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September 16, 2015

Amgen, Xencor to Partner on Cancer Immunotherapy, Inflammation Drugs

  • Amgen and Xencor will partner to develop and commercialize novel therapeutics in the areas of cancer immunotherapy and inflammation, the companies said today, in a collaboration that could generate more than $1.7 billion for Xencor.

    The partnership is one of two billion-dollar-plus announcements today involving Amgen, which also agreed to acquire drug developer Dezima Pharma from Forbion Capital Partners for up to $1.55 billion.

    The Xencor research collaboration is designed to combine Amgen's target discovery and protein therapeutics capabilities with Xencor's XmAb® bispecific technology platform, under which monoclonal antibodies are engineered to bind two unique drug targets, compared with the single antigen target binding of traditional antibodies. Xencor and Amgen reason that bispecific technology can simultaneously engage immune cells and tumor cells to localize antitumor immune activity.

    Amgen has full responsibility for preclinical and clinical development and commercialization worldwide. The partnership entails preclinical development of bispecific molecules for five programs proposed by Amgen, leveraging XmAb bispecific Fc domains engineered by Xencor to make half-life extended T cell engagers and dual targeting bispecific antibodies. Xencor says the XmAb Fc domain format allows it to tune the potency of the T cell killing, potentially improving the tolerability of tumor immunotherapy.

    Under their research and license agreement, the companies will also advance a preclinical bispecific T cell engager program directed at CD38 and CD3 for multiple myeloma.

    “We are especially excited about the T cell engaging bispecific antibody directed against CD38, which complements Amgen's [bispecific T cell engager] BiTE® platform, while growing our hematology and oncology portfolio that includes two bispecific T cell engager antibodies, BLINCYTO® (blinatumomab) and AMG 330, as well as Kyprolis® (carfilzomib) for relapsed multiple myeloma,” Sean E. Harper, M.D., Amgen evp of research and development, said in a statement.

    Amgen agreed to pay Xencor $45 million upfront and up to $1.7 billion in payments tied to clinical, regulatory and sales milestones for the six programs. Xencor is eligible to receive mid to high single-digit royalties for candidates directed against Amgen's targets, and high single to low double-digit royalties for Xencor's CD38 bispecific T cell engager.

    “This opportunity expands the reach of our technology with a partner that has proven experience in bispecifics and immuno-oncology," added Xencor president and CEO Bassil Dahiyat, Ph.D.

    Dr. Dahiyat added that Xencor will continue to focus on its internal programs, which include its immuno-oncology XmAb bispecifics, XmAb14045 in acute myeloid leukemia and XmAb13676 in B-cell malignancies. Xencor plans to begin clinical testing for two internal programs, XmAb14045 and XmAb13676, in 2016, he said.

    Xencor focuses on developing engineered monoclonal antibodies for the treatment of asthma and allergic diseases, autoimmune diseases, and cancer. According to the company, eight candidates that have been engineered with Xencor's XmAb technology are in clinical development internally and with partners.

    In addition to XmAb14045 and XmAb13676, Xencor's internally discovered programs include: XmAb5871, which completed a Phase Ib/IIa trial for rheumatoid arthritis and is in preparation for a trial in IgG4-related disease later this year; XmAb7195, which is in Phase Ia development for asthma; and XmAb5574/MOR208 which has been licensed to Morphosys and is in Phase II  trials for acute lymphoblastic leukemia and non-Hodgkin's lymphoma.

    With the Xencor collaboration, Amgen adds to its immuno-oncology focused partnerships. These include a collaboration with Merck on developing talimogene laherparepvec and Keytruda® (pembrolizumab) in melanoma and small cell cancer of the head and neck; a strategic research collaboration and license agreement to develop and commercialize next-generation new Chimeric Antigen Receptor (CAR) T cell immunotherapies with Kite Pharma; a research collaborative agreement focusing on Amgen's BiTE antibody constructs with MD Anderson's Moon Shots Program; and a collaboration with Roche on a cancer immunotherapy study with investigational medicines talimogene laherparepvec and atezolizumab.

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