Kintor gains global license from Pfizer to develop an innovative antibody drug for cancer
On January 24, 2018, Suzhou Kintor Pharmaceuticals, Inc. (Kintor) and the world’s largest pharmaceutical firm Pfizer Inc. held a press conference in Suzhou on development of an innovative antibody drug for cancer. According to the agreement, Kintor will be exclusively licensed by Pfizer to develop, manufacture and commercialize a new antibody drug for cancer. This drug is expected to be the world’s first humanized monoclonal antibody drug for ALK-1 (Activin receptor-Like Kinase-1) target. This is another important event after Kintor raising RMB288 million in C round financing recently.
The cooperation will take advantage of Kintor’s strong R&D capacity and Pfizer’s rich innovation capability to contribute to China’s efforts in drug innovation and provide clinical innovation and “made in China” clinical therapy plans for cancer treatment, provide clinicians and patients with effective choices and benefit patients in China and the rest of the whole world as well.
High incidence of cancers urges discovery of innovative drugsChina is a country suffering high incidence of cancers. The Cancer Statistics of China in 2015 shows that China has about 22% of new cancer cases and 27% of the world's cancer deaths, corresponding to an average of almost 12,000 new cancer diagnoses and 7,500 cancer deaths every day. Cancer has brought heavy burdens to patients, their families and the society, and seriously threatens the public health of China.
Of the cancers of high incidence, liver cancer is the second most common cancer “killer” in China. In 2015 China saw 466,000 new liver cancer cases, accounting for a half of the world’s total; meanwhile, 422,000 patients died from liver cancer. Liver cancer is hard to detect in early stage, and features high degree of malignancy, rapid progression and high difficulty in treatment. Though there are a variety of treatment choices such as surgery, liver transplantation and interventional therapy, the therapeutic effect of liver cancer is not satisfactory. Normally advanced liver cancer patients only have six months to live after diagnosis. To develop new drugs for the high incident cancer in China and bring innovative and effective treatment choices for liver cancer patients in China have become a common goal of Kintor and Pfizer.
New type AKL-1 target, innovative clinical application
Of the liver cancer therapies, combination of targeted therapies is one of the main development directions in future. Monoclonal drugs have been widely used in treatment of different diseases. Meanwhile, monoclonal antibody drugs for different targets are under development across the world. ALK-1, Activin receptor-Like Kinase-1, is mainly expressed in the vascular endothelial cells and associated with growth and migration of endothelia cells. By blocking the receptor, it can inhibit growth of the tumor blood vessel, and reduce tumor blood flow and angiogenesis so as to effectively slow the tumor progression. ALK-1 has a special target which generates widespread influence in the tumor biology by inhibiting angiopoiesis and causing changes of the tumor microenvironment. ALK-1 is a drug that changes the tumor microenvironment and conforms to the concepts of modern anti-tumor therapy in combination with other targeted drugs. This cooperation is reportedly to produce the world’s first humanized monoclonal antibody drug for ALK-1 receptor blocker.
The preliminary development of the drug was conducted by Pfizer which completed two Phase I clinical trials in the United States, Italy, Korea and Japan in 2014. It was verified by nearly 100 advanced solid tumor patients. This drug is safe and some patients made objective response. Liver cancer patients in the dose expansion group showed certain disease control rate. The preliminary trial results are to be verified in the Phase II clinical trials urgently.
Joining hands in innovation to bring new hopes to Chinese patients
“It is a mission of Kintor to explore new concepts of tumor therapy and develop the world-class innovative drugs. Since established in 2009, Kintor has been dedicated to discovery of innovative drugs for tumors. At present many tumor projects under research are processed successfully,” said Dr. Tong Youzhi, founder and president of Kintor, “it is well-known that the new drug development is a long process and usually takes more than 10 years, and poses high risks. However, we are optimistic about the future clinical development and application prospect of ALK-1 antibody drug. We will make great efforts to promote future clinical development and try to bring more timely and effective tumor therapies for patients. Meanwhile, we expect to introduce advanced products from Pfizer, the world’s premier bio-drug innovation corporation, to help us make leapfrog development in the clinical innovation capability.”
“The cooperation on ALK-1 is an important milestone of Pfizer’s localized R&D strategy,” said Mr. Wu Kun, head of Pfizer Innovative Health China, “As a leading foreign pharmaceutical corporation in China, Pfizer has actively responded to the strategic planning on vigorously developing biological industry and promoting medical innovation and transformation and upgrade set forth in the Healthy China 2030 Planning Outline. It has been dedicated to deepening the local R&D, introducing global R&D experiences and proprietary technologies and establishing innovative strategic partnerships with local pharmaceutical firms to comprehensively improve local R&D capability, systems, technological patents, talent fostering and innovation culture. The pharmaceutical giant will join hands with local enterprises to boost health and well-being of people of China and the rest of the world as well.”
According to the cooperation agreement, Kintor will obtain the right to globally develop, manufacture and commercialize ALK-1 licensed by Pfizer and get the preclinical and Phase I clinical trial results and support on proprietary technologies. Meanwhile, Pfizer also maintains related rights of choice at different R&D stages on development, manufacturing and commercialization in markets out of China. Kintor will carry out multi-center Phase II clinical trials and use in combination with other drugs on the basis of the existing Phase I clinical study, and launch related works to transfer the drug production to China. At the same time, Kintor will actively explore applications of the drug in treating diseases other than liver cancer to benefit patients as soon as possible.
Suzhou Kintor Pharmaceuticals, Inc. (839419) is a high-tech innovation-oriented enterprise dedicated to anti-cancer drug development. Its management and R&D team consists of professionals with doctor’s degree from renowned universities in China and the United States and rich experiences in management, R&D and high-tech product marketing in domestic and overseas biopharmaceutical firms. Kintor’s products under development include the new generation clinical anti-prostate cancer drug that inhibits androgen receptors, and kinase targeted inhibitors for breast, lung and liver cancers. Kintor is working hard to complete the pre-clinical R&D of the anti-cancer new drug and obtain the permit for clinical trials in China with two to three years to form a supply chain of pre-clinical R&D, clinical trial and final products of anti-cancer targeted drugs. It is improving its overall competitiveness and values and realizing the goal of growing into a pharmaceutical firm with international influence. Kintor was successfully listed on the New Third Board on December 12, 2016. It has also been included in the important drug innovation program of the 12th Five-Year Plan period and the 13th Five-Year Plan period and CFDA’s “Prioritized Review of New Drug” program. Tong Youzhi and Guo Chuangxin are included in the 1000 Talent Program of China.