Lineage granted stem cell production patent for cancer vax

The patent validates a system for production of antigen presenting dendritic cells from human embryonic stem cells (hESCs), used in Lineage Cell Therapeutics’ cancer immunotherapy program VAC2.

The United States Patent and Trademark Office (USPTO) issued Patent No. 10,344,262, entitled ‘Differentiation of primate pluripotent stem cells to hematopoietic lineage cells,’ to Lineage Cell Therapeutics in July.

The patent was filed by Asterias Biotherapeutics in February 2017. Asterias was acquired by clinical-stage biotech BioTime in March 2019, and since then BioTime has rebranded itself under the name Lineage Cell Therapeutics.

Image: iStock/Olivier-Le-Moal

According to Lineage’s CEO Brian Culley, “the issuance of this patent is important because the allowed claims support our differentiation process for the production of VAC2, our allogeneic, or “off-the-shelf” cancer immunotherapy program, currently being tested in a Phase I clinical trial in subjects with non-small cell lung cancer.”

The non-patent specific cancer vaccine candidate VAC2 has been designed to stimulate patient immune responses to telomerase, commonly expressed in cancerous cells.

It is produced using a directed differentiation method from pluripotent cell technology, comprised of mature dendritic cells.

“VAC2 is specifically designed to stimulate a patient’s immune response to a tumor antigen commonly expressed in cancerous cells but rarely found in normal adult cells,” said Culley.

Patent claims

According to Asteria’s filing, the claims of the patent are:

  1. A system for the production of antigen presenting cells comprising: a) a first isolated cell population comprising human pluripotent stem cells in a cell culture medium comprising granulocyte-macrophage colony stimulating factor (GM-CSF) and bone morphogenic protein 4 (BMP-4); and b) a second isolated cell population comprising mature dendritic cells which are the in vitro progeny of a portion of the first isolated cell population, wherein the system is stromal cell and interleukin 3 (IL-3) free.
  2. The system of claim 1, wherein at least 5% of the mature dendritic cells express one or more markers chosen from CD86 and CD83.
  3. The system of claim 2, wherein the mature dendritic cells expressing one or more markers chosen from CD86 and CD83 further express one or more of the following MHCII and CCR7.
  4. The system of claim 1, wherein the human pluripotent stem cells are human embryonic stem cells.
  5. The system of claim 1, wherein the system is serum free.
  6. The system of claim 1, wherein the cell culture medium comprising GM-CSF and BMP-4 further comprises one or more factors selected from vascular endothelial growth factor (VEGF), stem cell factor (SCF), and interleukin 4 (IL-4).
  7. A cell culture, comprising: a) a first isolated cell population comprising human pluripotent stem cells in a cell culture medium comprising granulocyte-macrophage colony stimulating factor (GM-CSF) and bone morphogenic protein 4 (BMP-4) and b) a second isolated cell population comprising dendritic cells which are the in vitro differentiated progeny of a portion of the first isolated cell population, wherein the cell culture is stromal cell and interleukin 3 (IL-3) free.
  8. The cell culture of claim 7, wherein the human pluripotent stem cells are human embryonic stem cells.
  9. The cell culture of claim 7, wherein the cell culture is serum free.
  10. The cell culture of claim 7, wherein the cell culture medium comprising GM-CSF and BMP-4 further comprises one or more factors selected from vascular endothelial growth factor (VEGF), stem cell factor (SCF), and interleukin 4 (IL-4).
  11. A first and a second population of cells, comprising: a) a first isolated cell population comprising human pluripotent stem cells in a cell culture medium comprising granulocyte-macrophage colony stimulating factor (GM-CSF) and bone morphogenic protein 4 (BMP-4) and b) a second isolated cell population comprising dendritic cells which are the in vitro progeny of a portion of the first isolated cell population, wherein the first and the second population of cells are stromal cell and interleukin 3 (IL-3) free.
  12. The first and the second population of cells of claim 11, wherein the human pluripotent stem cells in the first isolated cell population are human embryonic stem cells.
  13. The first and the second population of cells of claim 11, wherein the first and the second populations are cultured in a serum free medium.
  14. The first and the second population of cells of claim 11, wherein the cell culture medium comprising GM-CSF and BMP-4 further comprises one or more factors selected from vascular endothelial growth factor (VEGF), stem cell factor (SCF), and interleukin 4 (IL-4)

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