BIOtechNOW: International AIDS Conference Unveils Four New “Next Generation” Treatments for HIV

New data presented at the 2010 International AIDS Conference showed significant momentum for the emerging fields of therapeutic vaccines, anti-immune hyperactivation, and other immune based therapies for the treatment of HIV/AIDS.

New data presented by researchers at the XVIII International AIDS Conference on Thursday, July 22 showed significant momentum for the emerging field of therapeutic vaccines, anti-immune hyperactivation, and other immune based therapies under development for the treatment of HIV/AIDS.

The data was presented by eight companies to a standing-room only “community forum” held by the National Association of People with AIDS (NAPWA) and The AIDS Institute, two of the leading U.S.-based patient advocacy organizations.

"With proper funding, the innovative researchers at these companies will one day bring us better treatments that support or restore the immune systems of people living with HIV/AIDS," said Stephen Bailous, Vice President Community Affairs, NAPWA, which was the first patient membership advocacy group in the world created to respond to HIV/AIDS.

Anthony Fauci, M.D., director of the National Institute of Allergy and Infectious Diseases, told a plenary session of many of the approximate 25,000 Conference participants earlier in the week that “we need a good therapeutic vaccine” to boost the immune system of people living with the virus.

“The subject of a cure for HIV/AIDS is considered by many to be a distraction, or even a taboo topic,” said Bailous.  “But as some immune-based treatment candidates move through phase 2 clinical trials, the HIV and AIDS community is watching closely to see if there’s cause for optimism.”

Indeed. Nature magazine noted the buzz. Researchers are curious about a New England Journal of Medicine article from last year about a Berlin HIV patient who appeared to have been cured from HIV after a stem cell transplant of a donor with a rare genetic mutation. The nascent field of therapeutic HIV vaccines, anti-immune hyperactivation, and immune-based therapies was abuzz.

Now, some are thinking that biotechnology could lead us to a “functional cure.” An article published in a July 2010 issue of the journal Science, by Didier Trono of Lausanne’s Ecole Polytechnique, provides some optimism. Such a cure would help maintain the virus at extremely low levels in the body without the need for antiretroviral drugs, converting people living with HIV into so called “elite controllers,” or those very fortunate people living with HIV who have few if any symptoms because their immune systems keep the virus in check.

Four therapeutic HIV vaccines each showed new efficacy data at this conference:

  • FIT-06 from Finland’s FIT Biotech and DermaVir from Genetic Immunity each showed significant reduction in viral load in treatment-naïve patients in Phase 2 trials.
  • Also in a Phase 2 trial, AGS-004 from Argos Therapeutics showed large reductions in viral loads, allowing extended ART holidays for treatment-experienced patients.
  • Vacc-4x from Bionor Immuno presented a follow-up study to its phase 2a trial, which indicated that volunteers on the vaccine with moderate viral loads were able to safely stay off daily antiretroviral treatment for an average of 31 months.  That data was presented two years ago at the XVII International AIDS Conference in Mexico City. High responder volunteers had a reduction in viral load by 0.5 lg. In Vienna, Bionor researchers reported that these same individuals continue to show an immunologic response to the vaccine seven years later, which is unprecedented.

Data from the first placebo-controlled trial with volunteers on a therapeutic HIV vaccine, a phase 2b for Bionor’s Vacc-4x, is due in early September.  To many researchers, that’s when the rubber will hit the road for the category.

BIOtechNOW: International AIDS Conference Unveils Four New “Next Generation” Treatments for HIV
Bionor Pharma Chief Scientific Officer Maja Sommerfelt, Ph.D. presents at XVIII International AIDS Conference, NAPWA Community Forum

Bionor Pharma Chief Scientific Officer Maja Sommerfelt, Ph.D. presents at XVIII International AIDS Conference, NAPWA Community Forum

The presentations made at the NAPWA and AIDS Institute Community Forum were:

  • Topically Applied DermaVir Safely Boosts HIV-specific Immune Response and Reduces Viral Load Within Six Months in Treatment-naïve Individuals: A Randomized, Double-Blinded, Placebo Controlled Phase II HIV Therapeutic Vaccine Study, Julianna Lisziewicz, Ph.D., CEO, Genetic Immunity;
  • VS411 Safely Reduces Both Excessive Immune System Activation and HIV Viral Load within 28 Days in Treatment-Naïve Individuals: A Phase II HIV AV-HALT Anti-Immune Hyperactivation Study, Franco Lori, M.D., CEO, ViroStatics;
  • FIT-06 Therapeutic DNA vaccine Reduces Viral Load and Increases CD4 Cell Count in Two-Year Phase II Study, Mart Ustav, Ph.D., Senior VP and CSO, FIT Biotech;
  • Vacc4x - a Therapeutic HIV-1 Vaccine Based on Modified Peptides: Clinical trial results and update on clinical trial development, Maja Sommerfelt, PhD, Chief Scientific Officer Bionor Immuno;
  • Clinical Update on AGS-004: Overcoming the challenges to successful HIV Immunotherapy, Charles Nicolette, Ph.D., CSO and VP R&D, Argos Therapeutics;
  • TBR-652, a Potent Dual Chemokine Receptor 5/Chemokine Receptor 2 (CCR5/CCR2) Antagonist in Phase 2 Development for Treatment of HIV Infection, Richard Ogden Ph.D., Scientific Development Advisor, Tobira Therapeutics;
  • Gene Therapy-Based Cell Therapy for HIV and Therapeutic HIV Vaccines, Riku Rautsola, Ph.D., CEO, VirxSYS Corporation;
  • Advanced Development of Dual Acting Pyrimidinediones (IQP-0410 and IQP-0528) as Highly Potent Anti-HIV Therapeutic Drugs and Topical Microbicides, Daniel R. Caffoe, President and Chairman, ImQuest Life Sciences, Inc.;
  • PEPTERON, A Novel Class of Antiviral, Dr. Dorothy Bray, Ph.D., consultant to Receptopharm Inc.