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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2 Houston startups win big at SXSW 2025 pitch competition

winner, winner

Houston had a strong showing at this week's SXSW Pitch showcase in Austin, with two local startups claiming top prizes in their respective categories.

Little Place Labs, a Houston space data startup, won the Security, GovTech & Space competition. Clean-tech company Helix Earth, which spun out of Rice University and was incubated at Greentown Labs, won in the Smart Cities, Transportation & Sustainability contest.

As one of SWSX's marquee events, held March 8-10, the pitch competition featured 45 finalists, selected from 589 applicants, in nine categories.

"We faced impressive competition from a well-chosen set of finalists, and we're honored to be chosen as the winners. One of the judges even commented, ‘Who knew you could make air conditioning sexy,’” Brad Husick, Helix's co-founder and chief business officer, said in a release.

Helix Earth was launched in 2022 and is known for its space capsule air filtration system that was co-developed for NASA. The commercial air conditioner add-on technology, now in a pilot phase, has been used to retrofit HVAC systems for commercial buildings and can save up to 50 percent of the net energy, cutting down on emissions and operating costs, according to the company. Its co-founder and CEO Rawand Rasheed was named to the Forbes 30 Under 30 Energy and Green Tech list for 2025.

“This win validates our mission to drive sustainable innovation in commercial air conditioning and beyond. We are excited about the future of Helix Earth and the impact we will have in reducing energy consumption and emissions," Rasheed said in a statement.

Little Place Labs echoed that sentiment with a post on LinkedIn celebrating the win.

"This all started with a simple mission: To deliver real-time space insights to help first responders, mission planners, and decision-makers act before problems arise,” the post read. "Today, that mission feels even stronger."

The company uses advanced AI and machine learning to deliver near-real-time space analytics for both ground and space-based applications. Its software aims to help first responders, mission planners and decision-makers detect anomalies and make informed decisions quickly. It was co-founded in 2020 at Oxford by Houstonian and CEO Bosco Lai and Gaurav Bajaj and participated in the 2023 AWS Space Accelerator.

Two other Houston companies were selected as finalists:

  • Trez, a Latino-focused fintech company that uses AI and voice-command payroll through WhatsApp to provide culturally relevant payroll and streamline financial operations for Latino business owners.
  • Tempesst Droneworx, a veteran-owned software company that's Harbinger software providing real-time contextual intelligence for early warning detection, reducing time to decision and speeding time to action.

Jesse Martinez, founder of invincible, and Anu Puvvada of KPMG were two judges representing Houston.

According to SXSW, 647 companies have participated in SXSW Pitch over the years, with over 93 percent receiving funding and acquisitions totaling nearly $23.2 billion. See the full list of 2025 winners here.

A legacy of industrial technology excellence: UTSI International turns 40

Cheers to 40 Years

As UTSI International celebrates its 40th anniversary, president and CEO Shaun Six reflects on the company's history, achievements, and exciting future.

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In March 1985, Dan Nagala and a few friends took a risk, leaving their full-time jobs to pursue their passion and start their own company.

They founded UTSI Internationalamidst groundbreaking advancements in Industrial Control Systems and SCADA technology, revolutionizing remote operations for critical infrastructure. From the start, UTSI has been at the forefront of OT innovation and integration — a legacy we proudly carry forward today.

The legacy of Dan Nagala

Dan Nagala’s 50-plus-year career is too vast to cover every accomplishment, but if you’ve ever heard the phrase “Houston, we have a problem” in a movie, those screens in the control room and the logic causing the “blinky lights” to alert the operators, you’ve seen some of his work. Dan and his team ultimately paved the way for field communications to detect and communicate leaks on pipelines and give operators in remote locations situational awareness, expanding their ability to safely monitor and control their operations.

This capability was requested early on in the first pipeline control rooms, leading to UTSI’s first check-in 1985 (which I proudly have framed on my bookshelf). The protocols to communicate and do advanced calculations — which many would be tempted to call AI today — for the purpose of monitoring and control, was created from this group of enthusiasts who open sourced it and allowed it to proliferate, leading to over 80 percent of all critical infrastructure in the world now utilizing a variant thereof.

Given the novelty of the technology and the experience of UTSI, having implemented control systems and automation for pipelines in over 22 countries, Dan was asked to collaborate with industry experts, creating the first API leak detection and control room management standards for the American Petroleum Institute. These would later become regulation under PHMSA, DoT, and TSA, placing UTSI as the go-to experts in compliance in addition to their traditional expertise.

UTSI has delivered for the world’s largest infrastructure owners in multiple critical infrastructure sectors, like mining, water/wastewater, oil and gas, green energy, transportation authorities, etc. We have also done AI and cybersecurity, in addition to SCADA and ICS work for the DoD and DoE.

Strength in partners

I joined UTSI in 2022 as vice president, working under Dan, with the goal of gradually stepping into leadership. In 2023, I became CEO, president, and majority shareholder. While no one can truly fill Dan’s shoes alone, we’ve focused on strengthening our team, partnerships, and capabilities to continue UTSI’s legacy of excellence.

One of our first strategic partnerships was with Tory Tech, a leading API-compliant Control Room Management tool. UTSI has worked as integrators with Tory Tech for years and Dan worked as a CRM compliance advisor for them in the U.S. while they were setting up their headquarters in Houston. In 2024 we made it an official partnership, becoming a preferred integrator and focusing our team on training and development in the MaCRoM (Master Control Room Management) tool.

We've also made significant investments in our OT cybersecurity capabilities, expanding our team and partnering with industry leaders like Dennis Parker, Derrik Oates, Nozomi Networks, Fortinet, and Schneider Electric. These strategic moves ensure we deliver top-tier expertise, products, and solutions to better serve our customers.

Our partnership with ThreatGEN and the utilization of their AI-driven “AutoTableTop” tool not only utilizes our experience with TSA guidelines, but adds an element of reality that the traditional methods are lacking, making these engagements more interactive and beneficial for operators who are required to participate annually.

In 2024, UTSI also invested heavily in AI and Data Science by acquiring Houston-based AI company Pandata Tech and leveraging their Data-Quality-Methodology (DQM), Leak Geek, and time-series data science expertise to solve industry specific problems.

Moving up – in and around Houston

Building on our recent successes, we strategically relocated our office to the Netrality building (1301 Fannin St.), bringing us closer to clients and partners, while getting access to a Tier 3 Data Center with an uninterrupted 40-year power record.

Netrality is a SOC2-compliant facility with seven points of detection from the street to our server, including biometric screening. Our very own Roberto deLeon has architected our upgraded servers using the Purdue model as a basis of design while leveraging our relationship with Fortinet to standardize our hardware and software to the highest standards. We practice what we preach — every architecture, framework, and hardware recommendation we make is not just advised but actively implemented within our own operations.

Our investment in this space includes increasing our “SCADA R&D Lab” to play with toys from vendors, testing them out in our environment before we recommend and advise them to our clients and partners. Currently we’re working on LLMs for OT, building our own “DANN2.0” for use in-house. DANN is an homage to Dan Nagala (and, for the nerds, stands for Dan Artificial Neural Network), which we started in 2022 when I realized that knowledge capture is an industry wide epidemic and we need to be ready to integrate for our clients in a safe and local way at scale, in the OT environment.

Additionally, having come from a startup before joining UTSI, I wanted to get us closer to the heart of innovation, so we’ve added additional office space at The Cannon downtown. While there are many tech hubs around Houston, and we are proud to work with and partner with companies from Greentown Labs and the Ion, to name a few, we’ve found that The Cannon community is incredibly active and innovative, with experience in industrial use-cases.

Houston is set to become the Energy Transition capital, leading in hydrogen, carbon capture, and repurposing. With a 5:1 ratio of engineers leaving the industry and an average age over 60, we must innovate. The solution lies in combining a secure, cloud-free "ChatGPT for OT" with digital twins. Bringing the field to engineers is essential. We've partnered with a satellite constellation for asset imaging and U.K.-based Mods Solutions to leverage their CFIHOS-driven platform for intelligent digital twins — more on that partnership soon!

And we will need to leverage enhanced automation tools and actively monitor control networks to ensure security and respond quickly to issues, which is why we’ve partnered with Nozomi Networks.

Shaping the future

Although Dan has semi-retired to his cabin in Montana, he continues to do “the fun stuff” that brings him joy, such as conducting research for PRCI and assisting long-time clients. He also has been a mentor and advisor to me since I started at UTSI three years ago. I’m grateful for him and the group of industry experts he gathered around him to make UTSI such a well-known systems integrator and OT advisor for the world’s largest asset owners.

Our group of experts are active in the industry and will be speaking at events throughout the year, with a presence at Entellec, Level Zero, and participating at this year's API Cybernetics and PSIGs biannual conferences. We proudly serve on the BCarbon advisory board and GHPs Energy Committee.

Lastly, we have one request: We see a critical need for H2 and supercritical CO2 studies to develop simulation models, response plans, and leak detection best practices. These gases differ from those covered in existing standards. If you know anyone interested in funding or contributing, we’re collaborating with industry partners to secure support.

Houston named No. 2 most diverse major U.S. city for 2025

Ranking It

Houston has always been a diverse place, embracing people of many different cultural and socioeconomic backgrounds. And the city is earning new recognition in WalletHub's rankings of the most diverse large American cities for 2025.

The 2025 edition is the final installment in WalletHub's diversity study series, which annually compared 501 U.S. cities across 13 metrics in five categories that encompass "diversity" across socioeconomic, cultural, economic, household, and religious factors.

Cities were also ranked by population, with large cities defined as those with over 300,000 residents, midsize cities with 100,000 to 300,000 residents, and small cities with fewer than 100,000 residents.

Houston nearly topped the list of large U.S. cities, coming in at No. 2, and ranked at No. 5 in the overall national comparison.

The top three most diverse American cities, which have held their positions for the second consecutive year, are all located in Maryland: Gaithersburg (No. 1), Silver Spring (No. 2), and Germantown (No. 3).

Houston performed spectacularly in the study's overall rankings for socioeconomic (No. 14), cultural (No. 32), and religious diversity (No. 63), but fell behind in the categories for household (No. 129) and economic diversity (No. 165).

In the more detailed comparisons across educational-attainment, linguistic, and industry diversity, Houston ranked among the top 30 in all three categories out of the 501 cities included in the report.

Here's how Houston performed across the remaining eight categories in the study:

  • No. 44 – Racial and ethnic diversity
  • No. 129 – Household type diversity
  • No. 200 – Household size diversity
  • No. 201 – Income diversity
  • No. 207 – Occupational diversity
  • No. 239 – Birthplace diversity
  • No. 284 – Age diversity
  • No. 343 – Worker-class diversity

Embracing diversity is not only good for local communities, it's also beneficial for the economy, the report says.

"Not only have waves of immigration changed the face of the nation, they’ve also brought in fresh perspectives, skills, and technologies to help the U.S. develop a strong adaptability to change," the report's author wrote. "Economies generally fare better when they openly embrace and capitalize on new ideas. Conversely, those relying on old ways and specialized industries tend to be hurt more by changes in the market."

Houston is a repeat performer: It slipped one spot from its 2024 ranking, and previously topped the overall list in 2021 — showing that the city has consistently maintained in diversity over the years.

Other diverse Texas cities
Elsewhere in Texas, Arlington surpassed Houston as the No. 4 overall most diverse city, and took the No. 1 spot in the "large city" category.

Dallas ranked just outside the top 10 this year, landing in 11th place after previously ranking eighth overall in 2024. Dallas also appeared in sixth place in the national rankings for the most diverse large cities, so the city still has some catching up to do.

Fort Worth fell into No. 25 overall this year, in a three-place slip from last year's ranking. The city performed the best in the overall categories for socioeconomic and cultural diversity, earning a respective No. 58 and No. 61.

The top 10 most diverse cities in America in 2025 are:

  • No. 1 – Gaithersburg, Maryland
  • No. 2 – Silver Spring, Maryland
  • No. 3 – Germantown, Maryland
  • No. 4 – Arlington, Texas
  • No. 5 – Houston, Texas
  • No. 6 – New York, New York
  • No. 7 – Charlotte, North Carolina
  • No. 8 – Jersey City, New Jersey
  • No. 9 – Danbury, Connecticut
  • No. 10 – Los Angeles, California
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A version of this story originally appeared on our sister site, CultureMap.com.

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