications.

SOTIO Biotech, a clinical stage immuno-oncology company owned by PPF Group, presented preclinical data evaluating the mechanism of action and metabolic function of its BOXR T cell platform in a poster presentation at the Society for Immunotherapy of Cancer (SITC) 37th Annual Meeting, taking place in Boston, Massachusetts from November 8-12, 2022. An additional poster was presented on the trial design of AURELIO-04, an ongoing Phase 2 study evaluating the efficacy and safety of SOT101 in combination with pembrolizumab in patients with advanced solid tumors.

SOTIO to Present the AURELIO-04 Phase 2 Study Design and Findings from BOXR Research at the SITC Annual Meeting

SOTIO Biotech, a clinical stage immuno-oncology company owned by PPF Group, announced today that it will share two poster presentations, namely the Phase 2 AURELIO-04 study design of the IL-15 superagonist, SOT101 as a Trial in Progress and nonclinical data on mechanism of action of its BOXR T cell platform, at the upcoming Society for Immunotherapy of Cancer (SITC) 37^th Annual Meeting, taking place in Boston, Massachusetts from November 8-12, 2022.

SOTIO Doses First Patient in AURELIO-04 Phase 2 Trial of SOT101 in Combination with KEYTRUDA® (pembrolizumab)

• AURELIO-04 will enroll up to 320 patients and test the combination in multiple solid tumor indications
• Clinical collaborator, MSD (Merck & Co., Inc., Rahway, NJ, USA), will supply KEYTRUDA for the study that is being conducted in Europe and the US

SOTIO Biotech, a clinical stage immuno-oncology company owned by PPF Group, announced today that the first patient was dosed in its Phase 2, AURELIO-04 combination trial of SOT101, an IL-15 superagonist and MSD’s (Merck & Co., Inc., Rahway, NJ, USA) anti-PD-1 therapy KEYTRUDA^® (pembrolizumab), in patients with selected advanced/refractory solid tumors.

Data from SOTIO’s Phase 1/1b AURELIO-03 Trial of SOT101 Demonstrate Clinical Benefit in Patients with Solid Tumors

• Data demonstrate 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 checkpoint-inhibitor relapsed and refractory tumors;
• 15 out of 19 patients receiving SOT101 in combination with pembrolizumab had observed clinical benefit across all dose-levels;
• Updated results will be presented as an oral presentation at this year’s ASCO meeting by Dr. Elena Garralda from the Vall D’Hebron Institute of Oncology, Barcelona, Spain;
• AURELIO-04, a global Phase 2 study trial of SOT101 in combination with pembrolizumab in six distinct tumor types is expected to start in the coming weeks.

SOTIO Biotech, a clinical stage immuno-oncology company owned by PPF Group, announces updated interim safety and efficacy data from its Phase 1/1b AURELIO-03 dose escalation study of the IL-2/IL-15 receptor βγ superagonist, SOT101, as monotherapy and in combination with pembrolizumab in patients with advanced solid tumors. Data from the study show that SOT101 has a favorable safety profile. The recommended Phase 2 dose was defined at 12 µg/kg SOT101.

Oral Presentation of Interim Data from the AURELIO-03 Study of SOT101 at the 2022 ASCO Annual Meeting

• SOTIO will share interim safety and efficacy results from SOTIO’s AURELIO-03 study on Saturday, June 4
• AURELIO-03 is a Phase 1/1b dose escalation study of the interleukin-15 superagonist SOT101 as monotherapy and in combination with pembrolizumab in patients with advanced solid tumors

SOTIO Biotech, a clinical stage immuno-oncology company owned by PPF Group, announced today that it will deliver an oral presentation featuring interim safety and efficacy data from the Phase 1/1b AURELIO-03 study with its IL-15 superagonist, SOT101, as monotherapy and in combination with pembrolizumab at the upcoming American Society of Clinical Oncology (ASCO) Annual Meeting 2022, taking place in Chicago, Illinois from June 3-7, 2022.

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

• 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 company owned 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. 

SOTIO Announces Oral and Multiple Poster Presentations on Key Clinical Programs at the American Association of Cancer Research Annual Meeting (AACR) 2022

• Oral presentation will focus on interim efficacy and safety data from the Phase 1/1b AURELIO-03 study of SOT101 in combination with pembrolizumab
• Poster presentations will feature preclinical data on SOTIO’s immunocytokine SOT201 and the BOXR CAR-T cell therapy BOXR1030

SOTIO Biotech, a clinical stage immuno-oncology company owned by PPF Group, announced today that it will deliver an oral presentation featuring interim safety and efficacy data from its Phase 1/1b AURELIO-03 study with its IL-15 superagonist, SOT101, in combination with pembrolizumab, as well as two poster presentations at the upcoming American Association for Cancer Research (AACR) Annual Meeting 2022, taking place in New Orleans, Louisiana, April 8-13, 2022.

SOTIO Announces Clinical Collaboration with MSD to evaluate IL-15 Superagonist, SOT101, in Combination with KEYTRUDA® (pembrolizumab) in Patients with Solid Tumors

• The Phase 2 AURELIO-04 study is expected to enroll up to 300 patients across six different indications
• The study will be conducted in the US and selected European countries and will begin in the first half of 2022

SOTIO Biotech, a clinical stage immuno-oncology company owned by PPF Group, announced today that it has entered into a clinical trial collaboration and supply agreement with MSD, a tradename of Merck & Co., Inc., Kenilworth, NJ., through its subsidiaries, to evaluate the combination of SOT101, SOTIO’s IL-15 superagonist, and MSD’s KEYTRUDA® (pembrolizumab) in patients with selected advanced/refractory solid tumors in the phase 2 AURELIO-04 study.

SOTIO Secures €280m of Funding to Expand and Advance Clinical Pipeline

• PPF Group provides funding to advance SOTIO through key clinical milestones
• Proceeds shall be used to conduct two phase 2 studies with SOT101, including a checkpoint inhibitor combination trial
• Three programs (SOT102, BOXR1030, and SOT201) to advance through phase 1

SOTIO Biotech, a clinical stage immuno-oncology company owned by PPF Group, announced today that is has secured €280m of funding to significantly expand and advance its clinical pipeline, including its lead asset SOT101, an IL-15 superagonist, and three new clinical programs until end of 2023.

SOT101 Shows Clinical Benefit in Patients with Advanced Solid Tumors

• Majority of patients receiving SOT101 (SO-C101) + pembrolizumab had confirmed clinical benefit
• Clinical responses have been observed in patients progressing on previous anti-PD-1 treatment
• SOT101 monotherapy and in combination with pembrolizumab was well tolerated in patients with advanced/metastatic solid tumors

SOTIO Biotech, a clinical stage immuno-oncology company owned by PPF Group, today announced new data from the ongoing Phase 1/1b AURELIO-03 study of SOT101, an IL-15 superagonist, as a monotherapy and in combination with pembrolizumab in patients with advanced/metastatic solid tumors. The data are presented in three posters at the Society for Immunotherapy of Cancer (SITC) 36^th Annual Meeting from November 10-14, 2021.

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

SOTIO to Present New Data on the IL-15 superagonist SO-C101 at the Society for Immunotherapy of Cancer (SITC) 35th Annual Meeting

• SOTIO will present three posters, including a late breaking poster on the clinical data from the ongoing Phase 1 study of IL-15 superagonist SO-C101 for the treatment of advanced solid tumors.

SOTIO, a clinical stage immuno-oncology company, and Cytune Pharma, both owned by PPF Group, today announced that they will present a late breaking poster highlighting new clinical data on SO-C101 at the Society for Immunotherapy of Cancer (SITC) 35th Annual Meeting to be held virtually November 9-14, 2020. SO-C101 is an IL-15 superagonist currently being investigated in a Phase 1 trial for the treatment of advanced solid tumors. Two additional posters will also be presented summarizing the latest preclinical data on SO-C101. 

SOTIO Announces First Patient Dosed in Part B of Phase 1/1b Study with SO-C101 in Combination with Pembrolizumab in Patients with Solid Tumors

SOTIO, a clinical stage immuno-oncology company owned by PPF Group, today announced that the first patient has been dosed in Part B of the ongoing Phase 1/1b study of IL-15 superagonist, SO-C101, for the treatment of patients with advanced/metastatic solid tumors. Part B will examine SO-C101 in combination with PD-1 inhibitor pembrolizumab. The trial is conducted in partnership with Cytune Pharma.

SOTIO Presents New Data Showing Strong Anti-tumor Effect of IL-15 Superagonist SO-C101 in Mice at 2020 AACR Virtual Annual Meeting II

SOTIO and Cytune Pharma from the PPF Group, today presented new preclinical data highlighting the therapeutic potential of SO-C101, an IL-15 superagonist, as a monotherapy and in combination with PD-1 inhibitors in multiple tumor models. The data were presented in a virtual poster presentation at the 2020 American Association for Cancer Research (AACR) Virtual Annual Meeting II.

SOTIO to Present New Preclinical Data on IL-15 Superagonist, SO-C101, at the 2020 AACR Virtual Annual Meeting II

SOTIO, a clinical stage immuno-oncology company and Cytune Pharma, both owned by PPF Group, announced that they will present new preclinical data on SO-C101, an IL-15 superagonist currently being studied in a Phase 1 trial for the treatment of advanced solid tumors, in a virtual poster presentation at the 2020 American Association for Cancer Research (AACR) Virtual Annual Meeting II being held from June 22-24, 2020.

SOTIO initiates first-in-human clinical trial with IL-15 superagonist SO-C101

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.

SOTIO Receives Positive VHP Decision for SC103, a First-in-Human Clinical Trial in Patients with Advanced/Metastatic Solid Tumors

SOTIO, a biotechnology company belonging to the PPF Group, announces today that it received a positive decision further to the EU Voluntary Harmonisation Procedure (VHP) for the review of clinical trial application for the first-in-human clinical trial, study SC103, with its lead oncology asset SO-C101, a human fusion protein of IL-15 and the high-affinity binding domain of IL-15Rα. Study SC103 is a phase I/Ib study to evaluate the safety and preliminary efficacy of SO-C101 in patients with selected advanced/metastatic solid tumors. SOTIO expects to initiate the trial as soon as the concerned national (France and Spain) regulatory agencies and ethics committee approvals are granted. Enrolment of the first patient is planned in May 2019.

SOTIO and PPF complete acquisition of Cytune Pharma

SOTIO, a biotechnology company owned by the PPF Group, announces today the completion of the acquisition of Cytune Pharma by PPF. SOTIO will continue to develop the lead program SO-C101 (RLI-15) within its pipeline and intends to initiate first-in- human clinical trials in early 2019. SOTIO is spearheading all of PPF’s activities in the biotech sector and closely cooperated during Cytune’s acquisition process. All Cytune projects will be developed as part of SOTIO’s pipeline.

SOTIO to Present Translational Data of the IL-15 Superagonist SO-C101 at 2018 AACR Annual Meeting

SOTIO, a biotechnology company owned by the PPF Group, announces today presentation of a poster on SO-C101 at the upcoming American Association for Cancer Research (AACR) Annual Meeting 2018. The poster, titled “Use of RLI-15 a clinical grade fusion protein with IL-15 superagonistic activity for the activation of anti-tumor immune response,” will highlight preclinical and translational data evaluating SO-C101 (RLI-15). The AACR Annual Meeting will be held on April 14 – 18, 2018 in Chicago, Illinois. 

Cytune Pharma secures €6M in financing to advance lead immuno-oncology program to Phase I

Nantes, June 29, 2016 – Cytune Pharma SAS, a French biotechnology company focused on developing novel immunotherapies for the treatment of cancer, announced the closing of a €6M financing round from existing investors. Funds will be used to advance the RLI15 lead program to Phase I clinical trials. Key investor PPF Group and the founding shareholders also agreed on a full buyout of the remaining shares at the start of Phase I.

PPF Group acquires a minority stake in biotech company Cytune Pharma in cooperation with SOTIO

PPF Group has acquired a significant minority stake in Cytune Pharma SAS, a French biotechnology company focused on researching and developing new therapies for immune modulation aimed at enhancing immune response of patients suffering from cancer and infectious diseases. Cytune’s platform based on modified IL-15 offers the possibility of combinations with other immunotherapeutic strategies, including checkpoint inhibitors.