From Lonza.com

Basel, Switzerland, and Tokyo, Japan, 7 May 2015 – Lonza, the world’s leading developer and manufacturer of cells for regenerative medicine therapeutics, and Nikon Corporation announced today an exclusive collaboration in the field of cell and gene therapy manufacturing in Japan. Nikon will have access to Lonza’s quality and operating systems, facility design and ongoing consulting services for the establishment of a wholly owned Nikon cell and gene therapy contract manufacturing business. The Tokyo/Yokohama area of Japan is currently under consideration for the site location of the Nikon’s new facility.

Japan has become an attractive location for the future of regenerative medicine since the induction of the Revised Pharmaceutical Affairs Act, which became effective in November 2014. The act states conditional product approval may be granted in Japan at the time when clinical safety and an indication of efficacy of a regenerative medicine product are demonstrated. For this reason Japan is expected to be a promising location for the expedited clinical application of cell and gene therapy products.

The use of somatic stem cells (hematopoietic stem cells and mesenchymal stem cells) has already gained traction in the United States and European biotechnology and pharmaceutical markets, with the use of induced pluripotent stem cells (iPSCs) following quickly behind.

In addition, virally modified gene therapy has demonstrated promising clinical results in multiple disease indications, including cancer. Using viral vectors, immune and stem cells can be genetically modified and reintroduced to the patient as a targeted therapy.

The global reach of the regenerative medicine market and the advancement of stem cell manufacturing have driven this collaboration in Japan. With this collaboration Nikon will benefit from Lonza’s extensive track record in global cell manufacturing, while expanding its entry into the contract manufacturing market. Nikon will acquire the technical know-how to differentiate and manufacture cells, including somatic stem cells, as well as Lonza’s quality and safety evaluation standards and operational procedures in the manufacturing process. This collaboration will accelerate Nikon’s efforts to realize future practical applications of iPSCs in the field of regenerative medicine.

“This collaboration will contribute greatly to the growth of the global cell and gene therapy market,” said Andreas Weiler, Head of Emerging Technologies, Lonza Pharma&Biotech. “We are utilizing our expertise built over the last decade to work together with Nikon in bringing high-quality, innovative development and manufacturing to Japan. Because of its work in iPSC technology, we believe Nikon is an ideal partner for this collaboration in regenerative medicine.”

Nikon’s newly formed subsidiary, Nikon CeLL innovation Co., Ltd., will actively contribute to the early realization of Japan’s regenerative medicine market and over time will expand its business domain into adjacent technology areas. Furthermore, Nikon will also develop equipment and disposables needed to optimize the manufacture of high-quality cells, along with hardware and software from Japan to the international market.

Jan 13, 2015

Otsuka Pharmaceutical Co., Ltd. (Otsuka) today announces that the exclusive licensing contract that has been in effect with OncoTherapy Science, Inc. (OTS) for the development, manufacture, and marketing of a peptide therapeutic vaccine for the treatment of pancreatic cancer, will be allowed to expire, following 180-day prior notification, at the scheduled end date of the contract period. A sublicensing contract which has been in effect with Fuso Pharmaceutical Industries, Ltd. for the manufacture and marketing in Japan of OTS102, a therapeutic vaccine, will also be allowed to expire on the same date.

Otsuka will continue its efforts in oncology as a priority area. This will include the development of the peptide therapeutic vaccine OCV-C02, for which a phase 1 clinical study is currently underway in colon cancer based on a contract with OTS.

Mountain View, CA – January 5, 2015 – Amunix Operating Inc. (Amunix), a leader in the field of protein half-life extension, today announced a research and development partnership with Naia Limited (Naia), an international drug development company that employs an innovative global strategy to clinically advance drug candidates.  Amunix and Naia signed two exclusive worldwide licenses to further develop two Amunix receptor agonist product candidates: GLP-1-XTEN, a glucagon-like peptide-1 receptor agonist for the treatment of type 2 diabetes and GLP-2-XTEN, a glucagon-like peptide-2 receptor agonist for the treatment of short bowel syndrome.

Under the terms of each license agreement, Naia will be responsible for all preclinical and clinical activities of the product resulting from the collaboration. Upon achievement of certain development, regulatory, commercial and sales-based milestones, Amunix will be eligible to receive milestones totaling up to $70 million for each project, as well as tiered royalties on worldwide annual net sales for the licensed products upon commercialization.

“We are delighted to enter into this strategic partnership and we look forward to our collaboration with Naia, a new company founded and led by an experienced management team in the field of drug development,” said Volker.

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Almac Group, the contract development and manufacturing organization, today announced its key role in preparing and delivering one of the longest synthetically produced protein fragment to be used as a vaccine in a phase I clinical trial for malaria.

European Vaccine Initiative (EVI) – who is leading European efforts to develop effective, accessible and affordable vaccines against diseases of poverty, chose Almac to work on the unique “P27A” project based on their extensive peptide synthesis expertise and capabilities enabling them to complete a significant milestone in the development of this vaccine.

EVI’s primary objective was to assess the clinical safety and immunogenicity of the P27A protein as a malaria blood stage vaccine candidate.

P27A is an intrinsically unstructured, 104-amino acid long hydrophilic fragment derived from the Plasmodium falciparum malaria protein PFF0165c. It presents only one mutation in more than 90 plasmodium strains. Specific human affinity purified antibodies are inhibitory in vitro parasite growth and the antibody response in donors living in endemic areas is associated with protection against malaria.

P27A was manufactured by linear solid phase peptide synthesis, using orthogonal Fmoc/tBu protecting group strategy.  Development of the purification method of the crude protein fragment indicated that product of desired quality could be obtained by reverse phase HPLC which presented a challenge as this method did not scale-up effectively.

To address this issue, Almac combined their expertise and capabilities with the University of Lausanne, and developed an innovative size exclusion method as a preliminary purification prior to HPLC purification and counterion exchange to acetate. This process was applied to 50g of crude P27A to furnish of the final peptide at approximately 90% purity. A total of 2,000 vials each containing 60µg were successfully produced and released for use in clinical trial.

In January 2014, the two-centre phase I clinical trial of the P27A vaccine candidate started in Switzerland at the Centre Hospitalier Universitaire Vaudois, targeting adults from non-endemic areas.  In August 2014, the trial proceeded to the target population in Tanzania at the Ifakara Health Institute. The initial results of the clinical study are expected in early 2015.

Stephen Barr, MD Almac’s Sciences business unit commented “We are delighted with our innovative work on this project to enable us to deliver the long chain peptide vaccine for our client.  Our collaborative approach taken with the University of Lausanne proved invaluable to combine our skills and talent to develop this unique solution.”

Odile Leroy, Executive Director at European Vaccine Initiative “Collaborating with Almac has been an interesting and pleasant learning process on both sides, facing the technology challenges in a positive minded approach which was facilitated by an efficient project management”.

Find out more about Almac’s Peptide and protein service offering by visiting http://www.almacgroup.com/api-services-chemical-development/peptides-proteins/

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