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.

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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.”

Rice Alliance names Houston healthtech exec as first head of platform

new hire

The Rice Alliance for Technology and Entrepreneurship has named its first head of platform.

Houston entrepreneur Laura Neder stepped into the newly created role last month, according to an email from Rice Alliance. Neder will focus on building and growing Houston’s Venture Advantage Platform.

The emerging platform, which is being promoted by Rice Alliance and the Ion, aims to connect founders with the "people, capital and expertise they need to scale."

"I’ve spent a lot of time thinking about what it takes to make an innovation ecosystem more navigable, more connected, and more useful for founders," Neder said in a LinkedIn post. "I’m grateful for the opportunity to do that work at Rice Alliance, alongside a team with a long history of supporting entrepreneurship and innovation."

"Houston has the talent, institutions, and industry base to create real advantage for founders," she added. "I’m looking forward to listening, learning, and building stronger pathways across the ecosystem."

Neder most recently served as CEO of Houston-based Careset, where she helped bring the Medicare data startup to commercialization. Prior to that, Neder served as COO of Houston-based telemedicine startup 2nd.MD, which was acquired for $460 million by Accolade in 2021.

"Laura brings a rare combination of founder empathy, operational experience and ecosystem leadership," Rice Alliance shared.

Neder and Rice Alliance also shared that the organization is hiring developers to design the new Venture Advantage Platform. Learn more here.

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