Celsion’s New Subsidiary in China to Serve as Beachhead for Commercializing ThermoDox® in China and Southeast Asia
- Memorandum of Understanding completed with Chinese government officials in the Yuhang district of
Hangzhou, China’s biotech hub, to develop and commercialize innovative cancer therapies starting with ThermoDox®.
- Agreement includes numerous financial and non-financial incentives including grants tied to clinical research, personnel expenses and tax abatements subject to certain development and commercial milestones.
- Subsidiary will provide
Celsionwith base for commercializing ThermoDox® in Chinaand nearby developing markets including the Philippines, Malaysia, Thailand, Vietnam, Taiwanand South Korea.
- Celsion’s Chinese manufacturing partner, Hisun, to provide ThermoDox® with an economically viable cost structure in
Chinaand other emerging markets.
The primary purpose of this new subsidiary is to commercialize innovative cancer therapies starting with ThermoDox®, the Company’s treatment for hepatocellular carcinoma (HCC), or primary liver cancer. ThermoDox is currently in global Phase III studies including 17 sites in
The MOU provides numerous incentives from the
“We are delighted progress is being made with the Chinese government and Hisun as our manufacturing partner to establish a subsidiary in the biotech capital of China,” said Mr.
Mr. Tardugno added, “With China accounting for half of the 850,000 new cases of HCC worldwide, the disease is a major public health problem.
“We expect a second interim efficacy analysis for the OPTIMA Study to occur in the second quarter of 2020, so the timing is right to establish a subsidiary in
Celsion’s most advanced program is a heat-mediated drug delivery technology that employs a novel heat-sensitive liposome engineered to address a range of difficult-to-treat cancers. The first application of this platform is ThermoDox®, a lyso-thermosensitive liposomal doxorubicin (LTLD), whose novel mechanism of action delivers high concentrations of doxorubicin to a region targeted with the application of localized heat at 40°C, just above body temperature. ThermoDox® is positioned for use with multiple heating technologies and has the potential to treat a broad range of cancers including metastatic liver, recurrent chest wall breast cancer and non-muscle invading bladder cancers.
Celsion’s LTLD technology leverages two mechanisms of tumor biology to deliver higher concentrations of drug directly to the tumor site. In the first mechanism, rapidly growing tumors have leaky vasculature, which is permeable to liposomes and enables their accumulation within tumors. Leaky vasculature influences a number of factors within the tumor including the access of therapeutic agents to tumor cells. Administered intravenously, ThermoDox® is engineered with a half-life to allow significant accumulation of liposomes at the tumor site as these liposomes recirculate in the blood stream. In the second mechanism, when an external heating device heats tumor tissue to a temperature of 40°C or higher, the heat-sensitive liposome rapidly changes structure and the liposomal membrane selectively dissolves, creating openings that can release a chemotherapeutic agent directly into the tumor and the surrounding vasculature. Drug concentration increases as a function of the accumulation of liposomes at the tumor site, but only where the heat is present. This method damages only the tumor and the area subject to tumor invasion, supporting more precise drug targeting.
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Source: Celsion CORP