Kyowa Hakko Kirin and AstraZeneca Partner on Immuno-Oncology Clinical Study
July 30, 2014
Tokyo, Japan, July 30, 2014 --- Kyowa Hakko Kirin Co., Ltd. (Tokyo; 4151 President and CEO: Nobuo Hanai; "Kyowa Hakko Kirin") announced today that it entered into a clinical study collaboration with AstraZeneca (London, UK, CEO: Pascal Soriot). The Phase I/Ib immuno-oncology study in multiple solid tumors will evaluate the safety and efficacy of anti-CCR4*1 antibody mogamulizumab (generic name / code name: KW-0761), in combination with AstraZeneca's investigational anti-PD-L1 antibody, MEDI4736, and anti-CTLA-4 antibody tremelimumab.
Mogamulizumab, MEDI4736 and tremelimumab are anticipated as part of a new class of cancer treatments known as immunotherapies, which use the body's own immune system to help fight cancer. MEDI4736 and tremelimumab block the signals that help tumours avoid detection by the immune system, while mogamulizumab suppresses some of the immune cells that shield the tumour from the immune system.
Under the terms of the agreement, Kyowa Hakko Kirin and AstraZeneca will co-fund the study, which will be conducted by Kyowa Hakko Kirin. Phase I study is expected to establish a recommended dose regimen in both arms of the study. Phase Ib will assess the safety and efficacy of the two combinations. Results from these studies will determine the further clinical development of the combinations.
Mogamulizumab (product name in Japan: POTELIGEO®) was launched in Japan in May 2012 for the treatment of patients with relapsed or refractory CCR4-positive Adult T-Cell Leukemia-Lymphoma (ATL). The drug was approved for indication expansion and was granted marketing authorization for the treatment of patients with relapsed or refractory CCR4-positive, peripheral T-cell lymphoma (PTCL) and cutaneous T-cell lymphoma (CTCL) in March 2014. Clinical trials with mogamulizumab in ATL, PTCL, and CTCL are ongoing in the US, EU and other countries. Mogamulizumab is a novel, humanized monoclonal antibody directed against CCR4. Engineered by Kyowa Hakko Kirin's unique POTELLIGENT® Technology*2, the antibody is designed to kill target cells through enhanced antibody-dependent cellular cytotoxicity (ADCC).
The Kyowa Hakko Kirin Group companies strive to contribute to the health and well-being of people around the world by creating new value through the pursuit of advances in life 2 sciences and technologies.
- *1 :CCR4: CC chemokine receptor 4
CCR4 is one of the chemokine receptors involved in leukocyte migration, selectively expressed in type 2 helper T (Th2) cells and regulatory T (Treg) cells. - *2 :POTELLIGENT® technology
POTELLIGENT® technology is Kyowa Hakko Kirin's unique technology for the production of antibodies with enhanced ADCC activity. This technique enables production of antibodies with a reduced amount of fucose in their carbohydrate structure. Non-clinical studies have demonstrated that antibodies produced using this technology killed target cells more efficiently than conventional antibodies and exhibited stronger antitumor effects. For more information, please visit www.POTELLIGENT.com.
Contact:
Kyowa Hakko Kirin
Media Contact:
+81-3-3282-1903
or
Investors:
+81-3-3282-0009
