Houston immuno-oncology company reaches next FDA milestone, heads to phase 2 trial

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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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Houston-area lab grows with focus on mobile diagnostics and predictive medicine

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When it comes to healthcare, access can be a matter of life and death. And for patients in skilled nursing facilities, assisted living or even their own homes, the ability to get timely diagnostic testing is not just a convenience, it’s a necessity.

That’s the problem Principle Health Systems (PHS) set out to solve.

Founded in 2016 in Clear Lake, Texas, PHS began as a conventional laboratory but quickly pivoted to mobile diagnostics, offering everything from core blood work and genetic testing to advanced imaging like ultrasounds, echocardiograms, and X-rays.

“We were approached by a group in a local skilled nursing facility to provide services, and we determined pretty quickly there was a massive need in this area,” says James Dieter, founder, chairman and CEO of PHS. “Turnaround time is imperative. These facilities have an incredibly sick population, and of course, they lack mobility to get the care that they need.”

What makes PHS unique is not only what they do, but where they do it. While they operate one of the largest labs serving skilled nursing facilities in the state, their mobile teams go wherever patients are, whether that’s a nursing home, a private residence or even a correctional facility.

Diagnostics, Dieter says, are at the heart of medical decision-making.

“Seventy to 80 percent of all medical decisions are made from diagnostic results in lab and imaging,” he says. “The diagnostic drives the doctor’s or the provider’s next move. When we recognized a massive slowdown in lab results, we had to innovate to do it faster.”

Innovation at PHS isn’t just about speed; it’s about accessibility and precision.

Chris Light, COO, explains: “For stat testing, we use bedside point-of-care instruments. Our phlebotomists take those into the facilities, test at the bedside, and get results within minutes, rather than waiting days for results to come back from a core lab.”

Scaling a mobile operation across multiple states isn’t simple, but PHS has expanded into nine states, including Texas, Oklahoma, Kansas, Missouri and Arizona. Their model relies on licensed mobile phlebotomists, X-ray technologists and sonographers, all trained to provide high-level care outside traditional hospital settings.

The financial impact for patients is significant. Instead of ambulance rides and ER visits costing thousands, PHS services often cost just a fraction, sometimes only tens or hundreds of dollars.

“Traditionally, without mobile diagnostics, the patient would be loaded into a transportation vehicle, typically an ambulance, and taken to a hospital,” Dieter says. “Our approach is a fraction of the cost but brings care directly to the patients.”

The company has also embraced predictive and personalized medicine, offering genetic tests that guide medication decisions and laboratory tests that predict cognitive decline from conditions like Alzheimer's and Parkinson’s.

“We actively look for complementary services to improve patient outcomes,” Dieter says. “Precision medicine and predictive testing have been a great value-add for our providers.”

Looking to the future, PHS sees mobile healthcare as part of a larger trend toward home-based care.

“There’s an aging population that still lives at home with caretakers,” Dieter explains. “We go into the home every day, whether it’s an apartment, a standalone home, or assisted living. The goal is to meet patients where they are and reduce the need for hospitalization.”

Light highlighted another layer of innovation: predictive guidance.

“We host a lot of data, and labs and imaging drive most treatment decisions,” Light says. “We’re exploring how to deploy diagnostics immediately based on results, eliminating hours of delay and keeping patients healthier longer.”

Ultimately, innovation at PHS isn’t just about technology; it’s about equity.

“There’s an 11-year life expectancy gap between major metro areas and rural Texas,” Dieter says. “Our innovation has been leveling the field, so everyone has access to high-quality diagnostics and care, regardless of where they live.”

Aegis Aerospace appoints Houston space leader as new president

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Houston-based Aegis Aerospace's current chief strategy officer, Matt Ondler, will take on the additional role of president on Jan. 1. Ondler will succeed Bill Hollister, who is retiring.

“Matt's vision, experience, and understanding of our evolving markets position us to build on our foundation and pursue new frontiers,” Stephanie Murphy, CEO of Aegis Aerospace, said in a news release.

Hollister guided Aegis Aerospace through expansion and innovation in his three years as president, and will continue to serve in the role of chief technology officer (CTO) for six months and focus on the company's technical and intellectual property frameworks.

"Bill has played an instrumental role in shaping the success and growth of our company, and his contributions leave an indelible mark on both our culture and our achievements," Murphy said in a news release.

Ondler has a background in space hardware development and strategic leadership in government and commercial sectors. Ondler founded subsea robots and software company Houston Mechatronics, Inc., now known as Nauticus Robotics, and also served as president, CTO and CSO during a five-year tenure at Axiom Space. He held various roles in his 25 years at NASA and was also named to the Texas Aerospace Research and Space Economy Consortium Executive Committee last year.

"I am confident that with Matt at the helm as president and Bill supporting us as CTO, we will continue to build on our strong foundation and further elevate our impact in the space industry," Murphy said in a news release. "Matt's vision, experience, and understanding of our evolving markets position us to build on our foundation and pursue new frontiers."

Rice University launches new center to study roots of Alzheimer’s and Parkinson’s

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Rice University launched its new Amyloid Mechanism and Disease Center last month, which aims to uncover the molecular origins of Alzheimer’s, Parkinson’s and other amyloid-related diseases.

The center will bring together Rice faculty in chemistry, biophysics, cell biology and biochemistry to study how protein aggregates called amyloids form, spread and harm brain cells. It will serve as the neuroscience branch of the Rice Brain Institute, which was also recently established.

The team will work to ultimately increase its understanding of amyloid processes and will collaborate with the Texas Medical Center to turn lab discoveries into real progress for patients. It will hold its launch event on Jan. 21, 2026, and hopes to eventually be a launchpad for future external research funding.

The new hub will be led by Pernilla Wittung-Stafshed, a Rice biophysicist and the Charles W. Duncan Jr.-Welch Chair in Chemistry.

“To make a real difference, we have to go all the way and find a cure,” Wittung-Stafshede said in a news release. “At Rice, with the Amyloid Mechanism and Disease Center as a catalyst, we have the people and ideas to open new doors toward solutions.”

Wittung-Stafshede, who was recruited to Rice through a Cancer Prevention and Research Institute of Texas grant this summer, has led pioneering work on how metal-binding proteins impact neurodegenerative disorders, including Alzheimer’s and Parkinson’s diseases. Her most recent study, published in Advanced Science, suggests a new way of understanding how amyloids may harm cells and consume the brain’s energy molecule, ATP.

According to Alzheimer’s Disease International, neurodegenerative disease cases could reach around 78 million by 2030 and 139 million by 2050. Wittung-Stafshede’s father died of dementia several years ago.

“This is close to my heart,” Wittung-Stafshede added in the news release. “Neurodegenerative diseases such as dementia, Alzheimer’s and Parkinson’s are on the rise as people live longer, and age is the largest risk factor. It affects everyone.”
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