We are a privately held clinical-stage biotechnology company focusing on the development and commercialization of a revolutionary new
immune therapy technology platform for the treatment of chronic viral infections, cancer and allergy.
Our Immune Therapies are designed to boost specific immune response in order to modify or control presently incurable diseases.
Our proprietary platform technology includes
1. disease-specific antigen optimized plasmid DNA,
2. a nanomedicine formulation which encapsulates the plasmid DNA to closely resemble a virus,
3. a topical (through the skin) administration device which delivers the vaccine via dendritic cell to lymph nodes
of the immune system, and
4. a Digital Personal Medicine companion diagnostic software product we call My Genetic Immunity, which is
built on blockchain technology. It allows users to find the optimal vaccine product for a given disease.
The combination of these technologies support the rapid and cost-effective development of original
biologic (as opposed to drugs) vaccine products.
Our Lead Therapeutic Vaccine for the treatment of HIV we refer to as “DermaVir”, is effective in
boosting immune response which kills HIV-infected cells. Our human clinical trials in Phase I, Phase I/II
and Phase II have demonstrated our vaccine is capable of killing HIV-infected cells. DermaVir has an excellent
safety profile (safe as placebo), and it may be used as a co-treatment option if administered
with antiretroviral therapy.
We are raising funds in our Initial Coin Offering to
1. complete the regulatory documentation needed to seek United States Food and Drug Administration (FDA)
guidance on the best path to receive marketing approval, for our HIV vaccine, which may including Breakthrough
Therapy Designation and/or Fast-track,and
2. to complete development of our My Genetic Immunity Personal Digital Medicine platform. My Genetic Immunity
uses blockchain to match viruses with the most optimal vaccine solution available for treatment, transparently,
accurately and effectively, protecting genetic information in a private chain, a genetic wallet, with both private
and public key structures.
We are proud to announce that as of March 1st, 2018 we have successfully licensed our HIV vaccine
to a Russian pharma partner. They now hold exclusive distribution rights to C.I.S countries (Commonwealth of Independent States.)
As part of the agreement our new partner has agreed to bear all costs associated with the approval process, including
conducting a human clinical trial in Russian in order to qualify for marketing approval.
Post approval we will receive the customary double digit review share standard in the pharma industry.
In addition, the Russian trial design will be implemented with FDA accepted data gathering standards in mind,
meaning we will submit data gathered to the FDA in order to further support our US approval process.
Post approval our products will allow people to live better and longer lives.
For more information
Scientific publications index:
- “In vivo study of targeted nanomedicine delivery into Langerhans cells by multiphoton laser scanning microscopy.“Kolonics A, Csiszovszzki Z, Toke ER, Lorincz O, Haluszka D, Szipocs R. Exp Dermatol. 2014 Aug;23(8):596-605.
- “Vaccination of mice using the West Nile virus E-protein in a DNA prime-protein boost strategy stimulates cell-mediated immunity and protects mice against a lethal challenge.“De Filette M, Soehle S, Ulbert S, Richner J, Diamond MS, Sinigaglia A, Barzon L, Roels S, Lisziewicz J, Lorincz O, Sanders NN. Plos One. 2014 Feb 4;9(2):e87837.
- “Safety, tolerability, and immunogenicity of repeated doses of dermavir, a candidate therapeutic HIV vaccine, in HIV-infected patients receiving combination antiretroviral therapy: results of the ACTG 5176 trial.“Rodriguez B, Asmuth DM, Matining RM, Spritzler J, Jacobson JM, Matlliard RB, li XD, Martinez AI, Tenoria AR, Lori F, Lisziewicz J, Yesmen S, Rinaldo CR, Pollard RB. J Acquired Immune Defic Syndr. 2013 Dec a;64(4):351-9.
- “HIV vaccine to induce cytotoxic T cells recognizing conserved HIV-1/2-epitopes derived from the most frequent HLA types of the human population.“Somogyi E, Lisziewicz J. Immunotherapy. 2013 Aug 5;5(8):825-8.
- “DermAll nanomedicine for allergen-specific immunotherapy.“Garaczi E, Szaboo K, Francziszti L, Csiszovszki Z, Lorincz O, Toke ER, Molnar L, Bitai T, Janossy T, Bata-Csorgo Z, Kemeny L, Lisziewicz J. Nanomedicine. 2013 Nov;9(8):1245-54.
- “Nanomedicine applications towards the cure of HIV.” Lisziewicz J, Toke ER. Nanomedicine. 2013 Jan;9(1):28-38.
- “Collision-induced dissociation study of poly(2-ethyl-2-oxazoline) using survival yields and breakdown curves.” Biri B, Nagy L, Kuki Á, Toke ER, Deák G, Zsuga M, Kéki S. J Mass Spectrom. 2013 Jan;48(1):16-23.
- “HIV-specific immunotherapy with DermaVir, the first pDNA/PEIm pathogen-like nanomedicine.” Lisziewicz J., Lorincz O. European Journal of Nanomedicine Volume 4, Issue 2-4, Pages 81-87, DOI: 10.1515/ejnm-2012-0011
- “Single DermaVir Immunization: Dose-Dependent Expansion of Precursor/Memory T Cells against All HIV Antigens in HIV-1 Infected Individuals” by Julianna Lisziewicz, Nyasha Bakare, Sandra A. Calarota, Dénes Bánhegyi, János Szlávik, Eszter Újhelyi, Eniko R. Toke, Levente Molnar, Zsolt Lisziewicz, Brigitte Autran, Franco Lori. PLoS ONE 7(5): e35416. doi:10.1371/journal.pone.0035416(2012)
- “Structure and biological activity of pathogen-like synthetic nanomedicines” by Lorincz O., Toke E.R., Somogyi E., Horkay F., Chandran P.L., Douglas J.F., Szebeni J., Lisziewicz J. Nanomedicine: NBM 8 (2012) 497-506
- “A plasmid DNA immunogen expressing fifteen protein antigens and complex virus-like particles (VLP(+)) mimicking naturally occurring HIV” by Somogyi E., Xu J., Gudics A., Tóth J., Kovács AL., Lori F., Lisziewicz J. Vaccine 29 (2011) 744–753
- “Conference scene–active immunotherapeutics forum: meeting highlights” by Lisziewicz, J. Immunotherapy. 2009 Sep;1(5):743-8.
- “Nanomedicine for dendritic cell-targeted immunotherapy” by Gudics, A., Lisziewicz, J. European Journal of Nanomedicine DOI 10.3884/0003.1.7; 2010.
- “The Janus Face of Immune Stimulation by Nanomedicines: Examples for the Good and the Bad” by Lisziewicz, J., Szebeni, J. European Journal of Nanomedicine DOI 10.3884/0003.1.5; 2010.
- “Rational development of a stable liquid formulation for nanomedicine products” by Toke, E., Lorincz, O., Somogyi, E., Lisziewicz, J. International Journal of Pharmaceutics 392:261-267, 2010.
- “The potential of topical DNA vaccines adjuvanted by cytokines” by Lisziewicz, J., Calarota, S.A., and Lori F. Expert Opin Biol Ther. 7(10):1563-74, 2007.
- “Nanochemistry-based immunotherapy for HIV-1.” by Lori, F., Calarota, S.A., and Lisziewicz, J.: Curr Med Chem. 14(18):1911-9, 2007.
- “Induction of HIV-specific memory T-cell responses by topical DermaVir vaccine” by Calarota, S.A., Weiner, D.B., Lori, F., Lisziewicz, J. Vaccine 25(16):3070-4, 2007.
- “Combining antiretroviral drugs and immune therapies: an approach to achieve clinical benefit after treatment interruption” by Julianna Lisziewicz. Current Opinion in HIV and AIDS Typeset by Thomson Digital for Lippincott Williams & Wilkins.
- “HIV-1-Specific T Cell Precursors with High Proliferative Capacity Correlate with Low Viremia and High CD4 Counts in Untreated Individuals” by Sandra A. Calarota, Andrea Foli, Renato Maserati, Fausto Baldanti, Stefania Paolucci, Mary A. Young, Christos M. Tsoukas, Julianna Lisziewicz, and Franco Lori. The Journal of Immunology, February 27, 2008.
- “HIV-1 prophylactic vaccine comprised of topical DermaVir prime and protein boost elicits cellular immune responses and controls pathogenic R5 SHIV162P3” by Anthony D. Cristillo, Julianna Lisziewicz, Leilei He, Franco Lori, Lindsey Galmin, Jeffrey N. Trocio, Tami Unangst, Lucia Whitman, Lauren Hudacik, Nyasha Bakare, Stephen Whitney, Susana Restrepo, John Suschak, Maria Grazi Ferrari, H.K. Chung, Vaniambadi S. Kalyanaraman, Phillip Markham, Ranajit Pal. Elsevier Science Direct, Virology 366 (2007) 197-211.
- “DermaVir, a novel HIV immunisation technology” by Franco Lori!, Jeffrey Trocio, Nyasha Bakare, Laurene M. Kelly, Julianna Lisziewicz. Elsevier Vaccine 23 (2005) 2030–2034.
- “Control of viral rebound through therapeutic immunization with DermaVir” by Julianna Lisziewicz, Jeffrey Trocio, Jianqing Xu, Lucia Whitman, Amy Ryder, Nyasha Bakare, Mark G. Lewis, Wendeline Wagner, Angela Pistorio, Suresh Arya, and Franco Lori. AIDS 2005, Vol 19 No 1.
- “DermaVir: A Novel Topical Vaccine for HIV/AIDS” by Julianna Lisziewicz, Jeffrey Trocio, Lucia Whitman, Georg Varga, Jianqing Xu, Nyasha Bakare, Patrick Erbacher, Cecil Fox, Ruth Woodward, Phil Markham, Suresh Arya, Jean-Paul Behr, and Franco Lori. The Journal of Investigative Dermatology, 2004.
- “Therapeutic vaccination for future management of HIV/AIDS” by Julianna Lisziewicz, Nyasha Bakare, Franco Lori. Elsevier Vaccine 21 (2003) 620–623.
- “Induction of Potent Human Immunodeficiency Virus Type 1-Specific T-Cell-Restricted Immunity by Genetically Modified Dendritic Cells” by Julianna Lisziewicz, Dmitry I. Gabrilovich, Georg Varga, Jianqing Xu, Philip D. Greenberg, Suresh K. Arya, Marnix Bosch, Jean-Paul Behr, and Franco Lori. Journal of Virology, Aug. 2001, p. 7621–7628.
- “Control of SIV Rebound Through Structured Treatment Interruptions During Early Infection” by Franco Lori, Mark G. Lewis, Jianqing Xu, Georg Varga, Donald E. Zinn Jr., Carrol Crabbs, Wendeline Wagner, Jack Greenhouse, Peter Silvera, Jake Yalley-Ogunro, Carmine Tinelli, Julianna Lisziewicz. SCIENCE VOL 290 24 NOVEMBER 2000.
- “Control of HIV despite the Discontinuation of Antiretroviral Therapy” by Julianna Lisziewicz, Eric Rosenberg, Judy Lieberman, Heiko Jessen, Lucia Lopalco, Robert Siliciano, Bruce Walker, and Franco Lori. The New England Journal of Medicine, Volume 340:1683 May 27, 1999 Number 21.