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

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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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MD Anderson unveils $3.4B expansion with two new Houston cancer care facilities

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The cutting edge of cancer-fighting technology and science is getting even sharper after MD Anderson announced last week that it will open two new facilities in the Texas Medical Center within the next five years. Inspiration Tower and Prism will expand MD Anderson’s annual patient load in the TMC to 250,000 annually and will incorporate a variety of new techniques.

The $3.4 billion project will add 2 million square feet to MD Anderson's TMC footprint, bringing its total campus size to 22 million square feet by 2032. Located at the corner of Fannin Street and Holcombe Boulevard, the cancer center says the two new facilities will serve as its new "front door" to the TMC.

“Every detail of these buildings, from the technology to the treatment rooms, was designed around our patients who will receive their care in them and our employees who will work in them. The facilities will serve as a physical representation of hope for the patients and their families who will walk through the doors,” Dr. Jeffrey E. Lee, president ad interim of UT MD Anderson, said in a news release. “Inspiration Tower and Prism are the future of cancer care, and we are grateful for the longstanding support and guidance we’ve received from the UT System Board of Regents to bring these projects to life. These facilities are part of the most impactful capital expansion in UT MD Anderson’s history.”

Prism is especially exciting as it will represent fully half of the linear accelerator treatment in the TMC. Linear accelerator is a radiation treatment that uses magnetically charged fields to deliver targeted external radiation therapy, like shooting cancer with a rail gun. The treatment is safer and has fewer side effects than older radiation treatments.

In addition, Prism will contain 12 MRI machines, four CT scanners, two PET-CT units, 18 radiation vaults and seven radiation simulators. Patient comfort has also been put at a premium with multiple gardens and roof overlooks.

“Every patient we treat deserves an environment that reflects the excellence of the care they receive at UT MD Anderson,” Chris McKee, executive vice president and chief strategy officer at UT MD Anderson, added in the release. “Our new facilities will be innovative, agile, adaptable and beautiful, and they will allow us to care for more patients, more effectively – in an environment that enhances healing and well-being. We are building for our future and for every patient who will be counting on us.”

Prism is slated to open in 2030.

Inspiration Tower will have 25 floors of surgical, diagnostic, and treatment services. At 1.4 million square feet, it’s currently expected to be the largest cancer-specific treatment facility in the United States. The tower will be divided into units for specific types of cancer, making it easy to integrate the advancing research being done all over Houston.

Like Prism, Inspiration Tower is specifically designed to offer comfort and reassurance, with more garden space, terraces, and beautiful scenery to ease patient distress. It is expected to open in 2032.

Tesla will pull the plug on Cybertruck production at Texas factory in 2027

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Tesla’s Cybertruck, the hulking, stainless-steel pickup that inspired devotion and derision with its science-fiction looks, will cease production next year.

CEO Elon Musk announced the model’s demise Friday, November 6, with a curt post on X, his social media site, simply noting production of the vehicle “will be winding down” around the middle of 2027 at its facility outside Austin, Texas. Musk said the move was to allow increased production of its Cybercab robotaxi.

For the Cybertruck, a pet project of Musk who insisted it was Tesla’s best product, it marks an unceremonious end to one of the auto industry’s most ballyhooed debuts.

“Few vehicles in history have generated as much attention,” said Armen Hareyan, whose Torque News site covers autos. “The Cybertruck became a cultural symbol – loved, mocked and impossible to ignore.”

The Cybertruck rolled onto the scene in a dramatic unveiling in 2019, when a Tesla designer hurled a metal ball at the vehicle to demonstrate its supposedly unbreakable glass, only to see it shatter. He repeated the stunt on another window of the truck only to shatter that one, too.

Even as some critics scoffed, Musk was steadfast.

“I just wanted to make a futuristic battle tank — something that looks like it could come out of ‘Blade Runner’ or ‘Aliens’ or something like that but was also highly functional,” he told Automotive News. He called it “a better sports car than a Porsche 911” and “a better truck than an F-150.”

It struck some as the perfect vehicular reflection of the brash, convention-busting Musk.

“A really controversial vehicle unveiled by a controversial individual into a market where none of the electric trucks have been able to really capture demand,” said Spencer Penn, a former Tesla executive who left the company before the Cybertruck’s launch and now heads software developer LightSource.

Penn remembered watching the unveiling and feeling initially revolted by the sight of the Cybertruck, calling its appearance “madness.” But the more he looked at it, the more his opinion changed. He signed up for a pre-sale reservation, though ended up not getting a Cybertruck when Musk’s promises of a price tag under $40,000 went unmet and the first trucks sold for double or more. Penn called the Cybertruck part of Tesla’s adventurous spirit that drives innovation.

“Some of these bets work and some of these bets don’t,” he said.

While the decision to end Cybertruck production may be driven by sales realities, it's also a reflection of Tesla’s shift to autonomous vehicles, on which Musk is betting the company’s future.

Musk once forecast he’d make 250,000 Cybertrucks a year. Kelley Blue Book estimated Tesla sold just 20,237 of the vehicles last year, down about half from the year prior. Sales through the end of September this year were down another 28%, according to Kelley Blue Book.

If the imposing, sharp-angled, dystopian appearance of the Cybertruck weren’t enough to turn many potential buyers away, Musk did so himself by allying with a panoply of right-wing figures, most notably U.S. President Donald Trump. He alienated some customers as his image morphed from eccentric innovator to polarizing force trading his billions for political influence.

Once-passionate Tesla drivers rushed to sell off their cars, or slapped stickers on the bumper declaring, “I bought this before Elon went crazy.” Organizers staged demonstrations outside Tesla showrooms and urged investors to dump shares of the company’s stock. Anger spilled into violence, with Molotov cocktails hurled at Tesla vehicles, charging stations set ablaze, and dealerships covered in graffiti.

Lovers of the Cybertruck became targets, too, subjected to shouts of “Nazi!” and extended middle fingers.

Ross Blankenship is one of them. When he first laid eyes on the Cybertruck, he felt transported to a world from his childhood, when he would play “Halo,” the sci-fi video game. He had to have it.

“I had that sort of child in me wanting to be part of something cool that would change the future of automotive,” Blankenship said in a call from his Cybertruck as he drove through Sunnyside, Colorado. Even as Blankenship found he agreed with Musk on politics, he hated seeing a vehicle he loved turned into a political symbol. “I never bought it for any other reason than the fascination with the future technology of trucks … so that was a little heartbreaking.”

He would buy another Cybertruck again in a heartbeat, calling its end “a sad moment.”

UTHealth Houston officially opens new tower in TMC's Helix Park

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UTHealth Houston School of Public Health recently opened its new state-of-the-art tower in the Texas Medical Center’s Helix Park.

The 350,000-square-foot, 10-story campus at 1930 Old Spanish Trail was celebrated with an official ribbon-cutting ceremony on Oct. 28. The $229 million project will consolidate all UTHealth Houston School of Public Health operations into one facility. It will also connect students who are at the Austin, Brownsville, Dallas, El Paso and San Antonio campuses with peers and faculty through digital and distance learning.

Disciplines taught in the new tower will include epidemiology, genetics, nutrition, health policy, data science and health promotion, UTHealth shared when the building first broke ground in 2023.

Architects Kirksey Architecture and Smith Group designed the building, and Vaughn Construction served as general contractor. The facility features labs for studying human disease, classrooms and spaces to support interdisciplinary and community-based research, a broadcast studio and a teaching kitchen. A skybridge over Old Spanish Trail connects the new tower with a plaza that's shared with MD Anderson.

“This new facility reflects the kind of forward-looking investment that will serve Texans for generations,” Janiece Longoria, vice chairman of the UT System Board of Regents, said in a news release. “By creating an environment where talented people can learn, collaborate, and pursue new ideas, UTHealth Houston is building capacity to meet the challenges of tomorrow while strengthening its impact across our state.”

UTHealth says the system aims for the new campus to expand on collaborative research efforts and continue graduate education, as enrollment at the School of Public Health has increased by 27 percent over the last five years.

“This new building, with its state-of-the-art education technology and learning environment, will strengthen and advance the school’s mission to educate and train the next generation of experts who will advance scientific discovery, shape evidence-based health policy, and lead innovative solutions to the complex health challenges in communities throughout Texas and across the nation,” Kevin Morano, senior vice president, provost and chief academic officer of UTHealth Houston, added in a news release.

Attending the ceremony were Dr. Melina R. Kibbe, UTHealth Houston president and Alkek Williams Distinguished Chair; Eric Boerwinkle, dean, M. David Low Chair in Public Health and Kozmetsky Family Chair in Human Genetics at the School of Public Health; Texas State Representative Lauren Ashley Simmons, Texas House District 146; representatives of the offices of Senator John Cornyn and Harris County Commissioner Rodney Ellis; and Dr. Theresa Tran, director of the Houston Health Department.

"This building represents far more than a home for our school,” Boerwinkle added in the release. “It represents the people who make our mission possible: the faculty, staff, and students who fill each laboratory and classroom with curiosity, discovery, and purpose to improve the population’s quality of life.”

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