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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8 can't-miss Houston business and innovation events for December

where to be

Editor's note: Houston’s innovation scene is loading up the calendar before the holidays. From climatetech pitch days to the return of favorite festive shindigs, here's what not to miss and how to register. Please note: this article may be updated to include additional event listings.

Dec. 3 — SouthWest-Midwest National Pediatric Device Innovation Consortium

This annual event brings together members, colleagues and guests of the FDA-supported pediatric consortium who are dedicated to assisting device innovators throughout the lifecycle in delivering innovative solutions to patients. Featured speakers include Dr. Danielle Gottlieb from Le Bonheur Children's Hospital, Balakrishna Haridas from Texas A&M University and Dr. Chester Koh from Texas Children’s Hospital.

This event is Wednesday, Dec. 3, from 3:30-8 p.m. at Texas A&M EnMed Tower. Register here.

Dec. 4 — Resiliency & Adaptation Sector Pitch Day: Scaling Solutions to Address Climate Disruption

Join innovators, industry leaders, investors and policymakers as they explore breakthrough climate and energy technologies at Greentown's latest installment of its Sector Pitch Day series, focused on resiliency and adaptation. Hear from Adrian Trömel, Chief Innovation Officer at Rice University; Eric Willman, Executive Director of the Rice WaTER Institute; pitches from 10 Greentown startups and more.

This event is Thursday, Dec. 4, from 1-3:30 p.m. at the Ion. The Ion Holiday Block Party follows. Register here.

Dec. 4 — The Ion District Holiday Block Party

The Ion District, Rice Alliance and Greentown Labs will celebrate the season during the Ion District Holiday Block Party. Expect to find local bites, drinks, music and meaningful connections across Houston’s innovation ecosystem. Guests are invited to participate in Operation Love’s holiday toy drive supporting local families.

This event is Thursday, Dec. 4, from 4-7 p.m. Register here.

Dec. 8 — Pumps & Pipes Annual Event 2025

The annual gathering brings together cross-industry leaders in aerospace, energy and medicine for engaging discussions and networking opportunities. Connor Grennan, Chief AI Architect at the NYU Stern School of Business, will present this year's keynote address, entitled "Practical Strategies to Increase Productivity." Other sessions will feature leaders from Cena Research Institute, NASA Ames Research Center, ExxonMobil, Southwest Airlines and more.

This event is Monday, Dec. 8, from 8 a.m.-5 p.m., at TMC Helix Park. Register here.

Dec. 9 — Jingle and Mingle

Don your ugliest sweater and snap a pic with Startup Santa! Bayou City Startups, Rocket Network, Founder Institute and Energytech Nexus are bringing back their popular Jingle Mingle for the third year. Network and celebrate with founders, community stakeholders and others in Houston's innovation scene. Donations to the Houston Food Bank are encouraged in place of tickets.

This event is Tuesday, Dec. 9, from 5-7 p.m., at the Solarium in Midtown. Register here.

Dec. 9 — European Innovation Spotlight

Celebrate European cooperation and innovation with the European Innovation Council during an exclusive demo night and networking event at Greentown Labs. Hear from 15 EIC-backed founders supported by the European Union with top-class climatetech technologies, listen to a fireside chat and engage in a networking event following the pitches.

This event is Tuesday, Dec. 9, from 4:30-7 p.m., at the Ion. Register here.

Dec. 9-10 — Energy LIVE

Energy LIVE is Reuters Events' flagship ConfEx that brings the full energy ecosystem together under one roof to solve the industry's most urgent commercial and operational challenges. The event will feature 3,000-plus senior executives across three strategic stages, a showcase of 75-plus exhibitors and six strategic content pillars.

This event is Dec. 9-10 at NRG Park. Register here.

Dec. 15 — Innov8 Hub Pitch Day

Hear pitches from members of the latest Innov8 Hub Innovators to Founders cohort, which empowers academic scientists and innovators to become successful startup founders. Meet and network with the founders over light bites and drinks at a reception following the pitch competition.

This event is Monday, Dec. 15, at the Innovation Center at UH Technology Bridge (Bldg. 4). Register here.

Houston scores $120M in new cancer research and prevention grants

cancer funding

The Cancer Prevention and Research Institute of Texas has granted more than $120 million to Houston organizations and companies as part of 73 new awards issued statewide.

The funds are part of nearly $154 million approved by the CPRIT's governing board earlier this month, bringing the organization's total investment in cancer prevention and research to more than $4 billion since its inception.

“Today marks an important milestone for CPRIT and for every Texan affected by cancer,” CEO Kristen Doyle said in a news release. “Texas has invested $4 billion in the fight against one of the world’s greatest public health challenges. Over 16 years, that support has helped Texas lead the search for breakthrough treatments, develop new cancer-fighting drugs and devices, and—most importantly—save tens of thousands of lives through early cancer detection and prevention. Every Texan should know this effort matters, and we’re not finished yet. Together, we will conquer cancer.”

A portion of the funding will go toward recruiting leading cancer researchers to Houston. CPRIT granted $5 million to bring John Quackenbush to Baylor College of Medicine. Quackenbush comes from the Harvard T.H. Chan School of Public Health and is an expert in computational and systems biology. His research focuses on complex genomic data to understand cancer and develop targeted therapies.

The University of Texas M.D. Anderson Cancer Center also received $3 million to recruit Irfan Asangani, an associate professor at the University of Pennsylvania Perelman School of Medicine. His research focuses on how chromatin structure and epigenetic regulation drive the development and progression of cancer, especially prostate cancer.

Other funds will go towards research on a rare, aggressive kidney cancer that impacts children and young adults; screening programs for breast and cervical cancer; and diagnostic technology.

In total, cancer grants were given to:

  • The University of Texas M.D. Anderson Cancer Center: $29.02 million
  • Baylor College of Medicine: $15.04 million
  • The University of Texas Health Science Center at Houston: $9.37 million
  • Texas A&M University System Health Science Center: $1.2 million
  • University of Houston: $900,000

Additional Houston-based companies landed grants, including:

  • Crossbridge Bio Inc.: $15.01 million
  • OncoMAGNETx Inc.: $13.97 million
  • Immunogenesis Inc.: $10.85 million
  • Diakonos Oncology Corporation: $7.16 million
  • Iterion Therapeutics Inc.: $7.13 million
  • NovaScan Inc.: $3.7 million
  • EMPIRI Inc.: $2.59 million
  • Air Surgical Inc.: $2.58 million
  • Light and Salt Association: $2.45 million

See the full list of awards here.