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.

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. 

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 Bolsters Leadership Team with Appointment of Martin Steegmaier as Chief Scientific Officer

SOTIO Biotech, a clinical stage immuno-oncology company owned by PPF Group, announced the appointment of Martin Steegmaier, Ph.D., MBA, as chief scientific officer. Martin Steegmaier brings over 20 years of experience in oncology drug discovery, drug development and business development. His extensive knowledge of the biotech industry and clinical immuno-oncology will be crucial as SOTIO continues to advance multiple assets through the clinic. He will be responsible for preclinical and translational research globally.

SOTIO Strengthens Management Team with Appointment of Robyn Hunter as Chief Financial Officer

SOTIO Biotech, a clinical stage immuno-oncology company owned by PPF Group, announces the appointment of Robyn Hunter as chief financial officer. Ms. Hunter is an accomplished CFO who brings an extensive array of financial experience to SOTIO, including her extensive knowledge of biotech and capital markets. She joins SOTIO to oversee the long-term financing strategy.

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.

SOTIO Initiates CLAUDIO-01 Trial with Antibody-Drug Conjugate SOT102 in Patients with Gastric and Pancreatic Cancer

• CLAUDIO-01 is the first-in-human trial of SOT102, a CLDN18.2 (Claudin 18.2) targeting antibody-drug conjugate (ADC)
• The trial will enroll up to 109 patients with gastric and pancreatic cancer

SOTIO Biotech, a clinical stage immuno-oncology company owned by PPF Group, announced today that it has dosed the first patient in its Phase 1/2 CLAUDIO-01 trial of SOT102 in patients with gastric and pancreatic cancer. SOT102 is the lead program of SOTIO’s growing ADC pipeline built on multiple platforms.

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.

SOTIO Strengthens its Strategic Advisory Board with Esteemed Oncology Experts and Industry Veterans

SOTIO Biotech, a clinical stage immune-oncology company owned by PPF Group, announced the addition of three world-renowned clinical oncology research experts and biotechnology business development and commercialization veterans to its strategic advisory board. New members of the Strategic Advisory Board include Alise Reicin, M.D., Josep Tabernero, M.D., Ph.D. and Anthony Tolcher, M.D., FRCPS(C).

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.

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 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.

SOTIO Presents Positive Biomarker Data from DCVAC/OvCa Phase 2 Study in First Line Ovarian Cancer at the 2021 ASCO Annual Meeting

SOTIO, a clinical stage immune-oncology company owned by PPF Group, today announced the presentation of positive biomarker data from its Phase 2 trial with dendritic cell vaccine DCVAC/OvCa during a virtual poster presentation at the 2021 ASCO Annual Meeting. DCVAC/OvCa is being developed as a first line treatment in adults with ovarian cancer. The data demonstrate signs of efficacy and safety of DCVAC/OvCa combined with chemotherapy in patients with newly diagnosed epithelial ovarian carcinoma and provide strong rationale for potential study in larger clinical trials. 

SOTIO to Present Biomarker Data from its SOV01 – DCVAC/OvCa Phase 2 Study in 1st line Ovarian Cancer at the 2021 ASCO Annual Meeting

SOTIO, a clinical stage immune-oncology company owned by PPF Group, today announced the presentation of a virtual poster at the 2021 ASCO Annual Meeting. The presentation focuses on potentially predictive biomarker data from a phase 2 study of SOTIO’s dendritic cell vaccine (DCVAC/OvCa) combined with chemotherapy in patients with newly diagnosed epithelial ovarian carcinoma after primary debulking surgery.

SOTIO’s DCVAC Program is a cell therapy platform designed to improve efficacy compared to earlier generations of dendritic cell therapies by targeting multiple antigens and applying an immune-stimulatory technique. SOTIO has created this vertically integrated, personalized cell therapy platform to enable the efficient manufacturing of product doses for one year of treatment at commercially attractive costs.

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.

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.

Acquisition agreement with Boehringer Ingelheim for NBE-Therapeutics marks first major biotech exit for PPF Group

• €1.18 billion acquisition provides for significant returns to PPF Group as NBE’s largest shareholder
• SOTIO, a clinical stage immuno-oncology company, and a member of PPF Group, continues development of two ADC products under the collaboration with NBE

PPF Group, an international investment group, today announced the signing of a binding agreement to sell its stake in NBE-Therapeutics to Boehringer Ingelheim. NBE-Therapeutics is using its proprietary iADC™ platform to develop potential best-in-class antibody-drug conjugate (ADC) therapies for the treatment of solid tumors. The lead program NBE-002, an iADC targeting ROR1, entered the Phase 1 clinical testing in 2020. 

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 to Present at BIO-Europe Digital 2020

SOTIO, a clinical stage immuno-oncology company owned by PPF Group, today announced that Jens Hennecke, chief business officer of SOTIO, is presenting on our lead programs at BIO-Europe Digital being held on October 26-29, 2020. The presentation will be made available on demand on the Bio Europe website and accessible to attendees registered for the event.

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. 

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 Appoints Richard Sachse as Chief Medical Officer

SOTIO, a clinical stage immuno-oncology company owned by PPF Group, today announced the appointment of Richard Sachse, M.D., Ph.D., as Chief Medical Officer effective July 1, 2020. Dr. Sachse brings more than 25 years of experience in the biopharma industry as a physician and scientist and was most recently the deputy Chief Medical Officer of SOTIO.

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 opens office in Basel, Switzerland, to accelerate development of its pipeline products

SOTIO, a biotechnology company owned by the PPF Group, announce today the opening of offices of SOTIO Biotech AG at the Technology Park Basel, Switzerland. The SOTIO office will host the clinical development team, as well as other functions to progress its broad clinical development pipeline towards filing for marketing authorization and commercial launch.

SOTIO exercises second target option under existing collaboration with NBE-Therapeutics to develop next-generation antibody-drug conjugates

Basel, Switzerland & Prague, Czech Republic – November 7, 2019 – NBE-Therapeutics AG and SOTIO a.s. today announced that SOTIO has elected a second target for the development of a next generation antibody-drug conjugate (ADC) under their existing license and collaboration agreement. NBE and SOTIO will collaborate on the discovery, non-clinical development and manufacturing of this second undisclosed target. The development will be based on NBE’s proprietary antibody drug conjugate platform, including NBE’s site-specific SMAC-technology^TM conjugation and its new, highly potent anthracycline toxin platforms. SOTIO will take global responsibility for clinical development, registration and commercialization of the ADC products.

PPF and SOTIO invest $6.5 million in MaveriX Oncology and its lead program MVX-5005

• PPF Group, the majority owner of SOTIO, invests $6.5 million as part of MaveriX Oncology’s $20 million Series A financing round.
• SOTIO obtained an option to license and co-develop MVX-5005 in Europe. 
• MaveriX is eligible to receive up to $138 million in milestone payments.
• Norbert Prenzel, SOTIO’s Head of Business Development, will represent PPF on MaveriX Oncology’s Board of Directors.

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.

PPF expands its investment in the healthcare sector through acquisition of significant stake in T cell therapy company Autolus Therapeutics

• Investment provides 19.2% stake in Autolus
• Autolus is PPF’s second largest investment in the healthcare sector, after PPF’s majority-owned biotechnology company SOTIO

PPF today announces the acquisition of a 19.2% stake in Autolus Therapeutics plc, a leader in next-generation T cell programming technologies. The shares were acquired in the market through NASDAQ.

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’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.

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.

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.

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 50^th Annual Meeting on Women's Cancer. Final analysis of SOV02 data confirmed promising clinical efficacy of DCVAC/OvCa in patients with the 1^st recurrence of ovarian cancer.

SOTIO Appoints Dr. Harald Fricke as Chief Medical Officer

SOTIO, a biotechnology company owned by PPF Group, announces today the appointment of Harald Fricke, M.D., Ph.D. as Chief Medical Officer (CMO). Dr. Fricke has more than 30 years of experience in the field of immuno-oncology research and clinical development of new cancer therapies. At SOTIO, he will be responsible for clinical strategy and leading the expansion of SOTIO’s clinical-stage pipeline. 

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.

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.

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.

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.

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. 

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).

Radek Špíšek to become new CEO of SOTIO

SOTIO, a biotechnology company belonging to the PPF Group, announces today the appointment of Professor Radek Špíšek as Chief Executive Officer. Effective from March 1, 2018, he will replace the current CEO, Ladislav Bartoníček, who will remain active within SOTIO’s top management and will replace Radek Špíšek on the company’s Supervisory Board. The appointment of Radek Špíšek as the CEO will ensure continuity in the company’s management and strategic goals. 

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.

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).

SOTIO Establishes Strategic Advisory Board with world-renowned experts

SOTIO, a biotechnology company owned by the PPF Group, which develops innovative products for the treatment of cancer and autoimmune diseases, announced the creation of its Strategic Advisory Board today. SOTIO’s Advisory Board is comprised of internationally renowned experts in clinical research, translational medicine, business development and commercialization.

LDC and SOTIO Enter License and Collaboration Agreement for First-in-class Cancer Metabolism Program

Dortmund, Germany and Prague, Czech Republic – The Lead Discovery Center GmbH (LDC), Max Planck Innovation GmbH (MI) and SOTIO a.s. have signed a collaboration and license agreement providing SOTIO with exclusive rights to an oncology program addressing a novel target in tumor metabolism. It was discovered at the Max Planck Institute for Biology of Ageing and jointly advanced by the LDC and Max Planck scientists into drug discovery. 

Cellestia Biotech raises CHF 8 million seed financing from private investors and PPF Group to advance its lead anti-cancer compound CB-103 to clinical development stage

Basel, Switzerland – January 26, 2017 – Cellestia Biotech AG, a private biopharmaceutical company with strategic focus on anti-cancer drugs modulating the NOTCH signaling pathway, today announced the final closing of its seed financing rounds securing a total of CHF 8 million in funding. The total seed financing includes proceeds of CHF 0.5 million Seed A and CHF 2.3 million Seed B financing rounds conducted during 2016 and the proceeds of the final Seed C financing round closing at CHF 5.2 million today, in which PPF Group, as an institutional investor, and several private investors participated. The funds will enable Cellestia to advance the lead product CB-103 and to conduct and complete a first-in-man phase I clinical study. The preparations for launching the clinical program in 2017 are ongoing.

SOTIO and NBE-Therapeutics sign collaboration and license agreement for next-generation antibody-drug conjugates

Basel, Switzerland & Prague, Czech Republic – NBE-Therapeutics AG and SOTIO a.s. today announced that the companies have entered into a collaboration for the development of next-generation antibody-drug conjugates (ADCs) for improved cancer therapy. Under the agreement, NBE and SOTIO will collaborate on the discovery, non-clinical development and manufacturing of novel ADC products against undisclosed targets. The ADC products will be based on NBE’s proprietary antibody discovery and conjugation platforms, including NBE’s Transpo-mAb^TM antibody platform, its site-specific SMAC^TM conjugation technology and its novel ultra-potent toxin platform. SOTIO will have global responsibility for clinical development, registration and commercialization of the ADC products.

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.

SOTIO Presents its Clinical Development Program at the 2016 American Society for Clinical Oncology (ASCO) Annual Meeting

SOTIO, a biotechnology company owned by the PPF Group, presents its clinical development program of DCVAC medicinal products at the 2016 American Society of Clinical Oncology (ASCO) annual meeting in Chicago. DCVAC is an active cellular immunotherapy treatment for patients with cancer. SOTIO attends ASCO 2016 (June 3 to June 7, 2016) with its own exhibition booth and presents its 10 running clinical trials to expert community.

SOTIO Wins 2016 Global Innovation & Excellence Award for "Innovation in New Medicine Production"

SOTIO, a biotechnology company owned by PPF Group, announced today that it has been named as one of the winners of the Global Corporate LiveWire Innovation & Excellence Awards. SOTIO was presented with two awards: a global award for “Innovation in New Medicine Production” and a Czech-specific award for “Innovation & Excellence in Biotechnology”.

SOTIO documentary on Discovery Channel

On Monday December 14, 2015, a documentary feature on SOTIO was broadcast as part of the “Innovations” TV series on the Discovery Channel. The documentary footage was shot in late summer of this year at the SOTIO premises in Prague, at Motol University Hospital in Prague and at the Dana-Farber Cancer Institute in Boston. The episode details not only SOTIO’s research, manufacturing and clinical developments, but also gives the viewer a broader education on active cellular immunotherapy as a whole.

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.

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. 

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. 

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. 

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.

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.

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.

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. 

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.

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.

PPF Group expands in the field of biotechnology and immunotherapy

PPF Group has acquired a minority stake in OriBase Pharma, a biotechnology company which specialises in the development of new therapies in oncology. The acquisition will strengthen PPF’s research and product portfolio, currently represented by SOTIO which is developing a next-generation Active Cellular Immunotherapy based on activated dendritic cells for the treatment of cancer and autoimmune diseases. Cooperation between OriBase Pharma and SOTIO will enable the effective sharing of research, expertise and clinical development capacities in the area of immunotherapy and targeted therapies.

SOTIO Receives VHP approval to start Phase III Clinical Trial

SOTIO a.s., Prague, announced today that it received from the EU Heads of Medicines Agencies (HMA) a positive decision on a substantial amendment to its Phase III VIABLE Clinical Trial of DCVAC/PCa – an active cellular immunotherapy for the treatment of prostate cancer. The HMA originally approved SOTIO’s submission for the VIABLE Phase III clinical trial in March 2013. This amendment was submitted by SOTIO as part of the European Voluntary Harmonisation Procedure (VHP), based on feedback received from US Food and Drug Administration (FDA). Amendment was developed to ensure unification of the protocol design for EU and US. SOTIO plans to start recruiting patients in the trial beginning in March 2014. 

Ladislav Bartoníček to become new SOTIO Chief Executive Officer

A new Chief Executive Officer of SOTIO, a biotechnology company belonging to the PPF Group, will become from 1st March 2014 one of the PPF shareholders, Ladislav Bartoníček (49). He will replace in the office Karel Nohejl (44) who will continue working at the PPF Group in other positions.

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.

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.

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.

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.

SOTIO, LLC becomes a member of Massachusetts Biotechnology Council

SOTIO, LLC officially became a member of Massachusetts Biotechnology Council (MassBio), the largest biotechnology organization in Massachusetts.

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.

SOTIO participated at the BIO International Convention 2013

SOTIO successfully participated at the BIO International Convention 2013 (from April 22 to 25, 2013), an annual gathering of biotech industry leaders. This year’s convention held at McCormic Place in Chicago (US), with thousands of participants from pharmaceutical companies, biotechnology firms, university researchers etc.

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.

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.

SOTIO, a part of PPF Group

SOTIO has become a part of the PPF Group’s portfolio – one of the largest investment and finance groups in Central and Eastern Europe. The administrative process of the transfer of the equity interest was completed towards the end of 2012.

Two awards for Radek Špíšek, SOTIO Supervisory Board Member

Doctor Radek Špíšek was on Friday November 16th, 2012 appointed Professor of Medical Immunology by the President of the Czech Republic Václav Klaus. Professor Radek Špíšek together with Prof. Jiřina Bartůňková dedicated more than ten years to research in the field of active cellular immunotherapy and its use in the treatment of cancer.

SOTIO is building its own laboratories in Beijing

SOTIO representatives signed a contract for the lease of office and laboratory space at the “Huilongsen International Business Incubator (Beijing) Co., Ltd.” biotechnology park in Beijing, China this September. The park is located in the southern part of Beijing known as Yizhuang – one of the Chinese capital’s centers of residential and economic development.

SOTIO GMP Manufacturing Process to be Implemented at PCT

ALLENDALE, N.J. and WILMINGTON, Del., July 16, 2012 -- (NYSE MKT:NBS) and its subsidiary, Progenitor Cell Therapy, LLC ("PCT"), an internationally recognized Contract Development and Manufacturing Organization (CDMO), and SOTIO, LLC, a Delaware limited liability company that is responsible for organizing the U.S. part of a global pivotal Phase 3 clinical trial of SOTIO, LLC's affiliate, SOTIO a.s. ("SOTIO"), announced today that SOTIO, LLC has retained the services of PCT to manufacture clinical products for SOTIO's U.S. part of a global pivotal Phase 3 clinical trial. SOTIO, LLC is an affiliate of a Czech Republic-based biotechnology company developing new therapies based on activated dendritic cells, focusing on the treatment of cancer and autoimmune diseases. SOTIO, LLC will use the services of PCT to transfer and qualify at PCT's Allendale, New Jersey facility, SOTIO's GMP manufacturing process for the U.S. part of a global pivotal Phase 3 clinical trial for SOTIO's autologous dendritic cell vaccine expected to launch in early 2013, subject to FDA approval.