“`html
At MIT, a handful of notes on a whiteboard can evolve into a potentially revolutionary cancer therapy.
This situation materialized this week when the U.S. Food and Drug Administration authorized a system designed for addressing an aggressive type of bladder cancer. Over ten years ago, the concept originated in the laboratory of MIT Professor Michael Cima at the Koch Institute for Integrative Cancer Research, backed by funding from the National Institutes of Health and MIT’s Deshpande Center.
The initiative that began with a small group of researchers at MIT evolved into a startup, TARIS Biomedical LLC, co-founded by Cima and David H. Koch Institute Professor Robert Langer, which was acquired by Johnson & Johnson in 2019. In formulating the central idea of a device aimed at localized drug delivery to the bladder — a novel approach in bladder cancer treatment — the MIT team treated drug delivery as an engineering challenge.
“We talked to urologists and outlined the issues with previous treatments to establish a set of design criteria,” states Cima, a David H. Koch Professor of Engineering and a professor of materials science and engineering. “One of our criteria was that it had to integrate seamlessly into urologists’ existing routines. We aimed for urologists to intuitively understand how to use the system without even consulting the instructions for use. That’s essentially how it turned out.”
So far, the system has been utilized in patients thousands of times. In one study involving individuals with high-risk, non-muscle-invasive bladder cancer resistant to conventional care, physicians found no traces of cancer in 82.4 percent of patients treated with the system. More than 50 percent of those individuals remained cancer-free nine months post-treatment.
The outcomes are exceptionally rewarding for the team of researchers at MIT, which includes Langer and Heejin Lee SM ’04, PhD ’09, who developed the system as a component of his PhD dissertation. Cima mentions that numerous individuals deserve recognition beyond those who jotted on his whiteboard years ago.
“Creating drug products like this demands a tremendous amount of work,” remarks Cima. “There are probably over 1,000 individuals involved in devising and commercializing the system, including the MIT inventors, the consulted urologists, scientists at TARIS, scientists at Johnson & Johnson — and this excludes all the patients participating in clinical trials. I also want to stress the significance of the MIT ecosystem, and the necessity of providing individuals with the means to chase what may seem like outlandish ideas. We must continue to foster those types of endeavors.”
In the mid-2000s, Langer introduced Cima to a urologist at Boston Children’s Hospital who was looking for a novel treatment for a painful bladder condition known as interstitial cystitis. The traditional treatment involved frequent drug infusions into a patient’s bladder via a catheter, offering only temporary relief.
A team of researchers, including Cima; Lee; Hong Linh Ho Duc SM ’05, PhD ’09; Grace Kim PhD ’08; and Karen Daniel PhD ’09 began conversing with urologists and individuals who had conducted failed clinical trials on bladder therapies to determine what had gone awry. All that information was documented on Cima’s whiteboard over several weeks. Fortunately, Cima also noted “Do not erase!”
“We gained a wealth of knowledge during the process of documenting everything,” Cima reflects. “We discovered what not to create and what pitfalls to avoid.”
With a clearly defined problem, Cima secured a grant from MIT’s Deshpande Center for Technological Innovation, enabling Lee to concentrate on developing a superior solution as part of his PhD thesis.
One of the significant strides made by the team was the use of a specialized alloy that provided the device with “shape memory,” allowing it to be straightened and inserted into the bladder via a catheter. It would then fold up, preventing it from being expelled during urination.
The updated design could gradually release drugs over a two-week timeframe — significantly longer than any other method — and could subsequently be removed using a slender, flexible tube commonly employed in urology, known as a cystoscope. This advancement was sufficient for Cima and Langer, both serial entrepreneurs, to establish TARIS Biomedical and license the technology from MIT. Lee and three other MIT graduates joined the venture.
“It has been a genuine pleasure collaborating with Mike Cima, our students, and colleagues on this innovative drug delivery system, which is already transforming patients’ lives,” Langer states, “It’s an excellent illustration of how research at the Koch Institute begins with fundamental science and engineering and culminates in novel treatments for cancer patients.”
The FDA’s endorsement of the system for the treatment of particular patients with high-risk, non-muscle-invasive bladder cancer signifies that individuals with this condition may have a more effective treatment alternative. Looking ahead, Cima aspires for the system to be further explored to address other ailments.
“`