On March 27, 2020 Alphamab Oncology (stock code: 9966HK) reported that Jiangsu Alphamab Biopharmaceuticals Co., Ltd. ("Jiangsu Alphamab"), a wholly-owned subsidiary of the Company, has entered a clinical supply agreement with Pfizer Inc. ("Pfizer") to advance a clinical study to investigate KN026 in combination with Ibrance (palbociclib), an oral CDK4/6 inhibitor, in patients with previously-treated locally advanced and/or metastatic HER2-positive breast cancer (Press release, Alphamab, MAR 27, 2020, View Source [SID1234555955]). Jiangsu Alphamab, as the study sponsor, will oversee and run the trial, and Pfizer will supply palbociclib.
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Dr. Ting XU, Founder, Chairman and CEO of Alphamab Oncology commented, "Through the collaboration with Pfizer, we are on the right track to investigate the combination of KN026 and a CDK4/6 inhibitor for patients with HER2-positive breast cancer as a chemo-free regimen. By combining KN026 with palbociclib, we believe it has the potential to provide more effective treatment options for patients with HER2‑positive breast cancer."
This Phase Ib/II clinical trial is a multicenter, open-label study, aiming to evaluate efficacy, safety and tolerability of KN026 in combination with palbociclib in patients with locally advanced unresectable or metastatic HER2-positive breast cancer.
KN026 received IND approval from the National Medical Products Administration of China and U.S. Food and Drug Administration in 2018. Currently, it is in multiple phase I/II clinical trials in China and phase I clinical trials in the United States, targeting HER2 expression solid tumors cancers, such as breast cancer, gastric cancer, urothelial cancer and gynecological cancers.
About KN026
KN026 is an anti-HER2 bispecific antibody developed by Alphamab Oncology using the proprietary Fc-based heterodimer bispecific platform technology called CRIB (Charge Repulsion Induced Bispecific). KN026 can bind two non-overlapping epitopes of HER2 simultaneously, leading to a dual HER2 signal blockade. In pre-clinical studies, KN026 has demonstrated potentially equivalent or superior efficacy compared with Trastuzumab w/o combination with Pertuzumab. KN026 has increased binding capacity as well as better inhibition in HER2-positive tumor cell lines. Additionally, KN026 has also shown inhibitory effect on tumor cells with medium or low HER2 expression or Trastuzumab-resistant cell lines. KN026 phase I trials have shown good safety and preliminary efficacy.