Describe the company – the elevator pitch …
Genetic Immunity is a privately held clinical-stage biotechnology company focusing on the development and commercialization of a revolutionary immunotherapy technology platform for the treatment of chronic viral infections, cancer and allergy. Our therapeutic vaccines are designed to boost specific immune response in order to modify or control presently incurable diseases.
We developed a proprietary Platform Technology that includes a 1. a disease and antigen specific plasmid DNA (pDNA), 2. a nanomedicine formulation which encapsulates the pDNA to make it closely resemble a virus, and 3. a topical (through the skin) administration device which delivers the vaccine to dendritic cells of the skin, called Langerhans cell, and then to the lymph nodes of the immune system. Our technologies support the rapid and cost-effective development of original biologic (as opposed to drugs) products.
— Dermavir (@DermavirICO) February 15, 2018
Our Lead Therapeutic candidate vaccine is aimed to threat HIV. Celled ‘DermaVir’, it is effective in boosting immune response, which produces killer cell which in turn kills HIV-infected cells. Our three human clinical trials, a Phase I, a Phase I/II (funded the the National Institutes of Health and conducted by the Aids Clinical Trials Group), and a Phase II trial have demonstrated our HIV vaccine is capable of killing HIV-infected cells. DermaVir’s safety profile is comparable to placebo.
We are raising funds in our Initial Coin Offering (ICO) to complete the regulatory documentation needed to seek United States Food and Drug Administration (FDA) guidance on the best path to marketing approval, including applications for Breakthrough Therapy Status and Fast-track designation.
How are you different?
Compared to the current HIV treatment regiment, called antiretroviral therapy (ART or HAART), our vaccine is as safe as placebo, does not require adherence to a daily treatment regimen (Dermavir is only administered once every three months) and can be safely used at the moment of HIV diagnosis. HIV represent a $30B global market, however ART does not offer a cure for the disease. If the patients stops daily treatment viral count immediately increases. We are hopeful that Deramvir may represent a curative path forward in treating this deadly disease.
Why will you do well?
Our vaccine, once approved by the United States Food and Drug Administration and the European Medicines Agency has the potential to revolutionize the HIV treatment paradigm. It is only administered once every three months as opposed to ART’s daily regimen, it is virtually side effects free, can be easily given to pediatric (children) patients (adharance to daily ART treatmen for children is a big issue) and will also work for those already resistant to ART.
Where are you based?
We have operations in Europe, the United States amd Russia.
When was the company launched?
In its present form operations commenced in 2012 but the scientific research is over a decade in the making.
What have been your biggest wins to date?
Completion of three clinical trial (Phase I, Phase I/II and Phase II), communication with the Food and Drug Administration (FDA), filing a request for Breakthrough Therapy Designation, and the completion of that request by the upcoming submission of FDA requested documents.
Who are you trying to attract to your product?
Everyone interested in their own health, those already infected with this deadly disease, and people who want to make a positive change in the world around them.
What tips would you give to others looking to build their business?
Have a good idea, and never let go. Pursue that idea to its fullest potential. Never let anyone tell you you can’t do something. Stay fast to your principles and belief. It is a lot of sacrifice but if you hold fast to your goal sooner or later you will arrive at the well deserved end point. Never let anyone deter you.
Tell us about your team?
We have an international team of experts, composed of business people, scientists and regulatory specialists with decades of business and HIV experience. Our founders have raised in access of $10 million in capital, have signed consultant who have first hand HIV drug development and HIV approval experience. We also have an international network of HIV opinion leaders to advise us on development work.
What are your plans for the future?
Once our ICO end we will complete the FDA requested information packet and file with the agency. Afterwords we will seek a so called Type C meeting to discuss our clinical data to date, and to seek clear guidance of how to reach marketing approval for our HIV vaccine. At the same time we will commence development work on our Cancer vaccine portfolio. As mentioned above our Technology Platform can be easily adapted to address diseases other than HIV, among them cancer. In the next two years we will aim to develop and test cancer vaccines for a number of indications. We wil lalso be launcing a Digital Personal Medicine website (after FDA approval of technology) where users will be able to match their genetic code and HLA type to the best possible vaccine product available. In addition, we will also be conducting a clinical trial in Russia to seek approval there for our HIV vaccine with the help of our Russian License holder.
How do people get in touch with you?
Please visit our website at www.geneticimmunity.com for all relevant information.