A Houston health care company received the green light from the FDA to advance a treatment that's targeting a deadly cancer. Photo via Getty Images

The FDA has granted a Houston-based company a Fast Track designation.

Diakonos Oncology Corp. is a clinical-stage immuno-oncology company that has developed a unique dendritic cell vaccine, DOC1021. The vaccine targets glioblastoma multiforme (GBM), the most common and most lethal malignant brain tumor in adults. The aggressive tumors come with a life expectancy of about 15 months following diagnosis. About 7 percent of those diagnosed survive five years, while the 10-year outlook only sees a one-percent survival rate.

“The FDA’s decision acknowledges the potential of this new treatment approach for a very challenging disease,” Diakonos CEO Mike Wicks says in a press release. “Our protocol represents a first for cancer immunotherapy and could be viable for many types of cancers beyond GBM.”

FDA Fast Track designations are intended to expedite the haste with which drugs with early clinical promise are reviewed, likely taking them to market faster.

DOC1021 uses the body’s natural anti-viral immune response to fight GBM. The vaccine mimics viral infection with the patient’s cancer markers. Essentially, DOC1021 uses the body’s own natural ability to detect and eliminate infected cells.

The technology uses dendritic cells, white blood cells that are able to perceive threats, to its advantage. The unique cancer markers are loaded both internally and externally into the immune cells, just as they would simultaneously occur in a viral infection. The individualized treatment is administered through three precise injections that target deep cervical lymph node chains. By dosing this way, the immune responses are directed straight to the central nervous system.

The results have spoken for themselves: All of the patients who have tried the treatment have exceeded survival expectations. And just as importantly, DOC1021 appears to be extremely safe. No serious adverse effects have been reported.

“Because Phase I clinical trials are generally not statistically powered to demonstrate efficacy, detection of a statistically significant efficacy signal is very promising,” says William Decker, associate professor of immunology at Baylor College of Medicine and inventor of the DOC1021 technology.

The Phase 1 open-label trial of DOC1021 (NCT04552886) is currently taking place at both the University of Texas Health Science Center in Houston and at the MD Anderson Cancer Center at Cooper University Health Care in Camden, NJ. The trial is expected to complete this year.

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Houston digital health platform Koda lands strategic investment

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Houston-based advance care planning platform Koda Health has added another investor to the lineup.

The company secured a strategic investment for an undisclosed amount from UPMC Enterprises, the commercialization arm of the University of Pittsburgh Medical Center. The funding is part of Koda's oversubscribed series A funding round that closed in October, according to a release.

"UPMC Enterprises’ investment is a meaningful signal, not just to Koda, but to the broader market," Dr. Desh Mohan, chief medical officer and co-founder of Koda Health, said in the news release. "It validates that health systems are ready to invest in infrastructure that makes advance care planning work the way it should: proactively, at scale, and with the human support that these conversations require. Having UPMC Enterprises as a strategic investor puts us in a unique position to prove what's possible."

Koda has raised $14 million to date, according to a representative from the company. Its series A round was led by Evidenced, with participation from Mudita Venture Partners, Techstars and the Texas Medical Center last year. At the time, the company said the funding would allow it to scale operations and expand engineering, clinical strategy and customer success. The company described the round as a "pivotal moment," as it had secured investments from influential leaders in the healthcare and venture capital space.

Koda Health, which was born out of the TMC's Biodesign Fellowship in 2020, saw major growth last year, as well, and now supports more than 1 million patients nationwide through partnerships with Cigna Healthcare, Privia Health, Guidehealth, Sentara, UPMC and Memorial Hermann Health System.

The company integrated its end-of-life care planning platform with Dallas-based Guidehealth in April 2025 and with Epic Systems in July 2025. It also won the 2025 Houston Innovation Award in the Health Tech Business category. Read more here.

New 'living pharmacy' biotech company launches out of Rice venture studio

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Rice University’s biotech venture studio RBL LLC has launched a new “living pharmacy” company, Duracyte, designed to make cancer treatment easier on patients.

Backed by an up to $45 million Advanced Research Projects Agency for Health (ARPA-H) award, Duracyte aims to commercialize implantable biohybrid pharmacy devices that are designed to produce therapeutic proteins inside the human body around the clock, replacing the need for regular injections and infusions for some cancer patients.

The company’s main platform is its Hybrid Advanced Molecular Manufacturing Regulator (HAMMR), a rechargeable, implantable device that can sense biological signals, monitor tumor environments and adjust therapeutic output in real time. HAMMR has wireless communication capabilities, which allow patients and clinicians to remotely monitor results through an app every five minutes and make changes to treatment plans without a hosptial visit. Additionally, the device can generate its own oxygen supply, which is key for the therapeutic cells’ survival.

“Biologic medicines such as monoclonal antibodies, cytokines and metabolic regulators already account for a significant share of modern therapeutics, but the way we deliver them today often requires frequent injections or infusions that can be demanding for patients and lead to inconsistent drug levels,” Daniel Anderson, MIT professor and co-founder of Duracyte, said in a news release. “Our vision is to enable a continuous, stable therapy by producing these medicines directly inside the body, which could improve treatment consistency, reduce side effects and ultimately transform how biologic therapies are delivered across many diseases.”

Duracyte’s first clinical trial is slated to begin by the end of 2026 and will focus on recurrent ovarian cancer. The Phase I study will build upon existing work on encapsulated cytokine pharmacy technology, and the company hopes that within a few years this treatment can reach clinical application.

The development of Duracyte is supported by ARPA-H's Targeted Hybrid Oncotherapeutic Regulation (THOR) project, which supports a multidisciplinary research consortium co-led by Omid Veiseh, a professor of bioengineering at Rice. The consortium also includes others at Rice, The University of Texas MD Anderson Cancer Center, Stanford University, Carnegie Mellon University, Northwestern University and the University of Houston, plus industry collaborators like Chicago-based CellTrans.

“What we are building is the culmination of years of progress in cell engineering, biomaterials and implantable device technology,” Veiseh added in the release. “By combining these advances with real-time sensing and adaptive drug delivery, we are working with the support of RBL to create a true ‘living pharmacy’ that can deliver continuous, precisely controlled biologic therapies and fundamentally change how these treatments reach patients.”

RBL launched in 2024 and is based out of Houston’s Texas Medical Center Helix Park. Duracyte is the third company launched by RBL, including Sentinel BioTherapeutics, a clinical-stage immunotherapy company developing localized cytokine therapies for solid tumors, and SteerBio, a regenerative medicine company targeting lymphedema.

“Duracyte exemplifies the kind of breakthrough that Houston’s ecosystem is built to produce,” Paul Wotton, managing partner of RBL LLC and co-founder of Duracyte, added in the release. “With world-class clinical infrastructure, exceptional engineering talent and initiatives like the Texas Biotech Task Force driving alignment across industry, investment and talent, this region is uniquely positioned to move the most ambitious ideas in medicine from concept to patient, faster than anywhere else.”