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Phase I Clinical Data of KN046, an Innovative PD-L1/CTLA4 Bispecific Antibody of Alphamab Oncology, is to be Presented at the 2019 ASCO Annual Meeting

May 17, 2019 15:00 Eastern Daylight Time

SUZHOU, China, May 17, 2019 – Alphamab Oncology announced today that the phase I clinical trial of KN046 (PD-L1/CTLA4 bispecific antibody) has achieved expected results. Clinical data will be presented at the 2019 ASCO Annual Meeting with the title of “Preliminary safety, efficacy and pharmacokinetics (PK) results of KN046 (bispecific anti-PD-L1/CTLA4) from a first-in-human study in subjects with advanced solid tumors” (Abstract #2554) on June 1 (Saturday) from 8 a.m. to 11 a.m. (CST).

KN046 is the world's first recombinant humanized PD-L1/CTLA-4 bispecific antibody solely developed by Alphamab Oncology. PD-(L)1 and CTLA-4 are validated immuno-oncology targets and combination therapies of PD-1 and CTLA-4 have already been approved for melanoma and renal cell carcinoma. Such combinations are also in multiple late-stage clinical trials. However, the high toxicity of current CTLA-4 antibodies limits their therapeutic utility. Alphamab Oncology has developed KN046, a PD-L1 – CTLA-4 bispecific with differentiated innovative designs:
·      a proprietary CTLA-4 domain antibody with a much-improved safety profile;
·      fused to an anti-PD-L1 antibody to form a bispecific antibody;
·      engineered to target the tumor microenvironment.

The preclinical study results for KN046 have shown a profile of promising efficacy and lower toxicity, and results from clinical studies have demonstrated an improved safety profile, so it is expected to have the potential to become the cornerstone of next generation immuno-oncology therapy.

KN046 has undergone phase I clinical trials in Australia and China, and currently has entered phase II clinical trials in China. Preliminary clinical results indicate that KN046 has shown good safety and promising efficacy. Its safety data is similar to other single-target immunological checkpoint inhibitors reported previously. The PK data of the initial 4 cohorts supports the Q2W program.

Dr. Ting Xu, Founder, Chairman and CEO of Alphamab Oncology, said: “Results to be presented in the ASCO Meeting have demonstrated that KN046 has good safety and promising efficacy. Completion of KN046’s phase I clinical trial is a milestone for Alphamab Oncology in the field of immuno-oncology, and KN046 is expected to bring an innovative therapy to cancer patients. Alphamab Oncology will remain true to its original aspiration of “improving people’s well-being” and continue working hard to break new grounds. We are determined to build Alphamab Oncology into a world-class innovative biopharmaceutical company.”

About Alphamab Oncology
Alphamab Oncology is a leading biopharmaceutical company in China dedicated to the development of innovative biologics for cancer therapy globally. Thus 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 and 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