On February 22, 2022 OBI Pharma, Inc. (OBI), a Taiwan biopharma company (TPEx: 4174), and Odeon Therapeutics (Odeon), a China biopharma company, reported that have entered into an exclusive license agreement whereby OBI grants rights of OBI-999, a novel antibody-drug conjugate, and OBI-833, a therapeutic cancer vaccine, targeting the tumor antigen Globo H in China, Hong Kong and Macau to Odeon (Press release, OBI Pharma, FEB 22, 2022, View Source [SID1234608851]).

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Under the terms of the agreement, OBI will grant Odeon exclusive rights to develop, register and commercialize OBI-999 and OBI-833 for human cancer therapy in China, Hong Kong and Macao. Odeon will issue to OBI fully paid equity equivalent to US$ 12 million upon signing. OBI is eligible for development and commercialization milestones totaling up to US$ 188 million. The company is also eligible to receive tiered double-digit royalties on net sales. Odeon will also be responsible for all development costs and all subsequent regulatory and commercialization costs of OBI-999 and OBI-833 in China, Hong Kong and Macao.

"As a first-in-class ADC product targeting Globo H, OBI-999 has recently completed its Phase 1 study, showing excellent safety and PK profile. OBI-833 has also demonstrated great potential to become a differentiated immune-oncology therapeutic vaccine by activating the human immune system against the tumor antigen Globo H," said Tim Xiao, Chief Executive Officer of Odeon Therapeutics, "We look forward to working closely with OBI to bring these new treatment options to patients in China."

"We are excited to announce the license agreement which enables Odeon to develop, register and commercialize novel 1st-in-class anti-Globo H targeted Oncology therapeutics, OBI-999 and OBI-833 in China, Hong Kong and Macau," stated Kevin Poulos, Chief Commercial Officer OBI Pharma. "We look forward to partnering with Odeon to advance OBI-999 and OBI-833 to clinical development in the near future and potentially provide alternative novel options for cancer patients."

About OBI-999

OBI-999 is a novel first-in-class Antibody Drug Conjugate (ADC) with a proprietary linker technology that provides a consistent Drug-to-Antibody ratio (DAR) for cancer treatment targeting Globo H. 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. In pre-clinical xenograft animal models in multiple tumor types (pancreatic, lung, gastric, and breast), OBI-999 has demonstrated profound tumor shrinkage at various doses. In human Phase 1 study, OBI-999 was well-tolerated, and achieved a favorable safety margin. OBI-999 is currently in a Phase 2 clinical trial in medical centers in the US and Taiwan (ClinicalTrials.gov Identifier: NCT04084366). OBI Pharma owns global rights to OBI-999 except China, Hong Kong and Macao.

About OBI-833

OBI-833 is a novel cancer active immunotherapy targeting tumors with high Globo H expression. It consists of a synthetic Globo H antigen combined with a recombinant CRM 197 protein. OBI has completed a Phase I dose escalation and cohort expansion study of OBI-833 (ClinicalTrials.gov Identifier: NCT02310464). OBI-833 demonstrated a favorable safety profile and generated detectable anti-Globo H IgM and IgG responses. In addition, OBI-833 rendered durable stable disease status for some non-small cell lung cancer (NSCLC) patients who were co-treated with an EGFR-TKI. OBI has filed an IND application to the Taiwan FDA for a Phase II study of OBI-833 for NSCLC. OBI owns the global rights to OBI-833 except China, Hong Kong and Macao.

About Globo H

Globo H is a glycosphingolipid that specifically expressed in up to 15 different cancers, such as breast, prostate, lung, gastric, esophageal and colorectal cancers. Globo H is reported to play important roles in tumor development including cancer cell survival, angiogenesis, immune suppression, and T cell inhibition. OBI is a pioneer in the development of anti-Globo H cancer therapeutics, and holds proprietary technologies in synthesizing Globo H, the OPopS platform and the Large-Scale Enzymatic Synthesis method.