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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Mark Cuban calls AI ‘the greater democratizer’ for young entrepreneurs

eyes on AI

Texas billionaire Mark Cuban—whose investment portfolio includes Houston-based Holliball, a startup that makes and sells large inflatable holiday ornaments—believes AI is leveling the playing field for budding low-income entrepreneurs.

At the recent Clover x Shark Tank Summit in Las Vegas, the Shark Tank alum called AI “the greater democratizer.”

Cuban told Axios that free and low-cost AI tools enable disadvantaged teenagers to compete with seasoned professionals.

“Right now, if you’re a 14- to 18-year-old and you’re in not-so-good circumstances, you have access to the best professors and the best consultants,” Cuban said. “It allows people who otherwise would not have access to any resources to have access to the best resources in real time. You can compete with anybody.”

While Cuban believes AI is “the great democratizer” for low-income young people, low-income workers still face hurdles in navigating the AI landscape, according to Public Works Partners, an urban planning and consulting firm. The firm says access to AI among low-income workers may be limited due to cost, insufficient digital literacy and infrastructure gaps.

“Without adequate resources and training, these workers may struggle to adapt to AI-driven workplaces or access the educational opportunities necessary to acquire new skills,” Public Works Partners said.

Texas 2036, a public policy organization focused on the state’s future, reported in January AI jobs in Texas are projected to grow 27 percent over the next decade. The number 2036 refers to the year when Texas will celebrate its bicentennial.

As for the current state of AI, Cuban said he doesn’t think the economy is witnessing an AI bubble comparable to the dot-com bubble, which lasted from 1998 to 2000.

“The difference is, the improvement in technology basically slowed to a trickle,” Cuban said of the dot-com era. “We’re nowhere near the improvement in technology slowing to a trickle in AI.”

CPRIT hires MD Anderson official as chief cancer prevention officer

new hire

The Austin-based Cancer Prevention and Research Institute of Texas, which provides funding for cancer research across the state, has hired Ruth Rechis as its chief prevention officer. She comes to CPRIT from Houston’s University of Texas MD Anderson Cancer Center, where she led the Cancer Prevention and Control Platform.

Before joining MD Anderson, Rechis was a member of the executive leadership team at the Livestrong Foundation, an Austin-based nonprofit that supports people affected by cancer.

“Ruth has widespread connections throughout the cancer prevention community, both in Texas and across the nation,” CPRIT CEO Kristen Doyle said in a news release. “She is a long-term passionate supporter of CPRIT, and she is very familiar with our process, programs, and commitment to transparency. Ruth is a terrific addition to the team here at CPRIT.”

Rechis said that by collaborating with researchers, policymakers, public health leaders and community partners, CPRIT “can continue to drive forward proven prevention strategies that improve health outcomes, lower long-term costs, and create healthier futures for all.”

At MD Anderson, Rechis and her team worked with more than 100 organizations in Texas to bolster cancer prevention initiatives at clinics and community-based organizations.

Rechis is a longtime survivor of Hodgkin lymphoma, a type of cancer that affects the lymph nodes, which are part of a person’s immune system.