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

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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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Rice University, Houston Methodist launch new institute to revolutionize health care through AI, innovation

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Rice University and Houston Methodist have established through a multi-year joint effort the Digital Health Institute, which aims to transform healthcare through advanced technology and the collaborative expertises of the university and hospital.

Rice’s leadership in engineering, digital health and artificial intelligence will combine with Houston Methodist’s academic medicine and research infrastructure.

“This partnership embodies Rice’s bold vision to lead at the forefront of innovation in health and responsible AI,” Rice President Reginald DesRoches says in a news release. “By combining our strengths with Houston Methodist, we are creating a transformative platform to address critical challenges in healthcare with solutions that are ethical, accessible and impactful. This initiative exemplifies our commitment to driving interdisciplinary collaboration and advancing global health for the benefit of humanity.”

Leading the initiative will be Rice’s Ashutosh Sabharwal, the Ernest Dell Butcher Professor of Engineering and professor of electrical and computer engineering, and Houston Methodist’s Dr. Khurram Nasir, the Centennial Chair in Cardiovascular Medicine, and Dr. William Zoghbi, division chief of cardiovascular prevention and wellness. Rice and Houston Methodist have worked previously with the Center for Neural Systems Restoration that opened earlier this year and the Center for Human Performance that was established in 2022.

The Digital Health Institute allows for both institutions to share data, and resources that focus on key areas like the early detection through AI algorithms for early diagnosis of cancer, infections, cardiovascular diseases and other conditions, predictive analytics that utilize real-time monitoring that can predict and prevent events such as strokes and heart failure, and the development of novel sensors, wearables and ingestibles to innovate new remote monitoring and care pathways.

The Digital Health Institute will also work to utilize more personalized medicine efforts, developments of new novel and assistive technologies, expansion of telemedicine, and proactive self-care management through AI-driven patient self-management.

“This partnership between our institutions marks a bold new chapter in driving meaningful innovation at the intersection of healthcare and technology through solutions that are both visionary and practical,” Dr. Marc Boom, president and CEO of Houston Methodist, adds. “Our long-standing relationship with Rice University has produced impactful collaborations, but this initiative is by far the most transformative endeavor in our shared commitment of leading medicine through innovation.”

Rice President Reginald DesRoches and Houston Methodist CEO Marc Boom announced the new partnership at the Ion. Photo courtesy of Rice

Elon Musk wants to turn SpaceX's Starbase site into a Texas city

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SpaceX is launching a new mission: making its Starbase site a new Texas city.

Billionaire Elon Musk 's company last week sent a letter to local officials requesting an election to turn what it calls Starbase — the South Texas site where SpaceX builds and launches its massive Starship rockets — into an incorporated city. Residents of the area known as Starbase submitted the petition, according to the company.

The area is on the southern tip of Texas at Boca Chica Beach, near the Mexican border. Earlier this year, Musk announced he was moving the headquarters of SpaceX and his social media company X from California to Texas.

“To continue growing the workforce necessary to rapidly develop and manufacture Starship, we need the ability to grow Starbase as a community. That is why we are requesting that Cameron County call an election to enable the incorporation of Starbase as the newest city in the Rio Grande Valley,” Kathryn Lueders, the general manager of Starbase, wrote in a letter to the county.

It's not the first time turning Starbase into its own city has been floated. Musk proposed the idea in 2021 when he wrote a social media post that simply said, “Creating the city of Starbase, Texas.”

Cameron County Judge Eddie Treviño Jr., the county’s top elected official, said despite the talks of incorporation in 2021, this was the first time a petition was officially filed.

“Our legal and elections administration will review the petition, see whether or not it complied with all of the statutory requirements and then we’ll go from there," Treviño said on Thursday.

More than 3,400 full-time SpaceX employees and contractors work at the Starbase site, according to a local impact study issued by Trevino earlier this year.

SpaceX's rapid expansion in the region has drawn pushback from some locals. Earlier this year, a group called Save RGV sued the company in July over allegations of environmental violations and dumping polluted water into the nearby bay. SpaceX said in response that a state review found no environmental risks and called the lawsuit “frivolous.”

Editor's Picks: 7 favorite Houston Innovator Podcast episodes of 2024

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Editor's note: This year, recorded over 40 episodes of the Houston Innovators Podcast — a weekly discussion with a Houston innovator, startup founder, investor, and more. I've rounded up seven podcast episodes that stood out for me looking back at the year of recordings. Scroll through to see whom I selected and stream their individual episodes, and tune into the last episode of the year where I explain why I enjoyed each conversation.



Episode 220 - Better than just 'inclusive' - Denise Hamilton of WatchHerWork

Houstonian Denise Hamilton is coming out with a book she hopes helps leaders reach beyond inclusivity. Photo courtesy of WatchHerWork

Denise Hamilton says she's been used to looking around and realizing she's the only woman or African American in the room, and for the past nine years, she's been providing resources and education to trailblazing women like her. Now, she wants to prepare current and future leaders on how to go beyond inclusivity and work toward indivisibility.

Hamilton's book, "Indivisible: How to Forge Our Differences into a Stronger Future," publishes February 6 from Countryman Press. She explains that the book comes from years of her on personal experiences, as well as inspiration from the women she's met with her company, WatchHerWork, multimedia digital platform providing advice and resources for professional women.

"I've learned a lot of lessons about what skills work, what behaviors are not intuitive, and built WatchHerWork with the intention of creating a space where people can get all of that advice — and juicy goodness — so that they can learn what they needed to do to be authentically successful," Hamilton says on the Houston Innovators Podcast.

"This led to me being brought in as a speaker, and ultimately has led to me becoming an author," she continues. "It's always shocking when people want to listen to what you want to say. It's unbelievable." Continue reading the original article.

Episode 231 - Fostering a collaborative energy transition ecosystem - Barbara Burger

Houston energy leader Barbara Burger joins the Houston Innovators Podcast to discuss the energy transition's biggest challenges and her key takeaways from CERAWeek. Photo courtesy

When Barbara Burger moved to Houston a little over a decade ago to lead Chevron Technology Ventures, she wondered why the corporate venture group didn't have much representation from the so-called energy capital of the world.

“I had no companies in my portfolio in CTV from Houston, and I wondered why,” Burger says on the Houston Innovators Podcast.

Much has changed in the ecosystem since then, she says, including growth and development to what the community looks like now.

“There are a few things I’m proud of in the ecosystem here, and one of theme is that it’s a very inclusive ecosystem,” she explains, adding that she means the types of founders — from universities or corporate roles — and the incumbent energy companies. “The worst way to get people to not join a party is to not invite them.”

“No one company or organization is going to solve this. We have to get along,” she continues. “We have to stop thinking that the mode is to compete with each other because the pie is so big and the opportunity is so big to work together — and by and large I do see that happening.”Continue reading the original article.

Episode 233 - How a Houston angel earns their wings - Mitra Miller of Houston Angel Network

Mitra Miller, vice president and board member of the Houston Angel Network, joins the Houston Innovators Podcast to share her passion for growing angel investors in Houston. Photo via LinkedIn

One of the biggest components of a well-functioning startup ecosystem is inarguably access to capital, and Mitra Miller is dedicated to enhancing education around investment and growing Houston's investor base.

As vice president and board member of the Houston Angel Network, the oldest angel network in Texas and one of the most active angel networks in the country, Miller strives to provide guidance to new and emerging angel investors as well as founders seeking to raise money from them.

"Most founders have no idea or understanding of how investors think — we are not an ATM," Miller says on the Houston Innovators Podcast. "We are really partners you are getting married to for the next 5, 8, 10 years — sometimes longer. We need to bring your allies in every sense of the word." Continue reading the original article.


Episode 237 - Gearing up for 100x growth - Tim Latimer of Fervo Energy

Tim Latimer, CEO and co-founder of Fervo Energy, joins the Houston Innovators Podcast. Photo courtesy of Fervo Energy

Geothermal energy has been growing in recognition as a major player in the clean energy mix, and while many might think of it as a new climatetech solution, Tim Latimer, co-founder and CEO of Fervo Energy, knows better.

"Every overnight success is a decade in the making, and I think Fervo, fortunately — and geothermal as a whole — has become much more high profile recently as people realize that it can be a tremendous solution to the challenges that our energy sector and climate are facing," he says on the Houston Innovators Podcast.

In fact, Latimer has been bullish on geothermal as a clean energy source since he quit his job as a drilling engineer in oil and gas to pursue a dual degree program — MBA and master's in earth sciences — at Stanford University. He had decided that, with the reluctance of incumbent energy companies to try new technologies, he was going to figure out how to start his own company. Through the Stanford program and Activate, a nonprofit hardtech program that funded two years of Fervo's research and development, Latimer did just that. Continue reading the original article.

Episode 248 - Houston's beating heart - Dr. William Cohn of The Texas Heart Institute

Dr. William Cohn is the chief medical officer for BiVACOR, a medical device company creating the first total artificial heart. Photo via TMC

It's hard to understate the impact Dr. William Cohn has had on cardiovascular health as a surgeon at the Texas Heart Institute or on health care innovation as the director of the Center for Device Innovation at the Texas Medical Center. However, his role as chief medical officer of BiVACOR might be his most significant contribution to health care yet.

The company's Total Artificial Heart is unlike any cardiovascular device that's existed, Cohn explains on the Houston Innovators Podcast. While most devices are used temporarily for patients awaiting a heart transplant, BiVACOR's TAH has the potential to be a permanent solution for the 200,000 patients who die of heart failure annually. Last year, only around 4,000 patients were able to receive heart transplants.

"Artificial hearts historically have had bladders that ejected and filled 144,000 times a day. They work great for temporary support, but no one is suggesting they are permanent devices," Cohn says on the show. Continue reading the original article.

Episode 251 - Building enduring innovation ecosystems - Jon Norby of Anthropy Partners and EconWerx

Jon Nordby's career has been focused on cultivating a culture for innovation, and now he's focused on human potential technology opportunities. Photo courtesy

In his role overseeing startup accelerators for MassChallenge, Jon Nordby started noticing one industry vertical stood out in terms of success and opportunities: Human potential. Now, Nordby is a founding member of an investment firm looking for those opportunities.

Nordby, who served in various leadership roles at MassChallenge — including managing director and head of ecosystems — said he started realizing the opportunities within the organization's space and sports tech programs.

"What we realized over a couple of years running the program was that sports tech as a theme was too limiting," Nordby says on the Houston Innovators Podcast. "We were finding really great technologies, but we were limited at the market size of teams and leagues to deploy those technologies."

"Over the course of that program, we found that the things that were related more to human health and performance tended to out perform all of the other things related to sports tech — like media, entertainment, gambling," Nordby continues. "Still really great markets for those technologies, but we found a lot more traction for human performance." Continue reading the original article.

Episode 263 - Maintaining a legacy of innovation - Reginald DesRoches of Rice University

Rice University President Reginald DesRoches joins the Houston Innovators Podcast to discuss balancing tradition with growth, innovation, and global impact in education. Photo courtesy Tommy LaVergne/Rice University

How does a historic university maintain its legacy while still making room for growth and increased opportunities? That's what Rice University President Reginald DesRoches considers with every decision he makes.

"It's this idea of preserving what's special about the university, while also knowing we need to adapt to a new time, a new Rice, a new time in higher ed, and a new time in society," DesRoches says on the Houston Innovators Podcast. "There's a healthy tension between preserving what Rice is known for — the culture of care, the close-knit community — while knowing that we need to grow, have a global impact, and position Rice on a global scale. It's something that's constantly in my mind to make sure we do both." Continue reading the original article.


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