Immunity Project Update on World AIDS Day 2015
Over 36 million people are living with HIV and in 2014 over 2 million people died of AIDS. The fight is far from over. Our team is committed to continuing the development of the Immunity Project HIV vaccine prototype. We won’t stop until the eradication of HIV/AIDS is complete.
We deeply apologize for the infrequency of updates. We’ve been laser focused this year on preparations for our first human clinical trial and we have some big updates to share. In our last update we shared that we were able to successfully show that we can repeatedly vaccinate human blood in-vitro and that vaccinated human blood kills a statistically significant percentage of HIV infected cells. Our results were promising enough for us to present our data as a poster at a major HIV focused conference in South Africa last year called HIV R4P. We invite you to view our data and results here.
The next step is for us to conduct a Phase I/II human clinical trial. In order to move forward with a human clinical trial we need to be able to manufacture a large quantity of our vaccine in a GMP facility. Our original required budget for building a sterilizable precision spray dryer, renting space in a GMP facility and developing the necessary GMP process and procedures was estimated at $7MM. The primary drivers for this expense were the amount of vaccine we need to make, the cost of the equipment, the cost to rent a class 5000 clean room to facilitate sterile GMP manufacturing, and the cost of developing the necessary processes and procedures to show that we can consistently and reliably manufacture sterile vaccine. One way to dramatically reduce the required budget is to significantly reduce the amount of vaccine we need to manufacture. Earlier this year, Reid came across a recent peer-reviewed article published in Journal of Visualized Experiments discussing a methodology for intra-lymph node micro particle vaccine injection. This article shows that Intra-lymph node micro particle vaccine injection may require many orders of magnitude less vaccine compared with a traditional injection. The article also shows that there is a significant increased potency possible from this delivery approach. We invite you to read the article here.
After much discussion with one of our advisors, Dr. Paul Harris, a researcher at Columbia Physicians and Surgeons we decided to explore the idea of testing intra-lymph node delivery of the Immunity Project HIV vaccine prototype. Dr. Harris is an expert in structural characterization of MHC bound peptides and has significant experience with conducting similar experiments. Over the last 9 months, we worked closely with Dr. Harris and his team to create the experiment plan and pursue IACUC approval. On September 30th of this year we received formal approval to proceed. Dr. Harris has generously offered us use of his lab and resources for an order of magnitude less than market price. We will be moving forward with this experiment in Dr. Harris’s lab on the Columbia University campus starting in early January. If the experiment is successful we may be able to use up to 1000x less vaccine per dose while achieving greater efficacy. This means we might need to make far less vaccine, and build a much smaller precision spray dryer. The cost savings are enormous. We now only need $50k to build the sterilizable precision spray dryer vs. the $1MM we had originally budgeted. We are proud to announce that we were able to raise these funds and will complete construction of this equipment by the end of Q1 2016.
|Mechanical drawing of our multi-nozzle precision spray drying head.|
We’ve also made significant headway in securing a GMP facility partner. Triple Ring Technologies has generously agreed to provide the necessary facility space at a significantly reduced cost. We are planning on moving into their clean room space by the beginning of Q2 2016.
Our current challenge is identifying a partner pharmaceutical company or GMP expert who can help us with validation and the development of our processes and procedures. This is a crucial requirement to being able to produce sterile vaccine on a consistent basis. If you know anyone who might be able to help us, please get in touch.
As always, please feel free to reach out to team@ImmunityProject.org if you have any questions.
When we launched Immunity Project in January of 2014, we set out to do something that no one had done before. With your generous support, we funded and completed more experiments than organizations with exponentially more funding and resources, and we’ve made significant progress towards preparing for our first human clinical trial. Thank you for giving us the opportunity to continue developing and validating the Immunity Project HIV vaccine prototype.
We are optimistic and excited about what we have planned for 2016. Our goal is manufacture sterile vaccine and test our HIV vaccine prototype on our first human subject. This goal is very ambitious, but we think it is possible with your support. Together we can take the next major step towards a free HIV vaccine for everyone.
Immunity Project exists because of you. Our team wouldn’t be able to do the work that we do without your help and support. Thank you to Nora and the incredible team at Until There’s A Cure for believing in us. Thank you to Y Combinator for your support, advice and guidance. And thank you to all of our supporters for your generosity and for giving us the opportunity to make Immunity Project happen. Wishing you a happy holiday season.
– Reid and Naveen