This is our attempt to answer the most commonly asked questions
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HOW DID THE IMMUNITY PROJECT TEAM COME TOGETHER?
Immunity Project is a nonprofit partnership between Flow Pharma, a biotech firm with a novel HIV vaccine candidate, and Until There’s A Cure, a leading HIV/AIDS non-profit in the San Francisco Bay Area. The vaccine candidate was developed by Dr. Reid Rubsamen, CEO of Flow Pharma and his team, using HIV surface targets identified by statistical analysis of the behaviour of the immune systems of individuals who become infected with HIV but do not progress to AIDS. The team also includes Dr. Charles Herst, Dr. Igor Gonda and Dr. Tikoes Blankenberg.
This work has been made possible by an intensive effort by computer scientists at universities and industry focussed on hacking into the HIV life cycle by analyzing blood from HIV controllers – people who, despite being infected with HIV, have very low viral loads and do not develop AIDS. Statistical analysis of the behaviour of T-Cells from blood from these individuals shows that they attack specific beneficial targets which force the HIV virus to mutate into a weakened state. These targets have been formulated into the Flow Pharma vaccine candidate, which has the potential to turn HIV-uninfected individuals into HIV controllers. This would be truly game-changing in the HIV/AIDS epidemic.
WHY IS THIS TEAM QUALIFIED AND WHY HIV/AIDS?
HOW WILL THIS VACCINE WORK?
If proven effective, our vaccine will turn those who receive it into HIV controllers. HIV controllers are miraculous: they are naturally immune to HIV. Approximately 1 out of 300 of those living with HIV have this incredible super power. To develop our vaccine, we leveraged the work of accomplished computer scientists using statistical analysis to sift through blood samples from HIV controllers, identifying the specific virus surface targets favored by those individuals. These targets were then formulated into a vaccine prototype. This is a completely novel approach to solving this epidemic.
HOW IS IMMUNITY PROJECT’S VACCINE DESIGN DIFFERENT FROM OTHER HIV VACCINE RESEARCH?
ARE YOU TESTING ANY THERAPEUTIC BENEFITS FOR THE VACCINE?
CURRENT HIV VACCINE LANDSCAPE:
|Immunity Project||Other Vaccine Development Programs|
|Contains Live Viruses||No||Yes|
|Presents decoy targets to the immune system||No||Yes|
|Presents highly specific targets to the immune system||Yes||No|
PREVIOUS VACCINE CANDIDATES HAVE SHOWN NO BENEFIT OR HAVE EVEN CAUSED HARM. IS THIS SAFE?
The vaccine is being designed to minimize any safety concerns. We do not use any living or non-living organisms in our formulations. Instead, we use the epitopes of HIV, biodegradable microspheres and previously studied TLR-based immune adjuvants. These chemicals are already being used in FDA approved vaccines or in FDA monitored clinical trials. The epitopes on their own are too small to cause any response so they are encapsulated into microspheres (made of the same material as dissolvable sutures). Our vaccine has the potential to be one of the safest vaccine platforms ever developed.
WHEN DO YOU HOPE TO BEGIN A STUDY IN HUMANS?
We are crowd funding one additional experiment to show more efficacy in a controlled external environment. After the experiment we are crowd-funding is complete, we will be ready to go to the FDA to plan Phase I clinical trials in the US. As soon as we raise adequate funding, we can begin clinical manufacturing for human use and start Phase I clinical testing.
IF THE PHASE I TRIAL IN HUMANS IS SUCCESSFUL, WHAT ARE THE NEXT STEPS?
WHEN MIGHT THE VACCINE BE BROUGHT TO MARKET?
This vaccine will be brought to market once we have proven that it meets the highest standards of evaluation and production. The FDA provides guidelines and oversight towards maintaining these standards.
|Phase I||20-80 participants||Up to several months||Studies the safety of medication/treatment|
|Phase II||100-300 participants||Up to (2) years||Studies in efficacy/safety and dosing|
|Phase III||1000-3000 participants||Up to (1)-(4) years||Pivotal trials studying Studies the safety, efficacy|
|Phase IV||Thousands of participants||One (1) year||Studies the long-term effectiveness, safety; cost effectiveness|
WHAT DOES THE PRELIMINARY RESEARCH TELL US?
The team has conducted experiments with over 400 mice with positive results. Currently, the vaccine works in mice by inducing a cell-mediated immune response. In a petri dish we have been able to induce dendritic cells to take up the microspheres through a process called phagocytosis:
WHAT IS THE STATUS OF THIS RESEARCH BEING PUBLISHED IN A PEER REVIEWED JOURNAL?
We have submitted our data and are awaiting publication in a peer-reviewed journal. In the meantime, you can view our White Paper here: http://bit.ly/1ebKRTP
HOW MUCH IS NEEDED?
HOW EXACTLY WILL THE $482K FROM THE CROWD FUNDING CAMPAIGN BE USED?
Vaccinate humanized mice with (i) an Immunity Project HIV epitope (treatment group) or (ii) tetanus epitope (control group) (Transgenic NOG grafted with an Immunity Project-relevant HLA type). Harvest spleens 14 days post immunization, confirm presentation to killer T cells via Flurospot. Create in-vitro cell culture prep with separated CD4 and CD8 T-Cells wherein the CD4 cells have been inoculated with live HIV virus. Expected result: p24 HIV core antigen lower and CD4 counts greater with HIV-epitope immunized mice.
BUDGET FOR THE MOUSE EXPERIMENT
|Animal handling (dosing, housing, spleen harvest)||$150,000|
|Reagents (including HIV virus, media, antibodies, magnetic sep, p24 assay, MPLA, CpG, etc)||$100,000|
BUDGET FOR THE LAB
|40 HLA Type determinations||$30,000|
|HLA Subtyping determinations||$20,000|
|Larger capacity Clinical centrifuge||$6,000|
|Larger capacity CO2 incubator||$6,000|
HOW CAN YOU CONDUCT THE PHASE I FOR ONLY $25MM?
IMMUNITY PROJECT BUDGET SUMMARY
|Product Development (Animal & TOX Studies)||$4,500,000|
|Manufacturing / Process Development||$5,000,000|
|Management and Control of HIV Program||$2,000,000|
|Preparation for US and South African Clinical Studies||$1,5000,000|
|Grant support from Microsoft Research||($1,000,000)|
|Product Manufacturing for Phase I Clinical Trials||$200,000|
|Clinical Study in the United States (Estimated 20 Patients)||$200,000|
|Clinical Study in South Africa (Estimated 60 Patients)||$600,000|
|Total baseline HIV vaccine project budget||$15,000,000|
|Nasal formulation dose development||$8,000,000|
|Nasal formulation Phase I Clinical Testing Arm||$800,000|
|Subtotal Nasal formulation option||$8,800,000|
|Total Baseline Immunity Project Budget with Nasal Dose Option||$23,800,000|
IF THIS VACCINE CANDIDATE IS SO PROMISING, WHY CAN’T YOU GET ENOUGH FUNDS FOR IT FROM GOVERNMENT AND FOUNDATION GRANTS?
We are pursuing funding from all sources including private donors, and foundations. In the future we will be applying for government grants. Traditional funding sources are slow and we are motivated to move Immunity Project with the utmost speed. Therefore, we are continuously testing new methods of fundraising. We will be open sourcing our fundraising tactics for other non profits and mission driven researchers to use.
WHAT MILESTONES HAVE YOU REACHED?
- 2010 – Achilles heel biological markers identified on a HLA restricted basis for HIV
- 2011 – $1 million raised for platform development and animal studies from Microsoft Research
- 2013 – Animal studies successfully conducted with positive results
- 2013 – Partnership formed with Until There’s A Cure, a leading non-profit organization focused on HIV and AIDS, based in the Bay Area
- 2014 – Accepted into Y-Combinator Accelerator Program Winter Batch 2014