Innovative Drug Delivery System for Advanced Bladder Cancer Treatment Approved by FDA

At MIT, a simple brainstorming session transformed into a groundbreaking cancer treatment this week with the FDA’s approval of an innovative system designed to combat an aggressive form of bladder cancer. This journey began over a decade ago in the lab of MIT Professor Michael Cima at the Koch Institute for Integrative Cancer Research, supported by funding from the National Institutes of Health and MIT’s Deshpande Center. The initial concept, crafted by a small team of researchers at MIT, evolved into TARIS Biomedical LLC, co-founded by Cima and Robert Langer, a renowned professor at the Koch Institute. In 2019, this promising startup was acquired by Johnson & Johnson. The team developed a device aimed at local drug delivery to the bladder, marking a significant shift in bladder cancer treatment strategies by addressing drug delivery as an engineering challenge. Cima emphasizes the collaborative effort behind the design: “We consulted urologists and identified shortcomings in previous treatments to establish effective design parameters. Our goal was to create a system that seamlessly integrated into existing urological practices, allowing physicians to use it intuitively without extensive training.” The effectiveness of this system is evidenced by its extensive use in clinical settings. In a study involving patients with high-risk, non-muscle-invasive bladder cancer resistant to standard therapies, the system achieved an impressive 82.4% rate of no detectable cancer following treatment. Notably, over half of these patients remained cancer-free nine months post-treatment. The team at MIT, including Langer and Heejin Lee, who developed this technology as part of his doctoral research, finds great satisfaction in these results. Cima credits many contributors to this success, stating, “Developing drug products like this requires immense effort. Over 1,000 individuals have played a role in this project—from MIT inventors to consulting urologists, scientists at TARIS and Johnson & Johnson, not to mention the clinical trial participants. The MIT ecosystem’s support for innovative ideas has been crucial in this journey.” In the mid-2000s, Langer introduced Cima to a urologist from Boston Children’s Hospital seeking alternatives for treating interstitial cystitis, a painful bladder condition that typically required frequent catheter-based drug infusions, offering only temporary relief. Cima and his team engaged with urologists and examined past failed clinical trials to identify pitfalls and inform their design process. Cima recalls that writing down insights on his whiteboard was invaluable: “We documented everything, which clarified what we needed to avoid in our design.” With a clear problem definition established, Cima secured funding from MIT’s Deshpande Center, enabling Lee to focus on crafting an improved solution as part of his thesis work. A breakthrough came with the use of a unique alloy that provided the device with ‘shape memory,’ allowing it to be inserted through a catheter and expand within the bladder while maintaining position during urination. This new design permits sustained drug release over two weeks—outperforming previous methods—and can be removed using a common urological tool called a cystoscope. This progress led to the founding of TARIS Biomedical and the licensing of the technology from MIT, with Lee and three other MIT alumni joining the company. Langer expressed his enthusiasm about collaborating with Cima and their team on this innovative drug delivery system that is positively impacting patients’ lives: “This project exemplifies how research conducted at the Koch Institute transitions from foundational science and engineering into tangible cancer treatments.” With the FDA’s endorsement of this system for specific patients with high-risk, non-muscle-invasive bladder cancer, there is hope for enhanced treatment options for those affected by this condition. Looking ahead, Cima is optimistic about further applications of the system in addressing other diseases.