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

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.

The Texas Medical Center Innovation Factory has named the 16 companies making up the inaugural cohort in the Innovate UK Global Incubator Programme. Photo via tmc.edu

TMC names inaugural cohort for unique accelerator with UK

coming to HOU

Sixteen digital health and medical device startups founded in the United Kingdom have been selected for a customized accelerator at the Texas Medical Center's Innovation Factory.

In partnership with Innovate UK, TMCi created the Innovate UK Global Incubator Programme, a new accelerator that supports UK businesses as they build their United States go-to-market plan. The program builds the BioBridge relationship between TMC and the UK that was originally established five years ago.

“The TMC UK BioBridge program was launched with the UK Department for Business and Trade in 2018 to serve as a gateway for advancing life sciences and foster innovation and research between our two countries," says Ashley McPhail, chief external affairs and administration officer for TMC, in a news release. "We saw an opportunity to work with Innovate UK to develop a larger program with the UK after the success of the 11 companies that previously participated in our health tech accelerator."

The 16 companies will participate in the program from June to November. The cohort is expected to arrive in Houston on June 5 and have access to TMCi's facilities, network of mentors and potential clients, funding, potential customers, and curated programing — all while being a unique entry point into the US. The new offering joins three other globally recognized curriculums: Biodesign, Accelerator for Cancer Therapeutics, and Health Tech.

“TMCi nurtures long-term growth, development, and competitiveness to increase startups chances of success and global expansion," says Emily Reiser, associate director of TMC Innovation. "By bringing their novel technologies and exposing them to a curated selection of TMC’s expert network, startups receive support and evaluation to build, scale, and expand in the US market."

Two of the cohort's specialties include cardiovascular and oncology — two of TMC's strongest areas of expertise — with solutions ranging from surgical devices to AI-enabled risk stratification and hospital efficiency.

Innovate UK is the country's national innovation agency dedicated to supporting business-led innovation in all sectors.

“The United Kingdom is fully committed to improving global healthcare through scientific collaboration," says His Majesty’s Consul General in Texas Richard Hyde in the release. "Through the expansion of the TMC UK BioBridge and in partnership with Innovate UK, this programme will help to expose the brightest and best British companies to the world’s largest medical city. Our companies will collaborate and grow as they work to develop cutting edge technology. The partnership between the UK Government and TMC demonstrates that international collaboration can drive both economic growth and improvement to quality of life.”

The 16 companies making up the inaugural cohort are as follows, according to TMC.

  • AINOSTICS aims to revolutionize the treatment and prevention of neurological conditions, such as dementia, by developing innovative AI-enabled solutions that draw novel insights from routinely acquired non-invasive medical scans to deliver accurate diagnosis and outcome prediction, and in turn facilitate personalized care and timely access to disease-modifying treatments for patients.
  • Alvie is a blended human plus AI-enabled digital solution providing personalised pre and rehabilitation coaching and supportive care for cancer and surgery. Alvie's technology combines data profiling, risk-stratification and tailored prescriptions of health and well-being with curated educational content, targeted behaviour change coaching and expert support through chat messaging and virtual consultations.
  • C the Signs™ is a validated AI cancer prediction platform, which can identify patients at risk of cancer at the earliest and most curable stage of the disease. Used by healthcare professionals, C the Signs can identify which tumor type a patient is at risk of and recommend the most appropriate next step in less than 30 seconds. The platform has detected over 10,000 patients with cancer, with over 50 different types of cancer diagnosed, and with a sensitivity of >98% for cancer.
  • At PEP Health, We believe all patients deserve the best care possible. Our cutting-edge machine-learning technology enables healthcare organisations, regulators, and insurers the real-time, actionable insights they need to have a direct and dramatic impact on patient experiences.
  • PreciousMD improves the lives of lung-cancer and other lung-related illnesses patients worldwide by enabling imaging-based diagnostics needed for personalized treatment pathways.
  • Ufonia is an autonomous telemedicine company, we use large language models and voice AI to increase the capacity of clinical professionals.
  • My mhealth offers digital therapeutics for a range of long-term conditions- COPD, Asthma, Diabetes and Heart Disease. Our product has been successfully deployed in the UK and India, with >100,000 users registered to date. Our solutions empower patients to self-manage their conditions, resulting in dramatic improvements in outcomes, as evidenced through multiple clinical trials and real-world evaluations.
  • At Surgery Hero, we offer a clinically backed solution that ensures whole-human support before and after surgery. We help health systems, employers and health plans cut costs without sacrificing quality of care.
  • Panakeia's software platform enables extremely rapid multi-omics profiling in minutes directly from routinely used tissue images without needing wet lab assays.
  • QV Bioelectronics are striving to deliver longer, better quality lives for brain tumour patients. Using their first-of-its-kind implantable electric field therapy device, GRACE, QV will provide effective, focal & continuous treatment without impacting patient quality of life.
  • 52 North is a med-tech company focused on improving health outcomes and health equity by reinventing care pathways. The NeutroCheck® solution is a finger-prick blood test and digital platform built to significantly improve safety and quality of life for cancer patients, by helping to identify at-home those patients who are at risk of the most fatal side-effect of chemotherapy: neutropenic sepsis.
  • Somnus is fulfilling an unmet need in global healthcare by developing real-time, point of care blood propofol monitoring. Its products will improve the care of sedated and anaesthetised patients, save money for hospitals, and facilitate a major reduction in greenhouse gas emissions.
  • ScubaTx is a breakthrough organ transplant preservation company established to solve the global unmet need for cost-efficient and longer-duration organ preservation technology. ScubaTx has developed a simple, small and affordable device which uses Persufflation to extend the preservation of organs.
  • IBEX is on a mission to help people live active, healthy and productive lives by increasing their access to early diagnosis of osteoporosis. The IBEX BH software as medical device delvers routine, automated assessment of fracture risk from routine radiology for earlier detection and more equitable treatment of osteoporosis.
  • NuVision produces products derived from donated human amniotic membrane that are used in ophthalmology to help patients with chronic, traumatic and post-surgical wounds of the eye to be treated earlier and recover more fully and more quickly. The company’s products are also used in the management of dry eye disease, a debilitating conditions that affects around 17m people in the USA.
  • Calon Cardio-Technology is on a mission to improve quality of life for patients with Left Ventricular Assist devices (LVAD) and reduce the common post operative complications associated with these implantable heart pumps. We plan to do this by introducing a completely wireless heart pump system and augment patient follow-up with built-in remote monitoring capabilities.
Houston-based Moleculin Biotech now has four different oncology treatment currently in trials. Getty Images

Houston cancer-fighting biotech company introduces its 4th ongoing clinical trial

health report

A Houston-based biotech company has wrapped up enrollment for its most recent clinical trial of its cancer-fighting drug.

Moleculin Biotech Inc. (Nasdaq: MBRX) has launched its fourth ongoing trial — this time focusing on Cutaneous T-Cell Lymphoma, or CTCL, treatment. The company's other three trials include treatment for glioblastoma, an aggressive brain cancer, pancreatic cancer, one of the most virulent killers in oncology, and acute myeloid leukemia, or AML.

To treat these various types of cancers, Moleculin has a several drugs it's in preclinical or clinical trials testing — most biotech companies have only one they focus on. WP1220 is the drug that will be used in this trial for topical CTCL treatment of the cancer's resulting skin lesions.

"We believe there continues to be an unmet need for an improved topical therapy for Stage I-III CTCL skin lesions," says Walter Klemp, Moleculin's chairman and CEO, in a news release, "especially one that may avoid significant unwanted side effects."

WP1220 is what's known as a p-STAT3 inhibitor. STAT3 is a transcription factor that encourages tumor development. Moleculin's technology directly attacks the tumor, but also quiets T Cells, which allows the body's own immune system to fight the cancer itself. Essentially, it works both as chemotherapy and immunotherapy.

"This proof of concept, if successful, could be an important first demonstration of a therapeutic effect in humans from such a p-STAT3 inhibitor," Klemp continues. "We are pleased with how quickly this trial reached full recruitment and we are hopeful to be able to announce results from this trial yet this year."

Klemp founded the company in 2007, and Moleculin went public in 2016. Now, with the company's four clinical trials, Moleculin is even closer to saving lives with its products.

"Notwithstanding the relatively rare nature of CTCL, we believe showing activity with one of our STAT3 inhibitors, within our WP1066 family of molecules, could be an indicator of both the value of p-STAT3 as a target and the potential for our drugs in other cancers where STAT3 is highly activated," Klemp says in the release.

Houston-based Moleculin has three different oncology technologies currently in trials. Getty Images

Houston biotech company aims to enhance oncology treatment of highly resistant cancers

Med tech

Immunotherapy and personalized medicine get all the headlines lately, but in the fight against cancer, a natural compound created by bees could beat them in winning one battle.

In 2007, chairman and CEO Walter Klemp founded Moleculin Biotech Inc. as a private company. The former CPA had found success in life sciences with a company that sold devices for the treatment of acne. That introduction into the field of medical technology pushed him toward more profound issues than spotty skin.

"Coincidentally, the inventor of that technology had a brother who was a neuro-oncologist at MD Anderson," Klemp recalls.

The since-deceased Dr. Charles Conrad slowly lured Klemp into what he calls the "cancer ecosphere" of MD Anderson. In 2016, the company went public. And it looks like sooner rather than later, it could make major inroads against some of the toughest cancers to beat.

Klemp observed that while Houston has the world's largest medical center, "the tragic irony" is that other cities have far more biotech money ready to be invested.

"The Third Coast is really starved for capital," he says. "What drew me into this was I was one of the few entrepreneurs that lived here that knew the ropes in terms of tapping into East and West Coast capital structures and could make that connection for them."

The company has three core technologies currently being tested with some success, but the most promising is called WP1066, named for researcher Waldemar Priebe, "a rock star" in his native Poland, according to Klemp, who works at MD Anderson. Though Priebe came to the U.S. in the 1980s, he is still an adjunct professor at the University of Warsaw and conducts some of his trials in Poland because it's easier to get grant money there.

WP1066 uses propolis, a compound of beeswax, sap and saliva that bees produce to seal small areas of their hives, as a base. The molecular compound that Priebe discovered affects STAT3 (signal transducer and activator of transcription), a transcription factor that encourages tumor development. In short, the active compound in WP1066 both downregulates the STAT3, a long-time Holy Grail in the cancer research world, and directly attacking the tumor, but also quieting T Cells, which allows the body's own immune system to fight the cancer itself. Essentially, it works both as chemotherapy and immunotherapy.

WP1066 is demonstrating drug-like properties in trials at MD Anderson on glioblastoma, the aggressive brain cancer that recently took the life of the hospital's former president, John Mendelsohn, as well as John McCain and Beau Biden. It is also being tested against pancreatic cancer, one of the most virulent killers cancer doctors combat.

Priebe also created Annamycin, named for his oldest daughter, a first-line chemotherapy drug that fights Acute Myeloid Leukemia without the cardiotoxicity that can damage patients' hearts even as they beat their cancer.

WP1122 uses yet another mechanism to fight cancer.

"Most people don't know that morphine is essentially a modified version of heroin," Klemp explains.

The difference between the poppy-based drugs? Heroin can cross the blood-brain barrier. It's described as the dicetyl ester of morphine. WP1122 is the dicetyl ester of 2DG (2-Deoxyglucose), a glycolysis inhibitor, which works by overfilling tumor cells with fake glucose so that they can't consume the real glucose that makes them grow.

"The theory is, we could feed you so full of junk food that eventually you'd starve to death," Klemp elucidates. It can cross the blood-brain barrier and is metabolized slowly, meaning that it can be made into a drug in a way that 2DG cannot.

What's impressive about Moleculin is its diversity of drugs. Most companies have one drug that gets all or most of the attention. Moleculin has strong hopes for all three currently in trials.

"It's essentially multiple shots on the goal," says executive vice president and CFO Jonathan Foster.

Moleculin has 13 total employees, five of whom are based in Houston. An office in the Memorial Park area serves as a landing pad for employees and collaborators from around the world to get their work done when in Space City. The virtual office set-up works for the company because experts can stay in their home cities to get their work done. And that work is on its way to saving scores of lives.

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Gowing femtech company chooses Houston for first out-of-state expansion

A startup dedicated to comprehensive pregnancy, birth and postpartum care has expanded from its Chicago birthplace to Houston.

Last summer, Partum Health raised $3.1 million in seed funding, which makes it possible for the company to begin a nationwide expansion. That begins in Space City.

“We looked at states where there is work to do on outcomes for maternal health. Texas rose to the top and Houston, in many ways is fairly close to Chicago, our home city. The really thriving healthcare ecosystem attracted us as well,” CEO and Co-Founder Meghan Doyle tells InnovationMap.

As a mom of a seven-year-old and a nine-year-old herself, Doyle says that she experienced the gap firsthand in what’s available to women beyond what her obstetrician or midwife does.

“You had to work really hard to cobble together the care you needed. It was a matter of putting together my personal experiences of realizing it’s not just me, it’s systematic,” says Doyle. “I couldn’t get that problem out of my head.”

Neither could her co-founder and head of operations, Matt Rogers, a father of twins whose family had to navigate the NICU and life-threatening complications. They started working together on the business in earnest during the COVID shutdown and debuted Partum Health at the beginning of 2021.

Partum has begun partnering with obstetricians and midwives to help select complementary care that includes lactation support, pelvic floor physical therapy, mental health services, nutrition counseling and doula care. What’s unique about the plan is that, from aiding in behavioral health problems to addressing nutritional issues, the user’s team is distributed around the Houston area and are fully virtual. Physical therapy and other services that must be done in-person may take place either in-home or at third-party locations.

“We’re still in the process of credentialing with insurance companies,” says Doyle.

In Illinois, Partum is already working with BlueCross BlueShield, United Healthcare, Aetna and Cigna for clinical care, so Doyle says she is confident that those companies will soon follow suit in Texas.

While hiring a team in Houston that includes a client care lead, Doyle says that Partum is simultaneously providing services and getting to know the market better. They’re also building more bundled models of care to better assist users in their new landscape.

Doyle and Partum Healthcare participated in the Ignite Healthcare Network’s 2023 program, which concluded last week with a pitch competition. Ignite helps female healthcare founders to connect with mentors and other industry experts that will help them navigate the health tech ecosystem. Doyle was one of nine finalists, but did not place in the top three. But she says the program has helped prepare her for success nonetheless.

“In our world, you’re always pitching,” she admits.

The next steps for Partum include a 2024 rife with expansion. Because building relationships with insurance happens on a state-by-state basis, the company will be able to help women around Texas soon after the company is comfortably established in Houston. The Dallas-Fort Worth area will likely be first, followed by Austin and San Antonio.

“We know there’s a huge gap in access to care that may mean evolving a little bit and reaching out across the state,” Doyle says.

Last month, the Texas Health and Human Services Commission reported that 90 percent of the state’s pregnancy-related deaths are preventable. With access to care like what Partum provides, those complications could become a thing of the past.

University of Houston lines up entrepreneurship course featuring Taylor Swift's billion-dollar career

Cougar Red (Taylor's Version)

By any measure, Taylor Swift put on a masterclass with her Eras Tour this year — her Houston stop was a study in three-hours of pop-culture-perfect brand execution and fan frenzy.

Now, University of Houston is taking Tay studies to the next level with a new biz class.

Appropriately dubbed “The Entrepreneurial Genius of Taylor Swift,” the new class is part of the curriculum at coming to the C. T. Bauer College of Business at the University of Houston next spring. Swfities who’re super “ready for it,” however, can get a jump on enrollment now.

Study “the 1” at a No. 1 institution

Though Swifties and Tay (and Travis) fiends will surely soak up every class hour, the program isn’t just for fans, the prof notes in a press statement. And Bauer College offers serious cred for current and new students, as its Wolff Center for Entrepreneurship has long ranked No. 1 in the U.S.

“You definitely don’t have to be a hardcore fan — a Swiftie — to learn and appreciate the entrepreneurial genius that has made Taylor Swift an international phenomenon,” notes Kelly McCormick, the Professor of Practice leading the course, citing Swift’s expertise in marketing, fan engagement, community building, and brand strategies.

Don’t hate, hate, hate, hate, hate on this Tay tutorial

Sure, Swift haters night hate on a Taylor course. But before they do, they should consider that at age 33, Swift boasts an estimated net worth of $1 billion, according to Forbes. And her aforementioned Eras Tour? Swift earned more than $780 million on the U.S. leg alone this year on the tour, which — by current estimates — cues her up to become the highest-grossing female touring artist of all time.

Her Eras Tour concert film also just became the highest-grossing concert film in North America, raking between $95 million to $97 million in ticket sales during its opening weekend — alone.

Taylor Swift Houston 2023 Eras Tour
Swift can flex a $1 billion net worth, per Forbes. Photo by Marco Torres/Marco from Houston


And then of course, her music acumen and savvy. In 2021, Swift smartly re-recorded a version of her album Fearless and launched a series of releases of her back catalog, in order to secure ownership of her first six albums.That move came after the masters (the original recordings) sold for a reported $300 million in 2019.

Here in Houston, as CultureMap reported, the Post-Tay Effect (we’re making that a thing) had a lasting economic effect, notbaly for areas pet and food nonprofits.

Hardcore business aside, the class Still, the course will be Taylor-made for Swifties. McCormick, who also serves as managing director for the university’s startup accelerator RED Labs, has themed each session around a different album — or Era, obvi for fans — of Swift’s career.

What to expect on the “mornin' of your very first day”

So, when students take a deep breath and walk through the door of their very first day (obligatory “Fifteen,” callout) they will score friendship bracelet gifts — a huge Swiftie phenomenon — and will be treated to surprise songs during breaks and even Easter eggs hidden in class content. (That’s a clever nod to Swift, who regularly hides clues, callbacks, and “oh yeaaahhhh” moments for fans in her music videos, album artwork, and social media posts).

As for the Tay inspo, McCormick says she has been a Swift fan since the early days of mega-hits “Our Song” and “Love Story.” But like so many who were blown away by the sheer Tay Machine during the Houston Eras Tour stop in April, the professor quickly noted entrepreneurship lessons to be learned over Swift’s in her 17-year career.

Taylor Swift Houston
The professor says Swift's dazzling Eras Tour stop in Houston inspired the class. Photo: Bob Levey/Getty Images/Taylor Swift Twitter


“I saw the show and loved it,” McCormick adds. “And I realized I actually didn’t know that much about her career. I became absolutely enamored basically overnight and started getting into her whole discography. Taylor is truly impressive!”

She added: “Never have I ever — like ever — been so engrossed in someone’s career after so little time.” (Should anyone doubt all the Tay references, McCormick’s “never have I ever — like ever” comments is shoutout to Swift’s most popular singles, “We Are Never Ever Getting Back Together.” Very clever.)

Travis-Tay included?

But perhaps the top Tay lesson is how to ensure satisfied customers.

“The number one business lesson students can learn from Taylor is the way she treats her fans,” McCormick notes. “She is beloved because she truly does so much to make sure they are happy, appreciated and feel like they are important to her. If every company acted that way about their customers — they’d have way more customers.”

Oh, and, no word — and we didn’t ask, for the record — if Kansas City Chiefs tight end/Swift squeeze Travis Kelce is part of the curriculum. Also no word if, to quote “Fifteen,” students will “sit in class next to a redhead named Abigail.”

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This article originally ran on CultureMap.