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

green light

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.

Ad Placement 300x100
Ad Placement 300x600

CultureMap Emails are Awesome

Property Showcase

Italian aerospace company sets up first U.S. office at Houston Spaceport

welcome to houston

Como, Italy-based aerospace company Involve Space recently made the Houston Spaceport the site of its first U.S. office.

Involve Space develops high-altitude balloon platforms for Earth observation, scientific research and hardware testing. The balloons carry instruments into the stratosphere (a layer of the upper atmosphere) to collect images and data, conduct experiments and test technology.

The company plans to launch its first commercial missions from Houston by the end of this year, according to a news release.

“Houston is the global center of aerospace, and our presence at Houston Spaceport strengthens our international growth trajectory,” Jonathan Polotto, founder and CEO of Involve Space, said in the release.

Founded in 2021, Involve Space incorporates aerospace hardware, AI and geospatial tools into its offerings. Its proprietary CLEAR platform uses conversational AI to help customers interpret data and support decision-making.

Located at Ellington Airport, the Houston Spaceport provides a base for Involve Space’s North American operations, including business development and partnerships with aerospace companies and researchers.

Other tenants at the Houston Spaceport include NASA, Axiom Space, Venus Aerospace and Intuitive Machines.

Involve Space’s relationship with the Houston Spaceport began in January 2025, when it conducted its first U.S. pilot launch. During the five-hour mission, the balloon reached an altitude of about 85,000 feet and traveled about 250 miles across Texas.

One of Involve Space’s first U.S. customers is Houston-based Rhodium Scientific, a space biotech company. Polotto and Rhodium Scientific founder and CEO Olivia Gamez Holzhaus signed a deal to conduct biotech experiments aboard Involve Space’s stratospheric balloon platforms before planned missions to orbit.

“The presence of innovative platforms like those developed by Involve strengthens the Spaceport’s role as a site for testing, validating, and deploying advanced technologies between aeronautics and space,” Jim Szczesniak, director of aviation for Houston Airports, added in the release.

UH lands $3M grant to expand opioid overdose training

Overdose Response

The University of Houston has received a $3 million federal grant to expand its potentially life-saving overdose response training program.

The grant will support the Houston Health Department’s FRONTLINES program that trains first responders in Harris and Fort Bend counties to recognize opioid overdoses and administer the drug naloxone, which can counter the effects of an opioid overdose. The four-year grant comes from the Substance Abuse and Mental Health Services Administration within the Department of Health and Human Services, and it builds on eight years of work at UH, according to a release from the university.

As part of the expansion, UH medical, social work and psychology students will now also be able to take part in FRONTLINES’ overdose-response training. Some of the students will also be selected to help train community members, ultimately passing along the life-saving skills throughout Houston.

FRONTLINES is a collaboration with the City of Houston, the Fertitta College of Medicine, Baylor College of Medicine and the Houston Recovery Center. It was co-founded by Dr. James Bray, chair of the Department of Behavioral and Social Sciences at the University of Houston’s Tilman J. Fertitta Family College of Medicine, in 2018.

“When someone experiencing an opioid overdose is reached in time, naloxone can save their life,” Bray said in a news release. “We’ve seen the impact this training can have in Houston, and now we have an opportunity to extend that reach across Harris and Fort Bend counties, putting lifesaving knowledge and tools into the hands of more first responders.”

In 2024, around 450 residents of Harris County died from opioid overdoses, according to a Texas Department of State Health Services report. The report found that fentanyl was involved in about three-quarters of the deaths.

In 2025, UH also received a $2.6 million gift from the estate of Dr. William A. Gibson to expand its opioid research and develop a vaccine to help block fentanyl's effectiveness in entering the brain. The vaccine research is part of the Michael C. Gibson Addiction Research Program led by UH professor of psychology Therese Kosten and founding member of the UH Drug Discovery Institute Colin Haile. Read more about the grant and the vaccine’s development here.

Texas public libraries drive billions in economic impact, report finds

Beyond the Stacks

A new statewide study examining the economic impacts of public libraries has revealed they have generated over $3.8 billion in value to local communities — a return of $4.74 for every $1 invested.

The report, "Beyond the Stacks: Measuring the Economic and Community Value of Texas Public Libraries" was conducted by third-party consultancy JBK Economics Group in partnership with the Texas Library Association. About 300 of the total 513 public libraries in Texas participated in a survey for the report.

A major finding from the survey revealed that public libraries create billions in economic value for the communities they serve at a fraction of what it costs to pay employee wages and benefits, operating expenditures, and capital expenditures. About 11,200 jobs were directly and indirectly supported by public libraries, the report found.

The report found its $4.74 to $1 ratio by adding up the total value of the services provided by these institutions (an estimated $2.48 billion), and comparing it to total expenditures ($808.6 million).

"Public libraries had about the same economic footprint as the Texas motion picture and sound recording industry ($2.9 billion in Gross Domestic Product in 2024) or the Texas paper manufacturing industry ($4.0 billion in Gross Domestic Product in 2024)," the report said.

Many Houstonians are already familiar with Houston Public Library's expansive catalog and programming, but there are many more services the library provides that might fly under the radar. A few examples include access to subscription-based research databases and news outlets, and the Library of Things, a collection of cookware and bake ware, musical instruments, craft kits, and other tools or activity materials that are available for cardholders to borrow. Individual branches also provide free Wi-Fi, computer access, and meeting spaces.

Houston-area residents also have access to services at several other local libraries depending on their address, such as the Harris County Public Library, Montgomery County Memorial Library System, or Fort Bend County Libraries, just to name a few.

These are additional services and partnerships that Texas public libraries commonly provide, per the survey results:

  • 93 percent provide voter registration and/or serve as voting locations
  • 84 percent provide partnerships with local social services agencies
  • 82 percent provide job application assistance
  • 68 percent facilitate applications for government benefits
  • 38 percent provide on-site social services
  • 30 percent provide telehealth rooms and/or resources
"Public libraries are practical, welcoming and rooted in the communities they serve — they are unmistakably Texan," said Texas Library Association executive director Shirley Robinson in a press release. "This study puts a dollar value on the opportunities libraries create every day. Whether someone visits a library to apply for a job, access the internet, learn a new skill or simply find a new favorite book, those services create real value for Texans and their communities."

------

This article first appeared on CultureMap.com.

View All Listings