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PPF and SOTIO invest $6.5 million in MaveriX Oncology and its lead program MVX-5005
SOTIO, together with PPF, and MaveriX Oncology, Inc., today announce the investment of PPF Group in MaveriX Oncology Inc., a private biotech company with a proprietary pipeline of targeted, small-molecule cancer chemo-immunotherapeutics. PPF has committed to investing $6.5 million in MaveriX Oncology’s ongoing Series A financing contingent on key development milestones. In total, MaveriX is aiming to secure a total of $20 million in funding and the round will remain open for additional investors to join. The proceeds will enable MaveriX to advance the company’s lead program MVX-5005 through IND-enabling studies, and complete first-in-human Phase Ia/Ib clinical trials for the treatment of solid tumors in support of clinical proof-of-concept. The company will also advance further platform programs to drug candidate selection.
PPF expands its investment in the healthcare sector through acquisition of significant stake in T cell therapy company Autolus Therapeutics
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
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
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.
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-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.
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.