suzhou, may 18, 2020 - alphamab oncology (stock code: 9966 hk) announced today that the anti-her2 bispecific antibody kn026 independently invented and developed by jiangsu alphamab biopharmaceuticals co., ltd. (“jiangsu alphamab”), a wholly-owned subsidiary of the company, will be presented at the 2020 annual meeting of the american association for cancer research (aacr).
the american cancer research association (aacr) is one of the world’s longest-running and largest professional organization dedicated to advancing cancer research. focusing on all-around high-quality cancer researches and innovations, the aacr annual meeting is the spotlight of global cancer research, and showcases the most cutting-edge research results in oncology. affected by the outbreak of covid-19, this year's aacr annual meeting will be held online. jiangsu alphamab will present:
title: using translational tumor growth inhibition modeling approach and population pk analysis to predict efficacious doses for kn026, a her2 bispecific antibody
abstract no.: #1181
date: june 22, 2020, edt
"kn026 is an innovative biological drug developed with our proprietary platform, and the clinical results to be presented on aacr annual meeting reflect our team’s outstanding scientific research capabilities," said dr. ting xu, founder, chairman and ceo of alphamab oncology. “leveraging tumor suppression and group pk simulation to construct model is one our attempts to determine rp2d in early clinical settings. through great teamwork, we expect to develop and produce world leading innovative biological drugs, to better meet the medical needs of tumor patients. "
in the clinical study shared at the aacr annual meeting, in order to determine the target concentration, researchers explored the anti-tumor activity under different kn026 exposures at various initial tumor volume and different proliferation rates based on preclinical pk-pd data and tumor growth parameters in breast cancer patients. a population pk model was developed based on the pk data of patients from the fih (first-in-human) trials of kn026. leveraging modeling and simulation approach, various regimens were simulated to predict the drug effect on the time course tumor dynamics in humans and the probability of having the target population to reach effective concentration. this preclinical-clinical translational model was further validated by external data from human efficacy data, which can be used to facilitate the decision of a reasonable strategy for selection of clinical effective dose and dose schedule.
the use of the pk-pd modeling to aid decision in drug development, especially for the dose determination in early clinical trials, has become a popular tool. in the fih clinical trials of kn026, researchers combined tumor growth data in kn026 preclinical mouse xenograft tumor model, tumor growth dynamics parameters in target population and clinical pk data to construct translational pk-pd/tumor dynamics model with a drug-induced tumor decay with resistance, to provide references for kn026’s dose determination strategies in her2-positive solid tumor patients, and inform dose selection strategies. this study predicts that kn026 administration at 20mg/kg q2w and 30mg/kg q3w both can achieve expected clinical efficacy, kn026’s loading dose is conducive to improve the rate of tumor killing in the initial stage of administration, and achieve benefits for patient. the results of the translational medicine will be further optimized and updated with the data of the follow-up clinical trials of kn026, to help the researchers' further understanding of kn026's anti-tumor activity and drug resistance mechanism, thus improve the efficiency of research and development and expedite the research and development process.
we will release posters simultaneously on our website on june 22, edt. click (www.alphamabonc.com) to find out the latest clinical data of kn026 published on 2020 aacr annual meeting.
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 and pertuzumab alone or in combination, such as increased binding affinity, as well as better tumor 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 in china have shown good safety and preliminary efficacy.
kn026 received ind approval from the national medical products administration (nmpa) of china and u.s. food and drug administration (fda) in 2018. currently, it is in multiple phase i/ii clinical trials in china and phase i clinical trial in the united states. the results of phase i clinical trials show kn026 has excellent safety, tolerance and potentially superior anti-tumor activity in her2-positive breast cancer patients who progressed after multiple lines of anti-her2 treatment.
about alphamab oncology
alphamab oncology is a biopharmaceutical company focusing on innovative biologics medicine for oncology. on december 12, 2019, the company was listed in the mainboard of hong kong stock exchange with stock code 9966.
alphamab has fully integrated proprietary biologics platforms in bi-specifics and protein engineering. its highly differentiated in-house pipeline consists of eight anti-cancer drug candidates, four of which have advanced into phase i – iii clinical development phases in china, us and japan.
the company also has state-of-the-art manufacturing capability designed and built to meet nmpa and eu/fda’s cgmp standards. alphamab oncology is committed to further develop its robust pipeline in oncology/immunology to benefit patients around the world. visit http://www.alphamabonc.com for more information.
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