A Houston company with a promising immuno-oncology is one step closer to delivering its cancer-fighting drug to patients who need it. Photo via Getty Images

A Houston immuno-oncology company has recently made major headway with the FDA, including both a fast track and an orphan drug designation. It will soon start a phase 2 trial of its promising cancer fighting innovation.

Diakonos Oncology was born in 2016, the brainchild of Baylor researchers already hard at work in the realm of dendritic cell vaccines. Drs. Will Decker, Matt Halpert, and Vanaja Konduri partnered with Dan Faust, a Houston businessman and pharmacist, to bring their treatment to the public, says COO Jay Hartenbach.

The name Diakonos means “deacon or servant in Greek,” he explains. “A lot of companies end up focusing on treating a specific disease or cancer and what you end up having is a significant amount of potential but with a lot of tradeoffs and downsides. And so our goal is we need to eliminate the cancer but we can't harm or dramatically malign the patient in doing so.”

How do they do that? Because the therapy catalyzes a natural immune response, it’s the patient’s own body that’s fighting the cancer. Hartenbach credits Decker with the idea of educating dendritic cells to attack cancer, in this case, glioblastoma multiforme (GBM), one of the most aggressive cancers with which doctors and patients are forced to tangle.

“Our bodies are already very good at responding very quickly and aggressively to what it perceives as virally infected cells. And so what Dr. Decker did was basically trick the immune system by infecting these dendritic cells with the cancer specific protein and mRNA,” details Hartenbach.

Jay Hartenbach is the COO of Diakonos Oncology. Photo courtesy of Diakonos Oncology

But GBM isn’t the only cancer on which Diakonos Oncology has its sights set. Other notably stubborn-to-treat cancers that they’re working on include pancreatic cancer and angiosarcoma. The scientists are focused on meeting unmet medical needs, but also realize that treating such cancers would allow for the fastest determination of whether or not the treatment was effective.

The fast track designation, originally received last fall, means that the drug approval time for DOC1021, Diakonos’ glioblastoma vaccine, will be only six months. But Hartenbach highlights an additional boon, the fact that the special designation also allows for more frequent communications with the FDA.

“That’s very helpful for us, right as we're contemplating how to design the upcoming trials. From a business standpoint, it also is incredibly helpful because it provides a third party validation of what we're doing and the results that we're seeing,” he says.

What they’re seeing includes the survival of 13 out of 16 patients from the initial October 2021 enrollment. The three patients who passed away received the lowest dose of DOC1021. Hartenbach says that the remaining patients are thriving, with no serious adverse effects. With a median survival rate of 15 to 21 months, it’s hard to understate the significance of these patients’ success.

Diakonos Oncology is headquartered in Houston, with a staff of 10 in Space City and an additional eight distributed employees. Hartenbach says that the company’s hometown has been instrumental in its success. He mentions that the robust innovation of the Texas Medical Center meant that as the company has grown, there has never been a motivation to leave Houston.

“You're having a lot of both investment and companies actually moving to Houston,” Hartenbach says. “So we’ve been fortunate to have started there. There are bigger traditional biotech hubs, San Diego, Boston, and San Francisco, but Houston really is now putting itself on the map and it's getting a lot of attention.”

One of the companies responsible for that improved reputation? Diakonos Oncology and its promising approach to aggressive cancers.

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

Houston immunotherapy company achieves FDA designation for cancer-fighting vaccine

got the green light

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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3 Houston innovators who made headlines in May 2025

Innovators to Know

Editor's note: Houston innovators are making waves this month with revolutionary VC funding, big steps towards humanoid robotics, and software that is impacting the agriculture sector. Here are three Houston innovators to know right now.

Zach Ellis, founder and partner of South Loop Ventures

Zach Ellis. Photo via LinkedIn

Zach Ellis Jr., founder and general partner of South Loop Ventures, says the firm wants to address the "billion-dollar blind spot" of inequitable distribution of venture capital to underrepresented founders of color. The Houston-based firm recently closed its debut fund for more than $21 million. Learn more.

Ty Audronis, CEO and founder of Tempest Droneworx

Ty Audronis, CEO and founder of Tempest Droneworx

Ty Audronis, center. Photo via LinkedIn.

Ty Audronis and his company, Tempest Droneworx, made a splash at SXSW Interactive 2025, winning the Best Speed Pitch award at the annual festival. The company is known for it flagship product, Harbinger, a software solution that agnostically gathers data at virtually any scale and presents that data in easy-to-understand visualizations using a video game engine. Audronis says his company won based on its merits and the impact it’s making and will make on the world, beginning with agriculture. Learn more.

Nicolaus Radford, CEO of Persona AI

Nicolaus Radford, founder and CEO of Nauticus RoboticsNicolaus Radford. Image via LinkedIn

Houston-based Persona AI and CEO Nicolaus Radford continue to make steps toward deploying a rugged humanoid robot, and with that comes the expansion of its operations at Houston's Ion. Radford and company will establish a state-of-the-art development center in the prominent corner suite on the first floor of the building, with the expansion slated to begin in June. “We chose the Ion because it’s more than just a building — it’s a thriving innovation ecosystem,” Radford says. Learn more.

Houston university to launch artificial intelligence major, one of first in nation

BS in AI

Rice University announced this month that it plans to introduce a Bachelor of Science in AI in the fall 2025 semester.

The new degree program will be part of the university's department of computer science in the George R. Brown School of Engineering and Computing and is one of only a few like it in the country. It aims to focus on "responsible and interdisciplinary approaches to AI," according to a news release from the university.

“We are in a moment of rapid transformation driven by AI, and Rice is committed to preparing students not just to participate in that future but to shape it responsibly,” Amy Dittmar, the Howard R. Hughes Provost and executive vice president for academic affairs, said in the release. “This new major builds on our strengths in computing and education and is a vital part of our broader vision to lead in ethical AI and deliver real-world solutions across health, sustainability and resilient communities.”

John Greiner, an assistant teaching professor of computer science in Rice's online Master of Computer Science program, will serve as the new program's director. Vicente Ordóñez-Román, an associate professor of computer science, was also instrumental in developing and approving the new major.

Until now, Rice students could study AI through elective courses and an advanced degree. The new bachelor's degree program opens up deeper learning opportunities to undergrads by blending traditional engineering and math requirements with other courses on ethics and philosophy as they relate to AI.

“With the major, we’re really setting out a curriculum that makes sense as a whole,” Greiner said in the release. “We are not simply taking a collection of courses that have been created already and putting a new wrapper around them. We’re actually creating a brand new curriculum. Most of the required courses are brand new courses designed for this major.”

Students in the program will also benefit from resources through Rice’s growing AI ecosystem, like the Ken Kennedy Institute, which focuses on AI solutions and ethical AI. The university also opened its new AI-focused "innovation factory," Rice Nexus, earlier this year.

“We have been building expertise in artificial intelligence,” Ordóñez-Román added in the release. “There are people working here on natural language processing, information retrieval systems for machine learning, more theoretical machine learning, quantum machine learning. We have a lot of expertise in these areas, and I think we’re trying to leverage that strength we’re building.”