April 19, 2014 4:12 AM ET

Biotechnology

Company Overview of Profectus Biosciences, Inc.

Company Overview

Profectus Biosciences, Inc., a technology based vaccine company, engages in the treatment and prevention of chronic viral diseases. It offers vaccine products to address diseases caused by hepatitis C virus, human immunodeficiency virus, human papilloma virus, and herpes simplex virus, as well as for malaria. The company was formerly known as Maryland Biotherapeutics and changed its name to Profectus Biosciences, Inc. in 2004. Profectus Biosciences, Inc. was founded in 2003 and is based in Baltimore, Maryland with an additional office in Tarrytown, New York.

6411 Beckley Street

Suite 202

Baltimore, MD 21224

United States

Founded in 2003

Phone:

443-743-1100

Fax:

443-543-5013

Key Executives for Profectus Biosciences, Inc.

Chief Executive Officer and President
Executive Chairman
Chief Operating Officer and Vice President of Business Development
Chief Scientific Officer of Vaccines
Senior Director of Virology
Compensation as of Fiscal Year 2013.

Profectus Biosciences, Inc. Key Developments

Profectus Biosciences, Inc. Announces Initiation of Clinical Trial Evaluating its Therapeutic HIV Vaccine in Support of the 'Cure Agenda'

Profectus BioSciences, Inc. announced the initiation of a phase 1 study evaluating the safety and immunogenicity of a therapeutic HIV vaccine strategy. HIV-infected adults on stable antiretroviral therapy (ART) will receive the Profectus multi-antigen HIV plasmid DNA (MAg-pDNA: env, gag, pol, nef, tat and vif) vaccine administered with the Profectus GENEVAX(TM) interleukin-12 (IL-12) pDNA adjuvant, delivered using the TriGrid(TM) electroporation (EP) delivery system licensed from Ichor Medical Systems, as a priming vaccine. This will be followed by booster immunization with the Profectus recombinant vesicular stomatitis virus (rVSV)-vectored HIV vaccine delivered by intramuscular injection. The randomized, double-blind, placebo-controlled study is in support of the HIV Cure Agenda and is being sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health. The study, which will enroll 30 HIV-infected adults, is being conducted by NIAID's Dr. Michael Sneller under a protocol designated Theravax 13-I-0141. Pre-clinical studies conducted by Profectus have demonstrated that the prime-boost delivery of the HIV pDNA and HIV rVSV vaccines results in an HIV-specific cell-mediated immune (CMI) response of significantly increased magnitude and functionality as compared to delivery of the HIV pDNA or HIV rVSV vaccines alone. To address the goals of the HIV Cure Agenda the effect of vaccination on the rate of decay of the HIV-infected, CD4+ T-cell reservoir and the effect on rebound viremia following analytical treatment interruption will also be tested. The Theravax 13-I-0141 study will build upon promising results seen in other clinical trials of the Profectus MAg-HIV pDNA and HIV rVSV vaccine candidates: In HVTN-080, a fixed dose level of GENEVAX(TM) IL-12 pDNA was evaluated for its ability to augment immune responses to an experimental HIV pDNA vaccine delivered with EP in HIV-negative volunteers. The final data show that GENEVAX(TM) IL-12 pDNA delivered with EP is safe and significantly increases the percentage of vaccine recipients that mount a CMI response as compared to the HIV pDNA alone. In addition to improving the response rate, the inclusion of IL-12 DNA also lessened injection site discomfort. In ACTG-5281, a fixed dose of the Profectus HIV MAg-DNA vaccine with low, intermediate or high doses of GENEVAX(TM) IL-12 pDNA adjuvant delivered with the TriGrid(TM) device is being evaluated in HIV-infected subjects on stable anti-retroviral therapy. This placebo-controlled, dose-escalation study is being conducted by the NIAID-funded AIDS Clinical Trials Group at 14 sites in the US and has fully enrolled 60/60 subjects. No safety issues have been noted and immunologic assessment of the groups receiving the no and low doses of GENEVAX(TM) IL-12 have confirmed CMI responses in a subset of participants. In IAVI-B004, a fixed priming dose of the Profectus HIV MAg-pDNA vaccine with various dose levels of GENEVAX(TM) IL-12 pDNA adjuvant delivered with the TriGrid(TM) device, followed by booster immunization with a recombinant serotype 35 adenovirus delivering HIV gag, rt, int and env (rAd35 GRIN/ENV) was evaluated in HIV-negative volunteers. This placebo-controlled study was sponsored by the International AIDS Vaccine Initiative (IAVI) and conducted in collaboration with three clinical research partners in Africa enrolling 75 subjects. No safety issues have been noted. In HVTN-090, five dose levels of the Profectus rVSV-vectored HIV vaccine delivered by intramuscular injection were tested for safety and immunogenicity in HIV-negative volunteers. This placebo-controlled study has fully enrolled 60/60 subjects at four clinical sites. Results from this study confirm that the rVSV-vectored vaccine is safe and well-tolerated at all dose levels. Furthermore, 63% of vaccinated volunteers at the higher dose level tested demonstrated significant HIV gag-specific CMI responses. In HVTN-087, a fixed priming dose of the Profectus HIV MAg-pDNA vaccine with various dose levels of GENEVAX(TM) IL-12 pDNA adjuvant delivered with the TriGrid(TM) device, followed by booster immunization with the Profectus rVSV-vectored HIV vaccine delivered by intramuscular injection, is being evaluated in HIV-negative volunteers. This placebo-controlled study has fully enrolled 100/100 subjects at 6 clinical sites. No dose-limiting toxicities have been seen, and the immunogenicity data are anticipated in early 2014.

Profectus Biosciences, Inc. Presents at EBD Group AG's Biotech showcase 2013, Jan-07-2013

Profectus Biosciences, Inc. Presents at EBD Group AG's Biotech showcase 2013, Jan-07-2013 . Venue: Parc 55 Wyndham Union Square Hotel, San Francisco, California, United States.

Profectus Biosciences, Inc. Presents at 2012 BIO International Convention, Jun-18-2012

Profectus Biosciences, Inc. Presents at 2012 BIO International Convention, Jun-18-2012 . Venue: Beston Convention & Exhition Center, Boston, Massachusetts, United States. Speakers: John Eldridge, Chief Scientific Officer of Vaccines.

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