# US 10,370,350 B2 · Alpha-TEA salt forms: compositions and uses for treating disease > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 10,370,350 B2 - Document ID: US10370350B2 - Status: Granted - Kind: B2 - Application number: 14/916,271 - Filed: 2014-09-05 - Published: 2016-07-28 - Granted: 2019-08-06 - Earliest claimed: 2013-09-06 - Assignees: Research Development Foundation - Applicants: Research Development Foundation - Inventors: Michael O'Neill; Barbara Kidon; Thomas Adkins; Hongqiao Wu; Emmanuel T. Akporiaye - Web page: https://patentgrep.com/patent/US10370350B2 ## CPC - C07D 311/72: 3,4-Dihydro derivatives having in position 2 at least one methyl radical and in position 6 one oxygen atom, e.g. tocopherols - A61K 31/355: Tocopherols, e.g. vitamin E - A61K 35/17: Lymphocytes; B-cells; T-cells; Natural killer cells; Interferon-activated or cytokine-activated lymphocytes (when activated by a specific antigen A61K39/00) - A61K 39/39558: {against tumor tissues, cells, antigens} - A61K 45/06: Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca - A61P 31/00: Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics - A61P 35/00: Antineoplastic agents - C07C 215/08: with only one hydroxy group and one amino group bound to the carbon skeleton - C07C 215/10: with one amino group and at least two hydroxy groups bound to the carbon skeleton - C07C 229/26: having more than one amino group bound to the carbon skeleton, e.g. lysine - C07C 279/14: being further substituted by carboxyl groups - C07K 16/32: against translation products of oncogenes - C07K 2317/24: containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered - C07D: HETEROCYCLIC COMPOUNDS (macromolecular compounds C08) - 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) - A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS - C07C: ACYCLIC OR CARBOCYCLIC COMPOUNDS - 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) ## Abstract The present disclosure relates to salts of the compound (I), polymorphic forms thereof, methods for preparation and use thereof, and pharmaceutical compositions thereof. ## Claims ### Claim 1 A compound of the formula: wherein X1+ is: or a hydrate thereof. ### Claim 2 (depends on 1) The compound of either claim 1, wherein the X1+ is: or a hydrate, thereof. ### Claim 3 (depends on 1) The compound of claim 1, wherein the X1+ is or a hydrate, thereof. ### Claim 4 (depends on 1) The compound of claim 1, wherein the formula is further defined as: or a hydrate, thereof. ### Claim 5 (depends on 4) The compound of claim 4, wherein the compound is present as a polymorphic form having an X-ray powder diffraction pattern CuKα comprising two peaks at about 11.84° 2θ and 19.74° 2θ or a hydrate, thereof. ### Claim 6 (depends on 5) The compound of claim 5, wherein the polymorphic form has an X-ray powder diffraction pattern CuKα further comprising 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, or all of the peaks at about 6.24, 9.35, 14.92, 15.51, 17.03, 18.49, 20.73, 21.70, 22.81, 23.51, 24.85, 27.69, 28.31, 30.93, 32.30, 33.21, 35.02, and 39.30° 2θ. ### Claim 7 (depends on 1) The compound of claim 1, wherein the formula is further defined as: or a hydrate, thereof. ### Claim 8 (depends on 7) The compound of claim 7, wherein the compound is present as a polymorphic form having an X-ray powder diffraction pattern CuKα comprising a peak at about 9.69° 2θ or a hydrate, thereof. ### Claim 9 (depends on 8) The compound of claim 8, wherein the X-ray powder diffraction pattern CuKα further comprises 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, or all of the peaks at about 5.90, 7.77, 14.08, 17.58, 17.91, 18.31, 19.78, 20.10, 21.26, 22.17, 23.16, 24.77, 28.57, 29.71, 31.10, 31.69, 34.45, 34.99, and 36.24° 2θ. ### Claim 10 (depends on 1) The compound of claim 1, wherein the formula is further defined as: or a hydrate, thereof. ### Claim 11 (depends on 10) The compound of claim 10, wherein the compound is present as a polymorphic form having an X-ray powder diffraction pattern CuKα comprising a peak at about 20.14° 2θ or a hydrate, thereof. ### Claim 12 (depends on 11) The compound of claim 11, wherein the X-ray powder diffraction pattern CuKα further comprises 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, or all of peaks at about 9.67, 15.60, 21.47, 23.57, 27.07, 28.39, 30.49, 32.21, 33.30, 34.29, 34.96, 35.89, and 36.39° 2θ. ### Claim 13 (depends on 1) The compound of claim 1, wherein the formula is further defined as: or a hydrate, thereof. ### Claim 14 (depends on 13) The compound of claim 13, wherein the compound is present as a polymorphic form having an X-ray powder diffraction pattern CuKα comprising a peak at about 19.4, 18.40 and 19.77, or 21.73° 2θ or a hydrate, thereof. ### Claim 15 (depends on 1) A pharmaceutical composition comprising a compound, a salt, or a polymorphic form of claim 1 and an excipient. ### Claim 16 (depends on 15) The pharmaceutical composition of claim 15, wherein the pharmaceutical composition is formulated for oral, intraarterial, intravenous, intraperitoneal, topical, or inhalational administration. ### Claim 17 (depends on 1) A method of treating a breast cancer, comprising administering to the patient a therapeutically effective amount of the compound, salt, polymorphic form, or pharmaceutical composition of claim 1. ### Claim 18 (depends on 17) The method of claim 17, further comprising administering to the patient a second therapy. ### Claim 19 (depends on 18) The method of claim 18, wherein the second therapy is an immunotherapy, radiotherapy, chemotherapeutic agent, or surgery. ### Claim 20 (depends on 19) The method of claim 19, wherein the immunotherapy comprises administering a pharmaceutically effective amount of adoptively transferred T lymphocytes, an immune modulating antibody, or a therapeutic antibody. ### Claim 21 (depends on 19) The method of claim 19, wherein the chemotherapeutic agent is an anthracycline, taxane, methotrexate, mitoxantrone, estramustine, doxorubicin, etoposide, vinblastine, carboplatin, vinorelbine, 5-fluorouracil, cisplatin, topotecan, ifosfamide, cyclophosphamide, epirubicin, gemcitabine, vinorelbine, irinotecan, etoposide, vinblastine, pemetrexed, melphalan, capecitabine, oxaliplatin, BRAF inhibitors, or TGF-beta inhibitor. ### Claim 22 (depends on 20) The method of claim 20, wherein the immunotherapy comprises administering a pharmaceutically effective amount of trastuzumab.