On April 26 2011 Kyowa Hakko Kirin reported that it has submitted a new drug application (NDA) to the Ministry of Health, Labour and Welfare for KW-0761 under development for the treatment of adult T-cell leukemia-lymphoma (ATL) (Press release Kyowa Hakko Kirin, APR 26, 2011, View Source [SID:1234500291]).
KW-0761 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 submitted a NDA, and is also the world’s first POTELLIGENT antibody to be submitted for marketing approval. KW-0761 binds to CCR4 that is expressed on the surface of ATL cells. Clinical studies of KW-0761 in patients with relapsed CCR4-positive ATL in Japan met their primary endpoint, which allowed Kyowa Hakko Kirin to submit an NDA. KW-0761 was also granted an orphan drug designation for the treatment of CCR4-positive ATL by the Ministry of Health, Labour and Welfare.

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On April 20, 2011 ARIAD and Bellicum Pharmaceuticals reported that they have now broadened their previous agreement as a result of promising clinical data from Phase I/II trials of Bellicum’s ARGENT-regulated cancer vaccine and cell-therapy product candidates, both utilizing AP1903 to achieve chemical induction of dimerization (CID) (Press release Ariad, APR 20, 2011, View Source;p=irol-newsArticle&ID=1552552 [SID:1234500804]).

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Bellicum’s first product candidate, BPX-101 DeCIDe(TM) immunotherapy, is an autologous dendritic-cell cancer vaccine that includes an ARGENT-inducible regulatory construct. In the Phase 1/2 trial of patients with metastatic castrate-resistant prostate cancer at The University of Texas Health Science Center, Houston, patients received the Bellicum immunotherapy followed by AP1903 one day later. Data from the study showed that this small-molecule regulated immunotherapy was well tolerated and elicited both clinical and antigen-specific immune responses consistent with patient benefit in prostate cancer.

Bellicum’s second product candidate, CaspaCIDe(TM) DLI, is a donor lymphocyte infusion that contains the ARGENT-inducible safety switch. This is administered following a T-cell-depleted HSCT. In an investigator-sponsored Phase 1/2 trial also at Baylor College of Medicine, pediatric patients with acute lymphoblastic leukemia or acute myeloid leukemia undergoing HSCT received the CaspaCIDe cell therapy followed by administration of AP1903 upon diagnosis of graft-vs-host disease (GvHD). Interim data from the study showed that this small-molecule regulated cell therapy was well tolerated and rapidly reversed the deleterious systemic effects of GvHD.

ARIAD’s expanded exclusive agreement with Bellicum now covers products to treat the complications of cell transplantation, such as GvHD, in addition to certain cancer immunotherapies. ARIAD has an equity stake in Bellicum and is eligible to receive milestones on regulatory and clinical progress and royalties on future product sales. Bellicum is responsible for all manufacturing, regulatory and clinical activities and will hold the investigational new drug applications for these programs.

(Press release, Debiopharm, APR 14, 2011, View Source [SID:1234503768])

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On April 6, 2011 BioWa and Oxford BioTherapeutics Ltd (OBT) reported that they have entered into a license agreement to provide OBT with access to BioWa’s patented POTELLIGENT Technology platform for the development of antibody-dependent cellular cytotoxicity (ADCC) enhanced antibodies (Press release Oxford BioTherapeutics, APR 6, 2011, View Source [SID:1234500498]). OBT intends to use POTELLIGENT Technology to develop, manufacture and commercialize selected ADCC programs from its pipeline of preclinical antibodies for oncology which it has built based upon novel targets identified using its OGAP proteomic database. In return for the license, OBT will pay to BioWa undisclosed license fees, development and commercialization milestones and royalties on sales of any products that it commercializes.

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(Press release, Telik, APR 5, 2011, View Source [SID:1234504369])

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