Houston immuno-oncology company reaches next FDA milestone, heads to phase 2 trial

green light

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 geothermal unicorn Fervo officially files for IPO

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Fervo Energy has officially filed for IPO.

The Houston-based geothermal unicorn filed a registration statement on Form S-1 with the U.S. Securities and Exchange Commission on April 17 to list its Class A common stock on the Nasdaq exchange. Fervo intends to be listed under the ticker symbol "FRVO."

The number and price of the shares have not yet been determined, according to a news release from Fervo. J.P. Morgan, BofA Securities, RBC Capital Markets and Barclays are leading the offering.

The highly anticipated filing comes as Fervo readies its flagship Cape Station geothermal project to deliver its first power later this year

"Today, miles-long lines for gasoline have been replaced by lines for electricity. Tech companies compete for megawatts to claim AI market share. Manufacturers jockey for power to strengthen American industry. Utilities demand clean, firm electricity to stabilize the grid," Fervo CEO Tim Latimer shared in the filing. "Fervo is prepared to serve all of these customers. Not with complex, idiosyncratic projects but with a simplified, standardized product capable of delivering around-the-clock, carbon-free power using proven oil and gas technology."

Fervo has been preparing to file for IPO for months. Axios Pro first reported that the company "quietly" filed for an IPO in January and estimated it would be valued between $2 billion and $3 billion.

Fervo also closed $421 million in non-recourse debt financing for the first phase of Cape Station last month and raised a $462 million Series E in December. The company also announced the addition of four heavyweights to its board of directors last week, including Meg Whitman, former CEO of eBay, Hewlett-Packard, and Spring-based HPE.

Fervo reported a net loss of $70.5 million for the 2025 fiscal year in the S-1 filing and a loss of $41.1 million in 2024.

Tracxn.com estimates that Fervo has raised $1.12 billion over 12 funding rounds. The company was founded in 2017 by Latimer and CTO Jack Norbeck.

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

New UT Austin med center, anchored by MD Anderson, gets $1 billion gift

Future of Health

A donation announced Tuesday, April 21, breaks a major record at the University of Texas at Austin. Michael and Susan Dell are now UT Austin's first supporters to give $1 billion. In response, the university will create the UT Dell Campus for Advanced Research and the UT Dell Medical Center to "advance human health," per a press release.

The release also records "significant support" for undergraduate scholarships, student housing, and the Texas Advanced Computing Center for supercomputing research.

Both the new research campus and the UT Dell Medical Center will integrate advanced computing into their research and practices. At the medical center, the university hopes that will lead to "earlier detection, more precise and personalized care, and better health outcomes." The University of Texas MD Anderson Cancer Center will also be integrated into the new medical center.

That comes with a numeric goal measured in 10s: raise $10 billion and rank among the top 10 medical centers in the U.S., both in the next decade.

In the shorter term, the university will break ground on the medical center with architecture firm Skidmore, Owings & Merrill (SOM) "later this year."

“UT Austin, where Dell Technologies was founded from a dorm room, has always been a place where bold ideas become real-world impact,” said Michael and Susan Dell in a joint statement.

They continued, “What makes this moment so meaningful is the opportunity to build something that brings every part of the journey together — from how students learn, to how discoveries are made, to how care reaches families. By bringing together medicine, science and computing in one campus designed for the AI era, UT can create more opportunity, deliver better outcomes, and build a stronger future for communities across Texas and beyond.”

This is the second major gift this year for the planned multibillion-dollar medical center. In January, Tench Coxe, a former venture capitalist who’s a major shareholder in chipmaking giant Nvidia, and Simone Coxe, co-founder and former CEO of the Blanc & Otus PR firm, contributed $100 million$100 million.

Baylor scientist lands $2M grant to explore links between viruses and Alzheimer’s

Alzheimer’s research

A Baylor College of Medicine scientist will begin exploring the possible link between Alzheimer’s disease and viral infections thanks to a $2 million grant awarded in March.

Dr. Ryan S. Dhindsa is an assistant professor of pathology & immunology at Baylor and a principal investigator at Texas Children’s Duncan Neurological Research Institute (Duncan NRI). He hypothesizes that Alzheimer’s may have some link to previous viral infections contracted by the patient. To study this intriguing possibility, the American Brain Foundation has gifted him the Cure One, Cure Many award in neuroinflammation.

“It is an honor to receive this support from the Cure One, Cure Many Award. Viral infections are emerging as a major, underappreciated driver of Alzheimer's disease, and this award will allow our team to conduct the most comprehensive screen of viral exposures and host genetics in Alzheimer's to date, spanning over a million individuals,” Dhindsa said in a news release. “Our goal is to identify which viruses matter most, why some people are more vulnerable than others, and ultimately move the field closer to new therapeutic strategies for patients.”

Roughly 150 million people worldwide will suffer from Alzheimer’s by 2050, making it the most common cause of dementia in the world. Despite this, scientists are still at a loss as to what exactly causes it.

Dhindsa’s research is part of a new range of theories that certain viral infections may trigger Alzheimer’s. His team will take a two-fold approach. First, they will analyze the medical records of more than a million individuals looking for patterns. Second, they will analyze viral DNA in stem cell-derived brain cells to see how the infections could contribute to neurological decay. The scale of the genomic data gathering is unprecedented and may highlight a link that traditional studies have missed.

Also joining the project are Dr. Caleb Lareau of Memorial Sloan Kettering Cancer Center and Dr. Artem Babaian of the University of Toronto. Should a link be found, it would open the door to using anti-virals to prevent or treat Alzheimer’s.

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