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September 1, 2016

Amgen Buys Rights to Myeloma BiTE Immunotherapy from Boehringer Ingelheim

  • Amgen has acquired global development and commercialization rights from Boehringer Ingelheim for its Phase I bispecific T-cell engager (BiTE®) BI 836909 (AMG 420), an immuno-oncology drug for multiple myeloma, the companies said today.

    The value of the deal was not disclosed.

    BI 836909 (AMG 420) is designed to work by targeting B-cell maturation antigen (BCMA), a potential target for multiple myeloma. The candidate was originally licensed to Boehringer Ingelheim by Micromet, which was acquired by Amgen in 2012.

    Amgen said it will assume responsibility for the clinical development of BI 836909 (AMG 420), as well as transfer manufacturing and lead global regulatory activity for the BiTE candidate.

    BiTE antibody constructs are designed to engage two different targets simultaneously, thereby juxtaposing T cells to cancer cells. The constructs are designed to help place T cells within reach of the targeted cell, enabling the T cells to inject toxins and trigger apoptosis, according to Amgen.

    “Obtaining global rights to BI 836909 (AMG 420) advances Amgen's immuno-oncology strategy, allowing us to leverage our expertise with the BiTE platform to target BCMA in the multiple myeloma setting,” Sean E. Harper, M.D., Amgen evp of Research and Development, said in a statement. “BI 836909 (AMG 420) allows us to explore a potential new treatment approach that harnesses the immune system to fight multiple myeloma.”

    Jörg Barth, M.D., corporate svp, therapy area head, oncology at Boehringer Ingelheim, said immuno-oncology and T-cell engagers remained a key area of focus for the company notwithstanding the deal with Amgen.

    BI 836909 (AMG 420) joins a pipeline of Amgen Phase I BiTE candidates that includes AMG 211, an anti-CEA x anti-CD3 treatment being jointly developed with MedImmune for various cancers, and AMG 330, an anti-CD33 x anti-CD3 treatment for acute myeloid leukemia.

    Further advanced in clinical development is Blincyto®, an anti-CD19 x anti-CD3 BiTE candidate for which Amgen today received approval for its supplemental Biologics License Application (sBLA), to include new data supporting the treatment of pediatric patients with Philadelphia chromosome-negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).

    Blincyto is in a Phase III study in pediatric patients with high-risk first relapse B-precursor ALL and in Phase II studies in adults with relapsed/refractory Philadelphia chromosome-positive (Ph+) and minimal residual disease of ALL, as well as adults with diffuse large B-cell lymphoma. Blincyto is being developed in Japan by a joint venture between Amgen and Astellas Pharma.

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