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 researchers develop dissolvable implant for targeted cancer drug delivery

cancer research

Researchers at Houston Methodist have developed a biodegradable implant that can be used to safely and consistently deliver drug treatments to tumors and then dissolve without the need for further surgery.

The implant is only the size of a grain of rice, but its potential is staggering. The biodegradable nanofibrous drug-eluting seed (b-NDES) works as a reservoir parked inside a soft tumor, where it can slowly release immune-stimulating drugs over time. This overcomes a consistent problem with drugs such as immune checkpoint inhibitors. Normal systemic administration sees comparatively little of the drug making its way to the tumor, with most of it circulating throughout the body. The b-NDES is like deploying a small guerrilla fighting force embedded in enemy territory, doing maximum damage to the entrenched tumor.

"To improve cancer treatment, we're trying to start a fire inside the tumor itself," Corrine Chua, associate professor in the Center for BioNanoengineering at Houston Methodist Research Institute, said in a news release. "By activating immune cells directly within the tumor microenvironment, those cells can then travel throughout the body and seek out cancer wherever it exists. The b-NDES platform was developed to help keep therapeutic drugs concentrated inside tumors while minimizing exposure to healthy tissues.”

Chua co-led the study with Alessandro Grattoni, chair and director of the Center for BioNanoengineering at Houston Methodist Research Institute.

The study included support from the Nancy Owens Breast Cancer Foundation and the National Institutes of Health/National Cancer Institute.

Chau and Grattoni used preclinical models of triple-negative breast cancer, an aggressive form of cancer that is estrogen receptor-negative, progesterone receptor-negative and HER2-negative. Because of the receptor negativity, some popular treatments like tamoxifen and trastuzumab are ineffective. Chemotherapy has been shown to be the best course of action.

The b-NDES implant is deployed alongside radiation drugs. It keeps the drugs focused on the tumor, reducing the amount of harmful side effects typically seen when drugs are circulated more widely in the body. In 60 percent of the models, tumors were eliminated and did not cause side effects beyond the tumor site. Once the drugs have been deployed, the implant breaks down naturally.

While promising, more research will have to be done to expand use to other tumor types.

"Although the study focused on triple-negative breast cancer models, the approach could have broader applications for solid tumors," Grattoni added in the release. "It could potentially be used in cancers where there is a tumor lesion accessible for placement, including pancreatic or lung cancers."

New Houston platform Same Day Reels launches for on-demand content creation

In The Moment

If an event doesn't happen on Instagram, did it even really happen? In today's social media-driven age of branding and audience engagement, the answer increasingly is no.

Houston entrepreneur Karen De Amat is looking to fill the online content creation needs of companies with her new venture, Same Day Reels, which launched in early August. It will serve as a platform to connect companies and brands with talent that can help turn an event into a viral moment as it is happening.

"Events move quickly, and social media moves even faster,” said De Amat. “Same Day Reels was built to help brands capture the moment while it still matters. We are creating a more efficient way for businesses and creators to work together. Brands need content faster, and creators need more opportunities to turn their talent into real work. Same Day Reels brings those needs together.”

The company is focused on adding livestreams and concurrent short video content to "activations, launches, fundraisers, grand openings, conferences, hospitality experiences, and private celebrations." Such content can significantly increase the visibility of a product or brand according to digital marketing brands like Wyzowl, whose data found 63 percent of people in 2026 prefer to learn about new products via short video.

Packages offered by Same Day Reels will include filming, editing, and publishing content within hours of the targeted event.

De Amat says that her content creation platform will be a way to preserve the excitement of events and launches by enshrining them with immediate social media-driven memories.

“Event content is no longer just something you post after the fact,” De Amat said. “It is part of how people experience, remember and share the moment.”

Previously, De Amat is also the founder and CEO of Social Behavior, an influencer marketing company she launched from her home in 2014. It quickly garnered an array of clients and thrust De Amat into the spotlight, including numerous appearances on Fox 26's The Isiah Factor. Influencer Marketing Hub named her one of the top CEOs of influencer marketing companies in Houston in 2025.

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This article originally appeared on CultureMap.com.

Bristol Myers Squibb to build $2.3B Houston pharma manufacturing campus

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New Jersey-based pharmaceutical giant Bristol Myers Squibb Co. has officially named Houston as the home of its new state-of-the-art manufacturing site.

The 60,000-square-foot facility represents a $2.3 billion investment, according to a news release. It is expected to create 500 skilled jobs and will be located in Houston's Generation Park.

BMS first announced that it was considering Houston among 16 other cities for the facility in May. The new hub will manufacture small molecule, biologic and antibody-drug conjugates and is part of a $40 billion commitment to invest in the United States over five years. Construction is slated to begin next year, with the facility coming online in 2030.

"We're building the domestic manufacturing capabilities needed to deliver the next generation of medicines and support future scientific breakthroughs. Houston and the state of Texas offer the talent, infrastructure, and partnership needed to help bring that vision to life," Christopher Boerner, CEO and board chair of BMS, said in the release.

The new facility will feature a modular, multi-modal design, which will allow the company to reconfigure and add to its manufacturing capabilities over time. BMS says it expects the facility to "(grow) in scale and capability well beyond its opening configuration."

"Our decision to build this state-of-the-art manufacturing campus in Houston, Texas, reflects our confidence in the region’s ability to support a world-class, digitally advanced supply operation,” Karin Shanahan, EVP and chief supply chain and operations officer of BMS, added in the release. “This facility is designed to deliver the speed, quality, and reliability that patients depend on, combining flexible, modular manufacturing with advanced digital capabilities to ensure consistent supply across multiple modalities. It strengthens our ability to operate with resilience and positions us to reliably deliver medicines to patients today while adapting future demands.”

Texas Gov. Greg Abbott shared that the state has granted BMS a $4.89 million Texas Enterprise Fund (TEF) grant for the project. TEF grants, administered by the Texas Economic Development & Tourism Office, support business relocation or expansion projects that create "new, good-paying jobs in the community and attract significant new capital investment to the state." The development is also a qualified project under the Texas Jobs, Energy, Technology, and Innovation (JETI) program.

“Texas is a global hub for life sciences, where today’s innovations shape the future of healthcare,” Abbott said in a news release. “This $2.3 billion investment by Bristol Myers Squibb in the dynamic biotech ecosystem in Houston is a testament to the depth of our skilled workforce and the pipeline of talent coming through our nation-leading technical colleges and research universities. With lower operating costs and easy access to markets across the U.S. and the world, Texas drives affordability for consumers.”

"Bristol Myers Squibb’s announcement is a tremendous win for Texas and the Houston region, further reinforcing our position as a premier destination for life sciences and advanced manufacturing,” added Greater Houston Partnership President and CEO Steve Kean.

Last fall, Eli Lilly and Co. selected Generation Park, a 4,300-acre, master-planned commercial district near Lake Houston, for its $6.5 billion manufacturing plant. More than 300 locations in the U.S. competed for the factory. Read more here.

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