OUR COMPANIES NEWSROOM INSIGHTS ABOUT PPF GROUP SOCIAL RESPOSIBILITY CS PRESS RELEASES EVENTS SOT101 Shows Clinical Benefit in Patients with Advanced Solid Tumors Sotio 12/11/2021 | 3 minutes to read 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) 36th Annual Meeting from November 10-14, 2021. 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 In a combination of SOT101 with pembrolizumab in the AURELIO-03 study, the majority of the 13 patients with advanced/metastatic solid tumors had clinical benefit, including in checkpoint inhibitor (CPI) refractory patients. In this dose escalation study, investigators to date have observed three confirmed partial responses and four instances of long-lasting stable disease. These patients had a median of two lines of prior therapy (range 1-6). In addition, SOT101 in combination with pembrolizumab was generally well tolerated. Dose escalation in this study is ongoing. A SOT101 monotherapy arm of the study demonstrated encouraging efficacy signals in the 30 patients with advanced/metastatic solid tumors, including in CPI refractory patients. To date, there has been one confirmed clinical and radiological response and confirmed stable disease in four patients. Additionally, one patient had a partial response on SOT101+pembrolizumab combination therapy after experiencing a relapse on SOC101 monotherapy. SOT101 was well tolerated, and the majority of treatment emergent adverse events were Grade 2 or less. Patients in this dose escalation study have had a median of three lines of prior therapy (range 1-9). The recommended Phase 2 dose has been defined at 12 μg/kg and a Phase 2 monotherapy expansion study at this dose is ongoing in selected tumor indications. An analysis of biomarkers in the study shows that SOT101 activates both the innate and adaptive immunity. Key data show that SOT101 induced a robust immune-stimulatory response in various types of tumor microenvironments. Investigators observed a dose-dependent pharmacodynamic response in the blood of all patients in the monotherapy and SOT101+pembrolizumab arms, and clinically responsive patients showed increased CD8+ T cell and NK cell infiltration in the tumor. Furthermore, SOT101 restored the sensitivity to CPIs in CPI refractory/resistant patients. “These results represent a promising clinical path forward for SOTIO as they highlighted the strong safety and promising efficacy to date of SOT101 alone and in combination with pembrolizumab and have defined the recommended Phase 2 dose for SOT101,” said Radek Spisek, M.D., Ph.D., chief executive officer of SOTIO. “We are encouraged by the clinical responses we have observed in patients with advanced solid tumors. We look forward to continuing development of SOT101 with further follow up of this study, the continuation of the ongoing Phase 2 SOT101 monotherapy study, and the initiation of a Phase 2 combination study, during the next year.” Aurélien Marabelle, M.D., Ph.D., Immuno-Oncologist from the Drug Development Department at Gustave Roussy Cancer Center and principal investigator on the Phase 1/1b trial, added, “While the industry has made significant progress in providing novel cancer treatments in the last decade, we are still in desperate need of new therapeutic options for patients with cancer. The data presented at this year’s SITC underscore the potential of SOT101 to have a true impact on the treatment of advanced or metastatic solid tumors.” All poster presentations are available on the SOTIO Biotech website. Share on social networks Print Copy link Related Sotio 16/11/2021 SOTIO Expands its Antibody-Drug Conjugate Pipeline with Exclusive Collaboration and License Agreement with LegoChem Biosciences Sotio 10/12/2020 Acquisition agreement with Boehringer Ingelheim for NBE-Therapeutics marks first major biotech exit for PPF Group PPF Group, an international investment group, today announced the signing of a binding agreement to sell its stake in NBE-Therapeutics to Boehringer Ingelheim. Sotio 31/8/2020 SOTIO Acquires Rights to BOXR CAR-T Platform and Products from Unum Therapeutics SOTIO, a clinical stage immuno-oncology company owned by PPF Group, today announced that it has acquired the rights to Unum Therapeutics’ (Nasdaq: UMRX) BOXR cell therapy platform and BOXR lead programs to develop novel T cell therapies for the treatment of solid tumors. The proprietary Bolt-on Chimeric Receptor technology incorporates novel transgenes to enhance T cell function in the solid tumor microenvironment. Sotio 15/3/2020 PPF offered the Czech state 120 tonnes of medical equipment free of charge in the battle against coronavirus Today morning, PPF Group’s majority shareholder Petr Kellner met with the Prime Minister of the Czech Republic, Andrej Babiš, and Minister of Industry and Trade Jiří Havlíček, at the building of the Office of the Government. Sotio 14/10/2019 PPF and SOTIO invest $6.5 million in MaveriX Oncology and its lead program MVX-5005 SOTIO, together with PPF, and MaveriX Oncology, Inc., today announce the investment of PPF Group in MaveriX Oncology Inc., a private biotech company with a proprietary pipeline of targeted, small-molecule cancer chemo-immunotherapeutics. PPF has committed to investing $6.5 million in MaveriX Oncology’s ongoing Series A financing contingent on key development milestones. In total, MaveriX is aiming to secure a total of $20 million in funding and the round will remain open for additional investors to join. The proceeds will enable MaveriX to advance the company’s lead program MVX-5005 through IND-enabling studies, and complete first-in-human Phase Ia/Ib clinical trials for the treatment of solid tumors in support of clinical proof-of-concept. The company will also advance further platform programs to drug candidate selection. PRESS RELEASES NEWS TO EMAIL Get the latest press releases, interviews, podcasts, and insights. SUBSCRIBE TO NEWS FOLLOW US FOR MEDIA For Media Press Releases Interviews and Podcasts Subscribe To News Downloads Contacts MAY BE OF INTEREST Our Companies Newsroom Insights CONTACTS PPF Group Companies TERMS OF USE DATA PROTECTION SITEMAP COOKIES POLICY COOKIES SETTINGS 2021 © PPF GROUP Cookies Consent We are using cookies for the best experience on our websites. 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