PharmaCyte Biotech, a biotechnology company focused on developing cellular therapies for cancer and diabetes using its signature live-cell encapsulation technology, Cell-in-a-Box, is closer to submitting an Investigational New Drug application (IND) to the U.S. Food & Drug Administration (FDA). PharmaCyte said that its partner, Austrianova Singapore, has successfully completed encapsulation of the cells from PharmaCyte’s Master Cell Bank (MCB) in the second of two staggered and back-to-back manufacturing runs for the production of PharmaCyte’s clinical trial product. This product will be used for PharmaCyte’s planned clinical trial in patients with locally advanced, inoperable pancreatic cancer (LAPC).
 
“The encapsulation process was performed last week at Austrianova’s manufacturing facility in Thailand,” said Kenneth Waggone, chief executive officer, PharmaCyte. “After reviewing the first pictures of the encapsulated cells, we’re confident that this manufacturing run is progressing as well as our first successful manufacturing run.
 
“We are anxiously awaiting the completion of the second of the two back-to-back manufacturing runs and the results from the FDA required testing on each of those runs. Once the information from that testing is available, it will be incorporated into our Investigational New Drug application (IND) for submission to the FDA.”
 
Most of the work needed for PharmaCyte to submit an IND to the FDA has been completed. The rate limiting factor is and always has been for Austrianova to complete successfully two back-to-back manufacturing runs. During PharmaCyte’s recent shareholder update call, the company reported on Austrianova’s work to encapsulate successfully PharmaCyte’s genetically modified human cells that will be used to treat patients suffering from LAPC.
 
After months of extensive research and development (R&D) by a team of experts from Austrianova and PharmaCyte, a total of eight different changes were made to the manufacturing process. It was not until the eighth and final change was made that the encapsulated cells grew as well in Austrianova’s manufacturing facility in Thailand as they grew at Austrianova’s R&D facility in Singapore.
 
Once the recently encapsulated cells in this second of two manufacturing runs have completely filled the capsules, they will be placed into PharmaCyte’s clinical trial syringes and then frozen. A representative sample of those syringes will be thawed and undergo the FDA required “release testing.” All “release testing” related to safety of the encapsulated cells is being outsourced by PharmaCyte to independent third-party laboratories in Europe. All “release testing” related to functionality of the encapsulated cells is being handled by Austrianova at its GMP facility in Thailand.