Selecta RUS Becomes RUSNANO’s First Foreign Portfolio Company in the Pharmaceutical Sector to Open a Research Center in Russia

28 November 2012

Selecta RUS, the Russian subsidiary of Selecta Biosciences, Inc., became RUSNANO’s first portfolio company in the pharmaceutical sector to open a research center in Russia. At the new research center Russian and American scientists will develop immunotherapies and vaccines for the treatment and prevention of cancer as well as respiratory, infectious, autoimmune and allergic diseases. The pipeline of Selecta Biosciences, Inc., a clinical stage biotechnology company with headquarters in Boston, US, is based on the tSVP™ nanotechnology platform which was invented at the Massachusetts Institute of Technology and the Harvard Medical School. Selecta's lead product candidate is a first-in-class vaccine for smoking cessation and relapse prevention.

The total co-investment of RUSNANO in Selecta may reach up to $25 million in several tranches.

Selecta is dedicated to expanding its research, development, and manufacturing capabilities in Russia. It was announced that the President and Chief Executive Officer of Selecta Biosciences, Inc. Werner Cautreels, Ph.D, will become the General Director of the Russian subsidiary. In order to manage Selecta’s global and Russian operations and implement this pioneering strategy for the Russian biotech industry, he will move to Moscow. “It is a great honor for me to direct the global and Russian activities of Selecta, I am grateful to our Board members and to my colleagues for their trust—says Werner Cautreels.—I will deploy my experience to contribute to the implementation of Selecta’s plans in the field of scientific innovation and to the development of new treatments for patients.”

The goal of Selecta’s research center in Russia is to build a robust pipeline of nanovaccines and immunotherapies for the domestic and global market in accordance with international standards of scientific and clinical quality and good manufacturing practice (GMP). Selecta’s research center is located in Khimki at the ChemRar High Tech Center.

“I sincerely welcome Dr. Werner Cautreels to Russia. The establishment of Selecta RUS is aligned with the investment agreement with Selecta Biosciences Inc.,—said RUSNANO managing director Dmitriy Lisenkov.—This is a unique opportunity to attract technology platform for developing innovative vaccines to Russia.”

Technical Information

Selecta Biosciences SVP™ Technology—A new class of vaccines

Selecta Biosciences, Inc. is a biopharmaceutical company developing a new class of vaccines using self assembling synthetic nanoparticles to enable rational vaccine design. Thus new therapeutic applications are possible offering the potential of improved efficacy-safety profiles and simplified synthetic production process.

Selecta vaccines can be designed to target both humoral and cellular pathways of the immune system. The company is therefore pursuing a broad range of therapeutic applications, including cancer, autoimmune diseases, infectious diseases, and addiction. Building on the company’s novel approach, its product candidates have the potential to become first-in-class and best-in-class vaccines to treat and prevent diseases.

One type of products developed by Selecta are targeted Synthetic Vaccine Particles (tSVP™ platform). These vaccines are engineered to mimic the properties of natural pathogens to elicit a maximal immune response. tSVP™ vaccines are rationally designed to optimize the presentation of antigens to the nexus of the immune system and ensure a focused and durable response. They deliver antigen adjuvant combinations within the same biodegradable nanoparticle directly to antigen-presenting cells. This approach maximizes the immune response while keeping undesirable off-target effects at a low level, as the nanoparticle ensures that the vaccine components are released within the lymph nodes.

Another product type developed by Selecta are targeted tolerogenic synthetic vaccine particles (t2SVP platform) designed to evoke an antigen specific tolerance reaction of the immune system. These particles induce T-reg-cells to regulate unwanted immune reactions in diseases such as allergies, autoimmune deficiencies or in transplant rejection.

Selecta Nanoparticles mimic nature

Selecta Nanoparticles mimic nature

 

The 2011 Medicine Nobel Prizes for research on dendritic cells (Steinman) and Toll Like Receptors (Hoffman, Beutler) are validating the potential of Selecta’s technologies. SVP™ nanoparticles are targeted in size and shape to be taken up and presented by dendritic cells. They contain adjuvants that activate Toll Like Receptors. This activation is required as signal for the immune system to elicit a strong and durable immune response.

In 2012 Selecta Biosciences, Inc. has been awarded the prestigious 2012 Edison Gold Award for its proprietary Synthetic Vaccine Particle (SVP™) platform.

Technology Advantages

Selecta’s proprietary SVP™ platform is based on a combination of scientific breakthroughs in immunobiology and nanotechnology. The company’s targeted vaccines are designed to optimally interact with the body’s immune system to achieve the desired antigen-specific response (rational vaccine design). Depending on the cellular target and the molecular information encoded in the nanoparticle, the targeted vaccines can potently and specifically induce immune activation or immune tolerance to a broad range of antigens. The unique characteristics of Selecta’s SVP™ product platform are detailed below.

High Efficacy

  • Efficient lymph node delivery. The SVP™ technology is designed to flow freely in the lymphatics to the lymph nodes upon administration and to induce a strong immune response while using lower antigen and adjuvant dosages than conventional vaccines.
  • Controlled stoichiometry and kinetics of adjuvant, antigen, and immunomodulator. Self assembly technology enables SVP™ design variations that are analogous to structure–activity relation analyses used in small molecule research.
  • Proprietary T-Cell activation. Universal helper T-Cell antigens can be integrated within vaccines developed by Selecta to ensure a rapid, robust, and durable immune response.

Enhanced Safety Profile

  • Selective lymph node targeting. SVP™ efficiently focuses the exposure to vaccine components to the lymphoid tissues, thus minimizing systemic adverse effects.
  • Synthetic nanoparticle. SVP™ contains fully synthetic and clinically validated biodegradable components, avoiding safety issues commonly associated with biologically-derived and conjugated vaccines.

Rational and Modular

  • Selecta’s targeted vaccines can present a wide variety of antigens, including proteins, peptides, oligosaccharides, and small molecules, to treat or prevent a broad spectrum of diseases. Variations of antigen and adjuvant or immunomodulator can be combinatorially optimized in a rational design process. This enables the analysis of structure-activity relationships, leading to more effective and efficient development cycles.

Production Simplicity

  • Selecta’s targeted vaccines can be prototyped and manufactured at scale without the challenges and costs of the complex biological processes that form the basis for conventional vaccines. Furthermore, both cost and time-to-market risks are lower as manufacturing is based upon readily scalable processes using established pharmaceutical unit operations.

Product Development

Selecta has applied its proprietary platforms to develop a pipeline of novel product candidates with a broad range of therapeutic applications, including addiction, cancer, autoimmune, and infectious diseases. Selecta’s lead development programs include therapeutic and prophylactic vaccines and immunotherapeutics, such as a nicotine vaccine, a universal HPV cancer vaccine, a universal influenza vaccine and a tolerogenic vaccine for type 1 diabetes. Selecta is committed to rapidly advance its lead programs, and anticipates initiating its first human clinical trial in 2011.

Smoking Cessation SEL-068

Selecta's lead compound is a nicotine vaccine for smoking cessation (SEL-068). There are over a billion people who smoke worldwide, and more than 46 million in the United States. According to the US Center for Disease Control greater than 70% of smokers desire to quit, but only about 5% will be successful. A nicotine vaccine will create nicotine specific antibodies that capture the nicotine as it enters the blood. The nicotine—antibody complex is physically too large to cross the blood-brain barrier, and thus the antibodies induced by the nicotine vaccine prevent nicotine from reaching the brain and asserting its addictive effect. Clinical trials by others have shown a strong correlation between nicotine antibody levels and smoking cessation, but had difficulties in raising therapeutically effective antibody levels. Nicotine is normally not immunogenic, but when displayed on the surface of Selecta’s tSVP™’s it has elicited very strong antibody titers in preclinical studies with an improved safety profile. In non human primate studies in two different species SEL-068 has produced dose respondent and order of magnitude higher antibody levels than published.

The pre-clinical trials were conducted in 2011.

The current smoking cessation market is worth $4 bln and limited by the low efficacy of the currently marketed products.

Universal Influenza

Selecta is pursuing various strategies for universal influenza vaccines using different highly conserved epitopes. tSVP™ formulations have achieved high antibody titers in rodents with both subcutaneous and intranasal routes of administration. This approach could be applied also in pandemic situations to improve both efficacy and time to reach patient. The resulting product would have a strong value proposition in a market currently worth $5 bln.

Universal HPV

Selecta is developing a vaccine nanoparticle targeting epitopes of the Human Papilloma Virus (HPV) conserved over multiple strains.

The national cancer institute (NCI) tested this novel vaccine and detected virus neutralization for all 6 strains tested. A universal HPV vaccine would be complementary or could substitute current products with sales of more than $3 bln.

Malaria

Selecta has been approached by the National Institute of Health (NIH) to develop a vaccine against Malaria. Malaria is a growing parasitic disease threatening half of the world’s population. Due to the low immunogenicity of current vaccine technologies, no effective vaccine has been developed so far.

Type 1 Diabetes

T1 Diabetes is an auto-immune disease affecting more than 10 Million patients worldwide. The patient’s immune system is attacking the insulin producing beta cells in the pancreas resulting into lifelong dependency of insulin replacement therapy. Selecta is developing a tolerogenic vaccine together with the Juvenile Diabetes Research Foundation with the potential to prevent the onset of the disease.

Preclinical Highlights SEL-068

Preclinical Highlights SEL-068

Figure: SEL-068, Selecta’s tSVP™ nicotine vaccine, gives superior nicotine antibody titers (above) with significantly lower systemic cytokines leading to improved safety (below).

Left: nicotine arrayed on a nanoparticle with no adjuvant but including the T-cell memory antigen gives a low response (white bar), when adjuvant is admixed to that nanoparticle the response is improved to a titer of ~10,000 (red bar), Selecta’s tSVP™ with the T-cell antigen and adjuvant inside the particle gives an order of magnitude higher response (blue bar).

Right: The admixed adjuvant, used in current vaccine approaches, gives significant levels of systemic cytokines such as TNF-α and IL-6, which can be responsible for side effects such as aches, pains and fever (red line) while the Selecta tSVP™ has systemic cytokines 40 fold lower (blue line)—the same as when no adjuvant is delivered—while delivering nicotine antibody titers 10 fold higher than the admixd adjuvant. The targeted nature of the tSVP™ gives a maximal nicotine antibody titer with improved safety.

Additional information

Reference

RUSNANO was established in March 2011 as an open joint stock company created through reorganization of the state corporation Russian Corporation of Nanotechnologies. RUSNANO's mission is to develop the Russian nanotechnology industry through co-investment in nanotechnology projects with substantial economic potential or social benefit. The Government of the Russian Federation owns 100 percent of the shares in RUSNANO. Anatoly Chubais is CEO and chairman of the Executive Board of RUSNANO.

Work to establish nanotechnology infrastructure and training for nanotechnology specialists, formerly conducted by the Russian Corporation of Nanotechnologies, has been entrusted to the Fund for Infrastructure and Educational Programs, a non-commercial fund also established through reorganization of the Russian Corporation of Nanotechnologies.

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Selecta RUS LLC is a Russian company founded in 2011 by Selecta Biosciences Inc. and RUSNANO. Selecta RUS LLC together with Selecta Biosciences Inc. will develop a new class of fully synthetic vaccines and immunotherapies based on nanoparticles. The first product which the company plans to develop will be an effective vaccine for the treatment of nicotine addiction. In addition, Selecta RUS LLC will participate in programs focusing on development of innovative vaccines in other therapeutic areas such as in cancer, autoimmune diseases, and infectious diseases.

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Selecta Biosciences, Inc. is a biopharmaceutical company developing an entirely new class of targeted vaccines that induces an antigen-specific immune activation or antigen-specific immune tolerance for therapeutic and prophylactic applications. Selecta's pipeline currently contains a vaccine for smoking cessation and relapse prevention, a vaccine for Type 1 Diabetes, vaccines for several infectious diseases (such as chronic infections and malaria), and research approaches with cancer vaccines and in the field of allergies.