Establishment of Joint Research Chair by Takeda and Osaka University Development of platform for practical application and commercialization of nano-particle vaccines (2012-1-6)


Osaka, Japan, January 6, 2012 — Osaka University and Takeda Pharmaceutical Company Limited ("Takeda") announced today their agreement on the establishment of a Joint Research Chair for 3 years to develop a platform for the practical application and commercialization of vaccines using hydrophobic poly (γ-glutamic acid) (γ-PGA) nano-particles as adjuvant.

The Joint Research Chair at Osaka University is academic-industry collaboration research program, through which the university and external institutions such as business enterprises perform joint research to achieve outstanding results. They aim to bring results to society by expanding them to a new industry. The program was established in April 2006. Currently, more than 20 programs have been launched in advanced scientific areas including biotechnology.

Takeda launched the Vaccine Business Division on January 1, 2012, which pursues opportunity ranging from enhancing vaccine pipelines through in-licensing innovative vaccines and establishing new technology platform, to geographical expansion of the vaccine business outside of Japan. The Joint Research Chair established at Osaka University as part of Takeda's vaccine strategy, will contribute to further develop innovative technology in Takeda R&D including CMC research

More (http://www.takeda.com/press/article_44852.html)



Kringle Pharma's project entitled 'Recombinant human HGF for the treatment of spinal cord injury' is accepted by Japan Science and Technology Agency, JST, as its Adaptable and Seamless Technology transfer Program, A-STEP.(2011-10-24)


This project has been carried out for years having its base on the collaboration with Professors Hideyuki Okano and Yoshiaki Toyama's group at Keio University School of Medicine. JST will support Kringle to conduct a proof-of -concept clinical study of recombinant Human HGF for the treatment of acute spinal cord injury. The clinical development will be supervised by Assistant professor Masaya Nakamura in Keio University School of Medicine, as a principal investigator.



Microwave Chemical Co., Ltd. (MWCC) won the third place of the venture company finalist-25-members in the world in Global Entrepreneurship Competition of the BizBarcelona-2011 held in Barcelona. (2011-6-16)


This year the Global Entrepreneurship Competition was won by the U.S. company Imprint Energy. This company came up with a system that can print ultra-thin rechargeable batteries, using an existing technology and could be applied to any mobile device. The second place of this international competition between the 24 top business plans in the world was the company DeepScan, while the Japanese company Microwave Chemical Corporation was in the third place with their project of transforming used industrial oil into fuel.





In the ranking of the world's "TOP 30 INSTITUTIONS IN IMMUNOLOGY", Osaka University was ranked No. 1.(2011-4-17)


Data for the ranking were based on the "Essential Science Indicators" database of Thomson Reuters (Jan. 2000 - Dec. 2010), and ranked by citation impact (citations per paper).

Prof. Shizuo Akira (Director of IFReC) greatly contributed to Osaka University's ranking. Of the 61 highly cited articles from the immunology faculty at Osaka University, 56 were by Prof. Akira's group. Prof. Shion Sakaguchi, who joined IFReC from 2011, had previously contributed significantly to Kyoto University obtaining the 3rd ranking.
The research areas of specialization of Profs Akira and Sakaguchi are innate immunity and regulatory T cells, respectively.

TOP 30 INSTITUTIONS IN IMMUNOLOGY, 2000-2010 (THOMSON REUTERS)




Prof. Shizuo Akira of IFReC was awarded "The Canada Gairdner International Award".(2011-3-23)


The Canada Gairdner International Award which are recognized as among the most prestigious awards in biomedical science.
The Gairdner Foundation announced on March 23 that Dr. Shizuo Akira (Director of IFReC), Dr. Jules A. Hoffmann (Centre National de la Recherche Scientifique, University of Strasbourg, France), and three other scientists are awarded The Canada Gairdner International Award 2011.

Awarded for
"For revolutionizing our understanding of innate resistance to infection in the animal kingdom by discovering the role of Toll-like receptors and the array of microbial compounds that they recognize and respond to."

The discovery
Dr. Akira discovered Toll-like receptors act as a sensor for microbes and activate anti-microbial defenses, essentially mobilizing the immune system to fight infection. He discovered that these receptors recognize specific microbes, where we previously thought that the immune system attacked microbes in a non-specific manner.
Identifying the role of these Toll-like receptors provided insight into the immune system's first line of defense against microbial infection, as well as how inflammatory responses work during infection. More importantly, this work found that these Toll-like receptors are essential to adaptive immunity, where the immune system 'remembers' specific invading pathogens, so that it can mobilize more quickly and effectively if that pathogen invades in the future.
Application
As a result of the discovery that Toll-like receptor activation leads to adaptive immunity, a variety of therapies activating and de-activating Toll-like receptors are now in clinical trial for vaccines, cancer immunotherapy, allergies, autoimmune diseases, and septic shock. This work can lead directly to more effective vaccines against bacterial and viral infection, as well as cancer.





Avery-Landsteiner Prize awarded to Professor Shizuo Akira, Director of IFReC.(2010-10-1)


In the 40th Annual Meeting of the German Society for Immunology (DGFI) on September 22-5, 2010, Avery-Landsteiner Prize was awarded to Professor Shizuo Akira, Director of IFReC. Professor Akira is the third Japanese to be awarded the prize. The first and the second Japanese winners are Dr. Susumu Tonegawa (RIKEN, Nobel laureate of 1987) and Prof. Tadamitsu Kishimoto (the former president of Osaka University), respectively.

Avery-Landsteiner Prize

Website of DGFI




Investigation of CollategeneTM, HGF Plasmid for Ischemic Disease Treatment designated as the Fast Track development program by the FDA
(2010-9-17)


AnGes MG Inc. announced today that its US subsidiary, AnGes, Inc's investigation to develop CollategeneTM as a treatment for Critical Limb Ischemia (CLI) has been designated as a Fast Track development program by the Food and Drug Administration. (FDA)

Under the FDA Modernization Act of 1997, designation as a Fast Track product for a new drug or biological product means that the FDA will take actions as appropriate to expedite the development and review of the application for approval of such product.

Request for Fast Track designation was submitted by AnGes, Inc. in July 2010. This designation enables AnGes to acquire timely advice from the FDA to facilitate the development. Furthermore, the FDA may evaluate for filing and commence review of portions of an application for approval of a Fast Track product under certain conditions.

As previously announced, since our phase 3 global clinical study protocol has received SPA approval from the FDA, provided that we obtain robust positive data from the pending clinical study, it is possible that CollategeneTM will be granted Priority Review.

Dr. Ei Yamada, CEO of AnGes MG commented, "The fact that CollategeneTM obtained Fast Track status in addition to reaching agreement on SPA, reflects the unmet medical need and the CLI patients' high expectation for this new treatment option. In particular, because of the higher prevalence, the need for a new treatment in this field is greater in the US as well as in Europe, compared to Asian nations. It is our expectation to expedite the initiation of the global phase 3 clinical trial."






Semaphorins guide the entry of dendritic cells into the lymphatics by activating myosin II (Prof. Kumanogoh in Nature Immunology)(2010-3-31)


The recirculation of leukocytes is essential for proper immune responses. However, the molecular mechanisms that regulate the entry of leukocytes into the lymphatics remain unclear. Kumanogoh and their colleagues show that plexin-A1, a principal receptor component for class III and class VI semaphorins, was crucially involved in the entry of dendritic cells (DCs) into the lymphatics. Additionally, Kumanogoh and their colleagues show that the semaphorin Sema3A, but not Sema6C or Sema6D, was required for DC transmigration and that Sema3A produced by the lymphatics promoted actomyosin contraction at the trailing edge of migrating DCs. Their findings not only demonstrate that semaphorin signals are involved in DC trafficking but also identify a previously unknown mechanism that induces actomyosin contraction as these cells pass through narrow gaps.



NIBIO began the provision of a human iPS cell (subdivision) to the private company.


NIBIO began the provision of a human iPS cell (subdivision) to the private company. (2009-12-14)

The National Institute of Biomedical Innovation (NIBIO) has administered the cell bank up to now as a representative, public master bank in our country. It has been collecting and standardizing about 1000 kinds of cells mainly for human cells, and then offered them to each research institutes.

The provision (subdivision) of a human iPS cell was started for domestic universities and public research institutes in April, 2009, together with the technical guidance for its culturing.

Recently, it came to offer human iPS cells to the private company in our country.

【The kind of offered human iPS cell】

Nine kinds of human iPS cell (nine stocks) deposited by Akihiro Umezawa (Manager of Department of Reproductive Biology, National Research Institute for Child Health and Development (NCCHD)).

They were cloned from human fetal lung fibroblast cells into which four factors (Human OCT3/4, Human SOX2, Human KLF4, and Human c-MYC) had been introduced.



A patent of new decoy oligonucleotides was concluded in Japan (chimera (double) decoys of NF-κB and ets)(2009-10-22)


AngesMG announced that a patent of new chimera (double) decoy oligos for NF-κB and ets was concluded in Japan. This patent will be able to provide a new medicine for treatment of a disease due to genetic expression controlled by NF-κB and/or ets. And it intends for the chimera decoys that are expected to exert stronger anti-inflammatory action than conventional NF-κB decoys. As indication this new decoys intend for various aneurysm such as an aortic aneurysm, the cerebral aneurysm, etc. In this patented invention, the aneurysms is expected to be treated medically without surgical operation, by controlling transcription factor NF-κB and ets taking part in the inflammation and the resolution of the matrix that are pathogenesis of aneurysms.



PROTEIN-MALL KANSAI

A coordinated project for the protein, "Protein Mall Kansai", was newly established on May 8, 2009, and many Saito LSP-located enterprises have been participating as active members.(2009-8-20)


Recently, the importance of the protein study is recognized again with the progress of the genomics. While the Osaka area was proud of the bright results in a research field of the protein traditionally, a lot of research laboratories and venture companies related to the protein etc. have accumulated in not only the northern Osaka including Saito but also Kansai.

Thus, a non-profit association "Protein Mall Kansai (PMK)" was newly established in May, 2009 by participation of organizations that are interested in the research and development related to the protein. PMK aims at a joint research and promotion of the trust business through the exchange of information between members etc. Additionally, it promotes mutual use of study results and support of starting-up a new business by the planning of the collaborative project and developing the promotion activity etc.

Moreover, it aims to support the creation of protein-related drugs, new biomarkers and surrogate markers continuously in the future, and to construct the seamless and advanced value chain concerning the protein by developing the joint project business in the Kansai region.



AnGes MG, Inc. announced that the project "Development of New Medical Supplies by Applying Functional Peptides with Reproduction Mechanism of Plant" (Joint R&D with Morishita Jintan Co., Ltd. and Osaka University) was adopted for METI's Grants.(2009-7-14)


AnGes MG, Inc. announced that the project "Development of New Medical Supplies by Applying Functional Peptides with Reproduction Mechanism of Plant" (Joint R&D with Morishita Jintan Co., Ltd. and Osaka University) was adopted for METI's Grants.


This project aims at the development of new products using the functional peptides with antibacterial activity. Its main object is to develop new adjunctive medical supplies of the type that doesn't suppurate easily and recovers easily, by applying the functional peptide (natural healing peptide with regenerative function) of the plant origin.

  Concretely, it is related to the creation of safe, nonirritating and gentle first-aid adhesive tape and bedsore pad that can keep the wound area clean by preventing bacterial infection.



The 9th Bio-technology Business Competition JAPAN highest award and outstanding prize were decided. (2009-03-16)

Bio-technology Business Competition JAPAN Planning Committee (composed of 9 organizations including Osaka Chamber of Commerce and Industry, Osaka Prefecture, International Cultural Park Corporation, etc.) held the final qualifying trial of The 9th Bio-technology Business Competition JAPAN on March 16 at Osaka Industrial Creation Pavilion. It elected the highest award and the outstanding prizes (3 winners).

The highest award is as follows:

"Practical realization of ultrahigh-performance spider's thread protein fiber material that doesn't depend on petroleum"

    Kazuhide Sekiyama (CEO & President of Spiber Inc.) (Photo) and Junichi Sugahara (Director & Vice-President of Spiber Inc. )
Spiber Inc.


The outstanding prizes are as follows:

  • "Sleeping brain wave measurement, establishment of sleep evaluation technology, and construction of evaluation system"
        Yoshihiro Urade (Research Manager, Osaka Bioscience Institute)
        Masaki Yoshida (Osaka Bioscience Institute)

  • "The insect pest control for cruciferous plants using natural enemy attractant and activator"
        Junji Takabayashi (Prof., the Center for Ecological Research (CER), Kyoto University)
        Hiroyuki Matsubara (Marubeni Corporation)

  • "Construction of biological resources library and potential improvement strategy as lead compound search source"
        Akihiko Kanamoto (CEO, OP BIO FACTORY Co., Ltd.)
        Takuji Nakashima (Kitasato University)






Toyopolymer.Co,.Ltd. announced that new material "RUBYLER" for the prosthetic limb has developed. "RUBYLER" is more lightweight and less stuffiness than any other breathable prosthetic material (artificial limb), then it will be exhibited to Convertech Japan2009 (2/18-20 Tokyo). (2009-01-09)


Toyopolymer has developed a new material "RUBYLER" with a microporous structure that provides dimensional accuracy and workability superior to conventional silicone prosthetics. Unparalleled lightness is the most outstanding advantage. It also offers comfort to the wearer, with high safety.

More Imformation

Left is "RUBYLER"



Kringle Pharma Commences a Phase I/II Clinical Trial in Sweden on ChronSealR®,a Recombinant Human HGF-Based Therapy for the Treatment of Skin Ulcers (2009-01-28)


Kringle Pharma, Inc. (Head office located in Toyonaka, Osaka; President & CEO: Kunio Iwatani, "KRINGLE") is proud to announce that the clinical trial application of ChronSealR® to the Swedish authority, Medical Products Agency (MPA), dated 23 December 2008 was approved on 23 January 2009. Having its approval granted by the authority, KRINGLE will conduct a phase I/II clinical trial of ChronSealR® in Sweden.

ChronSealR® is a topical application therapy having recombinant human hepatocyte growth factor (HGF) as a main effective pharmaceutical ingredient. Its clinical trial has already been initiated in Norway from November 2008 (refer to our press release dated 3 December 2008). Regulatory approval granted by MPA allows KRINGLE to commence a multi-national clinical trial of ChronSealR® in two Scandinavian countries.

A therapeutic potential of HGF against skin ulcers was previously observed in the investigational pilot human studies which undertook at Linkoping University Hospital, Sweden. The upcoming phase I/II study in Sweden will evaluate the therapeutic efficacy of ChronSealR®. The phase I/II trial is designed as a randomized, double-blind, and vehicle controlled study for the subjects with venous leg ulcers. For more details, please refer to the US Food and Drug Administration (FDA) database ClinicalTrials.gov with identifier No. NCT00797706.



AntiCancer Japan, Ltd. launched the cancer cell labeled with GFP/RFP.(2009-1-7)


AntiCancer Japan, Ltd. announced that it signed a sales contract for the cancer cells labeled with the fluorescent protein gene (GFP and RFP) with Wako Pure Chemical Industries, Ltd. and began sales of such labeled cancer cells (tens of kind of cancer cells originated from various organs) to cancer researchers of the university and the public research institutes.

By using these GFP/RFP labeled cancer cells, you can readily make the model mouse bearing brightly fluorescing tumor (see a photograph shown below).




Kringle Pharma Europe AB Established in Sweden (2008-12-17)


Kringle Pharma,Inc. (Head office located in Toyonaka, Osaka; President & CEO: Kunio Iwatani, "KRINGLE") and Tripep AB (Head office located in Huddinge, Sweden; CEO: Jan Nilsson, "TRIPEP") have been engaged in co-development of ChronSeal®, a novel wound healing therapy using recombinant human hepatocyte growth factor (HGF) for venous leg ulcers in Norway and Sweden. (refer to their press release dated December 3, 2008 for details)

To facilitate the co-development efforts for ChronSeal® and push forward its clinical development, KRINGLE and TRIPEP agreed to jointly establish Kringle Pharma Europe AB ("KRINGLE EUROPE"), a consolidated subsidiary of KRINGLE, in Sweden. All the assets related to the ChronSeal®project will be transferred to KRINGLE EUROPE, from the date of its establishment, KRINGLE EUROPE will be a sole vehicle to further the clinical development of ChronSeal® and explore its licensing opportunities.

Overview of the subsidiary
Company nameKringle Pharma Europe AB
LocationStockholm, Sweden
Date of establishmentDecember 10, 200
Board membersKunio Iwatani (Chairman of the Board)
Jan Nilsson
Share capitalt100,000SEK
Shareholding ratio: KRINGLE 75% , TRIPEP 25%.


Kunio Iwatani stated "Recognizing the fact that phase 2 clinical study of ChronSeal® has already been initiated in Norway from November, I am expecting licensing activities related to ChronSeal® would gain great momentum. By launching KRINGLE EUROPE, KRINGLE will strengthen its efforts to achieve proof of concept (POC) of HGF as a pharmaceutical product and materialize a licensing deal with a pharmaceutical company."



Accomplishment of the GMP manufacturing facility for nucleic acid medicines (2008-12-05)


GeneDesign, Inc. announced that it has completed the GMP manufacturing facility for nucleic acid medicines first in Japan and straightened the system to support overall processes from their discovery to pre-clinical/clinical development.

In Japan, there was no organization with the system to support R&D of the nucleic acid drugs overall, thus it has been a bottleneck in the efficient development of such drugs until now. Recently, GeneDesign have completed the facility where a nucleic acid compound as an investigational new drug is manufactured into the sterilized products under the GMP control.

The nucleic acid related compound has been developing as an innovative drug which has a new action mechanism, as well as the antibody drug. GeneDesign adopted the sterile production system with an isolator and nucleic acid synthesis equipment, then accomplished the GMP facility with the advanced manufacturing environment maintenance system.

Using this new facility and nucleic acid intermediates hitherto supplied by the company, it became possible to manufacture a nucleic acid medicine lead compound consistently from small to large scale and to carry out its optimization study toward the drug material.

The support system offered by GeneDesign will bring more acceleration in development of nucleic acid drugs.



Kringle Pharma Initiated a Phase 2 Clinical Trial in Norway on ChronSeal®, a Recombinant Human HGF-Based Therapy for the Treatment of Skin Ulcers. (2008-12-03)


Kringle Pharma,Inc. (Head office located in Toyonaka, Osaka; President & CEO: Kunio Iwatani, "KRINGLE") proudly announces it has initiated a phase 2 clinical trial of ChronSeal®, a novel wound healing therapy using recombinant human hepatocyte growth factor (HGF) for venous leg ulcers in Norway.

A clinical trial application for the phase 2 study was submitted to the Norwegian Medicines Agency (NoMA) on August 4, 2008. It was approved by NoMA to conduct the study on October 3, and the recruitment of the study subjects has started from November.

A therapeutic potential of HGF against skin ulcers was previously observed in the investigational pilot human studies which undertook at Linkoping University Hospital, Sweden. The upcoming phase 2 study in Norway will evaluate the therapeutic efficacy as well as safety and tolerability of ChronSeal®. The phase 2 trial is designed as a randomized, double-blind, and vehicle controlled study for the subjects with venous leg ulcers. Detail of the clinical trial is released by US Food and Drug Administration (FDA) database ClinicalTrials.gov., which is found at below URL.
www.clinicaltrials.gov/ct2/show/NCT00797706?term=Kringle&rank=1
The clinical trial application was also submitted to the Medical Products Agency (MPA) in Sweden and is still pending.

Kunio Iwatani stated "I am extremely proud that KRINGLE has initiated a phase 2 clinical study of HGF for venous leg ulcers in Norway. Although it was based on the academic pilot studies, the therapeutic effects of HGF against venous leg ulcers are obvious and promising. Through this phase 2 clinical trial in Norway, KRINGLE is expecting to achieve proof of concept (POC) of HGF as a pharmaceutical product."



Adoption of Interprotein's VEGF project in Super Special Consortia for supporting the development of cutting-edge medical care on Nov. 21. (2008-12-01)


Interprotein Corporation (Interprotein) inform that "Project of Early Clinical Development for AntiCancer Medicine and Device", the Leader, Dr. Hiroyasu Esumi, Director of National Cancer Center Hospital East, which we are joining, was adopted in Super Special Consortia for supporting the development of cutting-edge medical care.

Interprotein's 'Orally available small molecule VEGF (vascular endothelial growth factor) inhibitor project' is one the subjects of the coalition and its clinical trials are planned to be conducted in the collaborative work with the Dr. Yasuhiro Fujiwara's clinical development team in National Cancer Center Hospital and a global pharmaceutical company under Dr. Fujiwara's supervision.

Anti-VEGF antibody drug has been clinically used and its efficacy to prolong survival periods ofpatients with solid tumors has been well established, though it is not orally available but injection use only.

Interprotein succeeded in obtaining the information on the binding mode of VEGF and its receptor based on X-ray crystallographic data of the VEGF/VEGF-receptor complex, and then generated small molecule inhibitors using in silico Drug Design methods. We new have Lead compounds and are conducting the Lead Optimization step in order to develop orally available small molecule inhibitors. We would like to conduct pre-clinical studies of the candidate compound and its clinical trials as soon as possible in the Special Zone.

Regarding detailed information on Super Special Consortia for supporting the development of cutting-edge medical care and "Project of Early Clinical Development for Anti Cancer Medicine and Device", please access to home page of Cabinet Office.



Osaka Bio Headquarters(*) and Shanghai Zhangjiang (group) Co., Ltd. signed the "Memorandum of Understanding" to strengthen bilateral partnership in the biotechnology field on Nov. 18. (2008-11-26)


Since 2006, both parties have held a pharmaceutical industry exchange conference every year alternately in Shanghai and Osaka. Toru Hashimoto, the governor of Osaka Prefecture, visited Shanghai on Oct. 27, then conducted an inspection tour of the Zhangjiang Bio-Park, and exchanged opinions with the parties concerned.

In such situation, "The 3rd pharmaceutical industry exchange conference" was held on Nov. 17-18 in OSAKA with the attendance of Shanghai Zhangjiang (group) Co.,Ltd., then the MOU was concluded

(*) Osaka Bio Headquarters: organized by industry, academia and government in last September, and aiming to make the northern Osaka area the top class biotechnology cluster of the world.



Kringle Pharma Achieved Permission to Conduct Phase 1 Clinical Studies on recombinant human HGF for the Treatment of ARF in US. (2008-10-30)


Kringle Pharma, Inc. (Head office located in Toyonaka, Osaka; President & CEO: Kunio Iwatani, "KRINGLE"), which is undertaking clinical development of recombinant human hepatocyte growth factor (HGF) for acute renal failure (ARF), is proud to announce that its IND (Investigational New Drug) application dated September 26, 2008 (refer our press release dated October 1, 2008) was permitted by FDA to initiate the phase 1 clinical study of HGF for ARF patients.

  KRINGLE will commence the phase 1 clinical study of HGF for ARF patients in US within this year.

  Nonclinical studies using animals have shown that supplementation therapy of recombinant human HGF protein has significant ability to suppress ARF and also to promote the regeneration function of the injured kidney. The safety of recombinant human HGF therapy in humans will be studied as part of the phase 1 clinical trial, then the efficacy of the therapy will be determined during phase 2 studies.

  Kunio Iwatani stated "I am extremely proud that KRINGLE has achieved a permission from FDA to initiate phase 1 clinical study of HGF for ARF patients. There are a significant number of patients suffering from ARF because of the lack of pharmaceutical agents that offer a fundamental cure for the disease. As we are keen to offer such a medication to patients as quickly as possible, we will be accelerating its clinical development following FDA's permission."



The 8th Bio-technology Business Competition JAPAN highest award and outstanding prize were decided. (2008-06-4)


Bio-technology Business Competition JAPAN Planning Committee (composed of 9 organizations including Osaka Chamber of Commerce and Industry, Osaka Prefecture, International Cultural Park Corporation, etc.) held the final qualifying trial of "The 8th Bio-technology Business Competition JAPAN on June 3 at Osaka Industrial Creation Pavilion. It elected the highest awards(2 winners) and the outstanding prizes(4 winners). The highest awards are as follows: