Houston immuno-oncology company reaches next FDA milestone, heads to phase 2 trial

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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 startup is off to the races with its innovative running shoes

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Despite Houston’s reputation as a sneaker town, there are few actual shoe companies headquartered in the Bayou City. One that is up and running is Veloci Running, an innovative enterprise that combines the founder’s history as a track runner for Rice University with the realities of running in a changing world.

Tyler Strothman started running cross country growing up in Wisconsin and Indiana before moving to Texas to attend Rice in 2020. Naturally, his college life was altered significantly by the COVID-19 pandemic. Unfortunately, Strothman contracted the virus, leading to pneumonia and causing him to consider other plans for his future.

One thing that stood out from Strothman’s running career was how bad his shoes fit.

“Traditional shoes narrowed in, cramped the front of my feet, and it was causing foot pain,” he said in a video interview. “But any other shoes that were shaped to better fit the natural foot shape were more barefoot (style)—they were more minimalist overall. And that was hurting my calf and Achilles. It was pulling on it, kind of like a rubber band.”

Strothman decided to start Veloci and went on to win the annual Liu Idea Lab for Innovation and Entrepreneurship's H. Albert Napier Rice Launch Challenge in 2025. The win secured $50,000 in startup money, which Strothman used to immediately launch his new runner-centered shoe design with himself as the CEO at the age of 24.

Along for the jog was Strothman’s college friend, Austin Escamilla, who serves as chief operating officer. Escamilla believed in Strothman’s vision, but the project immediately ran into snags beyond Veloci’s control, particularly with manufacturing in Asia.

“It was quite a year to start a shoe business, especially dealing with tariffs and global economic trade tensions,” he said in the same video interview. “We've luckily had some really good partners and really solid advisors throughout the journey who've either done it or had some good feedback and advice. It certainly takes a village, but every day is different. So, it's fun to come into work every day and problem solve.”

The flagship Veloci shoe is the Ascent, which comes in both men’s and women’s sizes. It combines the wide toe cage that Strothman wanted with extra support cushion for a softer, easier run. They retail at $180. Strothman has personally been testing them for a year, noticing reduced lower leg pain when he runs.

At the same time, Veloci has attended to some of the more unique running problems in Houston and other hot, Southern states. A combination of heat and humidity makes for a very soggy shoe if not designed with such environments in mind. The Ascent is built to be very open and breathable, allowing hot air to flow and keeping sweat from building up. These various comfort improvements have made the Ascent Strothman’s favorite running shoe.

“I put on more pairs of this Veloci shoe than I have in my other running shoes in the last seven years,” he said

Currently, Veloci is still a very niche brand. Since the company launched last year, they’ve sold roughly 10,000 pairs. Those sales come either directly through their website or from specialty running stores, most of which are located around the Houston area, like Clear Creek Running Company in League City.

Building community around the shoe through these specialty retailers has been a prime marketing strategy. Part of the $50,000 grant went to a custom van that Veloci can take to various 5Ks, runs and events to get people interested in the brand. The personal touch has helped news of Veloci spread through the running world.

“We went to many run clubs throughout the last year,” said Escamillia. “We've been to pretty much every one of the major run clubs at least once or twice. Folks who try on the shoes, love them, become fans and post and repost…. The marketing side's been a lot of fun.”

Intuitive Machines lands $180M NASA contract for lunar delivery mission

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NASA has awarded Intuitive Machines a $180.4 million Commercial Lunar Payload Services (CLPS) award to deliver science and technology to the moon.

This is the fifth CLPS award the Houston spacetech company has received from NASA, according to a release. It will be the first mission to utilize Intuitive Machines' larger cargo lunar lander, Nova-D.

Known as IM-5, the mission is expected to deliver seven payloads to Mons Malapert, a ridge near the Lunar South Pole, which is a "compelling location for future communications, navigation, and surface infrastructure," according to the release.

“We believe our space infrastructure provides the scalability and flexibility needed to support an increased cadence of new Artemis missions and advance national objectives. This CLPS award accelerates our expansion efforts as we build, connect, and operate the systems powering that infrastructure,” Steve Altemus, CEO of Intuitive Machines, said in the release. “We look forward to working closely with NASA to deliver mission success on IM-5 and to provide sustained operations and persistent connectivity in the cislunar environment and across the solar system.”

The delivery will include the Australian Space Agency’s lunar rover, known as Roo-ver, and another lunar rover from Honeybee Robotics, a part of Jeff Bezos' Blue Origin. Intuitive Machines will also deliver chemical analysis instruments, radiation detectors and other technologies, as well as a capsule named Sanctuary that shows examples of human achievements.

Intuitive Machines previously completed its IM-1 and IM-2 missions, which put the first commercial lunar lander on the moon and achieved the southernmost lunar landing, respectively.

Its IM-3 mission is expected to deliver international payloads to the moon's Reiner Gamma this year. It’s IM-4 mission, funded by a $116.9 million CLPS award, is expected to deliver six science and technology payloads to the Moon’s South Pole in 2027.

The company also announced a $175 million equity investment to fuel growth earlier this month.

TotalEnergies exits U.S. offshore wind sector in $1B federal deal

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TotalEnergies, a French company whose U.S. headquarters is in Houston, has agreed to redirect nearly $930 million in capital from two offshore wind leases on the East Coast to oil, natural gas and liquefied natural gas (LNG) production.

In its agreement with the U.S. Department of the Interior, TotalEnergies has also promised not to develop new offshore wind projects in the U.S. “in light of national security concerns,” according to a department press release.

Federal agency hails ‘landmark agreement’

The Department of the Interior called the deal a “landmark agreement” that will steer capital “from expensive, unreliable offshore wind leases toward affordable, reliable natural gas projects that will provide secure energy for hardworking Americans.”

Renewable energy advocates object to what they believe is the Trump administration’s mischaracterization of offshore wind projects.

Under the Department of the Interior agreement, the federal government will reimburse TotalEnergies on a dollar-for-dollar basis for the leases, up to the amount that the energy company paid.

“Offshore wind is one of the most expensive, unreliable, environmentally disruptive, and subsidy-dependent schemes ever forced on American ratepayers and taxpayers,” Interior Secretary Doug Burgum said in the announcement. “We welcome TotalEnergies’ commitment to developing projects that produce dependable, affordable power to lower Americans' monthly bills while providing secure U.S. baseload power today — and in the future.”

TotalEnergies cites U.S. policy in move away from U.S. wind power

In the news release, Patrick Pouyanné, chairman and CEO of TotalEnergies, says the company was “pleased” to sign the agreement to support the Trump administration’s energy policy.

“Considering that the development of offshore wind projects is not in the country’s interest, we have decided to renounce offshore wind development in the United States, in exchange for the reimbursement of the lease fees,” Pouyanné says.

TotalEnergies redirects capital to LNG, oil, and natural gas

TotalEnergies will use the $928 million it spent on the offshore wind leases for development of a joint venture LNG plant in the Rio Grande Valley, as well as for production of upstream oil in the Gulf of Mexico and for production of shale gas.

“These investments will contribute to supplying Europe with much-needed LNG from the U.S. and provide gas for U.S. data center development. We believe this is a more efficient use of capital in the United States,” Pouyanné says.

TotalEnergies paid $133.3 million for an offshore wind lease at the Carolina Long Bay project off the coast of North Carolina and $795 million in 2022 for a lease covering a 1,545-megawatt commercial offshore wind facility off the coast of New Jersey.

“TotalEnergies’ studies on these leases have shown that offshore wind developments in the United States, unlike those in Europe, are costly and might have a negative impact on power affordability for U.S. consumers,” TotalEnergies said in a company-issued press release. “Since other technologies are available to meet the growing demand for electricity in the United States in a more affordable way, TotalEnergies considers there is no need to allocate capital to this technology in the U.S.”

Since 2022, TotalEnergies has invested nearly $12 billion to promote the development of oil, LNG, and electricity in the U.S. In 2025, TotalEnergies was the No. 1 exporter of LNG from the U.S.

Industry groups push back on offshore wind pullback

The American Clean Energy Association has pushed back on the Trump administration’s characterization of offshore wind projects.

“The offshore wind industry creates thousands of high-quality, good-paying jobs, and is revitalizing American manufacturing supply chains and U.S. shipyards,” Jason Grumet, the association’s CEO, said in December after the Trump administration paused all leases for large-scale offshore wind projects under construction in the U.S. “It is a critical component of our energy security and provides stable, domestic power that helps meet demand and keep costs low.”

Grumet added that President Trump’s “relentless attacks on offshore wind undermine his own economic agenda and needlessly harm American workers and consumers.” He called for passage of federal legislation that would prevent the White House “from picking winners and losers” in the energy sector and “placing political ideology” above Americans’ best interests.

The National Resources Defense Council offered a similar response to the offshore wind leases being paused.

“In its ongoing effort to prop up waning fossil fuels interests, the administration is taking wilder and wilder swings at the clean energy projects this economy needs,” said Pasha Feinberg, the council’s offshore wind strategist. “Investments in energy infrastructure require business certainty. This is the opposite. If the administration thinks the chilling impacts of this action are limited to the clean energy sector, it is sorely mistaken.”

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This article originally appeared on EnergyCapitalHTX.com.

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