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 hospitals recognized as best in state, nation in annual report

better than all the rest

Houston’s University of Texas MD Anderson Cancer Center has retained its U.S. News & World Report crown as the best cancer hospital in the U.S.

In the same ranking, Houston Methodist Hospital once again came out on top as the best hospital in Texas. Last year, the hospital shared the top spot. Baylor St. Luke’s Medical Center ranked No. 4, followed by No. 5 Memorial Hermann Hospital.

The accolades appear in U.S. News’ 2024-25 ranking of the country’s best hospitals. Each hospital also ranked among various specialties, such as orthopedics; cardiology, heart, and vascular surgery; cancer; and neurology and neurosurgery.

Since U.S. News introduced its annual hospital survey in 1990, MD Anderson has been ranked one of the two best U.S. hospitals for cancer care. It has maintained its No. 1 ranking for 10 consecutive years.

“At MD Anderson, our mission is clear: to end cancer,” Dr. Peter WT Pisters, president of MD Anderson, says in a news release. “This ranking reflects our relentless commitment to excellence in patient care, research, prevention, and education.”

MD Anderson also ranked highly in three specialties:

No. 2 for ear, nose, and throat.
No. 9 for urology.
No. 14 for gastroenterology and GI surgery.

“The consistent top national recognitions [that] MD Anderson receives for delivering compassionate, evidence-based care is a testament to our dedication to those we serve,” Pisters says.

Elsewhere at the Texas Medical Center, Houston Methodist Hospital was named the No. 1 hospital in Texas for the 13th year in a row. Also, it was lauded as one of the country’s 20 best hospitals for the eighth time.

Along with the general ranking, Houston Methodist Hospital scored high marks in 10 specialties. These include diabetes and endocrinology (No. 6), gastroenterology and GI surgery (No. 7), and pulmonology and lung surgery (No. 8).

Meanwhile, four Houston Methodist community hospitals ranked well in Texas:

Houston Methodist The Woodlands Hospital (No. 8).
Houston Methodist Sugar Land Hospital (No. 9).
Houston Methodist Baytown Hospital (tied at No. 18).
Houston Methodist Willowbrook Hospital (tied at No. 23).

New app with tips for solo women travelers takes flight from Texas

explore mode activated

We all have that one friend whose office seems to be the nearest airport gate. We go to them for travel advice and hit save on their latest post for that hole-in-the-wall restaurant that had the best local food. That type of advice — especially between women — is indispensable for solo travelers, and now a new travel app based in Austin is helping organize it on a new platform without the social media noise.

Solo travel has gained a lot of momentum in the past few years, and it’s no longer just something one does during a gap year before or after college. It’s become the preferred way to travel for many, and women are at the forefront.

According to Condor Ferries, 72 percent of American women like to take solo trips, and the term “female solo travel” has increased 62 percent over the past three years across all search engines. What if there was a place where women solo travelers could get recommendations and travel itineraries created by other solo women travelers?

This concept is the backbone of Airheart, which aims to revolutionize the travel industry by offering a safe space for solo female travelers to find itineraries and travel guides that were crafted with them in mind.

"Traveling solo as a woman is an empowering act of independence," said Airheart founder Lindsey Renken in a press release. "At Airheart, we celebrate and support this journey, helping women discover new places, connections, and strengths."

The platform includes integrated planning tools, interactive maps, itineraries, and video tips all conveniently located in one place and customizable to the traveler’s preference. Once a user creates an account and accesses the site, the navigation is pretty straightforward.

There’s an explore option at the top of the home screen showcasing all the travel guides available for purchase within the platform, with destinations all over the world. At the moment, most are within the US, Mexico, Western Europe, and Asia. Once the user chooses a guide, a sidebar populates with a list of recommendations or a day-by-day itinerary. The right side of the screen is a map with all the pinned recommendations for easy navigating.

For those wanting to travel more within Texas this summer, Airheart offers a few destinations with a wide range of activities:

Big Bend/West Texas: For nature lovers, explore the beautiful mountain desert region of West Texas with a comprehensive guide that includes tips on how to get there and how to choose the best accommodation for your trip — something that becomes more complex in such a remote place.
Glen Rose: Escape to this charming small town just an hour-and-a-half Southwest of Dallas-Fort Worth, that is perfect for a weekend getaway full of outdoor adventures. These recommendations come from a local.
Fredericksburg: Indulge in the best wineries and restaurants that Central Texas has to offer with an itinerary crafted by a Texas native. This one is ideal for a quick day trip or a fun girls’ weekend.

Airheart, named after the pioneering aviator Amelia Earhart, is also focused on empowering female travel creators by allowing them to act as a type of modern travel agent. They can monetize both new and existing travel content by creating these guides and itineraries, while reaching a new audience on the platform.

“As an avid traveler, I’m always looking for something like this created by expert travelers. I can’t wait to be a seller and consumer,” said Tanna Wasilchak who contributed guides for Waco, Glen Rose, and Georgetown. “Solo traveling as a female can be intimidating at first, but it’s one of the most rewarding experiences I’ve ever had. Airheart is going to be such a game changer for this community.”

Perhaps the only downside for now is that Airheart is limited in what it can offer to its users with only 22 guides published on the site. However, the features and community-based aspect give the platform the potential to stand out in an otherwise saturated market. Guides ($29 each before taxes and fees) are available for users to browse and purchase at airheart.com.

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This article originally ran on CultureMap.

Houston startup adviser on navigating SAFE, convertible notes in funding rounds

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As both a founder and occasional early-stage investor in the Houston ecosystem, I've seen firsthand the opportunities and challenges surrounding seed funding for local startups. This critical first fundraising round sets the trajectory, but navigating the landscape can be tricky, especially for first time founders who may not be familiar with the lingo.

One key dynamic is choosing the right deal structure — SAFEs (Simple Agreement for Future Equity) vs. convertible notes are the most common vehicles early stage startups use to raise capital and are far more founder-friendly than a priced round.

Let's start first with what the have in common:

Both allow you to defer setting a valuation for your company until a later (likely priced) round, which is useful in early stages or pre-revenue companies
Both are cheaper and faster to execute than a priced round, which cash-strapped early stage founders like
Both can have terms like valuation cap, discount, conversion event, and pro rata rights.
Both are less attractive to investors seeking immediate equity (especially important if starting the QSBS clock is part of your investors strategy or if the investor is newer to startup investing)
Both can create messy cap tables and the potential for a lot of dilution for the founders (and investors) if they are used for multiple raises (especially with different terms)

While as you can see they have similarities, they have some important differences. Let's dig in on these next:

SAFEs:

Created by Y Combinator in 2013, the intent was to create a simplified, founder friendly agreement as an alternative to the convertible note
Is an agreement for future equity for the investor at a conversion event (priced round or liquidation event) which converts automatically.
It's not a debt instrument and does not accrue interest or have a maturity date.
Generally have much lower upfront legal costs and faster to execute

Convertible Notes:

A debt agreement that converts to equity at a later date (or conversion event like a priced round)
Accrues interest (usually 2 to 8 percent) and has a maturity date by which the note must either be repaid or convert to equity. If you reach your maturity date before raising a qualifying round, you can often renegotiate to extend the maturity date or convert the note, though be prepared to agree to higher interest rates, additional warrants, or more favorable conversion terms.
More complex and take longer to finalize due to non-standard terms resulting in higher legal and administrative costs

It's worth reiterating that in both cases, raising multiple rounds can lead to headaches in the form of complex cap tables, lots of dilution, and higher legal expenses to determine conversion terms. If your rounds have different terms on discounts and valuation caps (likely) it can cause confusion around equity and cap table structure, and leave you (the founder) not sure how much equity you will have until the conversion occurs.

In my last startup, our legal counsel — one of the big dogs in this space for what it's worth — strongly advised us to only do one SAFE round to prevent this.

Why do some investors tend to prefer convertible notes?

There are a few reasons why some investors, particularly angel investors from developing startup ecosystems (like Houston), prefer convertible notes to SAFEs.

Because they are structured as debt, note holders have a higher priority than equity investors in recovering their investment if the company fails or is liquidated. This means they would get paid after other creditors (like loans or credit cards) but before equity investors, increasing the likelihood of getting some of their money back.
The interest terms protect investors if the founder takes a long time to raise a priced funding round. As time passes, interest accumulates, increasing the investor's potential return. This usually results in the investor receiving a larger equity stake when the note converts. However, if the investor chooses to call in the note instead, the accrued interest would increase the amount of money owed, similar to a traditional loan
More defined conversion triggers (including a maturity date) gives investors more control and transparency on when and how their investment will convert.
Can negotiate more favorable terms than the standard SAFE agreement, including having both a valuation cap and a discount (uncommon on a SAFE, which usually only has one or the other), interest rates, and amendment clauses to protect them from term revisions on earlier investors by future investors (called a cram-down), etc.

We'll go over what the various terms in these agreements are and what to look out for in a future article

How to choose:

Consider your startup's stage and valuation certainty — really uncertain or super early? Either of these instruments are preferable to a priced round as you can defer the valuation discussion
Assess investor preferences in your network — often the deciding factor if you don't have a lot of leverage; most local angels prefer c-notes because they see them as less risky though SAFEs are becoming more common with investors in tech hubs like Silicon Valley
Evaluate your timeline and budget for legal costs — as I mentioned, SAFEs are way less expensive to execute (though still be prepared to spend some cash).
Align the vehicle with your specific goals and growth trajectory

There's no one-size-fits-all solution, so it's crucial to weigh these factors carefully.

The meanings of these round terms like "seed" are flexible, and the average seed funding amount has increased significantly over the past decade, reaching $3.5 million as of January 2024. This trend underscores the importance of choosing the right funding vehicle and approach.

Looking ahead, I'm bullish on Houston's growing startup ecosystem flourishing further. Expect more capital formation from recycled wins, especially once recently minted unicorns like High Radius, Cart.com, Solugen, and Axiom Space exit and infuse the ecosystem with fresh and hungry angels, new platforms beyond traditional venture models, and evolving founder demographics bringing fresh perspectives.