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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10 promising Houston startups that made headlines in 2025

year in review

Editor's note: As we reflect on 2025, we're looking back at the stories and startups that made waves in Houston's innovation scene. These 10 startups reached memorable milestones, won prestigious awards, found creative solutions, and disrupted their industries.

Persona AI: Houston humanoid robotics startup inks new deal to deploy its rugged robots

A concept design rendering of Persona AI's humanoid robot. The company is expanding at the Ion and plans to deliver prototype humanoids by the end of 2026 for complex shipyard welding tasks. Rendering courtesy Persona AI.

Persona AI is building modularized humanoid robots that aim to deliver continuous, round-the-clock productivity and skilled labor for "dull, dirty, dangerous, and declining" jobs. The company was founded by Houston entrepreneur Nicolaus Radford, who serves as CEO, along with CTO Jerry Pratt and COO Jide Akinyode. It raised $42 million in pre-seed funding this year and is developing its prototype of a robot-welder for Hyundai's shipbuilding division, which it plans to unveil in 2026. The company won in the Deep Tech Business category at this year's Houston Innovation Awards. Continue reading.

Rheom Materials: Houston startup unveils its innovative leather alternative at the rodeo

Rheom Materials presented its bio-based alternative, Shorai, a 93 percent bio-based leather, at the rodeo and plans to scale it up this year. Photos courtesy Rheom Materials

Rheom Materials presented its scalable, bio-based alternative known as Shorai, a 93 percent bio-based leather, through two custom, western-inspired outfits that showed off cowboy flair through a sustainable lens at the Houston Livestock Show and Rodeo earlier this year.

Next up, the company said it aimed to scale production of Shorai, the Japanese word for “future,” at a competitive price point, while also reducing its carbon footprint by 80 percent when compared to synthetic leather. The company also made a large-scale production partnership with a thermoplastic extrusion and lamination company, Bixby International, this year. Continue reading.

Koda Health: Houston digital health platform Koda closes $7 million funding round

Tatiana Fofanova and Dr. Desh Mohan, founders of Koda Health, which recently closed a $7 million series A. Photo courtesy Koda Health.

Houston-based digital advance care planning company Koda Health closed an oversubscribed $7 million series A funding round this year. The round, led by Evidenced, with participation from Mudita Venture Partners, Techstars and Texas Medical Center, will allow the company to scale operations and expand engineering, clinical strategy and customer success. Koda Health, saw major growth this year by integrating its end-of-life care planning platform with Dallas-based Guidehealth in April and with Epic Systems in July. The company won the Health Tech Business category at the 2025 Houston Innovation Awards. Continue reading.

Veloci Running: Student-led startup runs away with prestigious prize at Rice competition

The H. Albert Napier Rice Launch Challenge awarded $100,000 in equity-free funding to student-led startups, including first-place finisher Veloci Running. Photo courtesy of Rice University.

Veloci Running took home the first-place prize and $50,000 at the annual Liu Idea Lab for Innovation and Entrepreneurship's H. Albert Napier Rice Launch Challenge. The company was founded by Tyler Strothman, a former track and field athlete and senior at Rice, majoring in sport management. Inspired by the foot pain he suffered due to the narrow toe boxes in his running shoes, Strothman decided to create a naturally shaped shoe designed to relieve lower leg tightness and absorb impact. Additional prize winners included SteerBio, Kinnections, Labshare and several others. Continue reading.

Square Robot Inc.: Houston robotics co. unveils new robot that can handle extreme temperatures

The new robot eliminates the need for humans to enter dangerous and toxic environments. Photo courtesy of Square Robot

Houston- and Boston-based Square Robot Inc.'s newest tank inspection robot became commercially available and certified to operate at extreme temperatures this fall. The new robot, known as the SR-3HT, can operate from 14°F to 131°F, representing a broader temperature range than previous models in the company's portfolio. According to the company, its previous temperature range reached 32°F to 104°F. The company also announced a partnership with downstream and midstream energy giant Marathon Petroleum Corp. (NYSE: MPC) last month. Continue reading.

Bot Auto: Houston autonomous trucking co. completes first test run without human intervention

Bot Auto completed its first test run without human assistance in Houston. Photo courtesy Bot Auto.

Houston-based Bot Auto, an autonomous trucking company, completed its first test run without human assistance earlier this year. Bot Auto conducted the test in Houston. The transportation-as-a-service startup added that this milestone “serves as a validation benchmark, demonstrating the maturity and safety of Bot Auto’s autonomy stack and test protocols.” This summer, founder Xiaodi Hou told the Front Lines podcast that Bot Auto had raised more than $45 million. Continue reading.

Nomad: Screen-free hiking app developed in Houston earns 'Best of the Best' award

NOMAD aims to help hikers stay in the moment while still utilizing technology. Photo courtesy UH.

An AI-powered, screen-free hiking system developed by Varshini Chouthri, a recent industrial design graduate from the University of Houston, received this year's Red Dot’s “Best of the Best” award, which recognizes the top innovative designs around the world. Known as NOMAD, the system aims to help users stay in the moment while still utilizing technology. Continue reading.

Little Place Labs, Helix Earth, Tempest Droneworx: Houston startups win big at SXSW 2025 pitch competition

Two Houston startups won the SXSW Pitch showcase in their respective categories. Photo via Getty Images

Houston had a strong showing at the SXSW Pitch showcase in Austin this year, with several 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. Tempest Droneworx, a Houston-based company that provides real-time intelligence collected through drones, robots and sensors, won the Best Speed Pitch award. Continue reading.

6 Houstonians named to prestigious national group of inventors

top honor

Six Houston scientists and innovation leaders have been named to the National Academy of Inventors’ newest class of fellows. The award is the highest professional distinction awarded to academic inventors by the NAI.

The 2025 class is made up of 169 fellows who hold more than 5,300 U.S. patents, according to the organization. The group hails from 127 institutions across 40 U.S. states.

The Houston-based inventors are leading fields from AI to chemistry to cancer research.

“NAI Fellows are a driving force within the innovation ecosystem, and their contributions across scientific disciplines are shaping the future of our world,” Paul R. Sanberg, president of the National Academy of Inventors, said in a news release. “We are thrilled to welcome this year’s class of Fellows to the Academy. They are truly an impressive cohort, and we look forward to honoring them at our 15th Annual Conference in Los Angeles next year.”

The 2025 list of Houston-based fellows includes:

  • Vineet Gupta, Vice President for Innovation, Technology Development and Transfer at the University of Texas Medical Branch
  • Eva Harth, chemistry professor at the University of Houston
  • Dr. Raghu Kalluri, Professor and Chairman of the Department of Cancer Biology at The University of Texas MD Anderson Cancer Center
  • Sanjoy Paul, Executive Director of Rice Nexus and AI Houston and Associate Vice President for Technology Development at Rice University
  • Dr. Jochen Reiser, President of the University of Texas Medical Branch and CEO of UTMB Health System
  • Todd Rosengart, Professor and Chair of the Department of Surgery at Baylor College of Medicine

"It is a great honor to be named a Fellow of the NAI. It is deeply gratifying to know that the work my students and I do — the daily push, often in small steps — is seen and recognized," Harth added in a news release from UH.

The 2025 fellows will be honored and presented with their medals by a senior official of the United States Patent and Trademark Office at the NAI Annual Conference this summer in Los Angeles.