Shin Nippon Biomedical Laboratories, Ltd. ("SNBL"; CEO: Ryoichi Nagata; Tokyo, Japan) announces that an agreement has been concluded with ISA Pharmaceuticals through its fully-owned subsidiary ISA Therapeutics B.V.1) ("ISA"; CEO: Ronald Loggers; Leiden, Netherlands) on March 3, 2015. Under the agreement, SNBL will be evaluating its novel nasal vaccine delivery platform1) for prophylactic use of ISA's proprietary Synthetic Long Peptide (SLP®) immunotherapeutic, ISA1012).

SNBL has succeeded in developing a versatile nasal drug delivery platform technology that can be applied to various drugs, including delivery of small molecule compounds and peptides3), and is extending its application to delivery of vaccines. Development of a novel nasal influenza vaccine, TR-Flu4), is underway. The feasibility study aims to further promote the application of the nasal vaccine delivery technology to prophylactic use in preventing cervical cancer.

Human papilloma virus (HPV)5) infection is by far the highest risk factor of cervical cancer and is found in virtually all cervical cancer cases. Of the high risk HPV types, HPV16 is responsible for approximately half of all cervical cancer cases. Worldwide, cervical cancer is the second most common cancer in women after breast cancer. In Japan, approximately 10,000 women are diagnosed for cervical cancer, and approximately 2,700 infected women lose their lives annually. Since HPV can stay persistent in the body for over a decade before causing cancer, there is a strong demand to not only prevent infection but also to prevent infected people from developing cancer.

ISA101 is applicable to treat early stage, advanced and recurrent cancer induced by HPV infection. ISA101 has proven to be capable of eradicating pre-malignant lesions and of clearing persistent HPV16 infection. ISA is developing ISA101 in an injectable form and has successfully conducted several clinical studies in Netherlands and Belgium for advanced and recurrent cervical cancer.

Through the feasibility study of intranasally administered ISA101, SNBL plans to obtain basic research data regarding the induction of HPV-specific immune responses capable of homing to the cervix in order to assess its preventive effects on development of cervical cancer.

The effect of this new venture on the earnings of SNBL's current term is minimal.

For more than 55 years, SNBL has been a leader in helping biopharmaceutical companies generate high quality data with the exceptional precision needed to rapidly advance new medical therapies and innovations that improve patients' lives. SNBL's business consists of contract research in preclinical studies, clinical pharmacology studies, pharmacokinetics/bioanalysis, and clinical studies, as well as SMO business. In the recent years, SNBL is aggressively expanding the Translational Research business.

ISA Pharmaceuticals B.V. and its fully-owned subsidiary ISA Therapeutics B.V. represent an immunotherapy company developing rationally designed, fully synthetic immunotherapeutics against cancer and persistent viral infections. The company has built a proprietary immunotherapy platform based on the Synthetic Long Peptide (SLP®) concept and AMPLIVANT® technology, which enable the generation of safe and effective drugs with a known mechanism of action. SLP® immunotherapies are capable of fully harnessing and directing the body's own defenses towards fighting the disease. Its most advanced product is a highly efficacious therapeutic product against HPV-induced lesions. The company was founded in 2004 by Aglaia Oncology Fund and has its roots in the ground-breaking research performed by the group of the internationally renowned tumor immunologist Professor Kees Melief. R&D is performed in close collaboration with the Leiden University Medical Center, the Netherlands.

http://www.isa-pharma.com/

[Footnotes]

1) SNBL has developed a novel nasal drug delivery technology, covered by international patents, which significantly enhances the absorption of powder nasal drugs from the nasal mucosa. The technology has demonstrated its safety and efficacy in several clinical studies.

2) ISA101 consists of 13 synthetic long peptides (25-35 amino acids long) derived from the E6 and E7 oncogenic proteins of the HPV 16 virus.

3) Peptide is a molecule consisting of two or more of amino acids, which is known to cause various biological effects ranging from hormonal to neural.

4) TR-Flu is a new intranasal powder dosage form of influenza vaccine that utilizes SNBL's nasal delivery technology. TR-Flu also incorporates a process developed at SNBL that retains the vaccine's structure and activity during powderization. Unlike traditional vaccine injections, TR-Flu has the benefits of noninvasive administration and carries no potential risks of pain and accidents associated with needle injections.

5) HPV is typically transmitted through sexual contact and infects the anogenital region. Since early infection stage is usually subclinical with no symptom, approximately 80% of women are infected with HPV without their knowledge. Among more than 100 serotypes of HPV, high-risk HPV infection can progress to invasive cancer. Although most infection is cleared naturally by normal immune response, 1~2% of infected women develops intraepithelial neoplasia, a premalignant HPV-induced lesion. If appropriate treatment is received at this stage, only 0.2~0.3% develops cancer while 30% of infected women will develop cancer if no treatment is received.