About our project

The problem we solve: Covid-19 is a virus that is transmitted primarily as an airborne pathogen through the upper respiratory tract. As with the other highly pathogenic coronaviruses, SARS and MERS, it is able to breach the normally protective layers of the nose and throat and disable the underlying immune cells. In fact, the immune system itself aids and abets not only the transmission of the virus, but contributes to the overall devastation of the disease process itself known as a cytokine storm.

About our solution: Activation of the cannabinoid type 2 receptors (CB2) of the peripheral endocannabinoid system represents a homeostatic mechanism to counter the effects of the inflammatory response to pathogenic stimuli. Results from an NIH R21 grant for which I wrote the rationale, confirmed that three distinct, non-psychoactive derivatives of THC had a profound effect on the gene expression of vaginal tissue similar to what has been reported in other mucosal tissues and endothelial tissue. These effects can be classified as cytoprotective, i.e. increasing tissue resistance and integrity. The genomic analysis also showed an inhibition of the genes involved in the inflammatory response and upregulation of anti-inflammatory genes, again consistent with the findings in the literature. The nasal administration of the compound that emerges from these studies will help fortify the nasal tissues as well as promote IgA antibody production to prevent the entry and spread of the virus, known as immune exclusion

We have identified four non-psychoactive cannabinoids including CBD and an endocannabinoid known as palmitoylethanolamide (PEA) that have known effects on the immune response that may be beneficial in the setting of Covid-19. A collaboration with Dr. Patrick Hayden of Biosurfaces, Inc. is providing the research platform, i.e. the nasal and lung tissues, on which to test these compounds. We have sufficient quantities of research-grade material for the in vitro studies and eventually for the in vivo studies. We have had discussions with highly respected researchers in academia and the contract research organization space who have indicated a willingness to pursue the research in biosafety level three (BSL-3) facilities if the results of the preliminary studies are promising and if the funding is available. We are negotiating a contract to formulate the lead compound in time to deliver it in the animal studies. I have recently published an article in Frontiers in Immunology that challenges the current vaccine development program with its emphasis on intramuscular administration. 

About Our Company

How We Help Patients

Our product is a drug with very specific indications - either it will be used as a primary treatment for a viral infection such as the deadly Covid-19 virus or it will be used to boost vaccines that can be given intranasally. Clearly, if it can reduce the symptoms and speed recovery, then it will be of benefit to all patients. Further studies will be necessary to determine if it has value in other respiratory infections such as influenza or even, the common cold. 

How We Help Physicians

Ever since the discovery of the endocannabinoid system and the role that it plays in the immune system, researchers have been hypothesizing and then studying the effects that various compounds,  i.e. ligands that are selective for the CB2 receptor have. Unfortunately, this class of compounds has not been put to a real-world test except in the case of medicinal cannabis and CBD where the indications are very broad and based on anecdotal evidence.  My original research objectives were directed at HIV prevention and treatment, but without further funding, I have not been able to achieve that goal. However, given that we are currently in a health crisis that has not been seen for more than a hundred years, I feel very strongly that we need to pull all the stops and establish what value that these compounds have.

How We Help Hospitals

The outpatient treatment of Covid-19 should decrease the demand for hospital-based interventions. However, based on a study in mice exposed to a lethal dose of a bacterial endotoxin, all of the mice that were treated with THC survived whereas those that did not develop acute respiratory distress syndrome (ARDS) and died. Since most patients that are admitted to ICUs with severe acute respiratory syndrome (SARS), the early administration of our lead compound that is a synthetic derivative of THC may, in fact, prove to be superior to dexamethasone in preventing the progression of the cytokine storm responsible for the condition and help to restore homeostasis that is the primary function of the peripheral endocannabinoid system.

How We Help Partners

Whether shareholders or patients, we are all stakeholders in this process. By transitioning from a natural product that has been in human use for more than 10,000 years into a pill or spray or suppository without the psychoactive effects to treat a variety of medical conditions is clearly a great benefit to all of humanity.  Our goal is to keep the costs down to make the drug affordable to those who need it. Given the potentially massive demand for the drugs across all indications, small profit margins will nevertheless translate into substantial rewards. Crowdfunding will play an important role in the early stages of this venture.  

Innovation Details

Intellectual Property Summary

I have filed a provisional patent application in March 2020 for the use of our lead compounds to enhance mucosal immunity through the activation of the endocannabinoid system by nasal administration.  Nasal administration will not only protect the upper and lower respiratory tract against airborne pathogens, but it will also promote the barrier function in the genital mucosa based on the properties of the mucosal-associated lymphatic tissue.  The patent application also describes the use of the lead compound to act as an adjuvant for any vaccine that can be administered via mucosal surfaces, i.e. nose, mouth, rectal or vaginal. We also have a patent pending for the use of our compounds for the non-hormonal treatment of the genitourinary syndrome of menopause, i.e. vulvovaginal atrophy that causes itching, burning, recurrent urinary tract infections, and painful intercourse in 50% of menopausal and post-menopausal women.

Patent Link
http://appft.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PG01&p=1&u=%2Fnetahtml%2FPTO%2Fsrchnum.html&r=1&f=G&l=50&s1=%2220190240190%22.PGNR.&OS=DN/20190240190&RS=DN/20190240190

Clinical Information

We are at the pre-clinical phase of the studies but anticipate filing an investigational new drug application (IND) once we have strong animal data. We will need further funding for the pharmacokinetic studies prior to filing a Phase I clinical trial design. The cannabinoid class of drugs has a history as being the safest drug known to man. Our preliminary studies showed that our compounds are non-toxic in vaginal tissues suggesting that safety will not be an issue. We have another potential collaboration with an academic researcher who is developing a vaccine against the bacterium that is the primary cause of otitis media in children. If our compound succeeds as an adjuvant in those mouse studies, then further funding will be needed to advance the program into another animal model prior to human clinical trials. 

Regulatory Status

No filing with the FDA is anticipated at this time, however, if the animal safety and efficacy studies are successful, particularly in the context of Covid-19 or as an adjuvant, then an application for emergency use authorization can be made. In the meantime, if the results of the research show benefit of this class of drugs, then the natural products, i.e. cannabis and CBD can be used as neutraceuticals on an immediate basis without FDA approval in the setting of Covid-19. 

How we will use the funds raised

Since Immugen is a virtual company without its own laboratory and personnel, the funds will be used by Dr. Hayden and his colleagues at Biosurfaces, Inc.  for analyzing the nasal tissues and the endothelial/alveolar tissues for: 

1. Chemokine/cytokine expression in the culture medium of  the tissues treated with four compounds at two concentrations at three time points. - Eve Technologies in Calgary Alberta  is the most cost-effective approach to take.	$25K
   mRNA expression using RNAscope to analyze twelve different targets that will include customizable array sets. These will be used in the three tissue types - nasal, endothelial, and alveolar tissue.	$25K
   Western blot studies for specific proteins that have been identified in the literature or by the RNAscope as being beneficial or protective of the airway tissue.	$10K
   Flow cytometry studies of PBMCs that will be co-cultured in the medium of the airway tissue cultures, four compounds, two concentrations. This will be outsourced to a CRO or academic lab.	$15K
   ELISA assays for the immunoglobulins that will be produced in the in vitro immunization assays to determine isotype switching. -	$5K
   Ph.D. level part-time assistant to help Dr. Hayden for two months.	$10K
   Administrative overhead 10% only when the fundraising goal has been achieved.	$10K

    

Thank You

Other than government grants, crowdfunding for early-stage drug development may be the only means to advance novel concepts. The goals of this research are relatively straightforward and should provide answers to the questions that we are raising regarding the role if any, the cannabinoid class of drugs can have during the current pandemic - are they protective, how are they protective, or are they potentially harmful? Since it is nearly impossible to study cannabis itself, we have chosen several surrogate compounds that are closely related in structure and activity to THC but are non-psychoactive since they only bind to the peripheral receptors.  Since the majority of people are concerned about the psychotropic effects associated with cannabis, these non-psychoactive analogs of THC  can be taken by patients of all ages who may become infected with Covid-19. The results of these studies will also provide the information necessary for anyone who uses the natural products, either cannabis or CBD,  for medicinal or recreational use, to make the decision to use it if one has become infected. The public health impact will be significant and perhaps even change the negative perception of the drug that many lawmakers and policymakers have regarding the cannabinoid class of drugs.

Supporters

• 
  Dr. Craig Travis, M.D.
  11/22/2020 - Liked the project.
• 
  Langston Huge
  11/16/2020 - Liked the project.
• 
  Afua Hall
  11/04/2020 - Backed the project for $10

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