Alphamab Oncology Announced First Patient Dosed in the U.S. in A Phase II Pivotal Clinical Study of KN046

Alphamab Oncology Announced First Patient Dosed in the U.S. in A Phase II Pivotal Clinical Study of KN046

SUZHOU, China, Dec. 23, 2021 /PRNewswire/ -- Alphamab Oncology (stock code: 9966 HK) announced dosing of the first patient of its proprietary PD-L1/CTLA-4 bispecific antibody KN046 in the United States.

The patient received treatment in ENREACH-Thymic, a phase II, open label, multi-center pivotal clinical study to evaluate efficacy, safety and tolerability of KN046 in subjects with advanced thymic carcinoma. The trial has completed dosing of the first patient in China in January 2021, and about 68 patients will be enrolled in China and the US. The primary endpoint is the objective response rate (ORR) evaluated by the Independent Review Committee (IRC) according to the RECIST 1.1. The US FDA has granted orphan drug designation to KN046 for the treatment of thymic epithelial tumors. Thymic carcinoma is the most aggressive thymic epithelial tumor, and the prognosis for inoperable or metastatic thymic carcinoma is extremely poor, with no approved standard of care for patients who have failed platinum-containing chemotherapy.

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, thymic cancer, pancreatic cancer, HCC, ESCC and TNBC in Australia, the US and China. The results of these clinical trials have shown an advantage in survival for patients. Alphamab Oncology 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 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 Oncology 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. In November 2021, Envafolimab received marketing authorization from the Chinese National Medical Products Administration (NMPA) for the treatment of previously treated MSI-H/dMMR advanced solid tumors.

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.

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