Biopharmaceutical companies aim to make taking a biologic drug as easy as possible for patients, marketing many of these chronically administered drugs in self-injectable pens for quick and easy dosing. It’s a convenience with a cost. Injector pens increase the overall expense of these already expensive products. For patients, some still find it difficult to continue with the usual dosing regimen, while others find that effectiveness diminishes over time.
Biotechnology company Duracyte aims to overcome these obstacles by bypassing many of the complexities associated with the manufacturing, distribution and administration of biologic drugs. The startup’s technology brings drug production to patients via an implantable device that hosts genetically modified cells to make therapeutic proteins.
“They receive nutrients from the body, and there is the oxygen source that is generated in the device,” co-founder Omid Veiseh said of the implant cells. “The body is not going to run out of water, and the body is not going to run out of nutrients. So everything the cells need to survive comes from the body.”
Duracyte is incubated within RBL LLC, a biotechnology company creation studio trained by Rice University in 2024. With clinical testing expected to begin early next year, Duracyte has officially launched from RBL recently, as its scientists begin to share more about how the young company aims to transform the way drugs are made and dosed.
Implants offering prolonged delivery of therapy are already available. Paul Wotton, CEO of RBL and co-founder of Duracyte, highlighted hormone-delivering implants used for contraception and testosterone replacement. In the field of cell therapy, Wotton noted that Neurotech Pharmaceuticals won FDA approval last year for an implantable system that treats a rare eye disease. Encapsulated by a semi-permeable membrane, Neurotech cells draw from the eye the water and nutrients they need while the membrane protects them from the immune system. But Neurotech’s implant doesn’t need a power source.
The most densely populated cells in the Duracyte system require extra oxygen, Veiseh said. To solve this problem, Duracyte scientists turned to submarines, which generate oxygen through electrolysis, applying an electric field to water to split it into hydrogen and oxygen. In the Duracyte device, a small, built-in battery provides the energy for electrolysis. It also powers onboard sensors that monitor the timing and amount of drug produced as well as the patient’s response to therapy.
Wireless battery charging means the implant can produce the drug indefinitely as long as it is recharged, Veiseh said. Clinicians manage drug production via a mobile application in constant communication with the implant. Although all of these electronic components are commercially available technologies, Veiseh said this implant would have been impractical just five years ago. Miniaturization of electronics was not yet sufficiently advanced for this device, which is about the size of an oral medication capsule.
Duracyte has already met with the FDA, which views the technology as a combined product: a device and a drug substance. For the Duracyte implant, the FDA considers the cell to be the drug substance, Wotton said. These cells are not a cell therapy, but rather human cells designed to produce therapeutic proteins.
“It’s actually a cellular factory that produces these human proteins,” Wotton said. “The pharmacy on a cell [is the] kind of approach that we’re currently working on here.
The startup’s main indication is ovarian cancer. Implanted near the tumor site, the device will produce two therapeutic proteins, the signaling protein IL-12 and ipilimumab, a monoclonal antibody from the class of cancer immunotherapies called checkpoint inhibitors. Ipilimumab was marketed by Bristol Myers Squibb under the brand name Yervoy, but its patents have expired.
Immunotherapies are difficult to dose because they circulate throughout the body and cause toxicities, Veiseh explained. Using Duracyte’s technology, dosing can be controlled to match the patient’s physiology, meaning lower doses, reducing the risk of side effects. Beyond cancer, Veiseh sees this technology finding applications in enzyme replacement. A bigger opportunity could be in immunology, where chronic diseases mean patients may need frequent injections or infusions of biologic drugs. The dose levels and frequency of doses of many currently available biologic drugs can trigger an immune response that ultimately prevents these drugs from working.
Duracyte has also explored metabolic diseases, demonstrating that its technology can produce the GLP-1 peptide. Veiseh said weekly injections of a GLP-1 drug mean a patient is first overdosed, properly dosed midweek, then underdosed at the end of the week. Duracyte could avoid the peaks and valleys of drug levels in the body, producing GLP-1 during meals when patients need it, but not at night when they sleep, he said.
The technology that would become the Duracyte system began a decade ago, when Veiseh was a postdoctoral researcher working with MIT scientists Bob Langer and Dan Anderson. Both have extensive experience in developing innovative drug delivery methods. Veiseh said the research aims to introduce biomanufacturing to patients so that biological medicines can be produced inside the body. He continued this research when he joined Rice in 2016 as a professor of bioengineering.
The federal government was one of the first to support Rice’s work applying the implant to ovarian cancer. In 2023, this targeted research on hybrid oncotherapeutic regulation (THOR) was rewarded up to $45 million in federal research funding from the Advanced Research Projects Agency for Health. Since then, Duracyte has received additional funding commitments from the Defense Advanced Research Projects Agency, Breakthrough T1D, and the Gates Foundation. Veiseh said that in total, the company has more than $100 million to support its work to bring biologics production into patients’ bodies.
“If you can solve this problem, biologics will become much more cost-effective, scalable, and with tailored dosing, they will also become much more effective, which I think is the direction medicine is going — combination biologics, precise dosing,” Veiseh said.
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