Sorrento Therapeutics announced its subsidiary, Levena Biopharma completed construction and put into operation a 25,000 square foot Good Manufacturing Practice (GMP) manufacturing facility in Suzhou, China. The facility will be dedicated to supporting Sorrento's antibody drug conjugate (ADC) pipeline.
Sorrento currently has a dozen pre-clinical cancer focused ADCs partnered with biopharmaceutical companies worldwide, under the Levena brand. These partnerships have ADC candidates at various stages of development, including a HER2-targeting ADC which has an expected IND filing with the China Food and Drug Administration (CFDA) in 2017. Sorrento expects to receive service revenue and royalties on its partnered ADC programs. Additionally, Sorrento is advancing two proprietary anti-cancer ADC product candidates into IND enabling studies, including its proprietary anti-CD38 ADC and an anti-c-MET ADC. Both proprietary anti-cancer ADC programs were generated from Sorrento's fully human GMAB library and leverage on Levena's proprietary site-specific conjugation chemistry (K-Lock and C-Lock) and proprietary novel toxin payloads.
"ADC process development and manufacturing has historically been challenging to the industry as it requires a high level of technical expertise and specific know how,” Dr. Henry Ji, President and CEO of Sorrento. “Our new plant has been designed to provide full analytical support capabilities, GMP production of toxin-linkers based on our proprietary technology and methods, as well as GMP-grade bioconjugation of the antibody to produce ADCs. The launch of this state of the art plant, in addition to our existing ADC research sites in Nanjing, China and San Diego, demonstrates Sorrento's commitment to our ADC pharmaceutical partners as well as ensures a consistent supply for our own ADC franchise which is nearing the clinic."