Claims for Patent: 10,188,742

Summary for Patent: 10,188,742

Title:	Bi-specific antibodies and uses thereof
Abstract:	Disclosed herein is a bi-specific antibody that specifically directs a therapeutic agent to a cancer cell by targeting a tumor antigen of the cancer cell, and thereby suppresses the growth of the cancer or blocking the invasion or metastasis of the cancer. The bi-specific antibody of the present disclosure includes a first antigen binding site that binds to polyethylene glycol (PEG); and a second antigen binding site that binds to a target ligand, such as a tumor antigen.
Inventor(s):	Roffler; Steven R (Taipai, TW), Cheng; Tian-Lu (Kaohsiung, TW), Kao; Chien-Han (Kaohsiung, TW), Chen; Bing-Mae (Taipei, TW), Su; Yu-Cheng (Taipei, TW), Tung; Hsin-Yi (Taipei, TW), Chuang; Kuo-Hsiang (Taipei, TW)
Assignee:	KAOHSIUNG MEDICAL UNIVERSITY (Kaohsiung, TW)
Application Number:	15/123,243
Patent Claims:	1. A humanized bi-specific antibody against the terminal methoxy or hydroxyl group of polyethylene glycol (PEG) and a target ligand, comprising, a first antigen binding site that binds to the PEG; and a second antigen binding site that binds to the target ligand that is HER2; wherein, the first antigen binding site comprises the first VL-Ck domain consisting of SEQ ID NO: 12, the first VH-CH1 domain consisting of SEQ ID NO: 13, and the first HR-CH2-CH3 domain consisting of SEQ ID NO: 22; and the second antigen binding site comprises a humanized single chain variable fragment (scFv) consisting of SEQ ID NO: 15. 2. A pharmaceutical kit comprising the humanized bi-specific antibody of claim 1 and a PEGylated substance, wherein the substance is a protein, a peptide or a nanoparticle, wherein the nanoparticle contains a chemotherapeutic drug or an imaging agent. 3. The pharmaceutical kit of claim 2, wherein the chemotherapeutic drug is any of adriamycin, amifostine, bleomycin, busulfan, cisplatin, carboplatin, oxaliplatin, camptothecin, CPT-11, cytosine arabinoside, chlorambucil, cyclophosphamide, cytarabine, daunorubicin, doxorubicin, docetaxel, dacarbazine, dactinomycin, etoposide, 5-fluorouracil (5-FU), fluoxuridine, gemcitabine, hydroxyurea, ifosfamide, idarubicin, interferon beta, irinotecan, L-asparaginase, L-aspartic acid, lomustine, mechlorethamine, mitomycin, methotrexate, mitoxantrone, megestrol, melphalan, mercaptopurine, mitotane, paclitaxel (taxol), plicamycin, pentostatin, streptozocin, topotecan, tamoxifen, teniposide, thioguanine, vinblastine, vincristine, SN38 or a combination thereof. 4. The pharmaceutical kit of claim 2, wherein the imaging agent is a quantum dot (QD), a microbubble contrast agent, a fluorescence dye, a chelated radioisotope a paramagnetic iron or a gold nanoparticle. 5. The pharmaceutical kit of claim 2, wherein the protein is a chemokine or a cytokine; and the peptide is any of leuprolide, goserelin, octreotide, histrelin, abarelix, cetrorelix, degarelix, cilengtide, ATN-161, or IM862. 6. A method of imaging tissues in a subject comprising: (a) mixing a first sufficient amount of the humanized bi-specific antibody of claim 1 and a second sufficient amount of a PEGylated imaging agent to form an assembly; (b) Injecting the assembly of the step (a) to the subject; and (c) imaging the tissue of the subject by fluorescence imaging, electron spin resonance (ESR) imaging, X-ray imaging, computed tomography (CT), or magnetic resonance imaging (MRI).

Details for Patent 10,188,742

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Recordati Rare Diseases, Inc.	ELSPAR	asparaginase	For Injection	101063	01/10/1978		2034-03-03