News

NEWS

SOTIO and PPF complete acquisition of Cytune Pharma

Prague - 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.

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 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. 

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

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. 

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 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.

NEWS

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

Dortmund, Germany and Prague, Czech Republic, April 11, 2017 – 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. 

NEWS

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.

NEWS

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

Basel, Switzerland & Prague, Czech Republic October 20, 2016 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-mAbTM antibody platform, its site-specific SMACTM conjugation technology and its novel ultra-potent toxin platform. SOTIO will have global responsibility for clinical development, registration and commercialization of the ADC products.

NEWS

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.

NEWS

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.

NEWS

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”.

NEWS

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.

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

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. 

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

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.

NEWS

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. 

NEWS

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.

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, 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.

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 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.

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.

NEWS

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.

NEWS

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.

NEWS

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.

NEWS

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.

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