Royalty Report: Drugs, Cancer, Drug Discovery – Collection: 297060

License Grant

Pursuant to the agreement, the Licensee of the United Kingdom will fund the Licensor of the United Kingdom and sponsor development of BT7401 from current preclinical studies through the completion of a Phase IIa trial in patients with advanced solid tumors.

Licensor granted to a license to intellectual property in order for Licensee to design, prepare for, sponsor, and carry out the clinical trial and all necessary preclinical activities to support the trial. Upon successful development, and other conditions, we will assign or grant to Licensee an exclusive license to develop and commercialize the product.

License Property

The drug development referred to as Bicycle BT7401.

Licensor is a clinical-stage biopharmaceutical company developing a novel and differentiated class of medicines, referred to as Bicycles®, for diseases that are underserved by existing therapeutics. Bicycles are fully synthetic short peptides constrained to form two loops which stabilize their structural geometry.

BT7401 is a chemically synthesized, multivalent small molecule agonist of CD137, comprised of Bicycles connected by stable linkers through a central hinge. Though prior programs using antibodies to agonize CD137 have demonstrated robust and durable anti-tumor effects, they have been limited by severe hepatotoxicity observed in clinical trials. Preliminary toxicology studies suggest BT7401 may circumvent this limitation. In addition, BT7401 has shown significant pharmacologic activity in preclinical models. These findings indicate that BT7401 may offer an improved therapeutic index compared to that of antibody-based approaches.

“The modular nature of the Bicycle platform enables a number of opportunities to generate new therapeutics that could address unmet need in oncology and other serious diseases.”

Field of Use

The field of use is in patients with advanced solid tumors.

License Grant

The England / Wales Licensor granted to Research Center a license to our intellectual property in order to design, prepare for, sponsor, and carry out the clinical trial. Licensor retain the right to continue the development of BT1718 during the clinical trial. Upon the completion of the Phase I/IIa clinical study, Licensor have the right to obtain a license to the results of the clinical trial upon the payment of a milestone, in cash and ordinary shares, with a combined value in the mid six digit dollar amount. If such license is not acquired, or if it is acquired and the license is terminated and Licensor decide to abandon development of all products that deliver cytotoxic payloads to the MT1 target antigen, Licensor will assign or grant an exclusive license to develop and commercialize the product on a revenue sharing basis (in which case Licensor will receive tiered royalties of the net revenue depending on the stage of development when the license is granted).

License Property

BT1718 is a product candidate that is a Bicycle Toxin Conjugate which is being developed to target tumors that express Membrane Type 1 matrix metalloprotease, or MT1-MMP.   The Bicycle is chemically attached to a toxin that when administered is cleaved from the Bicycle and kills the tumor cells. BT1718 is being investigated for safety, tolerability and efficacy in an ongoing Phase I/IIa clinical trial in collaboration with a Research Center.

Bicycles are a unique therapeutic modality combining the pharmacology usually associated with a biologic with the manufacturing and pharmacokinetic, or PK, properties of a small molecule. Bicycles are excreted by the kidney rather than the liver and have shown no signs of immunogenicity to date, which we believe together support a favorable toxicological profile.

Licensor is a clinical-stage biopharmaceutical company developing a novel class of medicines, which we refer to as Bicycles, for diseases that are underserved by existing therapeutics. Bicycles are fully synthetic short peptides constrained to form two loops which stabilize their structural geometry. This constraint is designed to confer high affinity and selectivity and the relatively large surface area presented by the molecule allows targets to be drugged that have historically been intractable to non-biological approaches

Field of Use

BT1718 has demonstrated promising target-dependent efficacy and only a subset of the toxicities typically associated with other highly potent cancer treatments.

License Grant

The Parties desire to form a collaboration for the co-development and commercialization of certain products.

For each Project, Licensor grants an exclusive, exclusive even as to Licensor, worldwide, sublicensable exclusive right and license under Collaboration Rights, Licensor Patent Rights, and Licensor Know-How to make, have made, use, sell, offer to sell and import Product and such license shall automatically terminate for each Product of a Project as to which Licensee becomes an Opt-Out Party effective as of the Opt-Out Date or as to which Licensee becomes a Non-Selling Party.

For each Project, Licensor grants a non-exclusive license under Patent Rights owned by Licensor to perform research under the Research Plan for such Project, which license shall terminate for each Project when Licensee becomes an Opt-Out Party for such Project.

License Property

Licensor has know-how, expertise, intellectual property rights and technology with respect to chemical libraries and chemical synthesis.

Project means research activities with respect to identifying compounds with activity against an Approved Target, synthesizing compounds based on such identified compounds, identifying and selecting a Development Compound, developing, manufacturing, obtaining Regulatory Approval and commercializing a Product.

Product means a Development Compound and/or a Replacement Compound and/or a pharmaceutical composition that includes a Development Compound and/or Replacement Compound.

The Selected Compounds shall be provided as 384 well plates with each well containing 0.7 micromoles of compound per well, dissolved in 70 microliters of DMSO, with the compound being at a final concentration of 10 micromoles.

Licensor will provide Licensee access to its Discovery outSource(TM) services platform, including the world's largest commercially available chemical library, as well as medicinal and synthetic chemistry for the discovery and development of new active compounds.

Field of Use

Licensee possesses know-how, expertise, intellectual property rights and technology with respect to screening of libraries to identify compounds of interest and the development of compounds.

The target means a protein and/or peptide and/or polynucleotide.

The Parties have entered into a collaboration for the discovery and development of small molecule oncology therapeutics.