Royalty Report: Drugs, Cancer, Antibody – Collection: 67226

Licensed Product shall mean a product comprising a Humanized Antibody, the manufacture, use, offer for sale, sale, or importation of which by an unlicensed third party would infringe one or more Valid Claims of the Licensed Patent Rights, or which incorporates Licensor IP or Licensor Inventions.  The term “Licensed Product” does not include chimeric antibodies or murine antibodies.

Humanized Antibody shall mean an antibody that binds to Sphingosine-1-phosphate and is made by Licensor under this Agreement, the antibody comprising murine complementarity determining regions derived from Sphingomabâ„¢ together with human framework regions, and any modifications thereof.

Licensor IP shall mean (i) any Licensor Invention and (ii) all patented and non-patented proprietary technology and information, in any form whatsoever, that is (a) necessary or useful for making and using the Licensed Products, without regard to whether or not the technology or information is patentable; (b) owned, controlled, or developed by Licensor, as of the Effective Date or hereafter during the term of this Agreement; and (c) provided by Licensor to Licensee hereunder, including, but not limited to discoveries, formulae, materials, practices, methods, knowledge, know-how, processes, trade secrets, ideas, concepts, manufacturing, engineering, standard operating procedures, flow diagrams and charts, quality assurance, quality control data, technical data, manufacturing technology, research data and records, and all other confidential or proprietary technical and business information relating to the humanization of murine antibodies, generation of chimeric antibodies, or any gene expression vectors used in such methods and all improvements or modifications thereto.  For purposes of clarity, Licensor IP includes Licensor Inventions that satisfy (a), (b) and (c), above, while Licensor IP does not include Licensed Patent Rights as defined hereunder.

Licensor Invention shall mean any discovery or invention to the extent (i) made or conceived or reduced to practice by or on behalf of Licensor in the performance of the humanization of Licensees Sphingomabâ„¢ antibody under this Agreement, whether or not patentable, and (ii) covering only generally applicable methods or techniques for humanizing antibody proteins or for constructing a vector or reagent used to humanize or express an antibody.

Sphingomabâ„¢ is the original mouse version of this monoclonal antibody.

Under this original agreement, Licensee had the right to use the DuoBody technology to create panels of bispecific antibodies (up to 10 DuoBody programs) to multiple disease target combinations.

Licensee received approval from the FDA for amivantamab, as RYBREVANT, a therapy that was created using Danish Licensor’s proprietary DuoBody bispecific technology platform.

Under the terms of the agreement, Licensee will also be granted options to Licensor’s TIGIT-targeted antibody and next generation engineered IL-2 cytokine for evaluation as potential combination therapies with toripalimab, as well as certain negotiation rights to two early-stage checkpoint inhibitor antibodies.
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JS006, an antibody targeting TIGIT.
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JS018, a next-generation engineered IL-2 cytokine
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Two additional undisclosed early-stage novel immuno-oncology drug candidates.

JS006 is an antibody targeting TIGIT, a clinically validated immune inhibitory checkpoint. Anti-TIGIT antibodies have demonstrated synergistic anti-tumor activity in combination with anti-PD-1 antibodies.

JS018 is a next-generation engineered IL-2 cytokine designed to inhibit stimulation of regulatory T cells while retaining stimulatory activity on effector T cells and natural killer (“NK”) cells. The option to JS018 is exercisable prior to initiation of Phase 2 clinical development.

By this Collaboration, the Parties plan to file additional toripalimab BLAs with the FDA over the next three years for multiple rare and highly prevalent cancers, including non-small cell lung cancer (“NSCLC”).