f Alphamab Oncology to Present Multiple Clinical Research Data at the 2021 American Society of Clinical Oncology Annual Meeting (ASCO 2021) – Beranda Kaltim
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Alphamab Oncology to Present Multiple Clinical Research Data at the 2021 American Society of Clinical Oncology Annual Meeting (ASCO 2021)

SUZHOU, China, May 20, 2021 /PRNewswire/ -- Alphamab Oncology (stock code: 9966.HK) announced, data from three clinical studies of the PD-L1/CTLA-4 bispecific antibody KN046 will be presented in Poster session at the 2021 American Society of Clinical Oncology Annual Meeting (ASCO 2021) to be held from June 4th to June 8th; preliminary efficacy data of anti-HER2 bispecific antibody KN026 in patients with advanced HER2-positive gastric and gastroesophageal junction cancer published in abstract form.

KN046-202:
Title: A phase 2, open-label, multicenter study to evaluate the efficacy, safety, and tolerability of KN046 in combination with chemotherapy in subjects with advanced non-small cell lung cancer
Abstract Number: 9060
Poster Number: 200614
Presentation Format: Poster
Session Title: Lung Cancer-Metastatic Non-Small Cell Lung Cancer
First author: Professor Yunpeng Yang, Sun Yat-sen University Cancer Center
Abstract release time: May 19, 2021 at 5:00 p.m. ET

KN046-202 (NCT04054531) is a phase II, open label, multi-center clinical study designed to evaluate the efficacy, safety and tolerability of KN046 combined with platinum-based chemotherapy in patients with advanced non-small cell lung cancer. As of January 19, 2021, a total of 87 patients with advanced non-small cell lung cancer who have not received systemic treatment were enrolled, including 51 patients with non-squamous cell carcinoma and 36 patients with squamous cell carcinoma. The efficacy of 81 patients can be evaluated, the objective response rate (ORR) is 50.6%, the disease control rate (DCR) is 87.7%; the median PFS is 5.9 months, and the median OS is not reached; The median PFS of patients with squamous cell carcinoma with PD-L1 ≥1% was 10.8 months. The results show that KN046 is well tolerated and effective for the first-line treatment of advanced non-small cell lung cancer; progression-free survival (PFS) and overall survival (OS) benefit, especially for patients with squamous cell carcinoma with PD-L1≥1%.

KN046-204:
Title: Efficacy and safety of KN046 plus paclitaxel/cisplatin as first-line treatment for unresectable locally advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC)
Abstract Number: 4062
Poster Number: 198655
Presentation Format: Poster
Session Title: Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary
First author: Professor Jianming Xu, Fifth Medical Center, Chinese People's Liberation Army General Hospital
Abstract release time: May 19, 2021 at 5:00 p.m. ET

This KN046-204 study is an ongoing phase II trial in China designed to evaluate the efficacy and safety of KN046 monotherapy or KN046 in combination with chemotherapy for unresectable locally advanced, recurrent or metastatic ESCC. Patients were enrolled in 3 cohorts. In cohort 3, which is reported here, patients with unresectable locally advanced, recurrent or metastatic ESCC were treated with KN046 in combination with paclitaxel and cisplatin. The primary endpoint was investigator-assessed ORR. Key secondary endpoints were DCR, safety, PK and immunogenicity. As of January 14, 2021, the KN046+Paclitaxel/Cisplatin Study enrolled 15 male patients. 12 patients were included in the efficacy analysis and 15 patients in the safety analysis. The ORR and DCR were 58.3% and 91.6%, respectively, including one complete response of target lesions. KN046 plus paclitaxel/cisplatin was active and well tolerated as first-line treatment for patients with advanced ESCC.

KN046-IST-04:
Title: Efficacy and safety of KN046 plus nab-paclitaxel/gemcitabine as first-line treatment for unresectable locally advanced or metastatic pancreatic ductal adenocarcinoma (PDAC)
Abstract Number: 4138
Poster Number: 198868
Presentation Format: Poster
Session Title: Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary
First author: Professor Gang Jin, First Affiliated Hospital of Naval Military Medical University (Shanghai Changhai Hospital)
Abstract release time: May 19, 2021 Eastern Time at 5:00 p.m. ET

This first results of an ongoing uncontrolled Phase II study of KN046 in combination with standard chemotherapy for systemic therapy naïve Chinese patients with locally advanced or metastatic Pancreatic Ductal Adenocarcinoma (PDAC) show the safety and activity of KN046 in this heavy to treat population and confirms the rationale and feasibility for further evaluation. The primary endpoint is ORR. Key secondary endpoints are TTP, DCR, DOR, PFS, OS and safety. As of January 15, 2021, 17 patients were enrolled, of which 9 were eligible to a preliminary efficacy evaluation. The ORR was 55.6% (5 out of 9) and the DCR was 88.9%. This preliminary analysis indicates promising activity and tolerability for the combination of KN046 with nab-paclitaxel and gemcitabine as first-line treatment for patients with unresectable locally advanced or metastatic PDAC. Further confirmation in controlled trials is warranted.

KN026-202:
Title: The Preliminary Efficacy of KN026 (Anti-HER2 BsAb) in Advanced Gastric and Gastroesophageal Junction Cancer Patients with HER2 Expression
Abstract Number for Publication: e16005
Presentation Format: Abstract
First author: Professor Jianming Xu, Fifth Medical Center, Chinese People's Liberation Army General Hospital
Abstract release time: May 19, 2021 at 5:00 p.m. ET

KN026-202 is a single-arm, open label, multi-center phase II clinical study to test the KN026 efficacy and safety in advanced gastric and gastric junction adenocarcinomas with HER2 expression who have received at least prior first-line treatment. Two cohorts were included in this study, one is HER2 high expression cohort (IHC 3+ or IHC 2+ ISH+) and the other is HER2 low and medium expression cohort (IHC 1+/2+ ISH- or IHC 0/1+ISH+) based on the central lab evaluation .

KN026 demonstrated favorable safety and promising efficacy in Chinese HER2 overexpressing GC/GEJ patients, both, either pretreated with or without anti HER2 treatments. As of cutoff date, a total of 20 patients received around 20-weeks KN026 treatment in cohort 1 which was high expression. The ORR was 55.6% (10 out of 18) and the DCR was 72.2% (13 out of 18). The 9-month PFS rate was 60.4% (95% CI: 24.4% to 83.5%), while the DOR, mPFS and mOS were not reached. Among nine patients receiving prior-HER2 treatment, the ORR was 44.4% (4 out of 9), and the DCR was 66.7% (6 out of 9). The mPFS and mOS were 5.6 months (95%CI:1.3 to NE) and 11.0 months (95%CI: 1.4 to NE), respectively.

About KN046

KN046 is PD-L1/CTLA-4 bispecific antibody independently developed by Jiangsu Alphamab. Its innovative designs include: a different mechanism CTLA-4 fused with PD-L1 single domain antibody; engineered to target the tumor microenvironment with high PD-L1 expression, and Treg (suppress tumor immunity) clearing function.

There are about 20 clinical trials of KN046 in different stages covering more than 10 types of tumors including NSCLC, TNBC, ESCC, HCC and pancreatic cancer in Australia and China. The results of these clinical trials have shown an advantage in survival for patients. Alphamab has received FDA clearance to enter phase II trial of KN046 based on the clinical results in China and Australia. Moreover, KN046 has obtained the U.S. FDA's orphan drug designation for thymic epithelial tumor in September 2020. Four pivotal clinical trials are currently being conducted.

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 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 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 multifunctional 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 an 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.



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