PharmaCyte Biotech Proceeding with GMP Production of Pancreatic Cancer Product After Successful Changes to Manufacturing Process

LAGUNA HILLS, Calif.–(BUSINESS WIRE)–PharmaCyte
Biotech, Inc. (OTCQB: PMCB), a clinical stage biotechnology company
focused on developing targeted cellular therapies for cancer and
diabetes using its signature live-cell
encapsulation technology, Cell-in-a-Box^®, today announced
that it has made further important progress in optimizing the complete
manufacturing process, including significant improvement of the growth
characteristics of the cells from PharmaCyte’s Master Cell Bank (MCB)
after encapsulation. These encapsulated cells will be used, in
combination with low doses of the cancer prodrug ifosfamide, for the
treatment of locally advanced, non-metastatic, inoperable pancreatic
cancer (LAPC).

PharmaCyte can now provide additional information as an update to its
recent press release on the production of its clinical trial product
called, “CypCaps.” PharmaCyte, together with its team of experts, has
successfully implemented additional changes to the manufacturing process
that have resulted in a remarkably improved and more reproducible
encapsulated live cell product.

Use the link below to view a picture that captures the growth process
post encapsulation from day 8 to day 22 of the cells from the MCB. In
the linked picture, you will see the cells from the MCB growing in the
capsules over the course of 22 days. On day 22 the cells in the capsules
have stopped growing because of contact inhibition and have been placed
into syringes and frozen. They have also been thawed and tested for
viability and the level of enzymatic activity necessary to convert
ifosfamide from its inactive form to its cancer-killing form. Both tests
met the required specifications: https://pharmacyte.com/master-cell-bank-cell-growth-post-encapsulation

As previously reported, the cells from PharmaCyte’s MCB that were
produced by Eurofins Lancaster Laboratories showed slightly different
growth properties when compared to the cells that were previously tested
by Austrianova from PharmaCyte’s Research Cell Bank, a finding that is
not unusual when a new cell bank is established. Although minor in
nature, these different growth characteristics of the MCB cells
initially affected many of the steps required for the overall production
process of the CypCaps, necessitating counter measures to re-align and
restructure the production process.

PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, said, “With
these changes in place, GMP production of the CypCaps for PharmaCyte can
now proceed at Austrianova’s manufacturing facility in Bangkok, Thailand.

“This is great news for everyone who has worked so diligently through
what has been a complicated and meticulous process to get the production
of our clinical trial product exactly right before we approach the FDA
with an Investigational New Drug application. It’s also great news for
our many shareholders who have waited patiently as we navigated these
unchartered waters with encapsulating the live cells from our MCB.”