KN035, a Global Leading Subcutaneously-administered PD-L1 Antibody, Starts Late-stage Clinical Development

Tuesday, October 23, 2018 Clinical Trials News
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KN035's US Phase I clinical data was presented at the annual ESMO Congress

SUZHOU, China, Oct. 23, 2018 /PRNewswire/ -- Alphamab Oncology and 3D Medicines Inc. (3D Med) announced today

PD-L1 antibody KN035 has entered late stage clinical development, including phase III for bile tract carcinoma (cholangiocarcinoma) and phase II for MSI-H solid tumors have been initiated in China. It is also announced that the poster entitled "Phase I Study of KN035, A Novel Fusion anti-PD-L1 Antibody Administered Subcutaneously in Patients with Advanced Solid Tumors in the USA" (poster No. 1456) was presented at the 2018 Annual Congress of the European Society for Medical Oncology (ESMO).

KN035 is the first-in-class PD-L1 single-domain antibody with distinct features over all other PD- (L) 1 antibodies. KN035 has the advantages of subcutaneous injection and good stability at room temperature. These would be of great value to improve patients' compliance and quality of life and to help realize the goal of long-term management of cancer as a chronic disease. So far, more than 300 patients have participated in KN035 clinical trials in the United States, Japan and China.

The phase I trial in the United States was designed as a 3+3 open dose-escalation study in patients with advanced and inoperable tumors. The main endpoints were tolerance to KN-035 and safety, with the secondary endpoints were to evaluate the pharmacokinetic of KN-035, the maximum tolerance dose and the antitumor effect as a single drug. The drug was given subcutaneously at a dosage of 0.01, 0.03, 0.1, 0.3, 1.0, 2.5, 5.0 and 10.0 mg/kg weekly.

In the US phase I trial, a total of 18 subjects were enrolled as of July 5, 2018. In the 17 subjects who finished efficacy evaluation, 2 partial response (PR) and 5 stable disease (SD) were confirmed, according to the RECIST1.1 criterion. No dose-limiting toxicity (DLT) was observed in this trial. The exposure to KN035 increased proportionally with dose. Average half-life of KN035 was about 200 hours.

Dr. Ting Xu, Chairman and CEO of Alphamab Oncology, said, "KN035 is currently the sole PD-L1 antibody through subcutaneous injection with excellent bioavailability and distribution. We expect that the clinical progress of KN035 will further demonstrate its advantages. In addition to the indications being tested, we plan to leverage KN035's unique profile to explore its potential utility in maintenance, adjuvant therapy and neo-adjuvant therapy. We hope to provide patients with an alternative and convenient option."

Dr. John Gong, CEO of 3D Med, added, "We are excited with the data from the phase I clinical study conducted in the US. It demonstrated the safety and good pharmacokinetics of KN035 in patients with advanced cancer, as well as encouraging initial treatment efficacy. We look forward to further advancing the KN035 clinical trials in the US with the leading oncologists there"

About Alphamab Oncology:

Alphamab Oncology is a clinical-stage biopharmaceutical company dedicated to the discovery, development, manufacturing and commercialization of world-class innovative therapeutics for cancer treatment. With multiple in-house proprietary platforms, including bispecifics, protein engineering and antibody screening, Alphamab Oncology has built a robust pipeline in oncology/immunology. We strive to develop next-generation or best-in-class medicines to address global unmet medical needs.

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

About 3D Medicines

3D Medicines Inc. is committed to the development and commercialization of innovative drugs for cancer treatment and is a frontrunner in China's precision medicine industry. With its proprietary companion diagnostics platform, 3D Medicines aims to deliver precision medicine therapeutics to cancer patients in China and the rest of the world. 3D Medicines has built up an immuno-oncology pipeline composed of both large molecules and small molecules, which are currently in clinical and pre-clinical stages.

3D Medicines is also a leading NGS assay services provider in China. In the past 3 years, 3D Medicines has provided more than 10,000 NGS tests in over 200 Class III hospitals around China. Moreover, 3D Medicines provides the tailored services of developing companion diagnostics for other companies, home and abroad, to guide their biomarker-driven clinical trials of anti-cancer drugs.

3D Medicines was founded in Shanghai in 2010 and has over 500 employees worldwide.

Cision View original content:http://www.prnewswire.com/news-releases/kn035-a-global-leading-subcutaneously-administered-pd-l1-antibody-starts-late-stage-clinical-development-300736008.html

SOURCE Jiangsu Alphamab Biopharmaceuticals Co., Ltd.



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