Obi Pharma Inc.

Obigen Pharma, Inc.

Cheng-Der Tony Yu

I-Ju Chen

Jiann-Shiun Lai

Cheng-Chi Wang

Yih-Huang Hsieh

Yi-Chien Tsai

Chiu-Chun Lin

Wei-Han Lee

Yu-Hsin Lin

Yu-Chen Lin

Shu-Yi Lin

Peiwen Yu

Nan-Hsuan Wang

Yin-Cheng Hsieh

Wei Lee

Yu Chen Lin

Teng-Yi Huang

Yung-Kai Wang

Ming-Tain Lai

Yueh-Chin Wu

Yu-Chun Tseng

Nan Hsuan Wang

Yu-Hsin Tom Lin

Tzu-Wen Tsau

Woan Eng Chan

Kuan-Cheng Shen

Chung-Hao Chang

Yih Huang Hsieh

Pu-Ling Hu

Youe-Kong Shue

Chen-Hsin Liang

Chwen-Cheng Chen

Kuo-Pao Lai

Shu-Yu Lee

Chin-Sheng Chao

Cheng-Chi Irene Wang

Chien-Chih Ou

Yu-Ching Lin

Ming-Chen Yang

I Ju Chen

The present invention relates to a botulinum toxin type A complex, and a formulation thereof and a usage method therefor. The present invention provides the botulinum toxin type A complex, comprising an HA70 component, and an HA17 component, an HA33 component, an NINH component, and a BoNT/A1 component, wherein the botulinum toxin complex has a molecular weight of 740-790 kDa. Compared with the existing botulinum toxin complexes, the botulinum toxin complex of the present invention is smaller in molecular weight and higher in safety, and has a comparable treatment effect.

Botulinum toxin type a complex, and formulation thereof and usage method therefor

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.

Saponin adjuvant and evaluation method thereof

The invention encompasses therapeutic compositions including Globo H-KLH conjugates and/or therapeutic antibodies 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 Globo H moiety and a KLH moiety and/or a derivatized KLH moiety subunit optionally linked via a linker. The therapeutic compositions are in part envisaged to act as cancer 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. An effective immune response is one that reduces 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.

Compositions of a carbohydrate vaccine for inducing immune responses and uses thereof in cancer treatment

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.

Antibodies, pharmaceutical compositions and methods

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%.

Methods of making high enantioselective secondary alcohols

The present invention provides vaccines comprising carbohydrate antigen conjugated to a diphtheria toxin (DT) as a carrier protein, wherein the ratio of the number of carbohydrate antigen molecule to the carrier protein molecule is higher than 5:1. Also disclosed herein is a novel saponin adjuvant and methods to inhibit cancer cells, by administering an effective amount of the vaccine disclose herein.

Vaccines with higher carbohydrate antigen density and novel saponin adjuvant

Pharmaceutical composition comprising antibodies or antigen binding fragments thereof that bind to Globo H, stage-specific embryonic antigen 3 (SSEA-3) and 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 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.

Human antibodies, pharmaceutical compositions and methods

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.

Immunogenic/therapeutic glycan compositions and uses thereof

The disclosure provides a method of immunotherapy for a cancer patient, comprises administering vaccines against Globo series antigens (i.e., Globo H, Stage-specific embryonic antigen 3 'SSEA3' and Stage-specific embryonic antigen 4 'SSEA4'). Specifically, the method comprises administering Globo H-KLH (OBI-822) in patients with Metastatic Breast Cancer. The disclosure also provides a method of comprises selecting a cancer patient who is suitable as treatment candidate for immunotherapy. In addition, the disclosure provides therapeutic agents, including monoclonal antibodies (mAbs) that bind specifically to Globo series antigens and related biomarkers useful in focusing such therapeutic and diagnostic regimens.

Cancer immunotherapy by immune activation or immune modulation via Globo series antigens

The present invention provides antibodies or the antigen-binding portion thereof to a tumor-associate carbohydrate antigen. Also disclosed herein are pharmaceutical compositions and methods for the inhibition of cancer cells in a subject in need thereof. The pharmaceutical compositions comprise an antibody or an antigen-binding portion thereof and at least one pharmaceutically acceptable carrier.

Carbohydrate antibodies, pharmaceutical compositions and uses thereof

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.

Glycosynthase variants for glycoprotein engineering and methods of use

The present invention provides antibodies or the antigen-binding portion thereof, that bind to one or more carbohydrate antigens. Also disclosed herein are pharmaceutical pharmaceutical compositions and methods for the inhibition of cancer cells in a subject in need thereof. The pharmaceutical compositions comprise an antibody or an antigen-binding portion thereof and at least one pharmaceutically acceptable carrier.

Antibodies, pharmaceutical compositions and uses thereof

Growing community of inventors

Taipei, Taiwan

Cheng-Der Tony Yu