On March 28, 2019 OBI Pharma, Inc. (TPEx: 4174), a leader in Glycosphingolipid Immuno-Oncology therapeutics targeting the Globo Series antigens (Globo H, SSEA-3 and SSEA-4), reported that data highlighting OBI-888 (Globo H mAb) and OBI-999 (Globo H ADC) mechanism of action, anti-tumor efficacy and pharmacokinetics profile in multiple cancer types, will be presented at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting from March 29–April 3, 2019 in Atlanta, Georgia (Press release, OBI Pharma, MAR 28, 2019, View Source [SID1234534694]).

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Title: Anti-tumor efficacy and potential mechanism of action of a novel therapeutic humanized anti-Globo H antibody, OBI-888
Session: PO.IM02.16 – Therapeutic Antibodies 1
Date/Time: March 31, 2019 from 1:00 PM – 5:00 PM EST
Location: Section 23
View Source!/6812/presentation/2395

Title: Specificity, biodistribution, tumor targeting, and pharmacokinetics of a novel humanized anti-Globo H antibody, OBI-888, for cancer immunotherapy
Session: PO.ET07.01 – Targeted Therapies
Date/Time: April 3, 2019 from 8:00 AM – 12:00 PM EST
Location: Section 14
View Source!/6812/presentation/3113

Title: Novel Globo H targeting antibody-drug conjugate with binding specificity and anti-tumor efficacy in multiple cancer types
Session: PO.ET07.01 – Targeted Therapies
Date/Time: April 3, 2019 from 8:00 AM – 12:00 PM EST
Location: Section 14
View Source!/6812/presentation/3114

Preclinical studies showed that OBI-888’s mechanism of action involves antibody-induced tumor lysis which may have substantial therapeutic potential. OBI-888 is currently in a Phase 1 clinical study in solid tumor patients at the MD Anderson Cancer Center in Houston, Texas (USA). For OBI-999, preliminary pharmacological studies in established animal tumor models showed potent and long lasting anti-tumor activity in multiple cancer types, including breast, pancreatic, lung and gastric cancer. A US FDA IND submission is planned for 2019. OBI Pharma owns global rights to OBI-888 and OBI-999.

About OBI-888

OBI-888 is a novel first-in-class monoclonal antibody, which selectively targets Globo H, an antigen expressed in up to 15 types of epithelial cancer. This Globo H targeting antibody has been shown to induce tumor-killing via antibody-dependent cell-mediated cytotoxicity (ADCC), antibody-dependent cell-mediated phagocytosis (ADCP) and complement-dependent cytotoxicity (CDC).

OBI-888 is also anti-immunosuppressive and anti-angiogenic. In pre-clinical xenograft animal models in multiple tumor types (pancreatic, colon, lung, and breast), OBI-888 has demonstrated tumor shrinkage at various doses. In pre-clinical single and repeated dose toxicology studies, OBI-888 was well-tolerated with no adverse effects observed in all the doses tested.

About OBI-999

OBI-999 is an antibody-drug conjugate (ADC) treatment for cancer. OBI-999 uses a Globo H antibody to target cancer cells of high Globo H expression. By releasing a small molecule chemotherapeutic drug through the specificity of the antibody, it directly deploys cytotoxic therapy at the targeted cancer cells. Preliminary pharmacological studies and animal verification have already been completed and showed impressive and long lasting anti-tumor efficacy in multiple cancer types, including breast, pancreatic, lung and gastric cancer. It is currently undergoing Chemistry Manufacturing Control (CMC) planning and toxicology study design.