On Tuesday August 8, 2016, Lawrenceville, New Jersey-based Celsion Corporation (NASDAQ: CLSN), a company focused on developing a portfolio of innovative cancer treatments, announced the commencement of a Technology Transfer, Manufacturing and Commercial Supply Agreement with Zhejiang Hisun Pharmaceutical Co. Ltd., a leading pharmaceutical company in China, relating to the production for clinical and commercial purposes of GEN-1, Celsion’s proprietary gene mediated IL-12 immunotherapy. The agreement comes four years after a similar one for ThermoDox®, Celsion’s proprietary heat-activated liposomal encapsulation of doxorubicin. The agreement gives Celsion a domestically-based partner as it engages with the China Food and Drug Administration (CFDA) and secures long-term supply to one of the largest markets for ThermoDox® in the world.
Announcing the agreement, Michael H. Tardugno, Celsion’s chairman, president and chief executive officer, said:
“Hisun has already proven itself to be an exceptional partner through our existing ThermoDox® collaboration, and has been the source of high quality, cost-effective manufacturing. We are delighted to have the opportunity to expand our relationship, and to further harness their state-of-the-art manufacturing expertise and facilities through this newly established GEN-1 Agreement.”
The agreement calls for competitive unit costs that will support rapid market adoption and significant gross margins across global markets. It also states that Celsion will provide Zhejiang Hisun a certain percentage of China’s commercial unit demand and separately of global commercial unit demand, subject to regulatory approval. Celsion will undertake the necessary transfer of technology and information on related studies to Zhejiang Hisun, which will work with Celsion to gain CFDA approval for GEN-1.
GEN-1 is a deoxyribonucleic acid (DNA) mediated immunotherapy for the localized treatment of ovarian and brain cancers. It is currently under evaluation as a first line treatment, in combination with chemotherapy, in a phase I study of newly-diagnosed ovarian cancer patients. GEN-1, which is designed using the TheraPlas™ platform technology, is an IL-12 DNA plasmid vector encased in a nanoparticle delivery system, which enables cell transfection followed by persistent, local secretion of the IL-12 protein. A plasmid vector is a small piece of DNA used for cloning. Transfection is the process of inserting genetic material, such as DNA and double stranded RNA, into mammalian cells. Interleukin 12 (IL-12) promotes anti-cancer immunity.
Apart from its combination trials of GEN-1 with chemotherapy, Celsion has previously reported positive phase I results in trials of GEN-1 given as monotherapy in patients with peritoneally metastasized ovarian cancer. Combination trials of GEN-1 with PEGylated doxorubicin in patients with platinum resistant ovarian cancer have also produced encouraging results.
Celsion Corporation is a pharmaceutical company that specializes in the field of oncology. The company’s lead product is ThermoDox, a heat-activated liposomal encapsulation of doxorubicin, which is in a phase III clinical trial for the treatment of primary liver cancer and a phase II clinical trial for the treatment of recurrent chest wall breast cancer (the DIGNITY Study).
For more information, visit www.Celsion.com
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