Houston cell therapy company launches second-phase clinical trial

fighting cancer

March Biosciences is testing its MB-105 cell therapy in a Phase 2 clinical trial for people with difficult-to-treat cancer. Photo via march.bio

A Houston cell therapy company has dosed its first patient in a Phase 2 clinical trial. March Biosciences is testing the efficacy of MB-105, a CD5-targeted CAR-T cell therapy for patients with relapsed or refractory CD5-positive T-cell lymphoma.

Last year, InnovationMap reported that March Biosciences had closed its series A with a $28.4 million raise. Now, the company, co-founded by Sarah Hein, Max Mamonkin and Malcolm Brenner, is ready to enroll a total of 46 patients in its study of people with difficult-to-treat cancer.

The trial will be conducted at cancer centers around the United States, but the first dose took place locally, at The University of Texas MD Anderson Cancer Center. Dr. Swaminathan P. Iyer, a professor in the department of lymphoma/myeloma at MD Anderson, is leading the trial.

“This represents a significant milestone in advancing MB-105 as a potential treatment option for patients with T-cell lymphoma who currently face extremely limited therapeutic choices,” Hein, who serves as CEO, says. “CAR-T therapies have revolutionized the treatment of B-cell lymphomas and leukemias but have not successfully addressed the rarer T-cell lymphomas and leukemias. We are optimistic that this larger trial will further validate MB-105's potential to address the critical unmet needs of these patients and look forward to reporting our first clinical readouts.”

The Phase 1 trial showed promise for MB-105 in terms of both safety and efficacy. That means that potentially concerning side effects, including neurological events and cytokine release above grade 3, were not observed. Those results were published last year, noting lasting remissions.

In January 2025, MB-105 won an orphan drug designation from the FDA. That results in seven years of market exclusivity if the drug is approved, as well as development incentives along the way.

The trial is enrolling its single-arm, two-stage study on ClinicalTrials.gov. For patients with stubborn blood cancers, the drug is providing new hope.

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Co-founded by CEO Jessica Traver, IntuiTap says it plans to roll out the device at U.S. hospitals within the next year. Photo courtesy of IntuiTap

Houston health tech startup revolutionizing spinal taps receives FDA clearance

tap in

Houston startup IntuiTap Medical has gained clearance from the U.S. Food and Drug Administration for its VerTouch medical device.

The company says VerTouch is designed to make spinal punctures more accurate and consistent. The handheld imaging tool helps health care providers perform spinal punctures at a patient’s bedside.

IntuiTap says it plans to roll out the device at U.S. hospitals within the next year. The company is mulling global partnerships to help launch VerTouch.

IntuiTap’s proprietary spinal-mapping technology enables VerTouch to generate a 2D image of lumbar spinal anatomy, helping health care providers visualize a patient’s spine and guide them toward more precise needle placement.

Each year, 12.7 million Americans undergo an epidural, spinal block, or lumbar puncture, says IntuiTap.

“Having spent more than two decades pioneering the use of ultrasound to improve emergency lumbar punctures, I know the challenge of these procedures and that difficult training and image interpretation prevent ultrasound from being a complete solution,” Dr. Michael Blaivas, co-founder past president of the Society of Ultrasound in Medical Education, says in a news release.

IntuiTap says the FDA clearance “validates the safety and effectiveness” of VerTouch. The device has undergone testing at several institutions in the U.S., including Houston’s Texas Medical Center and Chicago’s Northwestern Memorial Hospital.

Jessica Traver, co-founder and CEO of IntuiTap, says the FDA clearance “marks a crucial milestone in our team’s journey to making epidurals, spinals, and lumbar punctures more accurate and efficient.”

Investors in IntuiTap include:

  • Dr. Paul Klotman, president of the Baylor College of Medicine
  • Venture capitalist Tim Draper
  • William Hawkins III, retired CEO of medical device giant Medtronic
  • Dr. Vip Patel, Founder of the Global Robotics Institute
  • Dr. Mary Klotman, dean of the Duke University’s medical school
  • Carrie Colbert, founder of Houston-based Curate Capital, a female-focused VC firm

“Our investment in IntuiTap was just as much about our faith in the technology, our faith in Jessica as the founder, and our conviction that innovation was sorely needed in this area,” Colbert says.

“The fact that the company is receiving FDA clearance is a huge leap forward, and as a venture capital fund who focuses on female-founded companies that benefit women, it’s extremely rewarding to know this device will impact so many women’s lives.”

In 2021, IntuiTap announced it had closed a $5.5 million series A funding round led by Curate Capital and The Pink Ceiling, a woman-centered investment firm. The startup was founded in 2016.

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

Houston immuno-oncology company reaches next FDA milestone, heads to phase 2 trial

green light

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.

The at-home COVID-19 tests are now available. EverlyWell/Facebook

Texas startup’s at-home COVID-19 test finally approved by feds

CORONAVIRUS RESPONSE

After its earlier effort was tripped up, Austin-based startup Everlywell on May 16 finally gained approval from the U.S. Food and Drug Administration to launch its at-home coronavirus test.

In a May 18 release, Everlywell says the self-administered test will be available later this month. The company, which specializes in at-home tests for an array of conditions, is the first to receive approval from the FDA for an at-home coronavirus test that's not associated with a lab or a manufacturer of diagnostic products.

The FDA's emergency authorization allows Everlywell to work with a number of certified labs that process authorized tests, rather than just a single lab.

"The authorization of a COVID-19 at-home collection kit that can be used with multiple tests at multiple labs not only provides increased patient access to tests, but also protects others from potential exposure," Dr. Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health, says in a release.

Everlywell's at­-home test determines the presence or absence of the novel coronavirus, which causes COVID­-19 illness. Everlywell's test kit uses a short nasal swab and includes:

  • A digital screening questionnaire reviewed by a healthcare provider.
  • Instructions on how to ship the test sample to a lab.
  • Digital results within 48 hours of the sample being received by the lab.
  • Results reviewed by an independent physician.

Anyone who tests positive test will receive a telehealth consultation. All positive test results are reported to federal and local public health agencies when mandated.

On March 23, Everlywell was supposed to start shipping 30,000 coronavirus test kits to U.S. consumers. But before a single test was sent, the FDA blocked distribution of at-home, self-administered tests from Everlywell and other companies. After that, Everlywell pivoted to supplying coronavirus tests to health care providers and organizations.

As with the company's previously approved coronavirus test, Everlywell says its test for individuals is sold at no profit. The $109 price covers costs such as overnight shipping to a lab, lab-processing fees, and kit components. Some health insurers cover coronavirus tests.

Everlywell says it's working with members of Congress to enable companies that are neither healthcare providers nor labs to be directly reimbursed by health insurers. The startup also is exploring how its coronavirus test could be made available for free.

"Widespread access to convenient testing will play a crucial role in the country's ability to address the pandemic and prevent overburdening our healthcare facilities. As the national leader in connecting people with high­-quality laboratory testing, we are committed to fighting the spread of this virus in America," Julia Cheek, founder and CEO of Everlywell, says in the Everlywell release.

The company continues to supply its coronavirus tests to qualified healthcare organizations and government agencies.

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This article originally ran on CultureMap.

The results are in for Houston-based Saranas' clinical trials. Courtesy of Saranas

Houston early bleeding detection device company reveals results of its clinical trials

blood tests

A Houston-based startup is closer to taking flight with a medical device designed to catch bleeding complications during medical procedures that involve blood vessels.

On May 22, researchers presented the results of a study showing the Early Bird Bleed Monitoring System from Houston-based Saranas Inc. detected various levels of bleeding in 63 percent of the patients who underwent endovascular procedures. These procedures treat problems, such as aortic aneurysms, that affect blood vessels.

No troubles were reported with the Early Bird device during the clinical trial, the researchers say.

Before this study, the Early Bird device hadn't been tested in humans. In all, 60 patients in five states participated in the clinical trial, which ran from August to December last year. Findings of the study were unveiled at the Society for Cardiovascular Angiography Interventions 2019 Scientific Sessions in Las Vegas.

The study's authors say they plan to continue evaluating the device at medical institutions that want to better manage bleeding during endovascular procedures.

"This is the first time we're seeing how this device could help in a real-world patient setting, and we were very encouraged by the results. Right now, patients have a risk of vessel injury when undergoing endovascular procedures where the femoral artery or vein is used for vascular access," Dr. Philippe Genereux, principal investigator for the study and a cardiologist at Morristown Medical Center in Morristown, New Jersey, says in a news release.

"This technology allows us to detect bleeding in real-time," Genereux adds, "which means we can take action quickly and improve the outcomes of the procedure and recovery for the patient."

In March, the Early Bird device — invented at Houston's Texas Heart Institute — received the U.S. Food and Drug Administration's approval as a "novel" medical device.

Saranas says Early Bird is the first and only device of its type. The FDA approval and the promising results of the clinical trial pave the way for the eventual launch of the device into the healthcare market.

A forecast from professional services firm KPMG predicts the global market for medical devices will reach nearly $800 billion by 2030. Early Bird aims to capture a sliver of that market by addressing an expensive and potentially fatal problem. One-fifth of patients experience bleeding complications during large-bore endovascular procedures. Research shows these complications are associated with a greater risk of death, longer hospital stays, and higher healthcare costs.

The Early Bird device is meant to decrease those complications by quickly alerting medical professionals to signs of bleeding during endovascular procedures.

As explained by the Texas Heart Institute, the Early Bird employs a sheath — a plastic tube that helps keep arteries and vessels open — embedded with sensors that measure the electrical resistance across a blood vessel. When the Early Bird senses a change in the electrical resistance, medical professionals receive audible and visual notifications about potential internal bleeding. If detected early, this bleeding can be minimized.

Altogether, Saranas has raised $12 million from investors, including a $2.8 million round in May 2018. The company was founded in 2013.

"What attracted me to Saranas is that our solution has the potential to meaningfully reduce serious bleeding complications that worsen clinical outcomes and drive up healthcare costs," says Zaffer Syed, who joined the startup as president and CEO in 2017. "In addition, our device may support access of important minimally invasive cardiac procedures by allowing them to be performed more safely."

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Texas Republicans are pushing to move NASA headquarters to Houston

space city

Two federal lawmakers from Texas are spearheading a campaign to relocate NASA’s headquarters from Washington, D.C., to the Johnson Space Center in Houston’s Clear Lake area. Houston faces competition on this front, though, as lawmakers from two other states are also vying for this NASA prize.

With NASA’s headquarters lease in D.C. set to end in 2028, U.S. Sen. Ted Cruz, a Texas Republican, and U.S. Rep. Brian Babin, a Republican whose congressional district includes the Johnson Space Center, recently wrote a letter to President Trump touting the Houston area as a prime location for NASA’s headquarters.

“A central location among NASA’s centers and the geographical center of the United States, Houston offers the ideal location for NASA to return to its core mission of space exploration and to do so at a substantially lower operating cost than in Washington, D.C.,” the letter states.

Cruz is chairman of the Senate Committee on Commerce, Science, and Transportation; and Babin is chairman of the House Committee on Science, Space, and Technology. Both committees deal with NASA matters. Twenty-five other federal lawmakers from Texas, all Republicans, signed the letter.

In the letter, legislators maintain that shifting NASA’s headquarters to the Houston area makes sense because “a seismic disconnect between NASA’s headquarters and its missions has opened the door to bureaucratic micromanagement and an erosion of [NASA] centers’ interdependence.”

Founded in 1961, the $1.5 billion, 1,620-acre Johnson Space Center hosts NASA’s mission control and astronaut training operations. More than 12,000 employees work at the 100-building complex.

According to the state comptroller, the center generates an annual economic impact of $4.7 billion for Texas, and directly and indirectly supports more than 52,000 public and private jobs.

In pitching the Johnson Space Center for NASA’s HQ, the letter points out that Texas is home to more than 2,000 aerospace, aviation, and defense-related companies. Among them are Elon Musk’s SpaceX, based in the newly established South Texas town of Starbase; Axiom Space and Intuitive Machines, both based in Houston; and Firefly Aerospace, based in the Austin suburb of Cedar Park.

The letter also notes the recent creation of the Texas Space Commission, which promotes innovation in the space and commercial aerospace sectors.

Furthermore, the letter cites Houston-area assets for NASA such as:

  • A strong business environment.
  • A low level of state government regulation.
  • A cost of living that’s half of what it is in the D.C. area.

“Moving the NASA headquarters to Texas will create more jobs, save taxpayer dollars, and reinvigorate America’s space agency,” the letter says.

Last November, NASA said it was hunting for about 375,000 to 525,000 square feet of office space in the D.C. area to house the agency’s headquarters workforce. About 2,500 people work at the agency’s main offices. NASA’s announcement set off a scramble among three states to lure the agency’s headquarters.

Aside from officials in Texas, politicians in Florida and Ohio are pressing NASA to move its headquarters to their states. Florida and Ohio both host major NASA facilities.

NASA might take a different approach, however. “NASA is weighing closing its headquarters and scattering responsibilities among the states, a move that has the potential to dilute its coordination and influence in Washington,” Politico reported in March.

Meanwhile, Congressional Delegate Eleanor Holmes Norton, a Democrat who represents D.C., introduced legislation in March that would prohibit relocating a federal agency’s headquarters (including NASA’s) away from the D.C. area without permission from Congress.

“Moving federal agencies is not about saving taxpayer money and will degrade the vital services provided to all Americans across the country,” Norton said in a news release. “In the 1990s, the Bureau of Land Management moved its wildfire staff out West, only to move them back when Congress demanded briefings on new wildfires.”

Houston research breakthrough could pave way for next-gen superconductors

Quantum Breakthrough

A study from researchers at Rice University, published in Nature Communications, could lead to future advances in superconductors with the potential to transform energy use.

The study revealed that electrons in strange metals, which exhibit unusual resistance to electricity and behave strangely at low temperatures, become more entangled at a specific tipping point, shedding new light on these materials.

A team led by Rice’s Qimiao Si, the Harry C. and Olga K. Wiess Professor of Physics and Astronomy, used quantum Fisher information (QFI), a concept from quantum metrology, to measure how electron interactions evolve under extreme conditions. The research team also included Rice’s Yuan Fang, Yiming Wang, Mounica Mahankali and Lei Chen along with Haoyu Hu of the Donostia International Physics Center and Silke Paschen of the Vienna University of Technology. Their work showed that the quantum phenomenon of electron entanglement peaks at a quantum critical point, which is the transition between two states of matter.

“Our findings reveal that strange metals exhibit a unique entanglement pattern, which offers a new lens to understand their exotic behavior,” Si said in a news release. “By leveraging quantum information theory, we are uncovering deep quantum correlations that were previously inaccessible.”

The researchers examined a theoretical framework known as the Kondo lattice, which explains how magnetic moments interact with surrounding electrons. At a critical transition point, these interactions intensify to the extent that the quasiparticles—key to understanding electrical behavior—disappear. Using QFI, the team traced this loss of quasiparticles to the growing entanglement of electron spins, which peaks precisely at the quantum critical point.

In terms of future use, the materials share a close connection with high-temperature superconductors, which have the potential to transmit electricity without energy loss, according to the researchers. By unblocking their properties, researchers believe this could revolutionize power grids and make energy transmission more efficient.

The team also found that quantum information tools can be applied to other “exotic materials” and quantum technologies.

“By integrating quantum information science with condensed matter physics, we are pivoting in a new direction in materials research,” Si said in the release.

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This article originally appeared on our sister site, EnergyCapitalHTX.com.

Houston humanoid robotics startup inks new deal to deploy its rugged robots

big deal

Houston-based Persona AI announced the expansion of its operations at the Ion and a major milestone in deploying its humanoid robots.

The company will establish a state-of-the-art development center in the prominent corner suite on the first floor of the Ion, and is slated to begin expansion in June.

“We chose the Ion because it’s more than just a building — it’s a thriving innovation ecosystem,” CEO Nicolaus Radford said in a news release. “This is where Houston’s tech future is being built. It’s a convergence point for the people, energy, and ideas that power our mission to redefine human-machine collaboration. For an industrial, AI-driven robotics company, there’s no better place to scale than in the heart of Houston.”

Persona AI’s new development center will be located in the suite utilized by the Ion Prototyping Lab, managed by TXRX Labs. The IPL will transition its operations to the expanded TXRX facility in the East End Maker Hub, which will allow the lab to grow its team and meet increased demand.

At the start of the year, Persona AI closed $25 million in pre-seed funding. Earlier this month, the company announced a memorandum of understanding with HD Korea Shipbuilding & Offshore Engineering, HD Hyundai Robotic, and Korean manufacturing firm Vazil Company to create and deploy humanoid robots for complex welding tasks in shipyards.

The project will deliver prototype humanoids by the end of 2026, with field testing and full commercial deployment scheduled to begin in 2027.

"As heavy industry faces growing labor constraints—especially in high-risk trades like welding—the need for rugged, autonomous humanoid robots is more urgent than ever,” Radford added in a separate statement. “This partnership with HD Hyundai and Vazil is more than symbolic—deploying to the shipyard is one of the largest real-world proving grounds for Persona's tough, humanoid robots.”

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