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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Pharma giant considers Houston for $1B manufacturing campus

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Another pharmaceutical giant is considering Houston’s Generation Park for a manufacturing hub.

According to a recent filing with the Texas Jobs, Energy, Technology and Innovation (JETI) program, Bristol Myers Squibb Co. is considering the northeast Houston management district for a new $1 billion multi-modal pharmaceutical manufacturing campus.

If approved, the campus, known as Project Argonaut, could create 489 jobs in Texas by 2031. Jobs would include operations technicians, engineering roles, administrative and management roles, production specialists, maintenance support, and quality control/assurance. The company predicts annual average wages for these positions to be around $96,000, according to the filing.

The project currently includes the 600,000-square-foot facility, but according to the filing, Bristol Myers Squibb “envisions this site growing in scale and capability well beyond its opening configuration."

The Texas JETI program offers companies temporary school property tax limitations in exchange for major capital investment and job creation. E.R. Squibb & Sons LLC applied for a 10-year tax abatement agreement in the Sheldon Independent School District.

The agreement promises a $ 1 billion investment. Construction would begin in 2027 and wrap in 2029.

“The proposed project reflects [Bristol Myers Squibb Co.’s] enduring commitment to bringing innovative medicines to patients and ensuring the long-term supply reliability they depend on,” the filing says. “The proposed project is purpose-built to support and manufacture medicines spanning multiple therapeutic areas and modalities, positioning the site as a long-term launch and commercial campus for decades to come. These medicines will provide therapies to the [Bristol Myers Squibb Co.’s] patients located in markets both nationally and internationally.”

The Fortune 100 company is considering 16 other cities for the new manufacturing facility in the Central and Eastern markets in the U.S. According to the Houston Chronicle, Bristol Myers Squibb Co is still in the “evaluation process” for its potential manufacturing site.

Last fall, Eli Lilly and Co. selected Generation Park for its $6.5 billion manufacturing plant. More than 300 locations in the U.S. competed for the factory. Read more here.

Houston health tech co. lands NIH grant for AI cancer prediction tool

fresh funding

Houston-based CellChorus and Stanford Medicine were recently awarded a Phase I Small Business Innovation Research grant for the company's AI platform to test how certain cancer patients will respond to therapies.

The funding comes from the National Cancer Institute of the National Institutes of Health. According to a filing, the grant totaled just under $400,000.

CellChorus, which spun out from the University of Houston’s Technology Bridge, has developed TIMING (Time-lapse Imaging Microscopy In Nanowell Grids), which analyzes the behavior of thousands of individual immune cells over time and can identify early indicators of treatment success or failure.

The company will work with Stanford's Dr. David Miklos and Dr. Saurabh Dahiya, who have built the Bone Marrow Transplantation and Cell Therapy Biobank. The biobank manages and stores biological samples from patients treated at their clinic and in clinical trials.

"Predicting which patients will achieve durable responses after CAR-T therapy remains one of the most important challenges in the field,” Miklos said in a news release. “We aim to uncover functional cellular signatures that can guide treatment decisions and improve patient outcomes.”

The project will specifically profile cells from patients with relapsed/refractory large B-cell lymphoma (r/rLBCL). According to CellChorus, only about half of r/rLBCL patients who receive CAR-T therapy "achieve a durable, long-term remission." Others do not respond to therapy or experience relapse.

“The sooner we know whether a cancer therapy is working, the better. To maximize patient benefit, we need technology that can provide a robust and early prediction of response to therapy. The technology needs to be scalable, cost-efficient, and capable of rapid turnaround times,” Rebecca Berdeaux, chief scientific officer of CellChorus, added in the release. “We are excited to work with Drs. David Miklos and Saurabh Dahiya and their colleagues on this very important project.”

CellChorus has previously received SBIR grants from federal agencies, including a $2.5 million award in 2024 from its National Center for Advancing Translational Sciences (NCATS) and a $2.3 million SBIR Fast-Track award from the National Institute of General Medical Sciences in 2023.

Houston museum showcases America's founding documents in rare exhibit

Experience History

As the United States prepares to celebrate its 250th birthday, Houstonians have a chance to see rare documents from the founding of the nation. Freedom Plane National Tour: Documents That Forged a Nation, presented by the National Archives Foundation, will be on display at the Houston Museum of Natural Science through Monday, May 25.

The collection includes a rare engraving of the original Declaration of Independence; official Oaths of Allegiance signed by George Washington, Aaron Burr, and Alexander Hamilton; a draft of the Bill of Rights; the Treaty of Paris, the documented that recognized America's independence from Great Britain; and the tally of votes approving the Constitution.

The National Archives specifically chose Houston as one of only eight cities in the country to host the exhibit as a means to help the documents reach a wider audience outside of the main hub of semiquincentennial events in New England and the Washington, D.C. area.

"One of the things we decided when we put the tour together because we wanted to be off the East Coast," said Patrick Madden, CEO of the National Archives Foundation, who was onsite for the exhibit's opening in Houston. "There's a lot of 250th celebration stuff happening in the original 13 colonies. How do we get it to major markets where larger numbers of people can see it? So in the case of Houston, obviously, [is a] major market in this part of the country, but also we've partnered with the museum twice before with National Archives exhibits, so we knew that they would be up to the task of handling the exhibit and the crowds."

The star of the collection is a rare engraving of the original Declaration of Independence. Secretary of State and future president John Quincy Adams commissioned 200 exact replicas of the document from engraver William J. Stone in 1823. Less than 50 now remain. Madden joyfully pointed out that there are errors in this document, a potent reminder that the men who forged a nation made mistakes.

"There's a couple of typos in it where they had to make corrections," said Madden. "So even the founders, you know, they're all human. That resonates because here these people are making this move against the most powerful nation in the world and putting their lives on the line for a country based on ideas."

Other impressive parts of the collection include official Oaths of Allegiance signed by George Washington, Aaron Burr, and Alexander Hamilton, as well as one of the drafts of the Bill of Rights. Many states would not ratify the Constitution until certain rights were included in the document, leading to Washington going on a national tour assuring state leaders enshrining protections was first on the list. The draft copy on display specifically shows the First Amendment in progress.

Houston is the fourth stop on the exhibition's tour, which will take the documents to Denver, Miami, Dearborn, and Seattle through the summer. Freedom Plane is just one part of a larger patriotic celebration at the HMNS, which includes a film series celebrating American science and culture and general Americana decoration throughout the main hall.

Admission to Freedom Plane is free to the public, but separate from general admission to the museum. Space is limited, and passes are available on a first-come, first-serve basis. Non-members should expect long waits or the possibility that the day's passes are sold out. Only museum members can reserve passes for specific times. Flash photography is prohibited due to the fragile nature of the documents.

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This article originally appeared on CultureMap.com.

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