News

NEWS

SOTIO Presents Poster on CLAUDIO-01 Trial at ESMO Congress

SOTIO Biotech, a clinical-stage immuno-oncology company owned by PPF Group, today announced it will be presenting a trial-in-progress poster at the European Society for Medical Oncology Congress taking place October 20-24, 2023 in Madrid, Spain. 

NEWS

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.

NEWS

SOTIO Exercises Option for Novel Antibody-Drug Conjugate Program under Agreement with LegoChem Biosciences

  • SOT106 is an antibody-drug conjugate (ADC) targeting an attractive surface antigen expressed on multiple solid tumors.
  • Preclinical efficacy and tolerability studies of SOT106 show promising results across multiple solid tumor indications and a beneficial therapeutic index.
  • SOTIO is actively exploring additional tumor targets to expand the collaboration with LegoChem Biosciences to up to five ADC programs.

SOTIO Biotech, a clinical stage immuno-oncology company owned by PPF Group, today announced that it has exercised its first of five exclusive, target-specific options with LegoChem Biosciences (LCB, KOSDAQ: 141080) for antibody-drug conjugate (ADC) SOT106, which is currently being evaluated in preclinical studies across a multitude of solid tumor indications. 

NEWS

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.

NEWS

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.

NEWS

SOTIO Expands its Antibody-Drug Conjugate Pipeline with Exclusive Collaboration and License Agreement with LegoChem Biosciences

  • SOTIO Biotech licenses LegoChem Biosciences (LCB) technology for five new antibody-drug conjugate (ADC) programs
  • Rights to LCB’s ADC platform acquired for total of up to $1027.5 million payable based on certain developments and regulatory achievements, including upfront and near-term success dependent milestones worth up to $29.5 million
  • SOTIO will be responsible for the research, development, manufacturing and commercialization of the ADC products

SOTIO Biotech, a clinical stage immuno-oncology company owned by PPF Group, today announced an exclusive, target-specific license and option agreement with LegoChem Biosciences Inc. (LCB, KOSDAQ: 141080), a biotechnology company focused on developing its clinical-stage platform technology enabling antibody-drug conjugates (ADCs) with an excellent therapeutic index. SOTIO will obtain rights to deploy LCB’s ADC technology for up to five therapeutic programs targeting distinct tumor-associated antigens.

NEWS

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) 36th Annual Meeting from November 10-14, 2021.

NEWS

SOTIO to Present New Data from Phase 1 Study of IL-15 Superagonist, SOT101, at the Society for Immunotherapy of Cancer (SITC) 36th Annual Meeting

  • SOTIO will present three posters discussing data that highlight the encouraging safety and efficacy for SOT101 (SO-C101) as a monotherapy and in combination with pembrolizumab for the treatment of advanced solid tumors.
NEWS

SOTIO Demonstrates Strong Potential of SOT102 (ADC Targeting Claudin 18.2) for Treatment of Solid Tumors in Preclinical Studies

  • Results from preclinical, proof-of-concept studies were presented at the 2021 AACR Annual Meeting
  • Results demonstrate strong potential of SOT102 to eliminate tumor cells in a target-specific manner
  • First-in-human study in gastric and pancreatic cancer patients with expected launch in early 2022

SOTIO, a clinical stage immuno-oncology company owned by PPF Group, announced new preclinical data of its antibody-drug conjugate (ADC), SOT102 (formerly SO-N102), for the treatment of solid tumors in a virtual poster presentation at the 2021 American Association of Cancer Research (AACR) Annual Meeting. The data, which demonstrate that SOT102 has strong potential to eliminate CLDN18.2-expressing tumor cells in a target-specific manner, provide proof of concept for SOT102 as well as SOTIO’s proprietary ADC platform.

NEWS

SOTIO to Present Preclinical Results Describing SOT102 as Treatment of Solid Tumors at the American Association of Cancer Research Annual Meeting

SOTIO, a clinical stage immuno-oncology company owned by PPF Group, today announced the presentation of a virtual poster at the 2021 American Association of Cancer Research Annual Meeting. The presentation focuses on preclinical data describing SOT102 which is intended for the treatment of CLDN18.2-expressing solid tumors.

NEWS

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. 

NEWS

SOTIO Acquires Rights to BOXR CAR-T Platform and Products from Unum Therapeutics

  • SOTIO will establish a T cell therapy R&D Center of Excellence in Cambridge, Massachusetts. 
  • Unum’s former chief technology officer Geoff Hodge to join SOTIO to lead BOXR development team and all research and development of the next generation T cell therapies. 
  • Lead program expected to initiate first clinical studies in 2021.
  • Rights to BOXR platform acquired for total of $11.5 million, including $8.1 million upfront and potential $3.4 million in milestones.

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. 

NEWS

SOTIO’s DCVAC/LuCa Significantly Improves Survival in Patients with Stage IV Non-small Cell Lung Cancer

  • DCVAC/LuCa decreased the risk of death in patients with stage IV NSCLC by 46%
  • Median overall survival (OS) reached 15.5 months in the treatment arm compared to 11.8 months in the control arm
  • Median Progression Free Survival (PFS) prolonged by 1.1 months
  • Final results of OS and PFS are statistically significant
  • SOTIO considers initiation of Phase II/III clinical trials with DCVAC/LuCa

SOTIO, a biotechnology company owned by the PPF Group, presented new statistically and clinically significant results from its Phase I/II clinical trial evaluating DCVAC/LuCa, an active cellular immunotherapy product, in patients with stage IV non-small cell lung cancer. The final analysis of the data confirmed the promising clinical efficacy of DCVAC/LuCa. SLU01 clinical trial results were presented by the principal investigator Libor Havel, MD, from Thomayer University Hospital in Prague (Czech Republic) at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago today.

NEWS

SOTIO to Present Final Phase I/II  DCVAC/LuCa Data at ASCO 2019 Annual Meeting

SOTIO, a biotechnology company owned by the PPF Group, today announces that final data from the SLU01 Clinical Trial with DCVAC/LuCa will be presented in poster session at the 55th Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago on June 2, 2019. Final analysis of SLU01 data confirmed promising clinical efficacy of DCVAC/LuCa active cellular immunotherapy product in patients with stage IV non-small cell lung cancer.

NEWS

SOTIO’s DCVAC/OvCa Significantly Improves Survival in Patients with Recurrent Ovarian Cancer

  • DCVAC/OvCa decreased the risk of death in second line treatment of ovarian cancer by 62%.
  • Overall survival (OS) increased significantly by 13.4 months. Median Progression Free Survival (mPFS) increased by 1.8 months.
  • SOTIO plans to initiate a global Phase III study with DCVAC/OvCa.
NEWS

SOTIO to Present Final Phase II DCVAC/OvCa Data at the 2019 SGO Annual Meeting on Women's Cancer

SOTIO, a biotechnology company owned by the PPF Group, today announces that final data from the SOV02 Clinical Trial with DCVAC/OvCa will be presented in the plenary session as an oral presentation at the 2019 SGO’s 50th Annual Meeting on Women's Cancer. Final analysis of SOV02 data confirmed promising clinical efficacy of DCVAC/OvCa in patients with the 1st recurrence of ovarian cancer.

NEWS

Phase II Clinical Trials of DCVAC Show Significant Benefit for Patients with Ovarian and Lung Cancer

Chicago/Prague - SOTIO, a biotechnology company owned by the PPF Group, presented results from its Phase II clinical trials evaluating DCVAC, an active cellular immunotherapy product, in patients with ovarian and lung cancer at the 2018 at the American Society of Clinical Oncology (ASCO) Annual Meeting today. The results were statistically and clinically significant and showed that compared to patients who did not receive DCVAC, application of DCVAC/OvCa in patients with ovarian cancer and DCVAC/LuCa in patients with lung cancer decreased the risk of progression or death significantly.

NEWS

SOTIO starts Phase I/II trial of DCVAC in combination with ONCOS-102: the Targovax adenovirus based immunotherapy

SOTIO, a biotechnology company owned by the PPF Group, announces today that the first patient was enrolled to the SP015 clinical trial of a combination of DCVAC/PCa, an active cellular immunotherapy, and ONCOS-102, an immune-priming engineered human serotype 5 adenovirus, for patients with prostate cancer. The trial is planned for the United Kingdom and the Czech Republic. SOTIO is collaborating with Targovax,a clinical stage immuno-oncology company developing ONCOS-102.

NEWS

SOTIO to Present Results from Phase II Clinical Trial of 1st-Line Ovarian Cancer Treatment in Oral Presentation at ASCO 2018 Annual Meeting

SOTIO, a biotechnology company owned by the PPF Group, today announces the presentation of new promising clinical data from its ovarian and lung cancer clinical trials evaluating DCVAC, an active cellular immunotherapy product. Data will be presented at the 2018 American Society of Clinical Oncology (ASCO) Annual Meeting, taking place from 1-5 June, in Chicago, IL, United States.

NEWS

SOTIO Receives Positive Opinion for Orphan Drug Designation for DCVAC/OvCa from European Medicines Agency (EMA)

SOTIO, a biotechnology company owned by the PPF Group, today announces that the European Medicines Agency's (EMA) Committee for Orphan Medicinal Products (COMP) has issued a positive opinion recommending orphan medicinal product (orphan drug) designation for DCVAC/OvCa for the treatment of patients with ovarian cancer. The EMA’s positive opinion follows a similar decision issued previously by the U.S. Food and Drug Administration (FDA).

NEWS

SOTIO broadens its Phase II clinical trial program in ovarian cancer

SOTIO, a biotechnology company owned by the PPF Group, today announced the enrollment of the first patient to a Phase II study testing DCVAC/OvCa in combination with standard of care chemotherapy for patients with ovarian cancer after first relapse. Based on positive signals from ongoing trials, SOTIO is also expanding its ongoing study testing DCVAC/OvCa as a maintenance therapy in first line treatment of patients with ovarian cancer.

NEWS

SOTIO completes enrollment of phase III VIABLE study in late stage prostate cancer

SOTIO, a biotechnology company owned by the PPF Group, today announced the enrollment of the last patient into the VIABLE study, a global Phase III clinical trial evaluating DCVAC/PCa in combination with docetaxel for patients with metastatic castration-resistant prostate cancer (mCRPC).

NEWS

SOTIO exhibits at ESMO 2015

SOTIO is presenting its clinical research program at the European Society for Medical Oncology’s European Cancer Congress 2015 in Vienna (ESMO 2015). SOTIO’s exhibit can be found at booth no.1107 in ESMO Exhibition Hall B. Over the course of the ESMO Congress, SOTIO’s representatives will meet with important key opinion leaders (KOLs), researchers participating in company clinical trials and other medical and clinical experts.

NEWS

SOTIO Announces VIABLE Clinical Trial (DCVAC/PCa) Poster Presentation at the 2015 American Society for Clinical Oncology (ASCO) Annual Meeting

SOTIO, a biotechnology company owned by the PPF Group, today announced that it will present an abstract highlighting the design, methods and objectives of its VIABLE study, the global Phase III clinical trial of DCVAC/PCa, an active cellular immunotherapy treatment for prostate cancer patients, in the poster session at the 2015 American Society of Clinical Oncology (ASCO) annual meeting in Chicago. 

NEWS

SOTIO launches first clinical trial of a new treatment for lung cancer, a disease which threatens more people globally than other cancers.

SOTIO, a biotechnology company owned by the PPF Group, today announced that the first patient has been enrolled into its recently launched international study in lung cancer a Phase I/II clinical trial using its Dendritic Cell Vaccine (DCVAC/LuCa), an active cellular immunotherapy treatment. Lung cancer has become the most common newly diagnosed tumour disease globally and is also the most frequent cause of death among patients suffering from cancer. 

NEWS

SOTIO Initiates US Part of VIABLE, a Global Phase III Clinical Trial for Prostate Cancer Immunotherapy Treatment Using DCVAC/PCa

SOTIO, a biotechnology company owned by the PPF Group, today announced that the first US patient has been enrolled in its VIABLE study, the global Phase III clinical trial for DCVAC/PCa, an active cellular immunotherapy treatment for prostate cancer patients. Initial patients were also recently enrolled into the study in Italy, UK, the Netherlands and Slovakia.

NEWS

SOTIO exhibits at ESMO 2014

SOTIO, the biotechnology company owned by PPF Group, is presenting its clinical research program at the European Society for Medical Oncology’s 2014 Congress in Madrid (ESMO 2014). SOTIO’s exhibit can be found at booth no.107 in ESMO Exhibition Hall no. 8. Over the course of the ESMO Congress, SOTIO’s representatives will meet with important key opinion leaders (KOLs), researchers participating in company clinical trials and other medical and clinical experts.

NEWS

SOTIO opens state-of-the-art laboratory in Chinese Beijing to produce therapeutical products against cancer diseases

SOTIO, a biotechnology company belonging to the PPF Group, today in a special ceremony opened its second laboratory facility for the production of active cellular immunotherapy against cancer diseases. After the Prague’s Holešovice, where in 2010 the company opened its first laboratories, this is the second locality in the world where SOTIO has developed so called cleanroom laboratories which meet international standards of Good Manufacturing Practices (GMP). In the initial stage, SOTIO will be producing in China therapeutical products for patients diagnosed with prostate and lung cancer. The gala opening took place at the presence of the Czech minister of health, Svatopluk Němeček.

NEWS

SOTIO presents Immunotherapy Research in Prostate, Ovarian and Head and Neck Cancer at 2014 ASCO Annual Meeting

SOTIO, a biotechnology company belonging to the PPF Group, announced that it will present four abstracts highlighting clinical progress and research results on DCVAC/PCa and DCVAC/OvCa treatments and head and neck squamous cell carcinoma at the 2014 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago. 

NEWS

SOTIO Initiates VIABLE, a Global Phase III Clinical Trial for Prostate Cancer Immunotherapy Treatment with DCVAC/PCa

SOTIO, a biotechnology company owned by the PPF Group, today announced that the first patient has enrolled in its VIABLE study, the global Phase III clinical trial for DCVAC/PCa, an active cellular immunotherapy treatment for prostate cancer patients.

NEWS

VIABLE Study to Proceed in US

The U.S. Food and Drug Administration (FDA) notified Sotio in April 2014 that its complete response to the July 2013 clinical hold on the VIABLE Study has been reviewed and that the FDA has determined that it is safe to proceed under the Investigational New Drug (IND) application.” VIABLE is a global Phase III clinical trial for prostate cancer immunotherapy treatment with DCVAC/PCa. FDA’s removal of the clinical hold represents a major achievement for SOTIO’s global and US development efforts. SOTIO’s aim is to enroll approximately 1,170 prostate cancer patients in the VIABLE study, including patients from Europe, Russia and the United States. Enrollment of the first European patient in VIABLE study is expected during first half of 2014.

NEWS

Phase II of Clinical Studies of SOTIO Ovarian Program Has Its First Patient

Last week was into the clinical trials of Phase II of the ovarian programme successfully enrolled the first patient. The patient was accepted into the SOV02 trials by doctors from the Ostrava University Hospital. According to information from cooperating Czech medical centres, further patients should be joining within the next few days. After obtaining all regulatory approvals, SOTIO expects to start enrolling patients also in Germany and Poland in early 2014.

NEWS

SOTIO Supports Local Prostate Cancer Awareness Day in Boston

On Thursday, September 12th, Sotio will be joining forces with esteemed Massachusetts state legislators, patient advocacy groups, and local Boston athletes in an effort to urge legislators to recognize prostate cancer as a public health priority. Sponsored since 2009 by the AdMeTech Foundation, the event will also include discussions on recent advances in the diagnosis and treatment of prostate cancer and a measure to increase funding to the National Institute of Health for the advancement of early detection initiatives.

NEWS

SOTIO will launch Phase II clinical trials for ovarian cancer

SOTIO is preparing to launch Phase II clinical trials at the end of September 2013 to assess the use of active cellular immunotherapy (DCVAC/OvCa treatment) combined with standard therapy in patients with epithelial ovarian cancer. SOTIO’s clinical trials will be conducted at medical centers in the Czech Republic, Germany and Poland. They will be focused on different groups of patients, based on the course of their disease and their reaction to standard therapy already used. Altogether 210 patients will be gradually enrolled in about 25 clinical centers. The initiation of the first of three clinical trials is scheduled for September 2013, the program will be completed in December 2017. Based on results of a tender, SOTIO has chosen Theorem Clinical Research as its strategic partner for organization of Phase II clinical trials in ovarian cancer program.

NEWS

SOTIO receives orphan-drug designation for Ovarian Active Cellular Immunotherapy

SOTIO has received orphan-drug designation from the U.S. Food and Drug Administration (FDA) for the active cellular immunotherapy (ACI) DCVAC/OvCa.

NEWS

SOTIO at ASCO Annual Meeting 2013

At this years annual meeting of the American Society of Clinical Oncology (ASCO) held from May 31 to June 4, in Chicago, Illinois; SOTIO will for the first time ever introduce itself to the worldwide oncology community.

NEWS

SOTIO receives EMA approval

SOTIO receives European Medicines Agency approval to initiate Phase III VIABLE Clinical Trial of DCVAC/PCa, an active cellular immunotherapy drug targeted for prostate cancer patients. Lead Candidate from SOTIO’s DCVAC program.

NEWS

SOTIO a.s. appoints Chiltern International

SOTIO a.s. has selected Chiltern International Limited to be the Contract Research Organization (CRO) that carries out the European part of its phase III global clinical trial entitled VIABLE, which will include 1,170 prostate cancer patients from Europe and the U.S.