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        English 中文簡體 中文繁體

        Alphamab Oncology Announces First Patient Dosed in Phase2 Clinical Study of KN026 for the Neoadjuvant Treatment of HER2 Positive Breast Cancer

        August 16, 2021 09:24 Eastern Daylight Time

        Suzhou, August 12, 2021 - Alphamab Oncology (stock code: 9966.HK) announced, phase II clinical study (study number: KN026-208) of the company's proprietary HER2 bispecific antibody KN026 for the neoadjuvant treatment of HER2 positive early or locally advanced breast cancer recently completed the first drug administration.

         

        Breast cancer is the number one malignant tumor that seriously threatens the health of women in the world, and it is also the most frequent tumor in Chinese women. HER2 positive breast cancer is one of the most aggressive subtype of breast cancer, accounting for about 15%-30%, with rapid progression and poor prognosis. Early-stage breast cancer is a malignant tumor with a high cure rate. Neoadjuvant therapy may also enable patients with locally advanced breast cancer to have radical surgery. HER2 targeted drug combination therapy is regarded as the standard neoadjuvant treatment, hence pCR rate and progression-free survival still needs to be improved, there is still a huge unmet clinical need in HER2-positive breast cancer.

         

        KN026-208 is a phase II multicenter clinical study evaluating the efficacy, safety and tolerability of KN026 combination therapy as a neoadjuvant treatment for HER2 positive early or locally advanced breast cancer. Treatment naïve HER2 positive early or locally advanced breast cancer patients will receive KN026 combined with docetaxel for 4 cycles of neoadjuvant therapy. After neoadjuvant therapy, patients who meet the surgical conditions will undergo surgery and pathological remission assessment. The study plans to recruit about 30 patients, with pathological complete response rate (pCR) as primary study endpoint.

         

        Dr. Ting Xu, Chairman and CEO of Alphamab Oncology commented, “HER2 expression is an important marker of poor prognosis in breast cancer. Several clinical studies have shown that KN026 has significant anti-tumor activity and good safety against HER2-positive advanced breast cancer. Through the KN026-208 trial, we look forward to bringing new adjuvant treatments with better efficacy and safety to patients with early or locally advanced breast cancer, improving the chances of cure through a higher rate of radical surgery. "

         

        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. KN026 has demonstrated potentially equivalent 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 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 good 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 focusing on innovation, production and commercialization of anti-tumor drugs. 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 includes fifteen tumor monoclonal antibodies and bispecific antibodies and a Covid-19 bispecific antibody. Four products have advanced into phase I-III clinical trials or pre-marketing stage in China, the United States, Japan and Australia. The BLA for Envafolimab (KN035) has been accepted and granted Priority Review by the National Medical Products Administration (NMPA).

         

        The Company also has state-of-the-art manufacturing capabilities designed and built to meet NMPA and EU/FDA’s cGMP standards and a complete quality system which has passed the on-site inspection of a European Union qualified person. Alphamab Oncology is committed to building a global leading, multi-dimensional drug development and commercialization platform, focusing on multifunctional biological innovative drugs, and to benefit patients in China and around the world.

         

        Alphamab Oncology Forward-Looking Statements

        This press release contains statements related to our future business and financial performance and future events or developments involving Alphamab Oncology that may constitute forward-looking statements. These statements include projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future performance. These statements may be identified by words such as "expect," "look forward to," "anticipate" "intend," "plan," "believe," "seek," "estimate," "will," "project" or words of similar meaning. We may also make forward-looking statements in other reports, in presentations, in material delivered to shareholders and in press releases. In addition, our representatives may from time to time make oral forward-looking statements. Such statements are based on the current expectations and certain assumptions of Alphamab Oncology’s management and business operation, many of which are difficult to predict and generally beyond Alphamab Oncology’s control. These are subject to a number of risks and uncertainties, including but not limited to, uncertainties inherent in research and development, future clinical data and analysis, decisions by regulatory authorities regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates, the absence of guarantee that the product candidates if approved will be commercially successful, the future approval and commercial success of therapeutic alternatives, Alphamab Oncology's ability to benefit from external growth opportunities, trends in exchange rates and prevailing interest rates, the impact of cost containment policies and subsequent changes thereto, the average number of shares outstanding and Alphamab Oncology’s disclosures. Should one or more of these risks or uncertainties materialize or should underlying expectations not occur or assumptions prove incorrect, actual results, performance or achievements of Alphamab Oncology may (negatively or positively) vary materially from those described explicitly or implicitly in the relevant forward-looking statement. Other than as required by applicable law, Alphamab Oncology undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.