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.

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.

Described herein are compounds for use in vaccine compositions which contain natural or synthetic carbohydrate antigens. Such vaccines may be highly immunologically active due to the conjugation with an immune-stimulating protein or with a monophosphorylated lipid A derivative, and may be self-adjuvanting due to the presence of a monophosphorylated lipid A derivative. Treatments for cancer and fungal and bacterial infections are described herein.

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.

This disclosure includes an immunogenic composition containing (a) a glycan conjugate including a carrier and one or more glycans, wherein each of the one or more glycans is conjugated with the carrier through a linker, and optionally (b) an adjuvant. The one or more glycan is each a Globo H derivative.

The present invention relates to a method for predicting human immune response to therapeutic cancer vaccine. This method includes a series of culturing procedures and a modified ELISPOT assay to detect total antibody, antigen specific antibody, and cytokine induction ability from human individual's PBMC.

In some embodiments, described herein is a method of tumor treatment or tumor vaccination. The method generally comprises applying to a human being in need thereof a tumor therapeutic composition or tumor vaccine defined herein. The tumor therapeutic composition or tumor vaccine can be produced by protein transfer of glycosyl-phosphatidylinositol (GPI)-anchored immunostimulatory or costimulatory molecules

In some embodiments, described herein is a method of tumor treatment or tumor vaccination. The method generally comprises applying to a human being in need thereof a tumor therapeutic composition or tumor vaccine defined herein. The tumor therapeutic composition or tumor vaccine can be produced by protein transfer of glycosyl-phosphatidylinositol (GPI)-anchored immunostimulatory or costimulatory molecules.

The present disclosure is directed to vaccines, antibodies, and/or immunogenic conjugate compositions targeting the SSEA3/SSEA4/GloboH associated epitopes (natural and modified) which elicit antibodies and/or binding fragment production useful for modulating the globo-series glycosphingolipid synthesis. The present disclosure relates to methods and compositions which can modulate the globo-series glycosphingolipid synthesis. Particularly, the present disclosure is directed to glycoenzyme inhibitor compound and compositions and methods of use thereof that can modulate the synthesis of globo-series glycosphingolipid SSEA3/SSEA4/GloboH in the biosynthetic pathway; particularly, the glycoenzyme inhibitors target the alpha-4GalT; beta-4GalNAcT-I; or beta-3GalT-V enzymes in the globo-series synthetic pathway. Moreover, the present disclosure is also directed to the method of using the compositions described herein for the treatment or detection of hyperproliferative diseases and/or conditions.

Entirely carbohydrate immunogens, monoclonal antibodies generated from immune responses to entirely carbohydrate immunogens, vaccine compositions, pharmaceutical compositions, and methods of making and using the same, are described.