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A Phase II Clinical Trial Launched for KN046 in Combination with Chemotherapy in Advanced NSCLC

September 06, 2019 10:00 Eastern Daylight Time

SUZHOU, China, September 3, 2019 – Alphamab Oncology, a leading clinical-stage biopharmaceutical company in China, announced today that a phase II clinical study has been launched for KN046 in combination with chemotherapy to evaluate the efficacy, safety and tolerability in patients with advanced non-small cell lung cancer (study number: KN046-202) and the study’s first patient will complete dosing in recent days.

KN046 is the world’s first recombinant humanized PD-L1/CTLA-4 bispecific antibody independently developed by the company. KN046 simultaneously targets two important immunomodulatory targets which have been commercially validated, with the potential to become the cornerstone of next generation immuno-oncology therapy in the future.

The KN046-202 trial is a multicenter, open-label, single-arm phase II clinical study that aims to evaluate the efficacy and safety of KN046 as first-line treatment in patients with non-small cell lung cancer. The trial will be conducted at approximately 10 clinical sites nationwide and is expected to recruit 50 subjects.

Professor Li Zhang from Oncology Department of Sun Yat-sen University Cancer Center said, "KN046, as a second-generation immune antibody, is very worthy of expectation in patients with advanced non-small cell lung cancer based on its promising phase I clinical data. We are confident to see a stronger signal of efficacy among the 50 subjects in KN046-202 project. Through the examination of tissue sections, we hope to find the most suitable patients and bring more therapeutic benefits to them."

Dr. Ting Xu, Founder, Chairman and CEO of Alphamab Oncology, said, “Alphamab Oncology is dedicated to the unmet medical needs for cancer therapy. After years of continuous research and development, it has developed several proprietary technology platforms including Bispecific and Mix-mAb Platforms, and has established a robust bispecific antibody pipeline represented by KN046. KN046 is now the only PD-(L)1/CTLA-4 candidate that has entered phase II clinical trials worldwide. We hope that KN046 can benefit more patients and their families with its further clinical development."

About KN046

KN046 is the world's first recombinant humanized PD-L1/CTLA-4 bispecific antibody independently developed by Alphamab Oncology. It simultaneously targets two important validated immunoregulatory targets thus activating tumor targeting T cells more effectively. Results of phase I clinical trials conducted in Australia and China have shown preliminary good safety and efficacy. Currently, we are completing the phase I dose escalation study in China and have initiated multiple phase II clinical trials for TNBC, ESCC and NSCLC.

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.