PTC Therapeutics has filed a 10-K – Annual report [Section 13 and 15(d), not S-K Item 405] with the U.S. Securities and Exchange Commission (Filing, PTC Therapeutics, MAR 2, 2015, View Source [SID1234502150]).

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Puma Biotechnology has filed a 10-K – Annual report [Section 13 and 15(d), not S-K Item 405] with the U.S. Securities and Exchange Commission (Filing, Puma Biotechnology, MAR 2, 2015, View Source [SID1234502152]).

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Raptor Pharmaceutical has filed a 10-K – Annual report [Section 13 and 15(d), not S-K Item 405] with the U.S. Securities and Exchange Commission (Filing, Raptor Pharmaceutical, MAR 2, 2015, View Source [SID1234502153]).

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On March 2, 2015 Celimmune LLC, a clinical development-stage immunotherapy company focused on treating and preventing autoimmune diseases reported that it has licensed a Phase 2-stage, anti-IL-15 monoclonal antibody (AMG 714) from Amgen (NASDAQ:AMGN) (Press release, Celimmune, MAR 2, 2015, View Source [SID:1234511963]). Under the provisions of this exclusive license agreement, Celimmune has the rights to develop, manufacture and commercialize AMG 714 on a worldwide basis excluding Japan. Concurrently, Amgen has been granted an exclusive option to reacquire AMG 714, upon completion of additional clinical studies. Financial terms of the agreements are not being disclosed. Celimmune plans to initiate Phase 2 studies of AMG 714 for the treatment of diet non-responsive celiac disease and refractory celiac disease (RCD).

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Dr. Francisco Leon, Celimmune’s CEO and Chief Medical Officer,stated, "Celiac disease is the only common autoimmune disease without any approved medication. Published literature demonstrates that the gluten-free diet is not a solution for the vast majority of patients. As such, Celimmune is delighted to have an opportunity to license an experimental therapeutic that will test one of the main hypotheses in the pathophysiology of celiac disease, namely that IL-15 plays a central role in RCD and non-responsive celiac disease. IL-15 appears to be an essential, non-redundant, growth factor for the intraepithelial lymphocytes, which cause intestinal mucosal atrophy and the progression to lymphomain RCD. IL-15 has been shown to be one of the key factors in the loss of tolerance to food antigens in celiac disease, and also is believed to be involved in Crohn’s disease and other autoimmune diseases."

Ashleigh Palmer, Celimmune’s Executive Chairman, said, "Our agreement with Amgen underscores Celimmune’s distinctive core competence focused on the translational and clinical development of high-potential therapeutics for priority autoimmune and other immunological diseases with high levels of unmet medical and socioeconomic need, including cancer. Celimmune, in partnership with our enabling networks, has deep management experience, proven capabilities and industry leading expertise in developing clinical-stage assets for celiac and other autoimmune diseases. AMG 714 could be the first drug to market for a celiac indication, and there are currently no other drugs in clinical development targeting the IL-15 cytokine. In addition to celiac, AMG 714 could have longer-term expansion and life cycle management opportunities within adjacent gastrointestinal autoimmune diseases."

About Celiac Disease
Celiac disease is a chronic hereditary systemic autoimmune and inflammatory disease triggered by gluten consumption. Celiac disease is characterized by damage to the lining of the small intestine, causing gastrointestinal dysfunction and debilitating symptoms. Nutritional malabsorption can lead to a failure to thrive in children and anemia and osteopenia in adults. Over the course of a life time, untreated or poorly managed celiac disease is often associated with deteriorating general health, multiple serious intestinal and extra-intestinal medical complications, and increased morbidity and mortality. Currently 1% of Western and 0.5% of Asian populations suffer from celiac disease and diagnosed prevalence is expected to increase dramatically with improved diagnostic tools and clinical awareness.

On February 27, 2015 Kite Pharma, Inc., (Nasdaq:KITE), a clinical-stage biopharmaceutical company focused on developing engineered autologous T cell therapy (eACT) products for the treatment of cancer reported that the Company has amended its Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute (NCI) (Press release, Kite Pharma, MAR 2, 2015, View Source [SID:1234512949]). The amendment will encompass emerging areas of research in the immune response to tumor neo-antigens, truly tumor-specific antigens generated as tumors accumulate genetic mutations. In addition, new T cell receptor (TCR) and new chimeric antigen receptor (CAR) product candidates targeting solid tumors have been added to the collaboration. The amendment broadens Kite’s ongoing research collaboration with the Surgery Branch at the NCI, led by Steven A. Rosenberg, M.D., Ph.D. and provides additional product candidates for Kite’s growing pipeline.

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"Neo-antigen immunotherapy will allow us to design a cancer treatment that can modify a patient’s T cells to recognize the unique genetic profile of the patient’s own tumor. This offers a new paradigm in cancer care and extends the significant progress we have achieved in collaboration with Dr. Steven Rosenberg, Chief of Surgery, and his clinical research teams at the NCI," said Arie Belldegrun, M.D., FACS, Kite Pharma’s President and Chief Executive Officer.

Under Kite’s amended agreement with the NCI, the additional programs will encompass:

Methods of rapidly identifying and developing TCR product candidates targeted against neo-antigens.

Optimizing new methods to manufacture this new class of individualized therapies.

Developing additional TCR product candidates retrovirally engineered to target tumor antigens, including for the treatment of colorectal and lung cancers.

David Chang, M.D., Ph.D., Kite Pharma’s Executive Vice President, Research and Development, and Chief Medical Officer, commented, "This year, we have substantially broadened our plan and vision for clinical development, engaging in a strategic R&D collaboration with Amgen, combining their cancer targets with our T cell platform technology, as well as expanding our agreement with Tel Aviv Sourasky Medical Center to develop novel approaches to CAR T cell therapy. The new research under our CRADA with the NCI further extends our clinical programs, particularly in regard to new TCR approaches. We are deeply committed to the rapid advancement of these programs for the benefit of patients."