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 raises $6M to scale home-based healthcare platform

fresh funding

As healthcare systems race to expand care beyond hospitals and into the home, investors are placing bigger bets on the infrastructure needed to make that shift possible.

This month, Rosarium Health announced it has raised $6 million in seed funding led by Kalos Ventures, with participation from ResilienceVC, Rock Health Capital, Symphonic Capital, Black Tech Nations Ventures and others.

The investment will help the Houston-based startup continue to build its platform, which features a national network of 800-plus clinicians and 3,000-plus contractors to coordinate home accessibility upgrades and modifications for seniors and people living with disabilities.

For founder and CEO Cameron Carter, the company’s mission grew out of firsthand caregiving experiences.

“From my own personal caregiving experiences, I realized that the benefits exist on paper, but not in reality,” Carter said in a news release. “Families are being left to figure out the paperwork and installations all on their own, which shouldn’t be how this works.”

While Medicare Advantage and Medicaid plans have expanded coverage for home-based services and accessibility modifications, the logistics behind delivering those services often remain fragmented.

Rosarium’s platform coordinates the entire process, from clinical assessments and referrals to contractor management, documentation, reimbursement and installation.

“A clinician can document that a home isn’t safe and a plan can approve a benefit, but there’s no one that’s responsible for making sure the work actually gets done,” Carter says. “We built the missing piece.”

The company was founded in 2021 as Rose Health and was a 2023 participant in the Texas Medical Center’s Accelerator for HealthTech program. It has scaled quickly, building a network of more than 800 clinicians and 3,000 contractors across 34 states.

Rosarium is currently in-network for 1.2 million Medicare and Medicaid lives, with projected coverage expected to reach nearly 4 million by the end of the year, according to the release.

“We’re excited to back Cameron because he and the team at Rosarium are building the infrastructure healthcare needs right now to make the home a safe and comfortable place of care,” Kate Ballinger, investor at Kalos Ventures, added in the release.

As part of the recent investment, Ballinger will join Rosarium’s board of directors.

With eyes on the future, Rosarium plans to grow its partnerships with Medicaid and Medicare Advantage plans, including CalViva and Community Health Plan of Imperial Valley, strengthening its presence in California while expanding access to underserved communities.

Additionally, Carter predicts that home-based healthcare will be part of a broader transformation happening across the industry.

“There’s a growing recognition that health outcomes are shaped by what happens in the home,” he said in the release. “The future of healthcare isn’t just treating people after something goes wrong. It’s creating environments that help prevent those problems in the first place.”

Houston business mogul Tilman Fertitta acquires Caesars in $17.6B deal

Money Moves

Houston billionaire Tilman Fertitta may currently be serving as America’s ambassador to Italy, but his company is as busy as ever. Fresh off its move to revive the Houston Comets WNBA franchise, his company, Fertitta Entertainment, has announced a $17.6 billion deal to acquire Caesars Entertainment, Inc.

Speculation about the deal has been circulating since at least March, according to various media reports. The deal combines Fertitta’s well-known Golden Nugget casino brand with all of the properties in the Caesars’ portfolio, including Las Vegas hotels Caesars Palace, Harrah's, Paris Las Vegas, Planet Hollywood, Horseshoe, The LINQ Hotel, Flamingo, and The Cromwell.

Overall, the combined company will include 60 domestic casino resorts and gaming facilities; online gaming including sports betting, iCasino, and Caesar’s online poker platform; retail sports betting at over 200 third-party locations through the William Hill brand; and over 550 Fertitta Entertainment outlets, including more than 450 Landry's full-service restaurants across America. The companies will combine their loyalty programs, Caesars Rewards, Golden Nugget's 24 Karat Select Club, and Landry's Select Club.

The terms will see Caesars’ shareholders receive $31 per share. Fertitta Entertainment will also acquire approximately $11.9 billion of Caesars' outstanding debt.

The transaction will be financed through a combination of equity contributed by Fertitta Entertainment, assumed Caesars' debt, and new committed debt financing arranged by a group consisting of 10 banks. It is subject to approval by Caesars’ shareholders and government regulators.

Fertitta Entertainment is the Houston-based company behind a diverse array of hospitality businesses, including The Golden Nugget, The Post Oak Hotel, River Oaks District, the Kemah Boardwalk, and Houston’s Downtown Aquarium.

It also operates a number of prominent restaurant brands, including Mastro's Restaurants, Del Frisco's Double Eagle Steakhouse, Morton's The Steakhouse, The Palm, McCormick & Schmick's, Landry's Seafood House, The Oceanaire Seafood Room, and Saltgrass Steak House.

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This article first appeared on CultureMap.com.