06 Oct Session D – Life Sciences Track
Life Sciences Track – Expanding Progress and Opportunities in Gene and Cell Therapy
- Jeff Galvin, CEO and Founder, American Gene Technologies
- Dawn Driscoll, MBA, Ph.D., GAICD, Chief Executive Officer, Cell Therapies Pty Ltd
- Bill Enright, CEO, Vaccitech
- Jon Rowley, Ph.D., Founder and Chief Product Officer, RoosterBio, Inc.
QUESTION: Tell us about RoosterBio
Our goal is to radically simplify the incorporation of living cells into tomorrow’s therapeutic products. We are not a therapeutics company, we are actually a tools company, and we supply cell banks and bioprocess media into the cell therapy and gene therapy field from which therapeutics are made. So they’re the cellular starting materials and the ancillary materials in manufacturing. So, we’ve taken the traditional media business model that was actually pioneered right here in Maryland and turned that business model on its head and focused it on the manufacturing and the product development. Our mission is to really fuel the rapid commercialization of scalable regenerative cures.
QUESTION: Tell us about Cell Therapies
We are a full service contract development and manufacturing organization. We’re fully licensed by the TGA, which is the Australian equivalent of the FDA, to produce cells for immunotherapy…various immunotherapy applications so we have a broad license for T-cell manufacturers in both clinical trial as well as commercial applications. And there’s really interesting quirk in Australia versus the US, where we’re required to have manufacturing inspections very early on in the development process, so we’ve already obtained those licenses so when clients come to us, they know that they’re coming to an organization that has basically de-risked the entire process and been through the process with a regulator.
American Gene Technologies is a clinical stage immunotherapy company, and we are really focused on using the T-cell side of the immune system to prevent disease or cure diseases, where we know T-cells are going to be important. We’re focused primarily right now in chronic infectious diseases like Hepatitis B, Human Papilloma Virus, as well as in oncology, so we’ve got multiple programs running in the clinic right now. The big news out of American Gene Technologies right now is obviously that we have been approved by the FDA to start a clinical trial for an HIV functional cure. And we’ve been working on this for a while. And we have a lot of preclinical data which is giving us significant confidence about our ability to actually cure HIV and a functional cure basically would be. And I’m pretty confident about it because we have really put together a dream team of HIV clinicians scientists and folks that are very experienced at it.
QUESTION: What can the Maryland stem cell research fund do to help accelerate cures in this field?
They’re already doing a lot. They’re funding a lot of basic translational research within the universities. Just a couple years ago, they put together funds specifically to help industry, which is to fund both product development as well as clinical trials that are being run in Maryland. And so there’s lots of opportunity there. We’re a small company here in Maryland and have grown over the last few years, and we’ve benefited from two of their two grants, specifically on the product development side and we successfully have launched two products based off of the funding that came out of there.
So they are actively helping the small companies here which is really great.
With workforce development, one thing that’s happening with lots of great companies that are moving to the area, the talent is getting slim. So the workforce development aspect, I think it would become an interesting area for them to expand into.
We’re finding it easier to get sort of entry level folks but a little bit harder to get experienced Ph.Ds.
QUESTION: When we were prepping for this session, I was surprised to hear about some of the projects Cell Therapies is working on with companies in the United States. Could you just tell us a little bit about those ones. You know the products that you’re working with.
There’s two fairly high profile projects and clients that we have which are very highly public knowledge, and I have my clients approval to talk about this publicly. The first being a company based in Boston that is developing various gene therapies for rare disorders. And we’re doing a lot of their product development and bringing those products into clinical trials in Australia for that company, and that’s been great because of their non-cancer applications. So, our team gets to become immersed in the biology of another disease state and really the biology of a different type of cell from what we work with most frequently. Another high profile client is Novartis. We are in the end stages of tech transfer and we’ll be launching manufacturing for Australia and quite a few other countries in this region. We’ve been pretty thoroughly road tested by some of the biggest companies in the world. We’re quite comfortable working remotely.
QUESTION: What are the major characteristics of MSCs that you think will be useful in the future in terms of treating different diseases, and you know sort of what’s the broadness of that platform.
Cell therapy developers have been figuring out how to take them outside the body, ex vivo, to expand them. And then just overwhelm the site of injury so you can infuse them and they will then home to the site of injury. A bunch get stuck in the lungs. So unless you’re treating a lung disorder like RDS, that might be a bug in some indications, it’s a feature. Some are directly injected into the site of injury. And, from my from my understanding, no one has really found a dose that is too high so you can really use a ton of these cells and overwhelm that site and really get that tissue regeneration starting. And then within a couple of weeks, you don’t see anything there, but the function of transplanting can last for months.