SEOUL, South Korea,Nov. 6, 2017/PRNewswire/ --Eutilex Co. Ltd. today announced that it has entered into a strategic partnership withChina'sfast-growing Zhejiang Huahai Pharmaceutical Ltd. -- a deal that infuses new momentum into Eutilex's antibody and anti-tumor T cell therapy development programs.
Under the agreement, Huahai takes a$30 millionequity stake in Eutilex and receives an exclusive license to develop and commercialize EU-101, a humanized monoclonal antibody developed by Eutilex for cancer treatment, inthe People's Republic of China,Taiwan,Hong KongandMacau.
EU-101 has mounted a powerful attack on tumors by activating essential parts of the immune system in early preclinical studies.
Eutilex is eligible to earn milestone payments from Huahai for EU-101 that may total as much as $35 million for 10 approved immuno-oncology indications.
Huahai also will pay Eutilex royalties from future EU-101 sales in its markets.
Huahai will be eligible to participate in Eutilex's worldwide licensing revenues and will receive royalties from net sales if Eutilex commercializes EU-101 in markets other than those for which Huahai has exclusive rights.
Meanwhile, Eutilex's lead adoptive T cell therapy, 4-1BB CTL, has been proven safe in multiple Phase 1 clinical trials on terminally-ill cancer patients, with none of the toxic side effects that have plagued CAR-T drugs.
Some patients with solid tumors or hematologic cancers who were treated with Eutilex's T cell therapy went into a period of remission that lasted as long as two-and-a-half years -- the length of follow-up monitoring for Phase 1 research.
The Huahai deal also is helping Eutilex further expand global clinical trials on T cell therapies (autologous Epstein-Barr virus (EBV)/LMP2A-specific CD8+T cells) and further develop its pipeline.
Huahai, long-known as a major producer of active ingredients for drugs, has recently been expanding into finished drugs. It has issued more thanone billion yuan(US$151.85 million) in bonds to build a new biopharmaceutical industrial park inHangzhou, China.
"Huahai is bringing strong technical, production and R&D skills to its partnership with us," Eutilex founder and CEO Dr.Byoung S. Kwonsaid.
Huahai chairman Dr.Baohua Chensaid: "With multiple immune-oncology assets and compelling safety and efficacy data, Eutilex is a very attractive partner."
The agreement with Huahai brings total investment in Eutilex from various sources to$58.7 millionsince the company's founding in 2015. InDecember 2016, Eutilex completed a$21 billionKRW (US$18.9M) Series A financing -- one of the largest private financings that year in South Korean life sciences -- with participation from DS Asset Management, Kolon Investment, G.N. Tech Venture and SNU Bio Angel.
The BFC Group served as a financial adviser to Eutilex on the partnership with Huahai.
About Lead Antibody Therapy, EU-101
EU-101 is a preclinical-stage human monoclonal antibody agonist that binds to 4-1BB -- also called CD137 -- a protein receptor expressed in many immune cells, particularly CD8+and CD4+T cells. When binding to CD137, EU-101 activates T cells and prolongs their life, resulting in a more potent attack on cancer that is not limited to any specific cancer or to the number of applicable cancer indications. EU-101 is being studied alone and in combination with immune checkpoint inhibitors, and has been shown to work with PD-1/PD-L1 inhibitors to produce an amplified immune response.
About Lead Adoptive T Cell Therapy, 4-1BB CTL
4-1BB CTL (autologous Epstein-Barr virus (EBV)/LMP2A-specific CD8+T cells) is an autologous T cell therapy that isolates tumor-specific CD8+T cells from the patient's own peripheral blood based on shared or viral-origin tumor antigens ("Ag"), for instance hTERT, WT-1, NY-ESO1, and EBV. Antigen-specific CD8+T cells are then enriched outside of the body (ex-vivo) in a streamlined manufacturing process.
This process is based on a unique property of 4-1BB -- also known as CD137 -- a protein receptor expressed in many immune cells, that is selectively expressed on Ag-engaged T cells. The process also has been proven effective in producing Neo-Ag-specific CD4+and CD8+T cells.
Pure tumor-specific CD8+T cells are then re-infused into the patient. These activated cancer-specific T cells are then able to detect and efficiently kill tumor cells without affecting surrounding healthy tissue.
This protocol can readily be translated into standard cGMP and is being used to produce EBV-, hTERT-, and WT-1-specific CD8+T cells for Phase 1 clinical trials.
Approximately 62 percent of EBV-positive lymphoma patients enrolled in Eutilex's Phase 1 study responded to the 4-1BB CTL therapy, experiencing a durable complete regression of 2 CR out of 2 NK/T lymphoma patients. An analysis of all patients enrolled in the study found either a complete absence of or minimal toxic side effects.
This 4-1BB based adoptive T cell therapy will provide a practical, safe, and effective treatment for many cancer indications, overcoming many shortfalls CAR-T technology. 4-1BB therapy is performed on an outpatient basis and is relatively simple compared to CAR-T therapy, which requires inpatient admission.
Eutilex will present additional details and data on 4-1BB CTL at the Tri-Con conference,February 11-16, 2018, inSan Francisco, California.
About Eutilex Co. Ltd.
Based inSeoul, South Korea, Eutilex is a clinical-stage biopharmaceutical company focused on the development of anti-tumor T cell and antibody therapeutics for the treatment of cancers and autoimmune diseases. The most advanced drug candidate is an adoptive T cell therapy, 4-1BB CTL, which has finished Phase 1 clinical trials and will begin Phase 2. Other pipeline candidates in development include monoclonal antibodies, EU-101, EU-102 and EU-103. For more information, please visithttp://eutilex.com/eng/home.php.
About Zhejiang Huahai Pharmaceutical Ltd.
Zhejiang Huahai Pharmaceutical Co., Ltd., a large scaled modern pharmaceutical group that integrates fomulations, APIs (Active Pharmaceutical Ingredients) and intermediates, is developing both domestic and international markets, and performing parallel development of science, industry and commerce. With a total asset of1,900 million yuan, the company has 11branches (subsidiaries) inthe United States,Shanghai,Hangzhou, and Linhai. It occupies an area of 800,000 square meters, and has a staff of 5000. The company is entitled as National Key Hi-tech Enterprise, National Pilot Enterprise of Innovation, andChina'stop 500 private enterprises, and possesses a "State Certified Enterprise Technology Center."
