On July 11 2018, Dr Chad Maki and Tom Ramos traveled to Washington DC for the long awaited meeting with the CVM regarding its feline Mesenchymal Stem Cell (MSC) product.  Also joining was Dr Dori Borjesson from UC Davis, who is closely collaborating with us on this project. The feline MSC product is being proposed to be used with cats who have not responded to the standard treatment for Feline Chronic Gingivostomatitis.

Dr Borjesson has studied this condition with these cells dating back to 2014 and has published numerous scientific papers on this topic. Dr Borjesson was one of the first apply feline MSCs with cats suffering from chronic stomatitis.  This cell type has shown to be effective in treating this disease. Dr Borjesson has collaborated with Dr Arzi (UC Davis) to treat FCGS.  In a recent trial, five cats responded to treatment by either complete clinical remission (n=3) or substantial clinical improvement (n=2).  Due to her significant contributions in this field, Dr Borjesson is regarded as an expert in this field and is highly respected by the CVM.

This meeting was an important step in the approval process. Over the last year, we have spent much time and effort validating our procedures for GMP production of feline MSCs.  The preparation of the required documents for the meeting was also a large undertaking.  When the CVM accepted our request for the meeting, it was highly encouraging since it signified that our idea for this type of cell therapy was regarded as noteworthy.

We met with Dr Lynne Boxer, the veterinary medical officer who is in charge of our feline MSC application and her regulatory team. Dr Boxer is the main contact at the CVM who is responsible to review and manage the applications of Investigational New Animal Drugs. Dr Boxer is also the main contact for the official guidance for industry documents which reflects the current position the CVM has on cell based products. We will be working closely with Dr Boxer over the length of the approval process, which can easily take 3 – 4 years.  The opportunity to establish a strong professional relationship with her is paramount to a successful product approval.

Dr Boxer and Dr Borjesson have an established professional relationship which dates back many years. This is potentially very beneficial since Dr Borjesson’s lab has generated a strong publication record on the use of feline MSCs in feline chronic gingivostomatitis. The Borjesson lab optimized the culture of feline MSCs and applied these cells to the feline chronic gingivostomatitis disease. They have been successful in healing some patients, as indicated in one of the recent publications.

The bulk of the meeting consisted of Dr Boxer giving us direct feedback on our questions and the proposed operations we prepared in advance.  The feedback from Dr Boxer was centered around her helping us to determine the best action to take in manufacturing the product. The biggest concern the FDA has is to ensure the product is safe and effective.  Since we are the one who will take the product through the approval process, it becomes our responsibility to provide all the data and evidence to support the product.

Overall the meeting went very well. The meeting had an official structure and good tone to it, where everything that was discussed was also documented.  These types of meetings are very organized, and the topics have to be approved by the FDA in advance. There were no outright concerns about the type of product and its proposed application.  Dr Boxer clearly described the expectations we have to comply with for tissue sourcing, manufacturing and quality assurance.  Some of the solutions are defined and it is a matter of applying established regulations to our process. Other solutions are not defined and we will have to be creative to develop the proper solution.  Our collaboration with Dr Borjesson, and input from the CVM, will have a significant impact on satisfying those challenges.

The meeting lasted two hours and it did require every minute.  Whilst it was very positive to see the support and encouragement from the CVM, it is not to say this is an easy path.  Quite the contrary, this will require a lot of work and effort to satisfy the regulatory requests. If we can satisfy the requirements, then our product will have a good chance for approval.

A central theme of the meeting was that the CVM said many times they are here to help us through the process. A dedicated team could possibly get through the approval process in 3-4 years. The CVM does not dictate any deadlines, as it is entirely up to us on the pace to execute.  Any delays along the timeline will lengthen the process. At this stage of the process, it was mainly focused on defining the characteristics of the feline MSC product and defining how it will be manufactured. As soon as this is completed, then the next major milestone is to conduct the safety trial in cats.

This was a major milestone moment for the company.  It represents a validation of our idea to create this type of cell therapy, which has the potential to be translated to a human model. It took over two years to reach this point, which involved developing the product and solidifying the application of the feline MSC product.  We recognize it will take considerable time and effort to go through the approval process for the feline MSC product. We see this as a great opportunity to potentially have the first allogenic cell therapy product approved for use in veterinary medicine.