From The Editor | July 13, 2022

TC BioPharm's In-House Clinical Trials


By Erin Harris, Editor-In-Chief, Cell & Gene
Follow Me On Twitter @ErinHarris_1


Of the topics TC BioPharm’s CEO Bryan Kobel and I discussed on Cell & Gene: The Podcast, it’s the publicly-traded, clinical stage cell therapy biotech’s commitment to U.K.-based in-house clinical trials that struck me most. Indeed, TC BioPharm conducts and manages its own clinical trials using its in-house team. The company boasts a progressive approach to clinical trials, which enables the ability to explore the therapeutic potential of its co-stim CAR product candidate, while working towards an effective treatment for patients in de-risked early studies.

“The more we looked at it, we decided we should really be doing these in house,” says Kobel, referring to TC BioPharm’s gamma delta t-cell clinical trials. Kobel explained that CROs were cost prohibitive, and so far, the company has been able to conduct in-house trials for a fraction of the cost of a CRO partnership. By managing trials internally, Kobel states that the company has garnered enough safety and efficacy data to take to the U.S. for both orphan drug status and to launch FDA trials.

Kobel explains that TC BioPharm is the first pivotal gamma delta trial on record. “We made mistakes early on; we went down the autologous route, and for us, that didn't work, because there’s going to be a small, treatable patient population, because these patients are really sick,” he says. “The cells you're garnering are inherently very sick, or at least inert and tired. Beyond that, it's not economical. I certainly think there will be a place for autologous therapies, always. But I do think that the future will allogeneic cell therapies.”

Kobel provides some advice for biotechs looking to conduct trials in house. “Get away from autologous as soon as you can and put yourself in a position to treat as many patients as you possibly can,” he states. “That's how you reach economies of scale. I would tell you that if you're a cell therapy company, you need to own your own product; you need to be vertically integrated. You really can't outsource. There’s a bottleneck, and not only is it a bottleneck from a production perspective, but also from a manufacturing perspective.”  

Kobel notes that because cell therapy cannot be easily reproduced like small molecules, and because cells are living, changing organisms, working with them every single day on both manufacturing and production fronts provides a broad knowledge base, which is a competitive advantage, but more importantly, it allows you to understand your product better. “One of our intangible assets is the knowledge base we've gleaned from working with these cells every single day since 2014,” he states. “We’re just scratching the surface of gamma delta t-cells, broadly speaking.”

To learn more about gamma delta t-cells, in-house clinical trials, and more, tune into the entire episode of Cell & Gene: The Podcast featuring TC BioPharm’s CEO, Bryan Kobel. And be sure to check out the entire catalog of Cell & Gene: The Podcast episodes, which feature some of the CGT sector’s best and brightest.