3SBio Signs Exclusive Patent License Agreement for DIG-KT, a Bi-Specific mAb targeting VEGFR2 and Tie-2 with PharmAbcine

SHENYANG, China and DAEJEON, South Korea, Jan. 14, 2015 /PRNewswire/ -- 3SBio Inc. ("3SBio"), a leading China-based biotechnology company focused on researching, developing, manufacturing and marketing biopharmaceutical products, today announced it has entered into an exclusive licensing deal with PharmAbcine Inc. ("PharmAbcine") for the development, manufacturing and marketing of DIG-KT, a bi-specific monoclonal antibody ("mAb") targeting both VEGFR2/KDR and Tie-2 pathways for cancer in the territory of Greater China (including mainland China, Taiwan, Hong Kong and Macau) and Korea. The deal included undisclosed upfront, milestone and royalty payments.

Angiogenesis is correlated with disease progression and poor prognosis in many tumor types, such as colon, lung, breast and pancreatic cancers. Two key pathways, VEGF / VEGFR2 (KDR), as well as angiopoietin (ANG) / Tie-2, act cooperatively to induce tumor angiogenesis and metastasis. It has been found that combined blockade of VEGF/VEGFR2 and ANG/Tie-2 pathways results in additive effects on vascular regression and anti-tumor efficacy. Researchers from PharmAbcine have developed DIG-KT, a bi-specific mAb to treat solid tumors. DIG-KT binds VEGFR2/KDR and Tie-2 simultaneously, and blocks binding of VEGFR2 ligands, including VEGF-A, VEGF-C and VEGF-D, as well as Tie-2 ligands, including Ang1, Ang2, Ang3 and Ang4. Consequently, DIG-KT inhibits ligand-stimulated activations of both VEGFR2/KDR and Tie-2, therefore inhibits ligand-induced angiogenesis, proliferation, and migration of human endothelial cells.

Current anti-VEGF drugs such as bevacizumab, sorafenib and aflibercept are efficacious. Still, over time cancer cells develop resistance via induction of ANG/Tie-2 pathway, an alternate route to angiogenesis. Drugs targeting the Tie-2 pathway alone may have similar limitations. DIG-KT, by concurrent dual receptor inhibition of VEGFR2/KDR and Tie-2, is expected to be more efficacious in both bevacizumab-naïve patients and those failing VEGF therapy due to development of resistance. Preclinical proof-of-concept, including in vitro binding assays and in vivo efficacy in animal models, has demonstrated superiority of DIG-KT over current drugs in bevacizumab-resistant murine models of glioblastoma and pancreatic cancer.

"This is our second collaboration with PharmAbcine," Dr. Jing Lou, Chairman and CEO of 3SBio, commented. "We are impressed by PharmaAbcine's high scientific standards and look forward to working with them as we seek regulatory approvals to move DIG-KT into clinical trials in China and notably Korea, in line with our strategy to develop 3SBio's development capabilities in key international markets. 3SBio continues to seek opportunities to expand its biologics pipeline. Novel mAb candidates, especially bi-specific mAbs, shed light on the treatment for refractory or metastatic cancers, such as pancreatic and breast cancers, which is consistent with 3SBio's core therapeutic areas of oncology and nephrology."

"We are very pleased to expand our partnership with 3SBio," Dr. Jin-San Yoo, President and CEO of PharmAbcine, commented. "3SBio is a well-established industry leader with long-term vision in the innovative biological field in China, which makes them an ideal partner for strategic collaborations in the long term. DIG-KT is a novel bi-specific mAb with great potential to treat refractory tumors. We are looking forward to working with them to develop this mAb in China and Korea, so that tens of thousands of patients suffering for cancers and other severe diseases can benefit from this drug candidate."

This is the second licensing agreement between 3SBio and PharmAbcine in less than two months. On November 18, 2014, 3SBio announced it had signed an exclusive patent license agreement for Tanibirumab, an anti-VEGFR2/KDR mAb.

About 3SBio Inc.

3SBio is a fully integrated, profitable biotechnology company focused on researching, developing, manufacturing and marketing biopharmaceutical products primarily in China. Since its founding in 1993, 3SBio's R&D efforts have resulted in four NDAs for biological medicines, including TPIAO, the first rhTPO approved worldwide.

Pipeline candidates include Uricase PEG-20, a modified pegylated recombinant uricase from Candida utilis for the treatment of refractory gout and tumor lysis syndrome which has completed US Phase 1 trials; NuPIAO, a long-acting erythropoiesis-stimulating agent (ESA) for anemia associated with renal failure or chemotherapy and peri-operative blood cell mobilization which has entered into Phase I clinical trial in China now; SSS07, an anti-TNF mAb for treating rheumatoid arthritis, psoriasis, and potentially other inflammatory diseases which has received China FDA's approval to initiate clinical trials; Leukotuximab/SSS19, an anti-CD43/JL-1 mAb for treating acute leukemia; and Tanibirumab/SSS23, a anti-VEGFR2 mAb for treating solid tumor.

A new state-of-the-art mammalian biological manufacturing facility in Shenyang is the first and only rhEPO facility in China that conforms to both Chinese and European pharmacopeia standards. Planning is underway to develop mAb manufacturing capabilities.

3SBio is China's leading specialist in nephrology and oncology supportive care with more than 600 sales professionals covering over 3,000 hospitals in key cities supported by a nationwide network of 120 distributors and logistics providers. EPIAO has been the top selling rhEPO product in China since 2002 with a market share over 40%.

Please visit www.3sbio.com for additional information.

About PharmAbcine Inc.

PharmAbcine is a clinical stage biotech company that develops fully human therapeutic monoclonal antibodies (mAbs) and next generation bi-specific antibodies using innovative discovery technology and excellent human resources for the treatment of human diseases, such as cancer and inflammatory diseases. Our mission is to develop a first-in-class and best-in-class mAb for those target diseases. PharmAbcine was spun out of the Korea Research Institute of Bioscience and Biotechnology belonging to the Korean government. For more information visit www.pharmabcine.com.

About DIG-KT

DIG-KT is a novel, first-in-class, fully human bi-specific mAb that binds and neutralizes VEGFR2/KDR and Tie-2 receptors simultaneously resulting in sustained inhibition of tumor growth and angiogenesis. VEGF and Tie-2 pathways, two important routes for formation of new blood vessels in various tumors, are critical for tumor growth and survival. The dependence of tumor growth and metastasis on blood vessels makes tumor angiogenesis a rational and validated target for cancer therapy.

Although current anti-VEGF drugs such as bevacizumab, sorafenib and aflibercept are efficacious, cancer cells develop resistance via induction of angiopoietin/Tie-2 pathway, an alternate route to angiogenesis. Drugs targeting the Tie-2 pathway alone may have similar limitations. DIG-KT, by concurrent dual receptor inhibition of VEGFR-2 and TIE 2, is expected to be more efficacious in both bevacizumab-naïve patients and those failing VEGF therapy due to development of resistance. Preclinical proof-of-concept, both in vitro binding assays and in vivo efficacy in animal models, have demonstrated superiority of DIG-KT over current drugs in bevacizumab-resistant murine models of glioblastoma and pancreatic cancer. DIG-KT project had been partly supported by International Collaborative R&D Program of KIAT (www.kiat.or.kr).

In October 2014, PharmAbcine entered into a license agreement with Triphase Accelerator Corporation to develop DIG-KT outside of Korea and Greater China. Triphase is a private drug development company with a primary focus on oncology and operations in San Diego and Toronto. It has a strategic relationship with Celgene for oncology-focused drug development opportunities.

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SOURCE 3SBio Inc.