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公开(公告)号:US12221461B2
公开(公告)日:2025-02-11
申请号:US17041175
申请日:2019-03-27
Applicant: OBI PHARMA, INC.
Inventor: Cheng-Der Tony Yu , Yih-Huang Hsieh , Wei Han Lee , Yu Chen Lin , Nan Hsuan Wang
IPC: C07J63/00 , A61K39/39 , G01N30/14 , G01N30/60 , G01N30/74 , G01N30/86 , G01N33/15 , A61K39/00 , G01N30/02
Abstract: The present disclosure is related to the six isomer structures (OBI-821-1990-V1A, OBI-821-1990-V1B, OBI-821-1990-V2A, OBI-821-1990-V2B, OBI-821-1858-A, and OBI-821-1858-B) of isolated OBI-821 adjuvant and the method for evaluating the quality thereof. The method of the present disclosure adopts hydrophilic interaction liquid chromatography (HILIC) and reverse phase high performance liquid chromatography (RP-HPLC) either alone or in tandem and is able to separate the isomers of OBI-821 adjuvant in the consequent chromatography. Accordingly, the quality of OBI-821 adjuvant can be further evaluated.
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公开(公告)号:US12090212B2
公开(公告)日:2024-09-17
申请号:US17133388
申请日:2020-12-23
Applicant: OBI Pharma, Inc.
Inventor: Michael Nientse Chang , Jiann-Shiun Lai , Wan-Fen Li , I-Ju Chen , Yi-Chien Tsai , Kai-Chuan Chen
IPC: A61K47/68 , A61K39/395 , A61K45/06 , A61K49/00 , A61K49/16 , A61K51/10 , A61P35/00 , A61P35/04 , C07K16/18 , C07K16/30 , C07K16/44 , C08B37/00 , G01N33/574 , A61K39/00
CPC classification number: A61K47/6855 , A61K39/39558 , A61K45/06 , A61K47/6803 , A61K47/6811 , A61K47/6817 , A61K47/6843 , A61K47/6857 , A61K47/6859 , A61K47/6863 , A61K49/0058 , A61K49/16 , A61K51/1018 , A61K51/1051 , A61K51/1054 , A61K51/1057 , A61K51/1063 , A61P35/00 , A61P35/04 , C07K16/18 , C07K16/3076 , C07K16/44 , C08B37/0006 , G01N33/57492 , A61K2039/505 , A61K2039/54 , A61K2039/545 , C07K2317/24 , C07K2317/56 , C07K2317/565 , C07K2317/567 , A61K39/39558 , A61K2300/00
Abstract: Antibody drug conjugates (ADC's) comprising a drug conjugated to antibody or antigen binding fragments thereof that bind to Globo series antigen disclosed herein, as well as methods of use thereof. Methods of use include, without limitation, cancer therapies and diagnostics. The antibodies of the disclosure can bind to certain cancer cell surfaces. Exemplary targets of the antibodies disclosed herein can include carcinomas, such as sarcoma, skin cancer, leukemia, lymphoma, brain cancer, glioblastoma, lung cancer, breast cancer, oral cancer, head-and-neck cancer, nasopharyngeal cancer, esophagus cancer, stomach cancer, liver cancer, bile duct cancer, gallbladder cancer, bladder cancer, pancreatic cancer, intestinal cancer, colorectal cancer, kidney cancer, cervix cancer, endometrial cancer, ovarian cancer, testical cancer, buccal cancer, oropharyngeal cancer, laryngeal cancer and prostate cancer.
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公开(公告)号:US20240139301A1
公开(公告)日:2024-05-02
申请号:US18253576
申请日:2021-11-19
Applicant: OBI Pharma, Inc.
Inventor: Ming-Tain LAI , Cheng-Der Tony YU , I-Ju CHEN , Wei-Han LEE , Chueh-Hao YANG , Chun-Yen TSAO , Chang-Lin HSIEH , Chien-Chih OU , Chen-En TSAI
CPC classification number: A61K39/001173 , A61K45/06 , A61K47/646 , A61P35/00 , A61K2039/545 , A61K2039/55544 , A61K2039/86
Abstract: The disclosure provides a method of active immunotherapy for a cancer patient, comprising administering vaccines against Globo series antigens (i.e., Globo H, SSEA-3 and SSEA-4). Specifically, the method comprises administering Globo H-CRM197 (OBI-833/821) in patients with cancer. The disclosure also provides a method of selecting a cancer patient who is suitable as treatment candidate for immunotherapy. Exemplary immune response can be characterized by reduction of the severity of disease, including but not limited to, prevention of disease, delay in onset of disease, decreased severity of symptoms, decreased morbidity and delayed mortality.
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公开(公告)号:US11833223B2
公开(公告)日:2023-12-05
申请号:US17160282
申请日:2021-01-27
Applicant: OBI Pharma, Inc.
Inventor: Cheng-Der Tony Yu , Jiann-Shiun Lai , I-Ju Chen , Chiu-Chun Lin
IPC: A61K39/395 , A61K47/68 , C07K16/28 , A61P35/00 , A61K31/4025 , C07K16/18 , C07K16/30 , A61K39/00
CPC classification number: A61K47/6857 , A61K31/4025 , A61K39/3955 , A61K39/39558 , A61P35/00 , C07K16/18 , C07K16/28 , C07K16/30 , A61K2039/505 , A61K2039/507 , A61K2039/54 , A61K2039/545 , A61K2039/86 , A61K2300/00 , C07K2317/24 , C07K2317/732 , C07K2317/92 , A61K39/3955 , A61K2300/00 , A61K39/39558 , A61K2300/00
Abstract: Pharmaceutical composition comprising antibodies or antigen binding fragments thereof that bind to stage-specific embryonic antigen 4 (SSEA-4) are disclosed herein, as well as methods of use thereof. Methods of use include, without limitation, cancer therapies and diagnostics. The antibodies of the disclosure can bind to certain cancer cell surfaces. Exemplary targets of the antibodies disclosed herein can include carcinomas, such as breast cancer, lung cancer, esophageal cancer, rectal cancer, biliary cancer, liver cancer, buccal cancer, gastric cancer, colon cancer, nasopharyngeal cancer, kidney cancer, prostate cancer, ovarian cancer, cervical cancer, endometrial cancer, pancreatic cancer, testicular cancer, bladder cancer, head and neck cancer, oral cancer, neuroendocrine cancer, adrenal cancer, thyroid cancer, bone cancer, skin cancer, basal cell carcinoma, squamous cell carcinoma, melanoma, and/or brain tumor.
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公开(公告)号:US11773118B2
公开(公告)日:2023-10-03
申请号:US17432668
申请日:2020-02-21
Applicant: OBI PHARMA, INC.
Inventor: Cheng-Der Tony Yu , Yih-Huang Hsieh , Shu-Yi Lin , Chin-Sheng Chao , Yin-Cheng Hsieh , Ming-Tain Lai
IPC: C07F9/24 , C07C231/14
CPC classification number: C07F9/2466 , C07C231/14
Abstract: A new process to synthesis of compound OBI-3424 R-form and S-form products is provided. The “R-form” compound OBI-3423 was first synthesized with 48% overall yield from compound OBI-3424-5 by installation of the labile phosphate motif at later stage. The stereo chemistry is established by 5 steps chemo-enzyme combination synthesis to afford 99% optical purity. After then, the “S-form” compound OBI-3424 is prepared with improving overall yield of 54% from compound OBI-3424-5. The stereo chemistry is established by 4 steps combination of chemo-enzyme synthesis with excellent optical purity of 99%.
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公开(公告)号:US20230181606A1
公开(公告)日:2023-06-15
申请号:US17626962
申请日:2020-07-14
Applicant: OBI PHARMA, INC
Inventor: Jianxin Duan
CPC classification number: A61K31/675 , A61K9/08 , A61K47/10 , A61K47/02 , A61J1/1468 , A61J1/065
Abstract: A stable AST-3424 injection preparation, being a solution containing 0.1-200 mg/ml or 1-200 mg/ml of AST-3424 active pharmaceutical ingredient. A solvent in the solution contains a C2-C8 monohydric alcohol. The preparation method comprises the following steps: subjecting the AST-3424 active pharmaceutical ingredient and a partial prescription volume of ethanol to a first dissolution and formulation; adding a prescription volume of propylene glycol for a second dissolution and formulation; and then adding the remaining prescription volume of ethanol for mixing and dissolving to obtain a solution containing 1-200 mg/ml of AST-3424 active pharmaceutical ingredient. Provided is an AST-3424 injection for injection, wherein the solvent is water, a glucose solution, ethanol, or propylene glycol, the solutes consist of the AST-3424 active pharmaceutical ingredient, an isotonic regulator, and a pH regulator. The concentration of the AST-3424 active pharmaceutical ingredient of the injection is 0.001-1.000 mg/ml, the pH of the injection is 6.8-10.5, and the solution is an isotonic solution.
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公开(公告)号:US11642400B2
公开(公告)日:2023-05-09
申请号:US15662162
申请日:2017-07-27
Applicant: OBI PHARMA, INC.
Inventor: Cheng-Der Tony Yu , Peiwen Yu , Kuo-Pao Lai , Wei-Han Lee , I-Ju Chen , Shu-Yi Lin , Yih-Huang Hsieh
IPC: A61K39/00
CPC classification number: A61K39/0011 , A61K39/00118 , A61K39/001173 , A61K2039/54 , A61K2039/545 , A61K2039/55511 , A61K2039/55577 , A61K2039/6037 , A61K2039/6081 , A61K2039/627 , A61K2039/64
Abstract: The present disclosure encompasses immunogenic/therapeutic compositions including Globo series antigens (SSEA-4, Globo H or SSEA-3) glycoconjugates and therapeutic adjuvants (OBI-821 or OBI-834) as well as methods of making and using the same to treat proliferative diseases such as cancer. The therapeutic conjugates include an antigen linked to a carrier. In particular, the therapeutic conjugates include a SSEA-4, Globo H or SSEA-3 moiety and a KLH moiety subunit linked via a linker. The therapeutic compositions are in part envisaged to act as cancer vaccines (single valent, bi-valent or tri-valent vaccines) for boosting the body's natural ability to protect itself, through the immune system from dangers posed by damaged or abnormal cells such as cancer cells. Exemplary immune response can be characterized by reduction of the severity of disease, including but not limited to, prevention of disease, delay in onset of disease, decreased severity of symptoms, decreased morbidity and delayed mortality.
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公开(公告)号:US11203645B2
公开(公告)日:2021-12-21
申请号:US16454750
申请日:2019-06-27
Applicant: OBI PHARMA, INC.
Inventor: Cheng-Der Tony Yu , Yih Huang Hsieh , Yin-Cheng Hsieh , Teng-Yi Huang , Yi-Chien Tsai , Nan-Hsuan Wang , Pu-Ling Hu
Abstract: The present disclosure relates to novel glycosynthase enzymes for glycoprotein engineering and/or homogeneous antibody remodeling. The enzyme variants, termed EndoSd-D232M and EndoSz-D234M, contain the glycan conjugation and/or modification activity at the conserved N297 glycosylation site of Fc region of an exemplary antibody. It has been demonstrated that the glycosynthase activities of EndoSd-D232M and EndoSz-D234M can be applied to various mAbs targeting different receptors, including, but not limited to, Globo H, SSEA-4, SSEA-3 series of receptors (OBI-888; Globo H ganglioside), Herceptin (Her 2 receptor), Perj eta (Her 2 receptor) and Vectibix (EGFR receptor). It has been found that both mAb-GlcNAc and mAb-GlucNAc(F) were suitable substrates for both EndoSd-D232M and EndoSz-D234M. The ADCC assay of related products, OBI-888-G2S2 and Herceptin-G2S2, showed that the remodeled homogeneous antibody, mAb-G2S2, has an increased relative activity ranging from 3 to 26 folds.
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公开(公告)号:US11041017B2
公开(公告)日:2021-06-22
申请号:US15473267
申请日:2017-03-29
Applicant: OBI Pharma, Inc.
Inventor: Cheng-Der Tony Yu , Jiann-Shiun Lai , I-Ju Chen , Chiu-Chun Lin
IPC: C07K16/00 , A61K39/395 , C07K16/18 , G01N33/92 , C07K16/44 , G01N33/574 , A61P35/00 , A61K39/00
Abstract: Pharmaceutical composition comprising antibodies or antigen binding fragments thereof that bind to stage-specific embryonic antigen 4 (SSEA-4) are disclosed herein, as well as methods of use thereof. Methods of use include, without limitation, cancer therapies and diagnostics. The antibodies of the disclosure can bind to certain cancer cell surfaces. Exemplary targets of the antibodies disclosed herein can include carcinomas, such as breast cancer, lung cancer, esophageal cancer, rectal cancer, biliary cancer, liver cancer, buccal cancer, gastric cancer, colon cancer, nasopharyngeal cancer, kidney cancer, prostate cancer, ovarian cancer, cervical cancer, endometrial cancer, pancreatic cancer, testicular cancer, bladder cancer, head and neck cancer, oral cancer, neuroendocrine cancer, adrenal cancer, thyroid cancer, bone cancer, skin cancer, basal cell carcinoma, squamous cell carcinoma, melanoma, and/or brain tumor.
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公开(公告)号:US10980894B2
公开(公告)日:2021-04-20
申请号:US15996192
申请日:2018-06-01
Applicant: OBI Pharma, Inc.
Inventor: Cheng-Der Tony Yu , Jiann-Shiun Lai , I-Ju Chen , Chiu-Chun Lin
IPC: C07K16/00 , A61K47/68 , C07K16/28 , A61P35/00 , A61K31/4025 , A61K39/395 , C07K16/18 , C07K16/30 , A61K39/00
Abstract: Pharmaceutical composition comprising antibodies or antigen binding fragments thereof that bind to stage-specific embryonic antigen 4 (SSEA-4) are disclosed herein, as well as methods of use thereof. Methods of use include, without limitation, cancer therapies and diagnostics. The antibodies of the disclosure can bind to certain cancer cell surfaces. Exemplary targets of the antibodies disclosed herein can include carcinomas, such as breast cancer, lung cancer, esophageal cancer, rectal cancer, biliary cancer, liver cancer, buccal cancer, gastric cancer, colon cancer, nasopharyngeal cancer, kidney cancer, prostate cancer, ovarian cancer, cervical cancer, endometrial cancer, pancreatic cancer, testicular cancer, bladder cancer, head and neck cancer, oral cancer, neuroendocrine cancer, adrenal cancer, thyroid cancer, bone cancer, skin cancer, basal cell carcinoma, squamous cell carcinoma, melanoma, and/or brain tumor.
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