Pipeline

Emvolio is developing products that can be used together to attack cancer as different levels, as well as be used alone or in combination with existing therapies.  The overarching approach to cancer is as follows:

  1. Treat innate immune suppression: Administration of oral apigenin/pterostilbene (Cancer Metabolic DeTox Product) to decrease immune suppressive toxic molecules made by tumor and tumor microenvironment.
  2. Treat adaptive immune suppression: Administration of MemoryMune to activate dormant memory cells recognizing the tumor. Administration of LymphoBoost to repair deficient IL-12 production.
  3. Stimulation of immune response to cancer stem cells (StemVacs).
  4. Consolidation and maintenance of immunity: Cycles of StemVacs, supported by innaMune and LymphoBoost

All of the 5 products are created using materials that do not require major regulatory efforts

Cancer Metabolic DeTox: Derived from plants, apigenin is GRAS
MemoryMune: Cultured donor blood cells
LymphoBoost: Repositioning of expired drug
innaMune: Cultured donor blood cells
StemVacs: Peptides

Description of Products:

Patent Title: Targeting the Tumor Microenvironment through Nutraceutical Based Immunoadjuvants
Disclosed are compositions useful for the treatment of cancer which modulate tumor associated immunosuppression, thus acting as immunoadjuvants.  In one embodiment a composition containing apigenin, is provided, said composition useful for inhibition of tumor associated immune suppression mediated through the molecule indolamine 2,3 deoxygenase (IDO).  In another embodiment, liposomal apigenin is administered as a means of decreasing IDO expression.

Product Name: Cancer Metabolic DeTox:This is an orally administered agent that is derived from various herbs termed apigenin.  The unique property of apigenin is that it inhibits a cancer associated metabolic pathway that degrades the amino acid tryptophan.  Specifically, apigenin inhibits the enzyme indolamine 2,3 deoxygenase (IDO), which is responsible for breaking down tryptophan in the vicinity of the tumor and generating by-products such as kynurenine.  It is known that immune activation is dependent on tryptophan being present in the tumor environment.  The depletion of tryptophan and generation of kynurenine by tumor cells and tumor associated cells is a major cause of immune suppression in cancer.  By administering Cancer Metabolic DeTox, the innate arm of the immune system has a chance to regenerate.  This positions the patient for better outcome after administration of specific immune stimulating vaccines.

Patent Title: Methods of Re-Activating Dormant Memory Cells with Anticancer Activity
Disclosed are methods, protocols and compositions of matter useful for stimulation of anticancer immune responses. In one embodiment of the invention culture of buffy coat cells is performed in an environment resembling non-physiological conditions.  Buffy coat derived products are subsequently harvested, concentrated, and added to a culture of monocytes and lymphocytes.  Conditioned media from said second culture is subsequently utilized as an injectable solution for stimulation of anticancer immunity.

Product Name: MemoryMune:This is a product derived from a two-step culture process of donor blood cells.  The product MemoryMune reawakens dormant immune memory cells.  It is known that many cancer patients possess memory T cells that enter the tumor, however, once inside the tumor these cells are inactivated.  MemoryMune contains a unique combination of growth factors specific for immune system cells called “cytokines”.

Patent Title: Stimulation of Immunity to Tumor Stem Cell Specific Proteins by Peptide Immunization
Treatment of cancer is disclosed through administration of proteins or specific peptides found on tumor stem cells in vivo, in a matter eliciting monocyte or dendritic cell migration in order to allow uptake of said administrated proteins or peptides, followed by administration of a maturation signal in vivo.  The invention provides for treatment of cancer through induction of anticancer immunity and/or immunity towards tumor initiating stem cells.

Product Name: StemVacs:Cancer stem cells are the root of cancer. They are involved in maintaining tumor masses, causing metastasis, as well as initiating tumor relapse.  In contrast to other cancer cells, cancer stem cells are extremely resistant to chemotherapy and radiation therapy. StemVacs is a subcutaneously administered vaccine comprised of immune stimulatory peptides resembling cancer stem cell specific proteins.

Patent Title: Augmentation of Anti-Tumor Immunity by Mifepristone and Analogues Thereof
The present invention relates to compositions of matter and methods useful for improving a treatment outcome and/or an alteration of immunity in a condition that benefits from immune stimulation.  In particular, one embodiment of the invention teaches administration of sufficient doses of mifepristone or a derivative, alone, or in combination with an immunotherapeutic such as, but not limited to, an antibody, a vaccine, a cytokine, or a medicament whose therapeutic activity is associated with immune modulation.

Product Name: LymphoBoost:  LymphoBoost is a proprietary formulation of Mifepristone, a drug approved for another indication, which we have shown to be capable of stimulating lymphocytes, particularly NK cells and T cells, both critical in maintaining anti-tumor immunity.

Patent Title: Activated Leukocyte Extract for Repair of Innate Immunity in Cancer Patients
Disclosed are compositions, methods of use, and pharmaceutical preparations useful for modulation of immune responses.  In one embodiment a composition is extracted polyvalently activated peripheral blood mononuclear cells through dialysis.  Said immune modulator is useful for treatment of cancer and alleviation of cancer associated immune depression.  In one embodiment, said immunomodulator acts as a costimulatory of T cell activation by modulation of cytokine production.  In one embodiment said immune modulator is concentrated for miRNA species capable of activating innate immune cells.

Product Name: innaMune:  This is a biological product derived from tissue culture of blood cells derived from healthy donors.  It is a combination of cytokines that maintain activity of innate immune system cells, as well as having ability to shift M2 macrophages to M1.

 

Patent Title Product Name
Stimulation of Immunity to Tumor Stem Cell Specific Proteins by Peptide Immunization  StemVacs is a subcutaneously administered vaccine comprised of immune stimulatory peptides resembling cancer stem cell specific proteins. IND#17448.
Targeting the Tumor Microenvironment through Nutraceutical Based Immunoadjuvants  Cancer Metabolic Detox is an orally administered all natural nutraceutical product that is comprised of various herbal ingredients which seek to selectively block the cancer associated metabolic pathway that degrades the amino acid tryptophan.
Activated Leukocyte Extract for Repair of Innate Immunity in Cancer Patients  innaMune is a biological product derived from tissue culture of blood cells derived from healthy donors. It is a combination of cytokines that maintain activity of innate immune system cells, as well as having ability to shift M2 macrophages to M1.
Augmentation of Anti-Tumor Immunity by Mifepristone and Analogues Thereof  LymphoBoost is a proprietary formulation of Mifepristone, a drug approved for another indication, which we have shown to be capable of stimulating lymphocytes, particularly NK cells and T cells, both critical in maintaining anti-tumor immunity.
Methods of Re-Activating Dormant Memory Cells with Anticancer Activity  MemoryMune is a product derived from a two-step culture process of donor blood cells. The product reawakens dormant immune memory cells. It is known that many cancer patients possess memory T cells that enter the tumor, however, once inside the tumor these cells are inactivated. MemoryMune contains a unique combination of growth factors specific for immune system cells called “cytokines”.