Merrimack is developing a companion diagnostic for seribantumab to measure the levels of five proteins involved in the ErbB pathway and predicts the activated state of ErbB3 for the diagnosis of cancer (Filing 10-K , Merrimack, MAR 30, 2012, View Source [SID:1234501371]).
Merrimack is developing a companion diagnostics for use of MM-111, to identify overexpression levels of ErbB2 (HER2), ErbB3 and heregulin levels for the diagnosis of cancer

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New Drug Application Approval for
POTELIGEO® (Mogamulizumab) Injection in Japan,
a Therapeutic Antibody for Adult T-cell Leukemia-Lymphoma (ATL)

In March 30 2012 Kyowa Hakko Kirin reported that it has received approval for a new drug application (NDA) from the Ministry of Health, Labour and Welfare (MHLW) for POTELIGEO (Mogamulizumab) Injection ("POTELIGEO") that is a therapeutic antibody for patients with relapsed or refractory CCR4-positive adult T-cell leukemia-lymphoma (ATL) (Press release Kyowa Hakko Kirin, MAR 30, 2012, View Source [SID:1234500290]).
POTELIGEO is a humanized monoclonal antibody produced by applying POTELLIGENT, a technology to produce antibodies with enhanced ADCC activity, which was developed exclusively by Kyowa Hakko Kirin. This product is the first antibody for which Kyowa Hakko Kirin has an NDA approved, and is also the world’s first POTELLIGENT antibody approved for marketing approval. POTELIGEO binds to CCR4 that is expressed on the surface of ATL cells. POTELIGEO was also granted an orphan drug designation for the treatment of CCR4-positive ATL by the MHLW.

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Shionogi Enters into Exclusive Licensing Agreement with OncoTherapy Science
to Develop and Market Cancer Peptide Vaccines

On March 30, 2012 Shionogi & Co., Ltd. (Head Office: Osaka; President & CEO: Isao Teshirogi, Ph.D.; hereafter "Shionogi") reported that it has entered into a worldwide licensing agreement with OncoTherapy Science, Inc. (Head Office: Kawasaki, Kanagawa; President & CEO: Takuya Tsunoda, Ph.D.; hereafter "OTS") to develop, manufacture and market cancer peptide vaccines (Press release, Shionogi, MAR 30, 2012, View Source [SID1234556291]).

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Shionogi had previously announced a licensing agreement with OTS on February 2, 2009 for specific peptides related to five different types of oncoantigens*, discovered by OTS, which are highly expressed on cancer cells. Since that agreement became effective, Shionogi has been globally developing therapeutic vaccines incorporating these oncoantigen peptides for the treatment of patients with several types of cancers, including bladder cancer and esophageal cancer. With the completion of this new agreement, Shionogi is expanding its relationship with OTS to encompass worldwide rights to peptide vaccines discovered by OTS, for all indications. As part of this new agreement, OTS will receive an up-front payment, milestone payments at successful completion of key phases, and royalties on sales.

This expanded alliance demonstrates Shionogi’s dedication to developing innovative treatment options, as quickly as possible, for the benefit of patients worldwide.

* Oncoantigens are protein antigens that are specifically expressed in tumor cells but not in healthy cells, are critical for cancer cell growth, and are highly antigenic, effectively inducing Cytotoxic T Lymphocytes (CTL) to help target and destroy tumor cells expressing the oncoantigen without killing healthy cells.

(Filing, 10-K, Poniard Pharmaceuticals, MAR 30, 2012, View Source [SID:1234506279])

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(Filing 10-K , Lion Biotechnologies, MAR 30, 2012, View Source [SID:1234501580])

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