The derivation process covered by the patent provides a means for commercial scale manufacturing of an allogeneic, off-the-shelf immunotherapy platform.
Matthew Vincent, director of business development at ACT explained to us: “Dendritic cell (DC) therapy is based on the concept that the cells of the immune system can be programed to effectively recognize and destroy cancer cells. Our current patent is directed to a process for generating dendritic cells in very large scale from a renewable stem cell sources (i.e., no need for donors) to be used in the manufacture of dendritic cell vaccines.”
Dendritic cells “play a critical role in the regulation of certain immune responses” and “are rapidly gaining in interest to create potent vaccines, particularly for the next generation of tumor vaccines,” Vincent said.
One such vaccine -- Northwest Biotherapeutics’ dendritic cell vaccine DCVax, which the company expanded manufacturing capacity for -- could be one of the top late-stage blockbusters.
“However, despite all the promise, current methods of generating human dendritic cells from adult donors are both inadequate and susceptible to high levels of variability between individuals. The current state-of-the-art methods can cause premature activation of precursor cells before becoming dendritic cells, and can produce contamination with undesired cell types rather than dendritic cells,” Vincent said.
But the “breakthrough here,” as Vincent puts it, “is based on the use of ACT’s proprietary hemangioblast cell technology.”
Hemangioblasts are a multipotent precursor cell that “can be derived in large scale quantities from a variety of renewable pluripotent stem cell sources (such as iPS cells or embryonic stem cells) and which can be efficiently differentiated into dendritic cells and other hematopoietic cell types,” he said.
Through the ability to generate highly pure preparations of dendritic cells, and at a large scale, ACT’s patented methods “are expected to translate into a much more efficient and lower cost manufacturing process for making therapeutic doses of activated dendritic cells that may be far more potent than dendritic cells produced from adult donor sources,” Vincent added.
“The addition of this new patent continues to strengthen our IP position around core cell therapy components and helps protect our leading position in the regenerative medicine field,” said Paul Wotton, President and CEO of ACT. “It is an exciting time to be here as we concentrate our efforts on developing cures for diseases and disorders of the eye and get ready to initiate phase 2 clinical trials for the treatment of Stargardt’s macular degeneration (SMD) and age-related macular degeneration (AMD).”