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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Houston researcher secures $1.7M to develop drug for aggressive form of breast cancer

cancer research

A University of Houston researcher has joined a $3.2 million effort to develop a new drug designed to attack a cancer-driving protein commonly found in triple-negative breast cancer.

Triple-negative breast cancer (TNBC) is one of the most difficult-to-treat forms of cancer and accounts for 10 percent to 15 percent of all breast cancer cases. The disease gets its name because tumors associated with it test negative for estrogen receptors, progesterone receptors and excess HER2 protein, making it difficult to target. Due to this, TNBC is often treated with general chemotherapy, which can come with negative side effects and drug resistance, according to UH.

UH College of Pharmacy research associate professor Wei Wang is developing a drug that can target the disease more specifically. The drug will target MDM2, a protein often overproduced in TNBC that also contributes to faster tumor growth.

Wang is working on a team led by Wei Li, director of the University of Tennessee Health Science Center College of Pharmacy’s Drug Discovery Center. She has received $1.7 million to support the research.

Wang and UH professor of pharmacology and toxicology Ruiwen Zhang have discovered a compound that can break down MDM2. In early laboratory models, the compound has shown the ability to shrink tumors.

Wang and Zhang will focus on understanding how the treatment works and monitoring its effectiveness in models that closely mirror human disease.

“We will study how the drug targets MDM2 and evaluate the most promising drug candidates to determine effective dosing, understand how the drug behaves in the body, compare it with existing treatments and assess early safety,” Wang said in a news release.

Li’s team at the University of Tennessee will be working on the chemistry and drug design end of the project.

“This work could lead to an entirely new class of therapies for triple-negative breast cancer,” Li added in the release. “We’re hopeful that by directly removing the MDM2 protein from cancer cells, we can help more patients respond to treatment regardless of their tumor type.”

10+ Houston innovation leaders in the spotlight at SXSW 2026

where to be

Houston's innovation scene will be well represented at South by Southwest (SXSW) this month.

The week-long, Austin-based conference and festival will spotlight some of the Bayou City's leaders in health care, energy, space and more. The event kicks off today, March 12, and runs through March 18. The SXSW Innovation Conference will feature keynotes, workshops, mentoring sessions and more throughout various venues in the city.

Here's who to see and when and where to find them:

March 12

Aileen Allen, venture partner at Mercury Fund

Mentor Session from 4-5:15 p.m. at Hilton Austin Downtown

Allen will host a mentoring session focused on funding, marketing, advertising, PR and the future of work.

March 13

Heath Butler, partner at Mercury Fund

SXSW Pitch-Smart Cities, Transportation, Manufacturing & Logistics from 2:30-3:30 p.m. at the J.W. Marriott

Butler will judge five innovative startups as they pitch their solutions to advance smart cities, enhance transportation systems, modernize manufacturing, transform logistics, and strengthen government infrastructure and civic operations.

Jonathan Cirtain, CEO and president of Axiom Space

The Clock is Ticking for Space - Replacing the ISS from 4-5 p.m. at the J.W. Marriott

Cirtain will discuss Axiom's pursuit of building the world’s first commercial space station.

March 14

Jesse Martinez, founder and CEO of LSA Global

SXSW Pitch-Intelligent Systems, Robotics, & Multisensory Technology from 10-11 a.m. at the J.W. Marriott

Martinez will judge five innovative startups as they pitch their technologies that aim to enhance the way people connect, communicate and share unique life experiences with those around them in a digital ecosystem.

Jennifer Schmitt, head of operations at Rhythm Energy

Powering Texas with Reliable Integrated High-Demand Energy from 10-11 a.m. at Marlow

Schmitt will join a panel to discuss how EirGrid, the state-owned electric power transmission operator in Ireland, is pioneering solutions as the country works toward 80 percent renewable integration by 2030.

Saki Sasagawa, director of business development for JETRO Houston

Now is Japan's Time: Leading the Future with Deep Tech from 10-11 a.m. at the J.W. Marriott

Sasagawa joins a panel that will share real-time insights from diverse perspectives on the forefront of Japan’s deep tech and IP businesses.

March 15

Bosco Lai, CEO and co-founder of Little Place Labs

SXSW Pitch Alumni: Where Are They Now? from 10-11 a.m. at the J.W. Marriott

Lai joins a panel of four former SXSW Pitch winners to share how they leveraged the platform to take their startups to the next level.

Tara Karimi, cofounder and chief science and sustainability officer at Cemvita

South by South America: The Rise of Southern Brazil Tech from 2:30-3:30. p.m. at The Line

Karimi will participate in a panel to discuss how Rio Grande do Sul, Brazil's southernmost state, is attracting elite talent and AI infrastructure and share insights on navigating the next wave of South American tech growth.

March 16

Dr. Pavitra P. Krishnamani, emergency medicine physician at The University of Texas MD Anderson Cancer Center

Viva La Revolution: How the Digital Age is Transforming Wellness from 11:30 a.m.-12:30 p.m. at Hilton Austin Downtown

Krishnamani will discuss the latest advancements and policies that can accelerate the digital age of health care, such as wearables, telehealth and artificial intelligence.

March 18

Charlie Childs, co-founder and CEO of Intero Biosystems

Spinning Out: What It Takes to Build a University Startup from 2:30-3:30 p.m. at The Line

Childs will join founders who spun their companies out of the University of Michigan to share the real story of navigating IP, early capital, team building, market validation and the “valley of death.”

Dr. James Allison, regental chair of immunology and director of The Allison Institute at The University of Texas MD Anderson Cancer Center

Dr. Padmanee Sharma, professor in the Department of Genitourinary Medical Oncology, Division of Cancer Medicine at The University of Texas MD Anderson Cancer Center

Beyond Checkpoints: Immunotherapy’s Next Act from 2:30-3:30 p.m. at the J.W. Marriott

Allison and Sharma will sit down with 21-year-old, Stage 4 cancer survivor Sharon Belvin and Time Magazine journalist Alice Park will discuss the future of immunotherapy and what challenges remain.

Last year, Houston startups Little Places Labs and Helix Earth won top prizes in their respective categories at the prestigious SXSW Pitch event, held this year from March 13-14. No Houston startups were named finalists to compete in this year's event.

NASA revamps Artemis moon landing program by modeling it after Apollo

To the moon

NASA is revamping its Artemis moon exploration program to make it more like the fast-paced Apollo program half a century ago, adding an extra practice flight before attempting a high-risk lunar landing with a crew in two years.

The overhaul in the flight lineup came just days after NASA’s new moon rocket returned to its hangar for more repairs, and a safety panel warned the space agency to scale back its overly ambitious goals for humanity’s first lunar landing since 1972.

Artemis II, a lunar fly-around by four astronauts, is off until at least April because of rocket problems.

The follow-up mission, Artemis III, had been targeting a landing near the moon’s south pole by another pair of astronauts in about three years. But with long gaps between flights and concern growing over the readiness of a lunar lander and moonwalking suits, NASA’s new administrator Jared Isaacman announced that mission would instead focus on launching a lunar lander into orbit around Earth in 2027 for docking practice by astronauts flying in an Orion capsule.

The new plan calls for a moon landing — potentially even two moon landings — by astronauts in 2028.

“Everybody agrees. This is the only way forward,” Isaacman said.

The hydrogen fuel leaks and helium flow problems that struck the Space Launch System rocket on the pad at NASA's Kennedy Space Center in February also plagued the first Artemis test flight without a crew in 2022.

Another three-year gap was looming between Artemis II and the moon landing by astronauts as originally envisioned, Isaacman said.

Isaacman stressed that “it should be incredibly obvious” that three years between flights is unacceptable. He'd like to get it down to one year or even less.

Isaacman, a tech billionaire who bought his own trips to orbit and performed the world’s first private spacewalk, took the helm at NASA in December.

During NASA’s storied Apollo program, he said, astronauts’ first flight to the moon was followed by two more missions before Neil Armstrong and Buzz Aldrin landed on the moon. What's more, he added, the Apollo moonshots followed one another in quick succession, just as the earlier Projects Mercury and Gemini had rapid flight rates, sometimes coming just a few months apart.

Twenty-four Apollo astronauts flew to the moon from 1968 through 1972, with 12 of them landing.

“No one at NASA forgot their history books. They knew how to do this," Isaacman said. “Now we're putting it in action.”

To pick up the pace and reduce risk, NASA will standardize its Space Launch System rockets moving forward, Isaacman said. These are the massive rockets that will launch astronauts to the moon aboard Orion capsules. At the same time, Elon Musk's SpaceX and Jeff Bezos' Blue Origin are speeding up their work on the landers needed to get the astronauts from lunar orbit down to the surface.

Isaacman said next year will see an Orion crew rendezvousing in orbit around Earth with SpaceX's Starship, Blue Origin's Blue Moon or both landers. It's similar to the methodical approach that worked so well during Apollo in the late 1960s, he noted. Apollo 8, astronauts' first flight to the moon, was followed by two more missions before Armstrong and Aldrin aimed for the lunar surface.

“We should be getting back to basics and doing what we know works,” he said.

The Aerospace Safety Advisory Panel recommended that NASA revise its objectives for Artemis III “given the demanding mission goals.” It’s urgent the space agency do that, the panel said, if the United States hopes to safely return astronauts to the moon. Isaacman said the revised Artemis flight plan addresses the panel's concerns and is supported by industry and the Trump administration.

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