Ascletis Pharma Inc. aims to start a phase 2 clinical study using an immuno-oncology drug to treat hepatitis B by the end of this year, CFO Lindi Tan told S&P Global Market Intelligence on the sidelines of the 2019 BIO Asia International Conference in Tokyo.
The Hangzhou-based company in January bought the commercial and development rights to Suzhou Alphamab Co., Ltd.'s PD-L1 class checkpoint inhibitor KN035 for anti-virus indications. AlphaMab will share about 15% to 20% of the sales.
The checkpoint inhibitors, which are normally used to treat cancer, block the interaction between cancer cells and T cells to enable the immune system to kill cancer cells. Studies have shown that by blocking such interactions, these checkpoint inhibitors are able to restore the T-cell function that is impaired by hepatitis viruses, which may be the key to curing hepatitis B, according to research published on Gut and Liver in 2018.
About 90 million people are infected with hepatitis B in China, according to the World Health Organization. Tan said the company will approach Chinese regulators between June and September 2019 to discuss the potential to go directly into a phase 2 trial, as the drug has been tested on patients with cancer.
Ascletis chose to partner with Alphamab because KN035 is the only PD-L1 drug in a late-stage study that can be administered at room temperature and given subcutaneously, or under the skin, Tan said. Subcutaneous injections for medicines such as insulin are routinely given by the patients themselves and do not necessarily require medical professionals or visits to the hospital. The fact that it can be administered at room temperature is important for transportation and administration as well.
"It has to be subcutaneous because you may be on once a week dosing. The economic conditions in China [make] it still very difficult for cold chain," Tan said in a panel discussion.
Tan said the company will look at dosing very carefully, and the dosage for hepatitis B will likely be one-tenth or even lower than that for cancer.
Tan also said the company has not set up a price range for the drug, but will likely price it above 20,000 yuan per year.
As of March 11, US$1 was equivalent to about 6.73 yuan.