Six aspects of allogeneic StemVacs

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TimGDixon
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Six aspects of allogeneic StemVacs

Post by TimGDixon »

I think i should spend a few minutes breaking down allogeneic StemVacs in its various aspects - each of these are novel and demanded that we file the IP that covers them - we live in a first file to file patent world so we operate that way - so i thought i would take each of these and give you more detail - i think there could even be a misconception that the most recent discovery somehow makes the rest obsolete - oh contrare... I'll make a post on each of these beginning with the first up to the last - "Treatment of SARS-CoV-2 with Dendritic Cells for Innate and/or Adaptive Immunity"

1. Pluripotent Stem Cell Derived Dendritic Cells and Engineered Dendritic Cells for Cancer Immunotherapy

2. Ex Vivo Generation of Immunocytes Recognizing Brother of the Regulator of Imprinted Sites (BORIS) Expressing Cancer Stem Cells

3. Stimulation of Natural Kill Cell Memory by Administration of Dendritic Cells

4. Stimulation of Dendritic Cell Activity by Homotaurine and Analogues Thereof

5. Augmentation of Natural Killer Cell Activity and Induction of Cytotoxic Immunity Using Leukocyte Lysate Activated Allogeneic Dendritic Cells: StemVacs

6. Treatment of SARS-CoV-2 with Dendritic Cells for Innate and/or Adaptive Immunity

she's like a rainbow...

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TimGDixon
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Re: Six aspects of allogeneic StemVacs

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6. Treatment of SARS-CoV-2 with Dendritic Cells for Innate and/or Adaptive Immunity

So this was the first allogenic version of StemVacs with the prior being autologous version. The original StemVacs would be very effective in treating Sars/CoV2 infection but we decided it was just too dangerous to make because multiple people would need to handle infected blood so we figured out how to do the same thing with an allogeneic donor source.

Treatment of SARS-CoV-2 with Dendritic Cells for Innate and/or Adaptive Immunity
Disclosed are means, methods, and compositions of matter for prophylaxis and/or treatment of SARS-CoV-2 by administration of dendritic cells in a manner and frequency sufficient to induce activation of innate and/or adaptive immune responses. In one embodiment the invention teaches administration of dendritic cells pulsed with one or more innate immune stimulants in a manner endowing said dendritic cell with ability to induce augmentation of natural killer (NK) cell number and/or activity. In another embodiment the invention teaches the use of dendritic cells stimulated with innate immune activators in a manner to allow for uptake of viral particles and presentation of viral epitopes to T cells in order to stimulate immunological activation and/or memory responses.

With the operation warp speed development of the current generation of vaccines does not makes this not necessary. The first claim (out of 240) from the filed patent argues that Sars/CoV2 is not necessary as a basis to make the product and use the product.

1. A dendritic cell capable of stimulating natural killer cell activity and/or natural killer cell number in a host, said dendritic cell generated by the steps of: a) obtaining a monocytic cell; b) treating said monocytic cell in a manner to induce differentiation along the dendritic cell lineage; and c) exposing said dendritic cell to a stimulator of innate immune functions for a sufficient time and concentration to endow said dendritic cell ability to activate NK cells.

In one embodiment, the invention was developed to address multiple aspects of the immune system in order to augment possibility of increasing overall survival of a patient suffering from COVID-19.

Specifically, it is known from studies of immune modulators that recruitment of multiple arms of the immune system associates with increased efficacy. For example, it is known that natural killer cells play an important role in immune destruction of viruses [1-7]. A clinical trial demonstrated that patients who possess elevated levels of natural killer cell inhibitory proteins (soluble NKG2D ligands) demonstrated lower responses to checkpoint inhibitors [8].

Indeed this should not be surprising since studies show that NK cell infiltration of tumors induces upregulation of antigen presentation in an interferon gamma associated manner, which renders tumor cells sensitive to T cell killing [9].

This patent covers, in part, the application of checkpoint inhibitors together with dendritic cells and/or NK cell therapy for induction of immunological responses to SARS-CoV-2.

Another example of the potency of combining immunotherapies is the example of Herceptin, in which approximately 1 out of 4 patients with the HER2neu antigen respond to treatment. Interestingly it was found that lack of responsiveness correlates with inhibited NK cell activity [10-12]. Indeed, animal experiments demonstrate augmentation of Herceptin activity by stimulators of NK cells such as Poly (IC) and IL-12 [13, 14].

The current invention which aims to integrate the main arms of the immune system so as to achieve for example, a synergistic induction of anticancer immunity, but provides the utilization of dendritic cells with or without NK cells as adjuvants for various therapies clinically utilized against COVID-19 including vaccines, sera from patients who have entered remission, ivermectin, hydoxychloroquine, remdesivir, and other agents.

1. Martin-Fontecha A, Thomsen LL, Brett S, Gerard C, Lipp M, Lanzavecchia A, Sallusto F: Induced recruitment of NK cells to lymph nodes provides IFN-gamma for T(H)1 priming. Nat Immunol 2004, 5(12):1260-1265.
2. Morandi B, Bougras G, Muller WA, Ferlazzo G, Munz C: NK cells of human secondary lymphoid tissues enhance T cell polarization via IFN-gamma secretion. Eur J Immunol 2006, 36(9):2394-2400.
3. Ksienzyk A, Neumann B, Nandakumar R, Finsterbusch K, Grashoff M, Zawatzky R, Bernhardt G, Hauser H, Kroger A: IRF-1 expression is essential for natural killer cells to suppress metastasis. Cancer Res 2011, 71(20):6410-6418.
4. Lopez-Soto A, Gonzalez S, Smyth MJ, Galluzzi L: Control of Metastasis by NK Cells. Cancer Cell 2017, 32(2):135-154.
5. Krasnova Y, Putz EM, Smyth MJ, Souza-Fonseca-Guimaraes F: Bench to bedside: NK cells and control of metastasis. Clin Immunol 2017, 177:50-59.
6. Putz EM, Mayfosh AJ, Kos K, Barkauskas DS, Nakamura K, Town L, Goodall KJ, Yee DY, Poon IK, Baschuk N et al: NK cell heparanase controls tumor invasion and immune surveillance. J Clin Invest 2017, 127(7):2777-2788.
7. Morvan MG, Lanier LL: NK cells and cancer: you can teach innate cells new tricks. Nat Rev Cancer 2016, 16(1):7-19.
8. Maccalli C, Giannarelli D, Chiarucci C, Cutaia O, Giacobini G, Hendrickx W, Amato G, Annesi D, Bedognetti D, Altomonte M et al: Soluble NKG2D ligands are biomarkers associated with the clinical outcome to immune checkpoint blockade therapy of metastatic melanoma patients. Oncoimmunology 2017, 6(7):e1323618.
9. Goding SR, Yu S, Bailey LM, Lotze MT, Basse PH: Adoptive transfer of natural killer cells promotes the anti-tumor efficacy of T cells. Clin Immunol 2017, 177:76-86.
10. Muraro E, Comaro E, Talamini R, Turchet E, Miolo G, Scalone S, Militello L, Lombardi D, Spazzapan S, Perin T et al: Improved Natural Killer cell activity and retained anti-tumor CD8(+) T cell responses contribute to the induction of a pathological complete response in HER2-positive breast cancer patients undergoing neoadjuvant chemotherapy. J Transl Med 2015, 13:204.
11. Lee SC, Srivastava RM, Lopez-Albaitero A, Ferrone S, Ferris RL: Natural killer (NK): dendritic cell (DC) cross talk induced by therapeutic monoclonal antibody triggers tumor antigen-specific T cell immunity. Immunol Res 2011, 50(2-3):248-254.
12. Beano A, Signorino E, Evangelista A, Brusa D, Mistrangelo M, Polimeni MA, Spadi R, Donadio M, Ciuffreda L, Matera L: Correlation between NK function and response to trastuzumab in metastatic breast cancer patients. J Transl Med 2008, 6:25.
13. Jaime-Ramirez AC, Mundy-Bosse BL, Kondadasula S, Jones NB, Roda JM, Mani A, Parihar R, Karpa V, Papenfuss TL, LaPerle KM et al: IL-12 enhances the antitumor actions of trastuzumab via NK cell IFN-gamma production. J Immunol 2011, 186(6):3401-3409.
14. Charlebois R, Allard B, Allard D, Buisseret L, Turcotte M, Pommey S, Chrobak P, Stagg J: PolyI:C and CpG Synergize with Anti-ErbB2 mAb for Treatment of Breast Tumors Resistant to Immune Checkpoint Inhibitors. Cancer Res 2017, 77(2):312-319.
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TimGDixon
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Re: Six aspects of allogeneic StemVacs

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5. Augmentation of Natural Killer Cell Activity and Induction of Cytotoxic Immunity Using Leukocyte Lysate Activated Allogeneic Dendritic Cells: StemVacs

This was next and was a discovery we were bound to make if you follow the science which we dedicate ourselves too.

Augmentation of Natural Killer Cell Activity and Induction of Cytotoxic Immunity Using Leukocyte Lysate Activated Allogeneic Dendritic Cells: StemVacs™
Stimulation of immunity would be beneficial in various chronic conditions such as viral infections and neoplasia. Autologous dendritic cell therapy has been widely described in the immunotherapy literature and has been approved by the FDA for treatment of prostate cancer. Unfortunately, the need to generate individual doses is costly and limited by ability of the patients to have sufficient starting cell numbers available to generate sufficient dendritic cells. Here we describe the process of preparing allogeneic dendritic cells utilizing a leukocyte lysate based approach. These data support development of StemVacs for conditions that would benefit from NK activation such as cancer and COVID-19.

In the spirit of not disclosing too much in each of these but enough to give you knowledge we can just look again to the first claim which looks at pulmonary inflammation.

1. A method of concurrently stimulating natural killer cell number and/or activity while decreasing pulmonary inflammation through administration of a dendritic cell population activated by exposure to leukocyte lysate.

Acute Respiratory Distress Syndrome (ARDS) is a condition of acute respiratory failure caused by a variety of factors which are related to inflammation and release of various activators of the innate immune system such as cytokines and pyrogenic factors [1-9].

It is widely known that ARDS generally presents with progressive hypoxemia, dyspnea and increased work of breathing. Patients often require mechanical ventilation and supplemental oxygen [10].

Over the years, our understanding of ARDS has advanced significantly, with elucidation of several of the molecular and cellular pathways involved in initiation, progression and resolution/fibrosis. However, ARDS still represents significant morbidity and mortality and therapeutic strategies to mitigate the foregoing have resulted in limited translational success. Part of this failure stems from the very different presentations of ARDS between people, as well as differences in their genetic composition.

ARDS is caused by many situations bacterial and viral pneumonia, sepsis, inhalation of harmful substances, head, chest or other major injury, burns, blood transfusions, near drowning, aspiration of gastric contents, pancreatitis, intravenous drug use, and abdominal trauma. Furthermore, those with a history of chronic alcoholism are at a higher risk of developing ARDS [11-13]. Alcoholism affects several parameters relevant to ARDS including: a) reduction in glutathione levels [14, 15], b) increasing levels of adhesion molecules on lung blood vessels so as to increase recruitment of inflammatory cells [16]; c) upregulating lung adenosine levels, resulting in impaired active Na(+) transport in the lung [17]; and d) suppression of pulmonary immunity [18].

One of the cardinal symptoms of ARDS is fluid accumulation in the lungs. When this occurs, the elastic air sacs (alveoli) in the lungs fill with fluid and the function of the alveoli is impaired. The result is that less oxygen reaches the bloodstream, depriving organs of the oxygen required for normal function and viability. In some instances, ARDS occurs in people who are already critically ill or who have significant injuries. Severe shortness of breath, the main symptom of ARDS, usually develops within a few hours to a few days after the precipitating injury or infection.

Unfortunately, many patients who develop ARDS do not survive. The risk of death increases with age and severity of illness. Of the people who do survive ARDS, some recover completely while others experience lasting damage to their lungs.

Currently there exist no effective pharmacologic therapies for treatment or prevention of ARDS. While inhibition of fibrin formation mitigated injury in some preclinical models of ARDS, anticoagulation therapies in humans do not attenuate ARDS and may even increase mortality. Protective lung ventilator strategies remain the mainstay of available treatment options. Due to the significant morbidity and mortality associated with ARDS and the lack of effective treatment options, new therapeutic agents for the treatment of ARDS and new treatment methods for ARDS are needed.

The present disclosure addresses the unmet need in the art by providing novel therapeutic agents useful in the treatment of ARDS which concurrently activate immunity, specifically NK mediated immunity and methods of treatment for ARDS and conditions related thereto through the administration of such novel therapeutic agents.

1. Balamayooran T, Balamayooran G, Jeyaseelan S: Review: Toll-like receptors and NOD-like receptors in pulmonary antibacterial immunity. Innate Immun 2010, 16(3):201-210.
2. Oppeltz RF, Rani M, Zhang Q, Schwacha MG: Burn-induced alterations in toll-like receptor-mediated responses by bronchoalveolar lavage cells. Cytokine 2011, 55(3):396-401.
3. Dolinay T, Kim YS, Howrylak J, Hunninghake GM, An CH, Fredenburgh L, Massaro AF, Rogers A, Gazourian L, Nakahira K et al: Inflammasome-regulated cytokines are critical mediators of acute lung injury. Am J Respir Crit Care Med 2012, 185(11):1225-1234.
4. de Pablo R, Monserrat J, Prieto A, Alvarez-Mon M: Role of circulating soluble chemokines in septic shock. Med Intensiva 2013, 37(8):510-518.
5. Parikh SM: Dysregulation of the angiopoietin-Tie-2 axis in sepsis and ARDS. Virulence 2013, 4(6):517-524.
6. Nakahira K, Kyung SY, Rogers AJ, Gazourian L, Youn S, Massaro AF, Quintana C, Osorio JC, Wang Z, Zhao Y et al: Circulating mitochondrial DNA in patients in the ICU as a marker of mortality: derivation and validation. PLoS Med 2013, 10(12):e1001577; discussion e1001577.
7. Tang L, Bai J, Chung CS, Lomas-Neira J, Chen Y, Huang X, Ayala A: Active players in resolution of shock/sepsis induced indirect lung injury: immunomodulatory effects of Tregs and PD-1. J Leukoc Biol 2014, 96(5):809-820.
8. Lefrancais E, Mallavia B, Zhuo H, Calfee CS, Looney MR: Maladaptive role of neutrophil extracellular traps in pathogen-induced lung injury. JCI Insight 2018, 3(3).
9. Yuan Z, Bedi B, Sadikot RT: Bronchoalveolar Lavage Exosomes in Lipopolysaccharide-induced Septic Lung Injury. J Vis Exp 2018(135).
10. Thompson BT, Chambers RC, Liu KD: Acute Respiratory Distress Syndrome. N Engl J Med 2017, 377(6):562-572.
11. Moss M, Bucher B, Moore FA, Moore EE, Parsons PE: The role of chronic alcohol abuse in the development of acute respiratory distress syndrome in adults. JAMA 1996, 275(1):50-54.
12. Moss M, Steinberg KP, Guidot DM, Duhon GF, Treece P, Wolken R, Hudson LD, Parsons PE: The effect of chronic alcohol abuse on the incidence of ARDS and the severity of the multiple organ dysfunction syndrome in adults with septic shock: an interim and multivariate analysis. Chest 1999, 116(1 Suppl):97S-98S.
13. Guidot DM, Hart CM: Alcohol abuse and acute lung injury: epidemiology and pathophysiology of a recently recognized association. J Investig Med 2005, 53(5):235-245.
14. Moss M, Guidot DM, Wong-Lambertina M, Ten Hoor T, Perez RL, Brown LA: The effects of chronic alcohol abuse on pulmonary glutathione homeostasis. Am J Respir Crit Care Med 2000, 161(2 Pt 1):414-419.
15. Liang Y, Yeligar SM, Brown LA: Chronic-alcohol-abuse-induced oxidative stress in the development of acute respiratory distress syndrome. ScientificWorldJournal 2012, 2012:740308.
16. Burnham EL, Moss M, Harris F, Brown LA: Elevated plasma and lung endothelial selectin levels in patients with acute respiratory distress syndrome and a history of chronic alcohol abuse. Crit Care Med 2004, 32(3):675-679.
17. Dada L, Gonzalez AR, Urich D, Soberanes S, Manghi TS, Chiarella SE, Chandel NS, Budinger GR, Mutlu GM: Alcohol worsens acute lung injury by inhibiting alveolar sodium transport through the adenosine A1 receptor. PLoS One 2012, 7(1):e30448.
18. Kaphalia L, Calhoun WJ: Alcoholic lung injury: metabolic, biochemical and immunological aspects. Toxicol Lett 2013, 222(2):171-179.
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TimGDixon
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Re: Six aspects of allogeneic StemVacs

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4. Stimulation of Dendritic Cell Activity by Homotaurine and Analogues Thereof

So this is very interesting and although it belongs in the area of immune modulation, it also belongs specifically to the field of stimulating immunity to cancer using a manipulated dendritic cell that has been activated, in this case with an amino acid known as homotaurine.

Stimulation of Dendritic Cell Activity by Homotaurine and Analogues Thereof
Disclosed are means, methods, and compositions of matter useful for enhancement of dendritic cell activity. In one embodiment the invention provides the use of GABA agonists such as homotaurine for stimulation of dendritic cell activity. In one embodiment said dendritic cell activity is enhancement of natural killer cell activity and/or of T cell activity. In one embodiment NK cell activity is ability to induce cytotoxicity in neoplastically transformed cells, whereas T cell activity is either cytokine production for CD4 cells or cytotoxicity for CD8 cells.

1. A method of augmenting ability of dendritic cells to stimulate NK cell and/or T cell activity comprising the steps of incubating said dendritic cells with a concentration of homotaurine.

Homotaurine is a natural amino acid found in seaweed. It is analogous to taurine, but with an extra carbon in its chain. It has GABAergic activity, apparently by mimicking GABA, which it resembles. "Agonist" refers to a substance which promotes (induces, causes, enhances or increases) the activity of another molecule or a receptor. The term agonist encompasses substances which bind receptor (e.g., an antibody, a homolog of a natural ligand from another species) and substances which promote receptor function without binding thereto (e.g., by activating an associated protein).
trader32176
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Re: Six aspects of allogeneic StemVacs

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Tim,

Last year you had a PR mentioning a cord blood based immunotherapy for covid 19 damaged lungs :

https://www.prnewswire.com/news-release ... 57622.html

1) will cord blood immunotherapy be useful in the future?

2) I'm listing those therapies / products that TSOI has for covid damaged lungs . This is my best guess @ this time :

JadiCell for lungs,
cord blood
StemVacs2
StemVacs -V
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TimGDixon
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Re: Six aspects of allogeneic StemVacs

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3. Stimulation of Natural Kill Cell Memory by Administration of Dendritic Cells

The particular invention teaches how to treat cancer by inducing a generation of natural killer cells that already possess an immunological memory towards cancer. Specifically we show that NK cells are capable of attaining immunological memory as a result of being exposed to allogeneic dendritic cells under conditions of not being pulsed which is one of these moments for Tom and I. I'm obviously the old guy hahahahahaha. Whoa!!!!!!!!!
giphy.gif
giphy.gif (3.56 MiB) Viewed 1517 times
Stimulation of Natural Kill Cell Memory by Administration of Dendritic Cells
Disclosed are means, methods and compositions of matter useful for induction of natural killer cell memory by administration of dendritic cells and/or exosomes thereof. In one embodiment a mammal suffering from cancer is administered allogeneic cord blood derived dendritic cells that are not pulsed exogenously. In one embodiment the dendritic cells are stimulated to possess chemotactic activity towards the tumor by culture of dendritic cell progenitors in hypoxia. Natural killer cell memory is induced, in part, by triggering of upregulation of cytokines associated with homeostatic expansion such as interleukin 7 and interleukin 15.
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TimGDixon
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Re: Six aspects of allogeneic StemVacs

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Yes but that was not StemVacs related. These six are all variations of the stemvacs platform.

But in regards to what you asked, yes we do.

Treatment of COVID-19 Lung Injury Using Umbilical Cord Plasma Based Compositions
Disclosed are means, methods and compositions of matter useful for treatment of lung inflammation associated with viral and bacterial infections, as well as with systemic inflammation, through administration of umbilical cord blood derived plasma-based compositions. In one embodiment the invention teaches administration of umbilical cord blood plasma together with pterostilbene, and/or sulforaphane, and/or thymoquinone, and/or Epigallocatechin gallate (EGCG) and/or n-acetylcysteine in an aerosolized manner to patients suffering from COVID-19 associated pulmonary deficiencies. In another embodiment, umbilical cord blood plasma is administered with immune stimulatory agents in order to concurrently inhibit propagation of viral load in the lung while suppressing pulmonary deficiencies.

trader32176 wrote: Thu Mar 18, 2021 7:03 am Tim,

Last year you had a PR mentioning a cord blood based immunotherapy for covid 19 damaged lungs :
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TimGDixon
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Re: Six aspects of allogeneic StemVacs

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2. Ex Vivo Generation of Immunocytes Recognizing Brother of the Regulator of Imprinted Sites (BORIS) Expressing Cancer Stem Cells


Oh, BORIS, BORIS, BORIS, where arte thou BORIS...if i have an obsession in cancer ... it is boris. My favorite quote in the world...

"When a tumor no longer mutates boris, it is no longer a tumor" - Thomas E Ichim, PhD

Ex Vivo Generation of Immunocytes Recognizing Brother of the Regulator of Imprinted Sites (BORIS) Expressing Cancer Stem Cells
Disclosed are means, methods and compositions of matter useful for induction of immunity towards cancer stem cells by providing a dendritic cell, wherein said dendritic cells express BORIS and/or peptides derived from BORIS, wherein said dendritic cell is cultured in the presence of one or more immunocytes. In one embodiment said dendritic cells are derived from umbilical cord blood sources and allogeneic to T cells, which are expanded ex vivo and used for the purposes of immunotherapy.

Obviosuly this pertains to the field of cancer immunotherapy, but more specifically it pertains to the field of targeting cancer stem cells, more particularly the invention relates to generation ex vivo of T lymphocyte killer cells targeting cells expressing brother of the regulator of imprinted sites (BORIS) and/or derivatives of said BORIS.

There is so much science on BORIS that its best i just provide a link to pubmed: https://pubmed.ncbi.nlm.nih.gov/?term=boris
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Re: Six aspects of allogeneic StemVacs

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1. Pluripotent Stem Cell Derived Dendritic Cells and Engineered Dendritic Cells for Cancer Immunotherapy

ELK CITY, Idaho, March 16, 2021 /PRNewswire/ — Therapeutic Solutions International, Inc., (OTC Markets: TSOI), announced today filing of a patent and new data covering what the Company believes to be the first gene-modified, stem cell derived, universal donor dendritic cell cancer immunotherapy.

The novel product, StemVacs-V™, is derived from a gene-modified stem cell which is designed to express proteins found selectively in cancer such as the antigen Brother of the Regulatory of Imprinted Sites (BORIS). Additionally, the stem cell is gene silenced for receptors which cancer generally uses to block immune cell activation. Once the stem cells are made into dendritic cells, the resulting product is an immunotherapy that: 1) Activates the immune system to selectively kill cancer, without toxicity; and 2) Is resistant to cancer-induced immune suppressive activities; and 3) Can be generated in an economical, reproducible, and consistent manner.

You guys have to get your heads around this - "the first gene-modified, stem cell derived, universal donor dendritic cell, cancer immunotherapy". We strive to be first in everything we do and this is a prime example - we are never satisfied with the science, it's never settled, contrary to what you are told.

Remember StemVacs began as an autologous product (and still is in that form) where we used the patients own blood to make an immunotherapy from and we had phenomenal results in MX but whaat this list of six new aspects of the same original invention is that we continued to improve and this time it was an outside force, covid-19. While companies closed their doors and went bankrupt or just barely hanging on, we did what we do best, put on our academic hats and went to work and what you really got from covid-19 was some of our best work ever - and we are not done - we have earth shattering stuff yet to come - we're on a roll and at least since may of last year we have averaged 2 new patent filings a month - thats 24 new ones since May of last year.

StemVacs is now allogenic and universal and all the six aspects are universal and that means all of this can be mass produced by the Pharaoh's of Pharma if they were so inclined to dance with us. Pharma was never going to mass produce StemVacs autologous, its patient by patient and they can't make money that way - but that does not mean the IP is somehow obsolete - we have two forms cleared by COFEPRIS (mexico's fda) to treat stages 1-4 in both prostate cancer and breast cancer. If you are a male with prostate cancer in the USA your options are very limited in stages 1-3 - its basically watch and wait for stage 4, then you can get the only immunotherapy approved in the USA for prostate cancer called ProVenge and guess what, its a dendritic cell product. However, if i had stage 1-3 myself i would have already been treated :shock:

So you all should rest up because next week you never know what i'll lay at your feet... keep your heads... you know what you own, own it!

Tim

PS: it just tickles me to no end every time i see Elk City in our wire line hahahahaha - thats right california i am taking my toys and playing somewhere else...
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