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  • Sendai Virus Vector

Sendai Virus Vector (SeV Vector): A Cytoplasmic RNA Vector

Sendai virus vector (SeV vector) is a vector based on the novel concept “Cytoplasmic RNA vector” that ID Pharma has successfully brought into practical use for the first time in the world. Its applications include a wide range of important bio-businesses such as gene therapy, gene vaccine, therapeutic antibody production, gene function analysis, and recombinant protein production. With this vector, ID Pharma is about to play an important role in medicine by bringing a new approach to the treatment of intractable diseases.

The master patent families ID Pharma owns for SeV vector technologies, including substance patents, have been already issued in many countries, including Japan, US, Europe, and China, strengthening ID Pharma ’s excellent standing in patent position. SeV vector already constitutes the basic element of the main products and technological services ID Pharma provides.

Cytoplasmic RNA Vector: Overcoming Fundamental Problems Associated with Gene Therapy Vectors in the Past

Sendai virus vector and other vectors

Vectors developed for gene therapy in the past had a fundamental problem; they have to enter cell nucleus as DNA in order to express genes they carry. In the nucleus, some vectors insert themselves into chromosomes (integration), while others may lead to genetic recombination with chromosomal DNA. In fact, there are reports of adverse events (leukemia), although rare, that resulted from the use of retrovirus vectors. Also it is known that, in some cases, adeno-associated virus vectors may cause irreversible alterations to the chromosome structure at the site of integration. Consequently, it has become very important to evaluate carefully the balance between risks and benefits before using these vectors in patients.

In contrast, ID Pharma ’s Sendai virus vector replicates its genome exclusively in the cytoplasm and produces protein in large quantity. It does not enter cell nucleus. Moreover, Sendai virus genome is made of RNA, a material chemically different from the patient’s chromosomal DNA. Therefore, there is no chance in principle that ID Pharma ’s Sendai virus vector ever alters the chromosomes in the cell nucleus, and thus it is fundamentally free of risks mentioned above that are associated with other conventional vectors.

Efficacy as Vector for Gene Therapy and Gene Vaccine

Sendai virus vector’s capability to express therapeutic genes in an incomparably high level is the basis of therapeutic efficacy expected of this vector; other conventional vectors may not be able to achieve such efficacy. In fact, the drug candidates of ID Pharma made on Sendai virus vector, for example, gene therapeutic medicine for Critical Limb Ischemia (CLI), Alzheimer's gene vaccine, and AIDS gene vaccine, all exhibited excellent efficacy in preclinical studies. In addition, Sendai virus vector-based drugs are effective in a small dosage, and requires less than 5 minutes of vector-cell contact time to introduce genes into cells, over ten-fold shorter than that required by other vectors. These features of Sendai virus vector make it an easy-to-use, low-burden vector for both doctors and patients.

Therapeutic Antibody Production

Sendai virus vector efficiently induces antibodies to such proteins as membrane proteins, which are elusive to conventional antibody production technologies. Because membrane proteins expressed from Sendai virus vector maintain their native structure and function, antibodies raised against them are likely to be “Functional antibodies.” ID Pharma is continuing to create drugs from such antibodies (therapeutic antibodies or antibody drugs).

Bio-business Other than Therapeutic Use

Sendai virus vector’s capability of highly efficient gene transfer and high-level gene expression both in vitro and in vivo are also useful in areas of bio-business outside therapeutic use. In fact, Sendai virus vector is already used for the production of antibodies for research and diagnostic use, production of recombinant proteins, and gene function analyses.

ID Pharma ’s RNA Vector Technology Leads the World

ID Pharma is one of the front-runners in the recombinant RNA virus vector technologies in the world. In fact, these technologies have received high praises from bio-industry as well as scientific societies in the field of virology and gene therapy. The technologies include the leading-edge technology of efficient construction of “RNA” vector through recombinant “DNA” manipulation, the technology to produce “Intransmissible vector” that can be administered to humans, the technology to control the level of transgene expression in cells, and the technology to produce high-quality vectors suitable for human use. Massive amount of related know-hows have been accumulated, and both master and application patents have already been issued in major countries including Japan, US, Europe, and China.

Proof of the Safety of SeV Vector: Clinical Usage

Kyushu University has performed clinical study using our SeV vector expressing the human fibroblast growth factor-2 (FGF-2) gene in patients with peripheral arterial disease (PAD) and no serious adverse events have been detected (Molecular Therapy 2013; 21 3, 707–714).

After proper preclinical safety studies, International AIDS Vaccine Initiative (IAVI) and ID Pharma has bigun clinical trial of vaccination to HIV with SeV virus vector in Eastern Africa and England in April, 2014 (http://www.iavi.org/country-programs/japan).