On October 23, 2018 Alphamab Oncology and 3D Medicines Inc. (3D Med) reported 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 (Press release, Alphamab, OCT 23, 2018, View Source [SID1234530317]). 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) (Free ESMO Whitepaper).

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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"