On September 28,2021 Alphamab Oncology (stock code: 9966.HK) reported, the company has entered a partnership agreement with Hangzhou Raygene Pharmaceutical Co., Ltd (Raygene Pharmaceutical) to jointly develop the combination therapy of the PD-L1/CTLA-4 bispecific antibody KN046 and the small molecule drug RG001 for the posterior line treatment of advanced HCC and liver metastasis CRC (Press release, Alphamab, SEP 28, 2021, View Source [SID1234650400]).
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Liver cancer and colorectal cancer are the common types of gastrointestinal cancers. According to the latest global cancer burden data released by the World Health Organization in 2020, liver cancer is the sixth most common cancer worldwide, and the third leading cause of cancer-related death globally. Over 50% of new cases and deaths occurred in China. Colorectal cancer is the third most common cancer worldwide and the second most common tumor in China. 83% of colorectal cancer patients in China were at a middle or advanced stage when diagnosed, and 44% of them had liver/lung metastasis.
KN046 is a bispecific antibody independently developed by Alphamab Oncology, which simultaneously targets PD-L1 and CTLA-4 immune checkpoints and could effectively activate T cells and enhance immune anti-tumor ability. The Phase II clinical data of KN046 combined with Lenvatinib in the first-line treatment of HCC were published at the ESMO (Free ESMO Whitepaper) 2021. KN046 in combination with Lenvatinib in first line HCC achieved 57% and 76% ORR and 95% and 95% DCR by RECISCT 1.1 and imRECIST, respectively. Based on the results from this study, a global phase III clinical study of KN046 in combination with Lenvatinib for the first line treatment of hepatocellular carcinoma is justified and currently in the planning phase.
RG001 (TATE) is a proprietary anti-tumor small molecule drug licensed in from abroad by Ruizhen Pharmaceutical. It could be acted as prodrug and transformed to cytotoxic metabolites in hypoxic tumor cell, and resulted in tumor cells killed. According to pre-study, it could achieve a synergistical effects to enhance anti-cancer capacity when combined with other immune checkpoint inhibitors.
According to the agreement, Alphamab Oncology and Raygene Pharmaceutical will conduct clinical trials evaluating safety and efficacy of KN046 plus RG001 or in sequential combination for the posterior line treatment of advanced HCC, CRC liver metastasis and other indications jointly decided by both parties, and to bring new options to patients who have progressed after receiving chemotherapy, small molecule targeted therapy or PD-1 therapy.
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 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.