Our lead product, AlloStim®, is a patented, “off-the-shelf”, bioengineered, non-genetically altered, ex-vivo differentiated and expanded CD4+ Th1-like memory cell with anti-CD3/anti-CD28 coated microbeads attached (a/k/a Bioengineered Allograft Cells or “BAG” cells). AlloStim® cells produce type 1 cytokines such as interferon-gamma, GM-CSF and TNF-alpha and express high density CD40L. AlloStim® has potent immunomodulatory properties that are used to reverse engineer immune mechanisms and imprint them upon the immune systems of patients with cancer, infectious disease and healthy elderly adults to slow or reverse the effects of aging. AlloStim® are Th1-like memory Th1 cells with phenotype: CD4+, CD45RO+, CD62Llo, CD40Lhi, CD25+, IFN-gamma+, IL-4-, perforin/granzyme A+.
Cell Lysate (CRCL)
Chaperone Rich Cell Lysate (CRCL) is a concentrated mixture of heat shock proteins purified from lysed tumor or viral infected cells. Cell are collected from a patient by biopsy and lysed in the laboratory. Using a unique process, heat shock proteins (HSP) are purified from the cell lysate in a manner which preserves the chaperoned peptides. The process enriches in HSP70, HSP90, gr94/gp96 and calreticulin. The chaperoned peptides contain tumor neoantigens.
AlloStim® has multiple immunomodulatory mechanisms depending on dose, frequency of dosing and dose route. By varying these parameters the magnitude and timing of the following immunomodulatory effects can be imprinted upon the immune system:
AlloStim® modulates the Th1/Th2 systemic and local microenvironment, shifting to Th1-dominant immunity. Tumors and viruses evade cellular immune attack by creating a Th2-dominant environment.
"Cold" to "Hot" tumor
Most human tumors lack any significant infiltration by immune cells capable of destroying tumor cells. Non-inflamed tumors are referred to as “cold” tumors. AlloStim® converts cold tumors to highly inflamed “hot” tumors.
AlloStim® can modulate the tumor microenvironment to down-regulate a variety of cytokines and cell types that create an immunosuppressive environment and increase cytokines and cell types which promote an inflammatory environment:
Down Regulates Checkpoint Molecules
AlloStim® naturally causes the down-regulation of checkpoint inhibitor molecules, such as PD-1/L1 and CTLA4 on tumor cells and immune cells in the tumor microenvironment. The selective down-regulation of checkpoint molecules only in and around the tumor minimizes side-effects and enables use as a monotherapy, without need to combine with checkpoint blockade.