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 space companies win NASA funding to build Mars exploration robots

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Two Houston-area spacetech companies have landed a portion of a $17 million award from NASA to develop robots for exploring the surface of Mars, the agency announced this month.

Houston-based Inuitive Machines and Webster, Texas-based MEI Technologies, which does business as Aegis Aerospace, were among the seven companies selected to receive the funding from NASA's Science Transport and Robotic Innovation for Deployment and Exploration (STRIDE) initiative.

According to the release from NASA, the companies are tasked with creating "innovative mobility systems" that would allow future Mars missions to access more challenging terrain and difficult-to-reach regions of the planet, and to travel farther distances. NASA estimated that the work will begin this fall.

NASA solicited proposals for participants in the STRIDE initiative in January. The seven named companies are the first selected to participate in the program.

The additional five companies to receive STRIDE funding include:

"STRIDE demonstrates NASA’s commitment to strong public-private partnerships, allowing the agency to explore new approaches for Mars surface exploration while identifying key capability gaps and development needs for commercial systems that could operate and traverse realistic Martian environments," NASA shared in the announcement.

Last month, Intuitive Machines was awarded $148.3 million to deliver its Nova-C lander to the moon. The funding was part of $600 million the space agency awarded to three companies as part of its Moon Base Program and was Intuitive Machines' sixth task order under NASA's Commercial Lunar Payload Services (CLPS) program. Astrobotic was also one of the companies to land funding for the Moon Base program, as well as Austin-based Firefly Aerospace.

Around the same time, Firefly Aerospace was awarded a $13 million subcontract from NASA’s Jet Propulsion Laboratory to develop technology for NASA’s SkyFall mission to Mars. The mission aims to deploy three Mars helicopters to "perform science and demonstrate airborne subsurface mapping and resource prospecting on the planet." Read more here.

SpaceX launches Starship test flight with most advanced Starlinks to date

Out in Space

SpaceX’s mammoth Starship rocket blasted off Friday, July 24, on another test flight stretching halfway around the world, this time releasing 20 of the most advanced Starlinks.

Towering 407 feet, Starship soared from the company’s base at the southern tip of Texas. NASA monitored the space-skimming flight, a critical step toward using the Starship as a lunar lander for moon crews.

The hourlong journey ended with a splashdown so soft that the spacecraft remained afloat in the Indian Ocean as the SpaceX webcast drew to a close, drawing cheers from employees back at the launch site.

Elon Musk’s SpaceX had replaced six of the 33 engines on the first-stage booster after they failed to ignite earlier in July, resulting in a last-second launch abort. The previous Starship flight in May also experienced engine trouble, which prevented the booster from making a controlled return.

This time, all of the engines fired at liftoff, but not enough of them lit back up for the booster's return, causing it to descend too fast and slam into the Gulf of Mexico. The spacecraft continued soaring eastward, popping out the Starlinks one by one 124 miles up before reentering.

It was the 13th flight of the world’s biggest and most powerful rocket, and the second this year of the new version dubbed V3. Like the previous demo, neither the booster nor spacecraft was meant to be saved, instead plunging into the sea.

The stainless steel, retro-looking spacecraft hovered upright over the Indian Ocean before lowering into the water, more than 10,000 miles from where the flight began.

It was the best reentry yet, according to SpaceX, with the intact booster floating amid just a few flames. Previous flights ended with the spacecraft engulfed in flames and exploding at splashdown — or rupturing in midair.

“We're really pumped about this,” said SpaceX engineer Kate Tice, calling it “lucky flight 13.”

The Starlinks accomplished all their jobs before reentering over the Indian Ocean.

After being ejected from the Starship’s Pez-like dispenser, the Starlinks managed to communicate via lasers with older Starlink models already in orbit. With more than 10,000 Starlinks currently providing internet, SpaceX boasts the world’s largest satellite constellation.

Six of the newly launched Starlinks carried cameras that photographed Starship’s heat shield at flight's end, beaming back amazingly crisp shots even as the spacecraft bobbed in the ocean. The heat shield was also equipped with sensors to measure the extreme pressure placed on the spacecraft during launch. Most of the heat shield’s thermal tiles were black, but some were deliberately painted white to simulate missing tiles, part of an experiment to test the shield’s robustness.

"We got all the heat shield data we needed and then some!" Musk said on X.

NASA Administrator Jared Isaacman offered congratulations. “Excited for what will be learned from this mission,” Isaacman noted on X.

SpaceX wants to make sure Starship’s heat shield can withstand the heat of entry before trying to return it to the Starbase launch pad near the Texas-Mexico border. The company already has used a pair of giant mechanical arms at the pad to capture a Starship booster. The company plans to do the same with the actual spacecraft, which is designed to be totally reusable.

NASA needs Starship to wrap up testing and reach orbit soon so the Artemis III astronauts — three Americans and one Italian — can practice docking their capsule with it next year.

Starship is also the vehicle with which Musk intends to build a city on Mars. He's already booking tourist trips to Mars, as well as the moon.

The latest test flight was delayed first by the July 16 launch abort, then again July 23 by thick clouds from Tropical Storm Bertha.

University of Houston debuts UH Health, expanding collaborative health care and research efforts

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The University of Houston has announced its cross-disciplinary academic venture, UH Health.

It will align UH’s efforts in education, research and clinical partnerships to create new opportunities to advance research and innovation, community impact, and education, according to a news release.

“From opening the state’s first college of optometry to developing groundbreaking vaccines, improving the health of all Texans has been a UH priority for decades,” UH President Renu Khator said in the release. “Now, with the launch of UH Health, we are bringing together the full strength of our health enterprise to expand our reach, advance research and transform the future of health for our communities.”

UH is adopting a fully collaborative model, with health professionals from various concentrations to help better understand overall patient care, which includes factors like clinical, behavioral and social factors that can influence health outcomes.

UH Health will also have partnerships with HCA Healthcare, Memorial Hermann Hospital, Baylor College of Medicine, MD Anderson Cancer Center and other Texas Medical Center facilities. In addition, UH Health will work with DHR Health in the Rio Grande Valley to create new opportunities for health care education, workforce development and research in one of Texas' medically underserved regions.

As part of UH Health, UH Health Family Care Center will provide integrated primary care and mental health services to the University and its surrounding communities at affordable prices to serve the Third Ward, East End and South Houston. The Household-Centered Care program will give students opportunities to work directly with community caregivers through patient home visits, while the 3rd Ward Place of Wellness offers health screenings, preventive services, education and other resources designed to support long-term health and well-being, according to UH. The College of Optometry will continue to see children and families via outreach programs and clinics across the community.

UH Health also aims to address shortages in health care professionals, providing a pipeline from the university to the workforce. According to the Texas Hospital Association, 64 percent of hospitals in the state are operating with reduced services and fewer beds due to staff shortages.

“Preparing the next generation of health care leaders is one of the most important investments we can make in the future of our state,” Jonathan McCullers, vice president for health affairs at UH and dean of the Tilman J. Fertitta Family College of Medicine at UH, added in the release. “UH Health is ensuring our graduates are equipped to work effectively in today’s complex healthcare environment.”

Additionally, UH shared it is investing $77 million into a 55,000-square-foot medical research facility aimed at boosting interdisciplinary research and scientific discovery.

“Healthcare is no longer delivered in isolation, and complex health challenges require coordinated solutions,” McCullers added. “UH Health allows us to work across disciplines to tackle health challenges, advance research and improve outcomes for patients and our community.”

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