Today we’d like to introduce you to Kevin D’Amour, Ph.D.
Dr. D’Amour, let’s start with your story. We’d love to hear how you got started and how the journey has been so far.
I began with a predecessor company straight out of graduate school, having just graduated from UCSD with a Ph.D. from the Division of Biology. The company was called Cythera and was comprised of 4 other scientists and one administrative ‘Jill of all trades’.
Over the next few years, we added a few more scientists to the ranks. Equipped with skill and determination, we were a small but mighty group with the goal to transform the treatment of type 1 diabetes (T1D). In 2004, CyThera merged with another stem cell company in Georgia, called Bresagen. Almost immediately, the Cythera-Bresagen combination also merged with an Irvine, CA-based company called Novocell, with the final combined company taking the name Novocell. In 2010, Novocell changed the name to ViaCyte.
During the first 6-8 years at the company, I was so stimulated by what seemed like weekly discoveries in the lab. Most of these discoveries on their own were just a small thing, but in looking back over that period, they built to significant advances in the stem cell field. Our group has accomplished and continues to accomplish many ‘world’s firsts’ along the path to deciphering the recipe for turning stem cells into pancreatic progenitor cells useful for T1D therapy.
I was fortunate to be able to grow in my levels of responsibility as the company grew and today hold the position of vice president, research and chief scientific officer, where I lead research advances in the stem cell program and am frequently called upon to address the biological aspects of ViaCyte’s technology platform with regulating bodies, such as the US patent office and the FDA, and investors.
We’re always bombarded by how great it is to pursue your passion, etc – but we’ve spoken with enough people to know that it’s not always easy. Overall, would you say things have been easy for you?
It has been anything but a smooth road, but this is expected when you are trail-blazing the development of an entirely new type of therapy. ViaCyte is developing multiple unique therapeutic candidates, which has necessitated innovation in several areas including cell biology, cell process development and scale-up, device-cell combination product development and manufacturing, as well as the evaluation of the products in preclinical and clinical testing.
Along the way, we not only educate ourselves but are translating that new knowledge and understanding to impact the regulatory path for this new therapeutic avenue.
What is important is that each time a challenge is encountered, in preclinical evaluation, manufacturing, clinical trials, etc. We are able to step back, learn from the results and use those learnings to improve the products. We truly believe we have the right technology, the right expertise and know-how and the right team to deliver a cure.
So let’s switch gears a bit and go into the ViaCyte story. Tell us more about the business.
What do you do, what do you specialize in, what are you known for, etc.
In its most simple description, ViaCyte is developing islet cell replacement therapies for diabetes. We expect these therapies to be a functional cure for type 1 diabetes; completely eliminating the need for patients to check blood sugar and inject insulin while making their blood sugar levels completely normal again.
The approach starts from stem cells, which we instruct to become pancreatic progenitor cells in the lab, in a process called directed differentiation. It essentially recreates in the dish the path by which the pancreas forms during fetal development. However, we stop the process at the progenitor cell stage, just before final maturation of the cells into all the cell types of the pancreatic islet cells. The pancreatic progenitor cells are then carefully loaded into a medical device to contain them for surgical implant under the skin, creating a cell-device combination product.
In one particular product, ViaCyte is developing, called PEC-Encap, the device is designed to protect the cells from rejection by the patient’s immune system. The device acts similar to a tea bag, keeping the pancreatic cells inside and the immune cells out but permitting oxygen, nutrients and therapeutic factors to freely flow in and out. The combination product is prepared on-site at ViaCyte and shipped to the clinical sites where surgeons perform a simple outpatient procedure to surgically implant the product under the skin.
In the weeks and months after implantation, the expectation is for the body to heal around the device and for the cells inside to further mature to become islet cells which secrete the hormones that control blood sugar, almost identically to how the normal pancreas does. Since in T1D, the patient’s immune system has malfunctioned and killed off the cells in the patient’s pancreas that secrete insulin, our therapies are intended to replace that lost cell type and thus restore normal insulin production and blood sugar regulation.
At a full therapeutic dose, the goal is that patient would no longer have to carefully monitor their blood sugar, food intake, and exercise, nor inject themselves with insulin. This would essentially create a ‘functional cure,’ as the patient would still have the autoimmunity that caused the disease in the first place. We also believe that our products could help patients with type 2 diabetes that have reached a point where they use insulin to help control their disease. For these patients, our cell replacement therapy would not be a cure, but it could be an effective therapy.
What are you most proud of as a company?
ViaCyte has led this field for many years, and the list of accomplishments that I am proud of is long. However, as a team member that has been part of this effort my entire career, getting into the clinic is certainly something I am very proud of.
The fact that ViaCyte received an allowance from the FDA to start the first ever pluripotent stem-cell based trial for diabetes with zero delays is truly something to be proud and excited about. This accomplishment is significant because, with very novel therapies like this one, companies can often spend many months or even a year on ‘clinical hold’ while they do further studies to address FDA concerns. The 30-day allowance is a testament to the quality of our team and our product.
For this first clinical study, called STEP-ONE, the FDA reviewed the ~ 7,500-page application in the required 30 days and gave us the green light to start clinical trials. This document represented a team effort that took the better part of 6 months to write and summarized the work of the team over the preceding ten years.
The day that news came, August 14, 2014, it truly brought tears to my eyes.
What sets you apart from others?
When I think about what sets ViaCyte apart as a company, I think about the amazing team that has worked with dedication and passion to make this company the leader in developing stem cell-derived cell replacement therapies for T1D. The team’s accomplishments have made ViaCyte the first to describe directed differentiation of human pluripotent stem cells into pancreatic cells.
And the first to demonstrate the differentiation of stem cell-derived pancreatic progenitor cells into glucose-responsive insulin-producing cells, both in vivo and in vitro. In addition, ViaCyte launched the first clinical trials for stem cell-derived islet replacement therapies for type 1 diabetes.
If you had to start over, what would you have done differently?
Very little, except to have committed slightly more resource to the more basic research functions within the company. As our products moved from research into development, the company is required to do everything the same way every time. This is important for making a consistent and reliable high-quality product, but it limits the innovation that comes from exploring the unknown – that’s both doing different things as well as doing things differently.
Overall, the path I have traversed so far has been extremely exciting and gratifying. I am grateful to be working at ViaCyte, as this is a special team. We are accomplishing great things and are near to making a dramatic impact on the way T1D is treated. By doing so we can make dramatic improvements in the lives of those touched by this very troublesome disease.
- Website: www.viacyte.com
- Facebook: https://www.facebook.com/ViaCyte/
- Twitter: https://twitter.com/ViaCyte
CONNECT San Diego, The Human Trial