Our Immune-Therapy Technology Platform
Our lead product candidate DermaVir is designed to boost immune response in order to kill HIV-infected cells in patients whose immune system has been compromised by the virus. As antiretroviral therapy is not capable of killing HIV infected cells in the reservoir, or to cure the disease, we believe DermaVir has the potential to be a new state of the art treatment paradigm in HIV/AIDS.
DermaVir utilizes all key elements of our Immune Therapy Platform. The API of DermaVir is a single pDNA immunogen safely expressing 15 HIV antigens, the broadest antigen repertoire seen among any of the HIV vaccine candidates to date. It is a ’pathogen-like’ nanomedicine administered topically with DermaPrep, our CE marked medical device. All elements of DermaVir's novel mechanism of action have been consistently demonstrated in vitro, in animal models (mice, rabbits, primates) and in human clinical trials.
Through these trials, we’ve demonstrated that DermaVir exhibits its specific pharmacologic effects by intensifying the patient's immune system to kill HIV-infected cells. Three seperate trials of DermaVir, with a total of ~70 HIV-infected patients, has shown excellent safety and tolerability in all doses. We found the optimal dose for boosting HIV-specific T cell immune response and demonstrated killing of HIV-infected cells by showing a statistically significant reduction of HIV-RNA in patients as compared to Placebo.
In additionan the the three completed trials we are now preparing a Phase III trial, to be conducted in Russian, involving 200 patients. The aim of this trial is to seek marketing approval in Russia.
A comparison of DermaVir to existing treatment:
Dermavir Existing HIV/AIDS Therapy
- Boosts immune system to kill HIV-infected cells
- Reconstitutes HIV-specific immunity
- Potential for remission
- Immune intensification may reduce HIV reservoirs (more to come)
- Interrupts viral life cycle
- Cannot reconstitute HIV-specific immunity
- No remission or cure even with treatment intensification
- Does not affect HIV-reservoirs
- No dose-limiting toxicities
- Toxicities limit optimal dosing and certain combination regimens
- Immunologic resistance different from drug resistance
- Combination of at least 3 drugs based on rapid resistance
- 4 x per year or less
- 1 x daily or more
DermaVir Family For Personalized HIV Treatment
HIV is a highly variable virus. We found that the therapeutic effectiveness of DermaVir depends on HIV sequence replicating in the patients and the patients' genetic background. To address this challenge we have developed a DermaVir Family, a family of Products containing related HIV-specific antigen sequences characteristic for the different Clades (subtypes) of the virus. To ensure the optimal therapeutic benefit for every patient, the treating physician will enter the information on the patient's HIV sequences and genetic background (HLA) into our eMINER software. After analyzing the data, the eMINER will select the optimal DermaVir Product from the DermaVir Product Portfolio and also calculate the specific T cell epitopes that will play a role in the immune boosting of the individual patient. The treating physician can then make an educated decision for selecting the optimal Product for his/her patient and could also prescribe the proper monitoring.
The targeted epidemics and our initial Product Portfolio are summarized in the Table below. According to UNAIDS, subtype-B presently represents approximately four million individuals (Europe, North, Central and South America, Caribbean, Australia). Our other product candidates can provide optimized treatment option for an additional 24.7 million HIV-infected individuals (2009 UNAIDS Report and HIV-1 Global Distribution, IAVI report Aug 2003).
DermaVir Product Family Geographical Target Infected population DermaVir B Europe, America, Caribbean, Australia 3 million DermaVir C Sub-Saharan Africa, South-Asia 22.5 million DermaVir BC Chine 1 million DermaVir BF South-America 1.4 million DermaVir AB East-Europe 10,000 Source: UNAIDS
In adition to our lead product candidate HIV vaccine our Technology Platform can be easily adapted to adress a number of other diseases, including a diverse range of cancers.
On January 29, 2019 we expanded out licensing and develpment agreement with JSC Pharmadis whereby we will jointly develop therapeutic peoducts to treat the following cancer types:
- glioblastoma - prostate cancer - colon & rectal cancer - Non-Hodgkin lymphoma - endometrial cancer - stomach cancer - bladder cancer - cervical cancer - lung cancer - thyroid cancer - leukemia - breast cancer - kidney cancer - ovarian cancer - liver cancer - myeloma - lip-oral cavity cancer - oesophagus cancer - brain cancer - gallbladder cancer
The first two cancer to be address are Glioblastoma and Prostate Cacner. We anticipate initiating Phase I trials for both of these indications ain Q3 of 2021.