Cell and gene therapies are becoming more mainstream, but an essential aspect of the drug development process is talking with clinicians about how it would fit into their practice, according to Joe Dupere, CEO of UK-based regenerative medicine company Rexgenero.
Rexgenero is advancing an experimental cell therapy for critical limb ischemia, a chronic condition that causes severe burning pain in the feet or toes as a result of blocked arteries in the lower limbs. Patients often get ulcers that can lead to amputation of the affected limb.
The company, headquartered in London, has R&D and manufacturing operations in Spain. Dupere talked with journalist Mike Ward at BIO-Europe 2019 in Hamburg, Germany, about the company’s progress and plans.
“There’s a lot of dialogue with the physicians and the surgeons that we cooperate with in our trial so they understand our product, its place in the treatment of this disease, and understanding when they can bring in patients and potential benefits,” Dupere said.
When it comes to involving clinicians in its studies, the earlier, the better, Dupere said he learned as the company advanced its investigational treatments.
“We live and breathe our design of our study, but surgeons are coming into this new, and to really understand how it works and really assist them in that journey with us so that they can bring patients in, we make it as easy as possible for them to participate,” he said.
Although the type of treatment isn’t as unusual as it once was, detailing how Rexgenero’s cell therapies could impact how care is currently provided is essential to getting buy-in from the physicians who would use it, he said.
“The challenge for us is to really demonstrate the superiority, in terms of the efficacy that we can show, and how that fits in with their practice,” he said. “That’s also marrying what they do already, which is a series of surgical and in endovascular procedures, [with] where the cell therapies can come in and really turbocharge that and have a really substantial impact on their patients.”
As Rexgenero focuses on its Phase 3 trials, its priorities have included thinking through how the product would be used if it were to make it to commercialization.
“There’s a whole range of other activities that we need to focus on as we get nearer to the market,” he said. “One is scaling up the manufacture, so that’s a truly commercial manufacturing process that can really deliver the product to as many patients as possible. The second is really understanding how this would be used in practice, so from a commercial perspective, how would you sell this product, how would you position it with the physicians, and how would you get the surgeons to understand where this treatment would work in their general practice.”
Duprere said the company also aims to expand into supplementary indications and establish a presence in the US.
Talking with investors as BIO-Europe, Duprere said he noticed “more of an appreciation” for biotechs that are doing cell therapy work outside of immune-oncology, a hot area for life sciences financings.
“I think when you talk about [strategic investors], the core value proposition of the disease and the treatment of the disease and the unmet need of the disease has been understood from the beginning, but utilization of a cell therapy to be able to address that market is something that they’re getting much more familiar with, certainly around things like the manufacture, some of the regulation that’s specific to cell therapies, and also the commercial path, when you’re dealing with a curative product where you give a single dose of the product and you expect a cure for the patient.”