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Researchers at the University of California at San Francisco have developed a way to quickly estimate a woman’s risk for invasive breast cancer. The model, based on a measure of breast density that is already reported with the majority of mammograms today, is the first to be validated across multiple ethnic groups living in the United States. The model could one day be used to help calculate a woman’s risk for breast cancer each time she has a mammogram, providing her with a realistic sense of her likelihood to develop breast cancer in the future. The findings, reported in The Annals of Internal Medicine, showed the model they developed was well calibrated and reasonably accurate across risk factor subgroups. However, the model slightly underestimated breast cancer rates in younger women (age 40-44) and underestimated cancer rates among Asian and Hispanic women. When the researchers compared their model to the widely used Gail model, they found the Gail model was poorly calibrated and underestimated the number of breast cancers by 12 percent. This was particularly true for African American women in whom the Gail model under-predicted the number of breast cancers by 45 percent. The researchers hypothesize this may be because the Gail model was developed and validated in Caucasian women only.

 

CANCER AND INFLAMMATION: AMGEN LICENSES MONOCLONAL ANTIBODY FROM KYOWA HAKKO
Thousand Oaks, California-based Amgen said it will receive an exclusive license to develop and commercialize Kyowa Hakko Kogyo’s humanized monoclonal antibody known as KW-0761 worldwide, except in Japan, Korea, China, and Taiwan. Kyowa Hakko will retain the development and commercialization rights in these countries. Under the terms of the deal, Amgen will make an upfront payment to Kyowa Hakko of $100 million. Kyowa Hakko could receive up to $420 million in additional payments, including development, approval and sales milestones. Kyowa Hakko will also be entitled to receive double digit royalties on sales. The antibody is currently being studied in inflammation and oncology settings. Kyowa Hakko has completed early-stage clinical studies of KW-0761 in healthy volunteers and allergic rhinitis patients, and is currently conducting early stage clinical studies in lymphoma patients. Amgen will initially acquire rights in all non-oncology indications, and may elect to reimburse Kyowa Hakko for its oncology-related development costs. It could also expand its license to include oncology and assume the development and commercialization of KW-0761 in oncology settings when Kyowa Hakko finishes the first mid-stage clinical trial of the antibody in lymphoma.

 

Researchers at the San Francisco-based Gladstone Institute of Cardiovascular Disease and the University of California at San Francisco have identified for the first time how tiny genetic factors called microRNAs may influence the differentiation of pluripotent embryonic stem cells into cardiac muscle. The researchers report in the journal Cell Stem Cell that two microRNAs, miR-1 and miR-133, which have been associated with muscle development, not only encourage heart muscle formation, but also actively suppress genes that could turn the embryonic stem cells into undesired cells like neurons or bone. The differentiation of embryonic stem cells into heart cells or any other type of adult cell is a complicated process involving many factors. MicroRNAs, or miRNAs, seem to act as dimmer switches to fine-tune levels of important proteins in cells. More than 450 human miRNAs have been described, and each is predicted to regulate tens if not hundreds of proteins that may determine cellular differentiation.

 

CANCER: RESEARCHERS FIND NOVEL WAY TO DEVELOP TUMOR VACCINES
Researchers at the University of Southern California have uncovered a new way to develop more effective tumor vaccines by turning off the suppression function of regulatory T cells. Under normal circumstances, regulatory T cells inhibit the immune system from attacking the body’s own cells and tissues to prevent autoimmune diseases. Cancer cells take advantage of regulatory T cells' suppressor ability, recruiting them to keep the immune system at bay or disabling the immune system’s attack provoked by tumor vaccines. The study, published in Nature Medicine, provides a new vaccination strategy to overcome the regulatory T cells’ immune suppression while avoiding over-activation of T cells that can turn against the body. The study identified a new molecular player called A20, an enzyme that restricts inflammatory signal transduction in dendritic cells. When it is inhibited, the dendritic cells overproduce an array of cytokines and co-stimulatory molecules that trigger unusually strong immune responses that cannot be suppressed by regulatory T cells. The resulting hyperactivated immune responses triggered by A20-deficient dendritic cells are capable of destroying various types of tumors that are resistant to current tumor vaccines in mice. Dendritic cells are the guardian cells of the immune systems and play an important role in activating immune responses to recognize and destroy tumor cells.

 

Researchers at the University of California at Los Angeles have discovered that blood stem cells, the cells that later differentiate into all the cells in the blood supply, originate and are nurtured in the placenta. The discovery may allow researchers to mimic the specific embryonic microenvironment necessary for development of blood stem cells in cell culture and grow them for use in treating diseases like leukemia and aplastic anemia, the researchers said. The findings, reported in the journal Cell Stem Cell, solve the mystery of where these cells originate. To generate blood stem cells that are safe for use in patients, it is imperative that scientists learn how to generate self-renewing blood stem cells in a more natural way, by providing the correct developmental cues from the environment in which the cells develop, the researchers said.

 

VACCINES: BAYER AND JUVARIS ENTER BROAD LICENSING DEAL IN VETERINARY FIELD
The Animal Health Division of Bayer HealthCare and Pleasanton, California-based Juvaris BioTherapeutics said that they have entered into a broad-based licensing agreement that provides Bayer with complete access in the veterinary field to the Juvaris mono-immunotherapy and vaccine technology. The technology is being developed by Juvaris for human healthcare. The companies will evaluate and execute product development programs directed at immune stimulation and disease prevention in a variety of animal species. In addition, the agreement anticipates that Bayer Animal Health will help financially support Juvaris' research, product formulation, development, and good manufacturing practices activities to support its alliance obligations. The license is worldwide in scope. The financial terms of the deal have not been disclosed.

Arcadia, California-based StemCyte said it formed a joint venture in India with Apollo Hospitals and Cadila Pharmaceuticals. The joint venture company, StemCyte India Therapeutics, will provide stem cell therapies derived from umbilical cord blood to treat patients with certain malignant blood disorders, including leukemia, lymphoma, and myeloma; inherited disorders such as sickle cell anemia and thalassemia; and immune deficiency diseases. In addition, StemCyte India Therapeutics will participate in clinical studies to develop cell therapies for indications for which there are unmet clinical needs. Financial terms of the transaction were not disclosed.

 

Aliso Viejo, California-based Avanir Pharmaceuticals said that it has executed a definitive agreement to sell its portfolio of human monoclonal anthrax antibodies to Emergent BioSolutions. As part of the transaction, Emergent acquired Avanir’s lead candidate (AVP-21D9) along with several additional anthrax antibodies. In addition, Emergent also received a limited exclusive license to use Avanir’s proprietary Xenerex Technology platform to develop future human monoclonal antibodies targeted against Bacillus anthracis. Under terms of the definitive agreement, Avanir has the potential to receive up to $1.75 million in upfront and milestone payments, as well as royalties on annual net sales if the product is commercialized.