www.avac.org

HIV Vaccine Research & DevelopmentUnderstanding the landscape – A Funders’ Briefing

Mitchell Warren

Executive Director, AVAC

29 March 2012

Funders Concerned About AIDS

Founded in 1995

Use education, policy analysis, advocacy and a network of global collaborations to accelerate the ethical development and global delivery of new HIV prevention options as part of a comprehensive response to the pandemic

About AVAC

We’re on a road to nowhere

If you don’t know where you’re going, any road will take you there

It is a long and winding road

Source: AVAC Report 2007: Resetting the Clock

Soundtrack for the Search for an AIDS Vaccine

Research is…

“Research is four things: brains with which to think, eyes with which to see, machines with which to measure and, fourth, money.”

Albert Szent-Györgyi, 1937 Nobel Laureate in Medicine

A Three-Part Agenda for Ending AIDS

CO

MB

IN

E

Deliver proven tools for immediate impactModel successful programsMobilize demand for new toolsReprogram resources for impactFund evidence-based scale-up

• Testing• Male Circumcision• Treatment

Demonstrate proven tools for immediate impactPlan for rollout in different settingsPrioritize use of tools for greatest impactPilot to guide real-world implementation

• PrEP• Microbicides

Develop long-term solutions to end the epidemicSustain research funding to capitalizeon new scientific insights

• Vaccines• Functional Cure

Years to Impact Zero to 5 5 to 10 10 to End

GOAL: A sustained d e c l i n e i n H I V infections (now at 2.7 million/year)

2011

In May 2011, the Pox-Protein Public Private Partnership or “P5” (formed by Sanofi Pasteur, Novartis, US NIH, Gates Foundation, the US MHRP and the HVTN) debuts, designed to move from the RV144 Thai prime-boost vaccine trial results to a potentially licensable product for Thailand and elsewhere.

In August 2011, the HVTN 505 Phase II trial of a DNA-Ad5 combination expands its scope to include an investigation of whether the experimental vaccine regimen prevents HIV infection.

In 2009, the RV144 Thai vaccine was the first ever to demonstrate a modest effect of 31.2% in preventing HIV infection. In September 2011, immune responses predictive of risk in RV144 trial identified.

More than two dozen phase I & II trials are ongoing in 20+ countries worldwide. Promising antibody and animal studies are continuing.

Follow-on studies from RV144 in South Africa and Thailand in devlelopmemt.

Highlights from 2011 in HIV Vaccines R&D

January February March April May June July August September October November December

Series of ongoing discoveries of new neutralizing antibodies, that provide potential new targets for AIDS vaccine development

Ongoing Phase I/II and II Preventive AIDS Vaccine Clinical Trials

2009 2010 2011 2012 2013 +1 2 3 4 1 2 3 4 1 2 3 4 1 2 3 4

Phase IIb trial to assess if DNA prime/rAd5 boost vaccine regimen significantly reduce viral load in individuals who become infected with HIV.

Phase I/II trial to assess the safety and immune response in the mucosa of the vector vaccines NYVAC-B and the rAd5.

Phase I/II trial to assess the safety and immune response of an adenovirus-based HIV-1 vaccine regimen.

Phase I/II trial to assess the safety and immune response of DNA priming and MVA boosting and to develop further HIV vaccine trial capacity building in Tanzania.

Phase I/II trial to assesses the safety and immune response of two Ad5 adenoviral vector vaccines.

HVTN 505 US

Phase II trial to assess safety of DNA and MVA vaccines and immune responses of participants to see if these vaccines are helpful in fighting HIV infection.

HVTN 205 US, Peru

HVTN 078 Switzerland

TaMoVac1 Tanzania, Mozambique

HVTN 083 US

HVTN 084

Ongoing

Ongoing

OngoingBrazil, Peru, Switzerland, US

Expected 2013

Q3 2014

No effective HIV vaccine is available today; however, more than two dozen phase I & II trials are ongoing in 20+ countries around the world, including follow-on studies from recent large-scale trials.

Investing in HIV Vaccine Research & Development

2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 20100

100

200

300

400

500

600

700

800

900

1000

Commercial *

Philanthropic

Multilaterals

Other **

Europe

US

Annual investments in HIV vaccine R&D 2000 – 2010 (US$ millions)

933 961

868 868 859

759

682

547548

366 327

* Commercial sector estimates not available for years 2000 to 2004. For years available commercial funding figures are estimates based upon a review of HIV vaccine programs at each company. ** Other includes all national public sector funding apart from funding from the US and Europe.

HIV Vaccine Expenditures 2010

Pre-clinical research Clinical trials Cohort & site development

Advocacy & policy development

US$ 231,930,000 spent on basic research in 2010 (27% of total)

US$ 352,190,000 spent on pre-clinical research in 2010 (41% of total)

US$ 214,750,000 spent on clinical trials in 2010 (25% of total)

US$ 51,540,000 spent on cohort & site development in 2010 (6% of total)

US$ 8,590,000 spent on advocacy & policy development in 2010 (1% of total)

Basic research

US$ 859 million was spent on HIV Vaccine R&D in 2010: what was it spent on?

Bottom line

There remains an urgent need for new HIV prevention options, including an AIDS vaccine

An AIDS vaccine is possibleNow is the most exciting and promising – and

increasingly complex – time in AIDS vaccine research

Investments in AIDS vaccine R&D today is an investment in the future and in ending the epidemic

It’s not just about the “product”