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May 18, 2016

Janssen, MacroGenics Launch Up-to-$740M+ Second Collaboration

  • MacroGenics said today it has licensed its preclinical cancer therapy MGD015 to Johnson & Johnson’s Janssen Biotech, under a global collaboration that could generate up to $740 million-plus for the clinical-stage biopharma.

    MGD015 is a bispecific molecule developed through MacroGenics’ proprietary Dual-Affinity Re-Targeting (DART®) platform. MGD015 is designed to work by redirecting T cells, via their CD3 component, to eliminate cells that overexpress an undisclosed antigen in various hematological malignancies and solid tumors. MacroGenics said it has been able to show that MGD015 can kill these targeted cells both in vitro and in vivo, with high response rates in several mouse tumor xenograft models.

    MGD015 is under development as a potential treatment for various hematological malignancies and solid tumors. MGD015 and other DART molecules are manufactured using a conventional antibody platform, without having to genetically modify T cells from individual patients, MacroGenics said.

    Janssen has agreed to pay MacroGenics a $75 million license fee upfront and fully oversee future clinical development of MGD015 through completion of IND-enabling activities.

    Janssen also agreed to pay MacroGenics up to an additional $665 million tied to achieving clinical, regulatory, and commercialization milestones. The deal gives MacroGenics the option of funding a portion of late-stage clinical development in exchange for a profit share in the U.S. and Canada.

    Upon commercialization, MacroGenics would also be eligible to receive double-digit royalties on any global net sales and has the option to co-promote MGD015 with Janssen in the U.S.

    The collaboration is subject to the termination or expiration of any applicable waiting periods under the Hart–Scott–Rodino Act.

    The MGD015 alliance is the second partnership between Janssen and MacroGenics. In December 2014, the companies launched an up-to-$700 million collaboration to develop another MacroGenics DART molecule against cancer, MGD011 (also called JNJ-64052781), which simultaneously targets CD19 and CD3.

    Last year, Janssen began dosing patients in a Phase I study of MGD011 in patients with relapsed or refractory B-cell malignancies, including diffuse-large B-cell lymphoma, follicular lymphoma, mantle-cell lymphoma, chronic lymphocytic leukemia, and acute lymphoblastic leukemia.

    The dose escalation study has an estimated primary completion date of October 2017 and was recruiting patients as of May 4, according to ClinicalTrials.gov.

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