English 中文简体 中文繁体

Alphamab Oncology Initiated KN046 Phase II Clinical Trial in NSCLC

April 30, 2019 15:00 Eastern Daylight Time

SUZHOU, China, April 30, 2019 - Alphamab Oncology announced that phase II clinical trial for non-small cell lung cancer has been launched for KN046, an innovative bispecific antibody developed by the company.

KN046, developed by Alphamab Oncology, is designed to target PD-L1 and CTLA-4, the only two clinically validated IO targets. KN046 simultaneously targets two important immunoregulatory targets thus activating T cells more effectively towards tumor. Results of phase I clinical trials conducted in Australia and China have shown that KN046 has good tolerability and promising albeit preliminary efficacy. KN046 will be developed for multiple malignancies such as GI cancer, lung cancer and breast cancer.

Professor Caicun Zhou, the leading PI, is the director of Tongji University Medical School Cancer Institute and director of Oncology Department of Shanghai Pulmonary Hospital. It is a multicenter, open-label, single-arm phase II clinical trial to evaluate the efficacy, safety and tolerability of KN046 in patients with advanced non-small cell lung cancer. This study is aiming to enroll approximately 149 patients at 10 to 15 sites nationwide, and Shanghai Pulmonary Hospital, as the leading site, initiated the trial today.

"Conducting clinical trials should abide by laws, regulations, ethical principles and scientific principles to maximize the benefit to human subjects,” said professor Caicun Zhou. “This study will observe the safety and efficacy in subjects who have failed first-line treatment and subjects who have failed PD-(L)1 inhibitor therapy. Our center will, lead other sites to complete this trial, which will benefit more patients as early as possible."

“Alphamab Oncology focuses on unmet medical needs in oncology. After years of continuous research and development, the company has developed multiple proprietary technology platforms such as Bispecific Platform and Mix-mAb Platform,” said Dr. Ting Xu, Chairman and CEO of Alphamab Oncology. “Leveraging these platforms, Alphamab Oncology has established an exciting portfolio, covering First-in-Class and Best-in-Class anti-cancer biologics, represented by KN046. The BLA for KN046 is anticipated in as early as 2021 if everything goes smoothly. We remain optimistic that KN046 will provide a better treatment option for clinicians and cancer patients when marketed."

About Alphamab Oncology  
Alphamab Oncology is a leading biopharmaceutical company in China dedicated to the development of innovative biologics for cancer therapy globally. So far, four drug candidates in Alphamab Oncology's pipeline have advanced into clinical development phase. With multiple in-house proprietary platforms for innovative biopharmaceuticals, Alphamab Oncology has built a robust pipeline in oncology/immunology to benefit cancer patients around the world.

Visit http://www.alphamabonc.com for more information.


Contacts:
Alphamab Oncology
Fengzhang Guan, +86-512-62850800 Extension 8807
fengzhangguan@alphamabonc.com