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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New Texas Stock Exchange officially begins trading in Dallas

Welcome to Y'all Street

Two-step aside, New York Stock Exchange and Nasdaq. The Dallas-based Texas Stock Exchange, nicknamed Y’all Street, just kicked off live trading with five stocks — and lots of Lone Star ambition.

“The Texas Stock Exchange aims to revitalize competition for [stock] issuers, establish the premier venue for listings, and create a world-class trading platform for all market participants,” the exchange says in a fact sheet.

The exchange — whose Texas-influenced nickname is a nod to New York City’s Wall Street — has collected at least $275 million in investments. The roughly 90 financial backers of TXSE include Bank of America, BlackRock, Charles Schwab, Citadel Securities, Dell Family Office, Fortress, Goldman Sachs, and JPMorgan Chase.

Representatives of TXSE couldn’t be reached for comment. On its website, the exchange calls itself “the most well-capitalized equities exchange to ever be approved” by the U.S. Securities and Exchange Commission (SEC).

Not to be outdone, NYSE has launched Dallas-based NYSE Texas and Nasdaq has expanded its presence in Dallas.

Y’all Street adds to Dallas-Fort Worth’s rising status as a major hub for financial services, with The Wall Street Journal naming North Texas the country’s second biggest financial hub after New York City.

“A homegrown national exchange means more jobs, more investment, and more growth opportunities for businesses and communities across the Lone Star State,” Gabriela von zur Muehlen, senior vice president and chief policy officer at the Texas Association of Business, told The Texas Tribune.

Bulent Temel, an associate professor of practice in economics at the University of Texas at San Antonio, told Texas Standard that TXSE “is going to boost the credibility of the Texas economy.”

Texas’ estimated gross domestic product (GDP), a yardstick for the size of an economy, climbed to a record-setting $2.9 trillion in 2025, making it the state with the second highest GDP after California. DFW’s estimated GDP in 2023 stood at $744.6 billion, eclipsing the GDP of many countries.

“The center of gravity for American capitalism is now headquartered in the Boom Belt,” Abbott proclaimed in April, referring to an 11-state region (including Texas) in the South and Southeast that’s seeing tremendous economic and population growth. “The Texas Stock Exchange is the natural extension of that capitalism. It ensures that capital markets will reflect the quadrant that is driving American growth.”

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This article originally appeared on CultureMap.com.

Orion vehicle manager reflects on Artemis II, looks to 2028 moon mission

Q&A

Humanity is finally headed back to the moon after more than half a century. This year's launch of the Artemis II mission in the Orion spacecraft put four crew members in lunar orbit and tested the new ship developed by Lockheed Martin.

Everything went smoothly, safely returning astronauts home, but there is always room to improve. InnovationMap chatted via email with Orion vehicle manager Branelle Rodriguez, shortly after a talk at The Ion, for insight on how Orion might perform in the future as the next lunar landing approaches in early 2028.

InnovationMap: How satisfied are you with the way Orion operated on this past mission?

Branelle Rodriguez: Orion performed exceptionally well during Artemis II, successfully demonstrating critical spacecraft capabilities, including life support systems, displays and controls, and executing manual piloting operations. Artemis II brought humans back to the moon, achieving key exploration and scientific imagery, while validating systems essential for future Artemis missions.

IM: What is the most important thing you learned about improving Orion for the next mission?

BR: The Artemis II mission provided invaluable insights into crew operations and spacecraft performance in a deep-space environment. With every mission, NASA applies lessons learned to continuously improve Orion’s operations, validate design and ensure mission readiness. Artemis II offered our first opportunity to evaluate several new systems and gain a deeper understanding of what it is like for astronauts to live and work inside the spacecraft. The operational, technical and human factors data collected are being integrated across the program to refine future missions, reduce risk and enhance overall mission success.

IM: How has Orion helped the mission to explore space?

BR: Orion is one of NASA’s foundational elements for human deep space exploration—not only supporting the mission but serving as a core component of it. It is currently the only spacecraft capable of carrying crew on deep space missions and returning them safely to Earth from the high speeds required from the vicinity of the moon. No other spacecraft has the technology to endure the extremes that come with human deep-space travel, such as advanced environmental and life support, navigation, communications, radiation shielding, and the world’s largest ablative heat shield to protect the astronauts during reentry into Earth’s atmosphere. Orion has already taken astronauts to explore space farther than ever before—252,756 miles from Earth— and will carry crews to the moon on future missions to explore the lunar South Pole region. The astronauts’ observations, samples, and data collected on these future missions will expand our understanding of our solar system and home planet.

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This conversation has been edited for brevity and clarity.

Houston VC funding nears $1B in first half of 2026, report says

by the numbers

Despite a weak second quarter, venture capital funding for Houston-area startups approached $1 billion in the first half of 2026, the region’s highest first-half total since 2022, according to the latest PitchBook-NVCA Venture Monitor.

This year’s first-half total of $962.4 million represented a nearly 8 percent increase over last year’s first-half total of $891.7 million. Dating back to 2016, this year’s first-half haul lags behind only 2021 and 2022 for the most first-half funding.

Houston’s year-over-year VC jump of 73 percent in the first quarter of 2026 more than made up for the year-over-year drop of 34 percent in the second quarter of 2026, according to the report.

Deal count tells a more encouraging story: Houston startups closed 102 deals in the first half, up from 93 a year earlier and the region’s busiest first half since 2022. However, the average deal size shrank, as no single funding source dominated the total.

Keep in mind that PitchBook and NVCA routinely revise quarterly numbers upward to reflect deals that were reported after a previous quarter’s data was published. So, in the case of Houston, numbers initially reported for the first quarter of 2026 may not match newly reported numbers.

Perhaps the most notable Houston-area deal announced in the first half of this year was Cart.com’s $180 million growth equity investment, led by Springcoast Partners. Cart.com is an e-commerce platform and logistics provider.

PitchBook-NVCA data shows Houston’s VC activity is growing modestly, delivering better numbers in the first half of 2026 versus 2024 and 2025, but it still sits below the highs of 2021 and 2022. This is one sign that so far in 2026, the national VC boom isn’t benefiting non-hub markets like Houston the way it’s boosting some hub markets, especially Silicon Valley and New York City.

Nationwide, AI dominated VC funding in the first half of this year. The sector made up 86 percent of VC from January through June. The report notes that the markets have still struggled to unlock IPOs, with SpaceX being the biggest exception, and few M&A deals outside health care have been significant.

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