IOTA Trial: Cell Therapy Team
Q&A With Eris Jordan, VP Clinical and Medical Affairs
We sat down with Eris Jordan, to hear the story-behind-the-story of Aurion Biotech’s announcement of its IOTA trial in corneal endothelial cell therapy
Q: Thank you for taking time to speak with us.
EJ: I’m delighted to do so.
Q: First off, why did Aurion Biotech conduct a clinical trial in El Salvador?
EJ: We chose El Salvador and Clínica Quesada for multiple reasons. Clínica Quesada has an excellent reputation for high-quality patient care. I’ve had the pleasure of working with Drs. Gabriel and Rodrigo Quesada and their terrific staff on previous projects and they consistently deliver exceptional service to their patients. The geographic proximity of this clinic to the US makes it easy for our US surgeons to travel there to perform the procedures and continue close follow-up care of patients. In this effort, we’ve established a good working relationship with the El Salvadoran Institutional Review Board and Ethics Committee. Professor Kinoshita and his team’s extensive work provided a solid foundation for the government to welcome this project.
Q: What did you hope to learn?
EJ: Having acquired the IP from Professor Kinoshita, we felt it was important to conduct a proof-of-concept trial outside of Japan, with US surgeons as lead investigators, and with non-Japanese patients. Although Professor Kinoshita remains a key contributor to our clinical development and is a member on our Medical Advisory Board, the COVID-19 pandemic has made in-person collaboration nearly impossible. So, initiating this trial made sense. You could say that our goals were modest: can we do this? I’m happy today to answer that question: yes, we can.
Q: Why in November of 2020?
EJ: It was a good time for Clínica Quesada, and it was a good time for our surgeons. It was certainly not a good time for weather conditions. On the day we were supposed to depart for El Salvador, a Category 4 hurricane was barreling down on Central America. We had an emergency conference call, looked at the weather forecasts and conditions, said a prayer to the weather gods, and decided to go for it. The team was unanimous in their desire to brave the hurricane – amid a global pandemic! – to treat the patients we had lined up. It was truly a humbling moment for me, and for all of us at Aurion Biotech.
Q: Wow! That takes determination. And a leap of faith.
EJ: GRIT! Fitting, as grit is one of our core values (the others are stewardship and transformation). We felt we had an obligation to treat patients (that’s where stewardship comes in). We had worked for months to line up schedules and we really, really wanted to move forward. It’s because we believe this procedure has the potential to transform patient care in this indication. So, we did move forward. Fortunately, the hurricane didn’t foil our plans: air travel continued and the entire team made it to San Salvador. Every single patient was able to get to the clinic for treatment. Amazingly, we pulled it off.
Q: How do you know this cell therapy procedure works? What do you actually measure? What’s considered healthy?
EJ: Professor Kinoshita’s extensive research and clinical trials with 65 patients have validated this procedure. Efficacy and safety data have been published in New England Journal of Medicine[1], and in Ophthalmology Journal[2]. Our job was to try and do exactly what he and his team did, and that includes the assessments. We examine corneal clarity using a slit lamp. Pre-op, we look for signs of corneal endothelial dysfunction (a “cloudy” cornea). Post-op, we hope to see a clear cornea. We also take quantitative measures, such as central corneal thickness (expressed in microns, or µ); 540 – 560 microns is considered average. We assess best corrected visual acuity (BCVA) using the Snellen scale, and a healthy range is 20/20 – 20/40. We also count endothelial cell density or ECD, (expressed as cells/mm2); a healthy range for ECD is somewhat age-related: healthy eyes aged 50+ measure in the 1,500 – 2,000 cells/mm2 range.
Q: When will you share data from the Iota clinical trial?
EJ: We hope to publish key findings once we have sufficient time to analyze the data. Keep in mind that IOTA-Part 1 commenced last November (2020). For patients treated in IOTA-Part 2 in May 2021, we are just beginning assessments. So far, we are pleased with initial findings but want to be sure that our analysis is thorough, and that we track patients over the next twelve months and beyond.
Q: One last question: why did you name this trial IOTA? I checked that word definition: it means “small” or “jot.” Yet this seems like a very significant effort.
EJ: Well, our unofficial fourth core value is humor. So, we named the trial in honor of that Category 4 hurricane, since it nearly ruined our best-laid plans! Also it’s a propos (if unintentional): small can be mighty. Our small, healthy, tightly-packed corneal endothelial cells can deliver mighty results in vivo.
[1] New England Journal of Medicine: March 2018
[2] AAO Ophthalmology Journal: 2020