How and when did your company start, and where are you located?
SOTIO was established in 2010 and since 2012 majority share is owned by PPF Group (investment company focusing among other sectors also on biotechnology). The company is based in Prague, Czech Republic, and has offices in the US, China and Russia.
How many employees do you have, and how do you find and attract them?
We currently employ around 370 professionals. Attracting of new colleagues differs in each region where we are present. The most developed biotech-specific labor market is logically in the US. On the contrary, in the Czech Republic and China it is more challenging to find highly qualified staff with relevant experience in biotechnologies and clinical development. The main reason being a very short history of the sector in these regions. In the Czech Republic we are the first company ever who entered Phase III of clinical development. For local employees it is attractive to work for the most advanced Czech biotech company. At the same time for some expert positions there is the only possibility to attract professionals from Western Europe where biotech and pharmaceutical industry has a much longer history.
What are the main focus and platform technology(ies) of your company?
We are focusing on 2 key areas:
a) Developing a new Active Cellular Immunotherapy (“ACI”) based on activated dendritic cells for the treatment of cancer and autoimmune diseases. SOTIO's proprietary ACI-MAP (Active Cellular Immunotherapy Multiple Antigen Presentation) technology leverages a method of inducing an immunogenic death of whole tumor cells in the production process. This enables efficient pulsing of patient's DCs with a broad range of tumor antigens. DCs pulsed with tumor cells killed by High Hydrostatic Pressure (‘HHP’) by immunogenic cell death have an increased ability to induce cytotoxic T cell responses, reducing the expansion of T regulatory cells when tested in vitro. This increases the probability of inducing efficient immune response in vivo. SOTIO's ACI requires patients to be treated at regular intervals (every 2-6 weeks) for up to a year or more. This concept is supported by preclinical evidence and clinical observations that one leukapheresis yields sufficient DCVAC product for long term immune boosting which leads to long-term stimulation of the patient's immune system. While immunotherapy alone is an area focusing on early stage cancer patients, SOTIO's ACI-MAP technology is also being investigated in patients with advanced cancer in combination with multiple treatments modalities in a synergistic way to control disease progression.
b) Business development activities – SOTIO serves as PPF's hub for further expansion in the biotechnology industry, searching for investment opportunities, in-licensing, investments and partnership projects. We are looking to partner with other companies and institutions that develop promising biotechnology projects. Our general targets are innovative therapies that harness the immune system and focus primarily on immuno-oncology and autoimmune diseases.
Can you provide a short overview of your product pipeline?
SOTIO is verifying safety and efficacy of its dendritic cell based DCVAC products through multiple clinical trials. Currently we are running 10 clinical trials, VIABLE Study being our pivotal Phase III trial evaluating DCVAC/PCa (for patients with prostate cancer). Recruitment is currently underway in around 20 European countries and at additional research sites in the United States.
There are also 5 Phase II clinical trials in prostate cancer (DCVAC/PCa product) and 3 Phase II clinical trials in patients with ovarian cancer (DCVAC/OvCa product). Phase I/II clinical trial evaluating DCVAC/LuCa for patients with lung cancer has been the latest addition to the SOTIO clinical study pipeline. SOTIO is currently in starting phase of 2 other Phase I clinical trials with DCVAC/PCa, combining ACI treatment with oncolytic viruses and in neo-adjuvant settings.
SOTIO's affiliated company - Cytune Pharma, a French biotechnology company focuses on the development of a modified IL-15 (RLI) acting as a potent stimulant of NK cells and cytotoxic T cells. RLI will enter the Phase I stage in cooperation with SOTIO in 2017.
We are also running several research projects with leading Chinese hospitals.
Who is your competition, and what advantage(s) do your products/technology offer?
There are many pharmaceutical / biotech companies entering the area and starting new and new clinical trials; this will lead to quite a strong competition for patients to be enrolled in the study and in case of success also to high competition after market registration. More and more combination trials will be realized by companies in the field, e.g. combination of active cellular immunotherapy with checkpoint blockers, oncolytic viruses etc.
Treatment with DCVAC represents a new method of immunotherapy and compares favorably to similar existing treatment methods:
• A single blood sampling (leukapheresis) can yield more than 15 doses of ACI Treatment
• Patients receive DCVAC over the long-term to continuously boost the immune response. The duration of one treatment cycle is approximately one year
• Treatment of DCs with immunogenically killed prostate cancer cell line exposes them to multiple tumor antigens (other existing treatments usually use single antigens)
• Administered in combination with chemotherapy, which most mCRPC patients eventually require, with the potential to enhance the overall treatment efficacy
• Cells obtained from leukapheresis are cultured to differentiate into dendritic cells, which are the starting material for the immunotherapy
• After manufacturing the DCVAC is frozen for easy delivery and storage until each dose is needed. Cold storage does not reduce viability of the cells
• DCVAC can be easily administered by patient's doctor
What were the “highlights” in your recent product development?
Recently we finished enrolment of patients in all our Phase II trials with DCVAC/PCa and DCVAC/OvCa.
What have been the most critical problems in developing products in your field, and how can your company's technology help overcome these problems?
Our DCVAC platform is an autologous approach, meaning that in a first step certain cells get recovered by leukapheresis, transported to the manufacturing facility, processed and then shipped back to the patient and administered. Apart from an increased logistical effort compared to off-the-shelf products, autologous approaches in general – like most DC vaccine and CAR-T approaches – are considered more burdensome to the patient. In contrast to other DC vaccine approaches, our DCVAC approach offers the advantage of producing product for about one year of treatment from one manufacturing run, thereby reducing burden for the patient and manufacturing costs and efforts.
What is your company's value proposition?
Our company has built a team with know-how typical for mid-sized biotech company, containing expertise in research, manufacturing, logistics, clinical development, pharmacovigilance, data management, statistics, business development, market access and other supporting functions.These central functions will serve for further clinical development not only for SOTIO but also for other biotech companies from PPF Group or partner companies collaborating with us.
Our innovation capabilities are driven by:
• internal research
• process development
• acquisitions/inlicensing of new innovative companies/compounds
Based on our long-term research we came to conclusion that ACI technology could work not only in treatment of selected cancer diseases, but also in autoimmunity diseases. We are preparing to launch clinical trial(s) also in this area.
What business development strategy do you pursue?
Our strategy is to diversify and broaden our product portfolio. We are searching for investment opportunities, in-licensing, acquisition and partnership projects. We are looking to partner with other companies and institutions that develop promising biotechnology projects. We focus our efforts on products and product candidates for the treatment of cancer.
How does your company attract partners?
SOTIO is running a state of the art scouting and evaluation process to identify new projects. What makes us attractive is our mid- and long-term strategy of building a fully integrated pharma company, and our financial backing. For an organization of our size, each project that joins our pipeline will be very important.
Who are your most important partners?
Most important partners in preclinical and clinical development are our affiliated companies Cytune Pharma and OriBase Pharma.
In the area of research it is 2nd Faculty of Medicine of Charles University in Prague and Motol University Hospital in Prague. We also closely collaborate with leading research centers studying cancer immunology, cell apoptosis, immunogenic cell death, and autoimmunity issues: Centre de Recherche des Cordeliers (Paris), INSERM U892 Centre de Recherche en Cancérologie (Nantes), University of Leuven (Belgium) and Rigshospitalet (Denmark).
CRO Chiltern is very important partner for conducting our international Phase III trial with DCVAC/PCa which is recruiting patients in 20 European countries and the US.
How do you balance performing work in-house vs. out-sourcing?
We are building our structure the way to be able to realize whole drug development process from research to market access. Costs and quality of work product is the key driver when deciding whether activities are performed in-house or outsourced.
What are your product development goals for the next 3 years?
We will focus on advancing our clinical trials with DCVAC in prostate, ovarian and lung cancer.
We are diversifying our investments in different compounds and technologies (both by own research and business development).
For more information: http://www.sotio.com/