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 leads U.S. in population growth for 2025, Census says

Boomtown

Imagine that the Houston metro area swallowed a city the size of Pearland in just one year. That’s essentially what happened from 2024 to 2025, with the Houston metro ranking first in the U.S. for population growth based on the number of people.

New estimates from the U.S. Census Bureau show the 10-county Houston metro added 126,720 residents from July 1, 2024, to July 1, 2025. That’s just shy of Pearland’s roughly 133,000-resident tally.

To calculate population, the Census Bureau counts births, deaths, new residents, and moved-away residents.

Region’s population approaches 8 million

On July 1, 2025, the Houston metro’s population hovered slightly above 7.9 million, up 1.6 percent from the same time in 2024. In the very near future, the region’s population should break the eight million mark.

This follows massive growth in the past 20 years. From 2005 to 2025, the region’s population soared by 39 percent. By comparison, the growth rate from 2021 to 2025 sat at nine percent.

A forecast from the Texas Demographics Center indicates that under a middle-of-the-road scenario, the Houston metro’s population will reach nearly 8.5 million in mid-2030 and more than 9.5 million in mid-2040.

Dan Potter, director of Rice University’s Houston Population Research Center, attributes much of the region’s population surge to people moving to the area from outside the U.S. In Harris County, this means a combination of military personnel returning home, people living or working overseas coming back to the U.S., and immigrants relocating to the U.S., he tells CultureMap.

But Harris County fell short from 2024 to 2025 when it comes to people moving here from elsewhere in the U.S., according to Potter. Counties surrounding Harris County benefited from that trend, drawing new residents who preferred to settle in the suburbs.

“The incredible pull and attraction of the Houston area is its economy, its people, and its affordability, and the significant growth that was observed in 2024 and again in 2025 speaks to the magnetism of the region,” Potter says. “That pull to Houston is too strong to be turned off overnight.”

Cooling economy and immigration shifts slow down growth

Whether looking at urban or suburban places, population growth in the Houston area slowed in 2025 and appears to be slowing even more this year, Potter says.

“A cooling economy and changes to immigration policy are a one-two combination that could knock out the region’s population growth,” says Potter, citing the region’s addition of a less-than-expected 14,800 jobs in 2025 as an example.

Weaker population growth may not be felt evenly across the metro area, according to Potter.

A continuing influx of people from Houston to outlying counties such as Brazoria, Fort Bend, Liberty, Montgomery, and Waller could curb growth in Harris County, Potter said. Why? If the number of people arriving from other other countries flattens or even drops, then there could be “doughnut-style population growth for the next few years, where Harris County and Houston see declines while the suburban counties see an increase.”

Harris County represents 40 percent of region’s population lift

Houston-anchored Harris County accounted for almost 40 percent of the region’s population spike from 2024 to 2025. In one year, Harris County grew by 48,695 residents, or 1 percent, pushing its population past five million. That increase put Harris County in first place for numeric growth (rather than percentage growth) among all U.S. counties.

From 2020 to 2025, Harris County’s growth rate was 6.6 percent. It remains the country’s third largest county based on population, behind Southern California’s Los Angeles County and Illinois’ Chicago-anchored Cook County.

Harris County is on track to surpass Cook County in size in the near future. As of July 1, 2025, a nearly 150,000-resident gap separated population-losing Cook County and fast-growing Harris County.

The Texas Demographics Center predicts Harris County’s population will be 5.37 million in mid-2030 and just short of six million in mid-2040.

Suburban counties see significant population gains

Harris County isn’t the only county in the area that experienced a growth spurt from 2024 to 2025:

  • Waller County’s population climbed 5.69 percent, winding up at 69,858. Its growth rate ranked second among U.S. counties.
  • Liberty County’s population rose 4.4 percent to 121,364, putting its growth rate in eighth place among U.S. counties.
  • Montgomery County gained 30,011 residents, with its population landing at 781,194. That placed it at No. 4 among U.S. counties for numeric growth.
  • Fort Bend County picked up 24,163 residents, arriving at a total of 975,191 and positioning it at No. 8 among U.S. counties for numeric growth. Fort Bend County, the region’s second largest county based on population, is projected to break the one million-resident mark by July 2030, according to the Texas Demographics Center.

“Lower mortgage rates from 2009 to 2022 and the rise of remote work have made suburban housing more attractive, especially for families seeking affordability,” Pramod Sambidi, the Houston-Galveston Area Council’s assistant director of data analytics and research, said last year. “Additionally, suburban areas are seeing more multifamily developments than before the pandemic.”

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This article originally appeared on CultureMap.com.

5 Houston-area companies named among world's most innovative for 2026

In The Spotlight

Led by Conroe-based Hertha Metals, five organizations in the Houston area earned praise on Fast Company’s list of the World’s Most Innovative Companies of 2026.

Hertha Metals ranked No. 1 in the manufacturing category.

Last year, Hertha unveiled a single-step process for steelmaking that it says is cheaper, more energy-efficient and just as scalable as traditional steel manufacturing. It started testing the process in 2024 at a one-metric-ton-per-day pilot plant.

At the same time, Hertha announced more than $17 million in venture capital funding from investors such as Breakthrough Energy, Clean Energy Ventures, Khosla Ventures, and Pear VC.

“We’re not just reinventing steelmaking; we’re redefining what’s possible in materials, manufacturing, and national resilience,” Laureen Meroueh, founder and CEO of Hertha, said at the time.

Meroueh was also recently named to Inc. Magazine's 2026 Female Founders 500 list.

Hertha, founded in 2022, says traditional steelmaking relies on an outdated, coal-based multistep process that is costly, and contributes up to 9 percent of industrial energy use and 10 percent of global carbon emissions.

By contrast, Hertha’s method converts low-grade iron ore into molten steel or high-purity iron in one step. The company says its process is 30 percent more energy-efficient than traditional steelmaking and costs less than producing steel in China.

Last year, Hertha said it planned to break ground in 2026 on a plant capable of producing more than 9,000 metric tons of steel per year. In its next phase, the company plans to operate at 500,000 metric tons of steel production per year.

Here are Fast Company’s rankings for the four other Houston-area organizations:

  • Houston-based Vaulted Deep, No. 3 in catchall “other” category.
  • XGS Energy, No. 7 in the energy category. XGS’ proprietary solid-state geothermal system uses thermally conductive materials to deliver affordable energy anywhere hot rock is located. While Fast Company lists Houston as XGS’ headquarters, and the company has a major presence in the city, XGS is based in Palo Alto, California.
  • Houston-based residential real estate brokerage Epique Realty, No. 10 in the business services category. Epique, which bills itself as the industry’s first AI brokerage, provides a free AI toolkit for real estate agents to enhance marketing, streamline content creation, and improve engagement with clients and prospects.
  • Texas A&M University’s Nanostructured Materials Lab in College Station. The lab studies nano-structured materials to make materials lighter for the aerospace industry, improve energy storage, and enable the creation of “smart” textiles.
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This article first appeared on our sister site, EnergyCapitalHTX.com.

UH lands $11.8M for first-of-its-kind early language development study

speech funding

Researchers at the University of Houston have secured an $11.8 million grant from the National Institutes of Health to conduct a first-of-its-kind study of early language development.

Led by Elena Grigorenko, the Hugh Roy and Lillie Cranz Cullen Distinguished Professor of Psychology, and research professor Jack Fletcher, the study will follow 3,600 children aged 18 to 24 months to uncover how language skills develop at this critical stage and why some children experience delays that can influence later growth.

The NIH funding will also support the development of the new national Clinical Research Center on Developmental Language Disorders at UH, which aims to bring experts from psychology, education, health and measurement sciences to study how children learn language.

“This will be the first national study to estimate how common late talking is using a large, representative sample of Houston toddlers,” Grigorenko said in a news release. “By following these children as they grow, we hope to better understand the developmental pathways that can lead to conditions such as developmental language disorder and autism.”

UH’s team will partner with the pediatric clinic network at Texas Children’s Hospital, where children will be screened for early language development, allowing researchers to identify those who show signs of delayed speech. Next, researchers will follow the cohort through early childhood to examine how language abilities evolve and how early delays may lead to later challenges.

The Clinical Research Center on Developmental Language Disorders will be the 14th national research center established at UH, and will include researchers from multiple UH departments, as well as partners at Baylor College of Medicine and the Texas Center for Learning Disorders.

“This level of investment from the National Institutes of Health reflects the significance of this work to address a complex challenge affecting children, families and communities,” Claudia Neuhauser, vice president for research at UH, said in a news release. “By bringing together experts from multiple disciplines and partnering with major health systems across the region, the project reflects our commitment to advancing discoveries that impact our community.”

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