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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Houston mental health nonprofit expands platform statewide to connect more Texans with care

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As mental health conversations evolve, the necessary pivot becomes how organizations across Texas navigate improved ways to help people access the care they need before their challenges become crises.

That’s why Mental Health America of Greater Houston recently announced that it is expanding its Care Connect platform statewide.

The expansion will address perhaps the most persistent barrier to behavioral healthcare—helping people find and navigate services that already exist.

Care Connect’s extended reach comes at a time when more than 3.5 million adults in the state live with some kind of mental health condition and scores of those in need continue to struggle with accessing care despite the growing awareness of mental health needs.

According to President and CEO Renae Vania Tomczak, Care Connect’s main goal was to remove as many obstacles as possible that Texans face when seeking mental health support.

“Care Connect was about a two-year planning process,” Tomczak says. “It really began with asking what challenges people in the Greater Houston Area were facing regarding mental health. It’s not just accessing care, but the difficulty in navigating the mental healthcare system.”

While provider shortages remain a challenge in some communities, Mental Health America of Greater Houston found that many individuals and families struggle simply to determine where to turn, how to identify the right provider and whether services are affordable.

“We wanted to make it easier for people who have questions, who may never have had a mental health challenge before, or they’re a caregiver for somebody who has a mental health issue,” Tomczak says. “We wanted to be the place that people can come to get their questions answered and be connected to care.”

Care Connect combines a vetted network of more than 1,000 providers and services across Texas with personalized navigation support.

Searches generate care results based on insurance coverage, language preferences, ZIP code and clinical specialties.

Additionally, one-on-one guidance and follow-up support are provided by bilingual resource specialists.

The platform also seeks to address affordability, one of the most significant barriers to mental healthcare access. Through participating providers, eligible individuals can receive six to eight counseling sessions at no cost.

“We have several providers who are willing to provide six to eight counseling sessions at no cost for people who do not have the means to pay for services themselves,” Tomczak says.

When provider matches are unavailable, the organization can connect individuals with master’s-level mental health professionals working under the supervision of licensed clinicians.

The statewide rollout builds on the platform’s early success in the Houston region, where it has helped thousands of individuals connect with mental health resources since launching last fall.

According to Tomczak, the decision to expand was driven in part by growing demand from outside the organization’s traditional service area.

“Last month we decided to take this program statewide,” she says. “It’s not just Houston that can use help in connecting to appropriate mental health services, but the whole state.”

The Care Connect program’s promotion through healthcare providers, community organizations and public-sector partners across Texas is now one of Mental Health America of Greater Houston’s top priorities.

Their goal is to create a stronger referral ecosystem that ultimately helps those who need access to mental health care more quickly.

To facilitate that, the organization has also added free mental health screenings to its website so that users will better identify any symptoms related to anxiety, depression and other conditions.

“Once they do that, then where do they go?” Tomczak says. “They’re not sure who to call and who can help them. At that point, we hope they’ll call us and talk to somebody live who can answer their questions and help them get started on the right path to improving their mental health.”

With eyes on the future, Tomczak believes public understanding of mental health has improved in recent years, particularly following the COVID-19 pandemic, which brought new attention to the effects of stress, isolation and uncertainty.

“The more we talk about it and have the opportunity to share that mental health conditions are traceable, the better,” she says.

According to Tomczak, long-term, Care Connect aims to reduce roadblocks that exist between recognizing the need for help and receiving it.

Ultimately, Care Connect hopes to create a robustly connected behavioral health system that gives Texans the ability to access mental health services swiftly and with confidence.

“No one should have to navigate mental health challenges alone,” Tomczak adds. “Care Connect is here to help connect people with resources, services and answers to ensure they get the care they need to take the next step toward better mental health.”

ExxonMobil sets date to make Texas its legal HQ

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Energy giant Exxon Mobil Corp. has set a date to move its legal headquarters to Texas.

The Spring-based company announced this week that the redomiciliation from New Jersey to Texas is expected to be effective July 1. Exxon's board of directors unanimously recommended redomiciling in the Lone Star State in March, and shareholders approved the move to Texas at the company’s annual meeting in May.

As part of the move, ExxonMobil Holdings Corp. will replace Exxon Mobil Corp. of New Jersey and become the publicly traded parent company. Exxon reports that its shares will continue to trade on the New York Stock Exchange under the ticker symbol “XOM,” and that shareholders do not need to take action.

At the time of the recommendation, Exxon said the move would not affect business operations, management, strategy, assets or employee locations.

Exxon Chairman and CEO Darren Woods added that the redomiciliation was in part due to Texas' business-friendly environment and policies.

"Over the past several years, Texas has made a noticeable effort to embrace the business community. In doing so, it has created a policy and regulatory environment that can allow the company to maximize shareholder value,” Woods said in a news release. "Aligning our legal home with our operating home, in a state that understands our business and has a stake in the company’s success, is important.”

The Associated Press reports that about 30 percent of Exxon's employees work in Texas. Exxon's legal headquarters has been based in New Jersey since 1882, when it was Standard Oil Company.

Exxon moved its operational headquarters from Irving, Texas, to the Houston area in 2023.

Exxon was the highest-ranking Houston-area company on this year's Fortune 500 list, coming in at No. 9. Houston tied with Chicago for the second-most Fortune 500 headquarters on this year's list, with Texas leading the nation for the most Fortune 500 headquarters (57).

“Texas is the undisputed headquarters of headquarters,” Gov. Greg Abbott said in a news release. “The world’s leading businesses invest with confidence in Texas because of our welcoming business climate, predictable regulatory environment, and skilled and growing workforce. People and businesses are choosing Texas because Texas works.”

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This article originally appeared on our sister site, EnergyCapitalHTX.com.