# US 10,865,250 B2 · Anti-cancer fusion polypeptide > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 10,865,250 B2 - Document ID: US10865250B2 - Status: Granted - Kind: B2 - Application number: 15/571,561 - Filed: 2016-05-04 - Published: 2019-01-10 - Granted: 2020-12-15 - Earliest claimed: 2015-05-04 - Assignees: Pieris Pharmaceuticals GmbH - Applicants: Pieris Pharmaceuticals GmbH - Inventors: Marlon Hinner; Christine Rothe; Shane Olwill; Rachida Siham Bel Aiba; Ulrich Moebius; Corinna Schlosser; Thomas Jean Jaquin - Web page: https://patentgrep.com/patent/US10865250B2 ## CPC - C07K 16/32: against translation products of oncogenes - A61P 35/00: Antineoplastic agents - C07K 14/435: from animals; from humans - C07K 16/2878: {against the NGF-receptor/TNF-receptor superfamily, e.g. CD27, CD30, CD40, CD95} - A61K 2039/505: {comprising antibodies} - C07K 2317/52: Constant or Fc region; Isotype - C07K 2317/73: Inducing cell death, e.g. apoptosis, necrosis or inhibition of cell proliferation - C07K 2317/92: Affinity (KD), association rate (Ka), dissociation rate (Kd) or EC50 value - C07K 2318/20: Antigen-binding scaffold molecules wherein the scaffold is not an immunoglobulin variable region or antibody mimetics - C07K 2319/00: Fusion polypeptide - C07K 2319/70: containing domain for protein-protein interaction - C07K: PEPTIDES (peptides in foodstuffs A23; obtaining protein compositions for foodstuffs, working-up proteins for foodstuffs A23J; preparations for medicinal purposes A61K; peptides containing beta-lactam rings C07D; cyclic dipeptides not having in their molecule any other peptide link than those which form their ring, e.g. piperazine-2,5-diones, C07D; ergot alkaloids of the cyclic peptide type C07D519/02; macromolecular compounds having statistically distributed amino acid units in their molecules, i.e. when the preparation does not provide for a specific; but for a random sequence of the amino acid units, homopolyamides and block copolyamides derived from amino acids C08G69/00; macromolecular products derived from proteins C08H1/00; preparation of glue or gelatine C09H; single cell proteins, enzymes C12N; genetic engineering processes for obtaining peptides C12N15/00; compositions for measuring or testing processes involving enzymes C12Q; investigation or analysis of biological material G01N33/00) - A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS - A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D) ## Abstract The disclosure provides a fusion polypeptide specific for both CD137 and HER2/neu, which fusion polypeptide can be useful for directing CD137 clustering and activation to HER2/neu-positive tumor cells. Such fusion polypeptide can be used in many pharmaceutical applications, for example, as anti-cancer agents and/or immune modulators for the treatment or prevention of human diseases such as a variety of tumors. The present disclosure also concerns methods of making the fusion polypeptide described herein as well as compositions comprising such fusion polypeptide. The present disclosure further relates to nucleic acid molecules encoding such fusion polypeptide and to methods for generation of such fusion polypeptide and nucleic acid molecules. In addition, the application discloses therapeutic and/or diagnostic uses of such fusion polypeptide as well as compositions comprising one or more of such fusion polypeptides. ## Claims ### Claim 1 A fusion polypeptide that is capable of simultaneously binding both CD137 and HER2/neu, wherein the fusion polypeptide comprises at least two subunits, wherein the first subunit comprises an immunoglobulin, which first binding domain has binding specificity for HER2/neu, and wherein the second subunit comprises a lipocalin mutein having binding specificity for CD137, wherein the fusion polypeptide comprises the amino acid sequences shown in SEQ ID NOs: 9 and 10. ### Claim 2 (depends on 1) The fusion polypeptide of claim 1, wherein the fusion polypeptide is capable of binding CD137 with an EC50 value comparable to or lower than the EC50 value of the lipocalin mutein specific for CD137 included in the fusion polypeptide. ### Claim 3 (depends on 1) The fusion polypeptide of claim 1, wherein the fusion polypeptide is capable of binding CD137 with an EC50 value of about 1 nM or lower. ### Claim 4 (depends on 1) The fusion polypeptide of claim 1, wherein the fusion polypeptide is capable of binding HER2/neu with an EC50 value comparable to or lower than the EC50 value of the immunoglobulin specific for HER2/neu included in such fusion polypeptide. ### Claim 5 (depends on 1) The fusion polypeptide of claim 1, wherein the fusion polypeptide is capable of binding HER2/neu with an EC50 value of about 1 nM. ### Claim 6 (depends on 1) The fusion polypeptide of claim 1, wherein the fusion polypeptide is capable of simultaneously binding CD137 and HER2/neu with EC50 values of about 4 nM or lower. ### Claim 7 (depends on 1) The fusion polypeptide of claim 1, wherein the fusion polypeptide is capable of co-stimulating T-cell responses. ### Claim 8 (depends on 1) The fusion polypeptide of claim 1, wherein the fusion polypeptide is capable of inducing IL-2 secretion and T cell proliferation.