Unique cell therapy developed in Houston doses inaugural patient

cancer-fighting innovation

At Rezvani Lab in MD Anderson Cancer Center, scientists train immune cells to fight cancer. Photo via Getty Images

Replay, a genome-writing company headquartered in San Diego, has announced that its first patient has been dosed with an engineered T-Cell Receptor Natural Killer (TCR-NK) cell therapy for relapsed or refractory multiple myeloma.

What does that have to do with Houston? Last year, Replay incorporated a first-in-class engineered TCR-NK cell therapy product company, Syena, using technology developed by Dr. Katy Rezvani at The University of Texas MD Anderson Cancer Center.

Rezvani, a professor of stem cell transplantation and cellular therapy, is the force behind MD Anderson’s Rezvani Lab, a group of 55 people, all focused on harnessing natural killer cells to combat cancer.

“Everybody thinks that the immune system is fighting viruses and infections, but I feel our immune system is capable of recognizing and killing abnormal cells or cells that are becoming cancerous and they're very powerful. This whole field of immunotherapy really refers to the power of the immune system,” Rezvani tells InnovationMap.

Dr. Katy Rezvani is a professor of stem cell transplantation and cellular therapy and the force behind MD Anderson’s Rezvani Lab, which is focused on harnessing natural killer cells to combat cancer. Photo via mdanderson.org

At Rezvani Lab, scientists train immune cells to fight cancer. While cancer drugs like chemotherapy are still the norm, immunotherapy has gained ground, led by Houston research, including the work of Nobel laureate Jim Allison. The harnessed cells are taught to attack cancerous cells, while ignoring healthy ones, says Rezvani. “We’re turning them into heat-seeking missiles,” she explains.

However, there must be a beacon to signal to those “missiles” that there is something to attack. Much of the field has used chimeric antigen receptors (CARs) to achieve that. But they have limitations.

“CARs can only recognize beacons that sit on the surface of the tumor cells,” Rezvani says. “So basically, it's like the tumor cell has to have a hat on it.”

She says that this usually means that the targets that send off a signal are relatively limited, mostly blood cancers. Using T cell receptors (TCRs) may be able to open up the field to look beyond the “hat.” In other words, TCRs can peer inside cells and see what differentiates a tumor cell from healthy cells. With Replay, Rezvani Lab has developed a first-in-class and first-in-human approach of engineering natural killer cells to express the TCR.

There are six different FDA-approved products that use CAR-T cells, but Rezvani says that her TCR-NK-based technology, though still in its early phases, shows great promise.

“We could use it to target many different types of antigens, many different types of cancers, especially solid tumors," she explains. "These cell therapies have a lot of potential — we call them living drugs… It's not like chemotherapy where you have to keep giving different multiple cycles, these cells are very long lived.”

Rezvani, who started her career in London, says that Houston has been instrumental in the success of her lab.

“There are so many opportunities because we have access to some of the most brilliant minds in research,” Rezvani says. “We have some of the best clinicians in the world. We have patients who come to us who are willing to participate in our clinical trials — really put their trust in us — and are committed and want to participate in these clinical studies.”

The role of funding also plays a part. As Rezvani admitted, bringing a new technology to the market is expensive. The philanthropists who help support trials can’t be forgotten among Houston’s finest.

Whether or not Syena produces the first TCR-NK product on the market, Rezvani is enthusiastic and hopeful for the future of her patients.

“The field of immunotherapy is really expanding, the field of cell therapies is expanding, and there is so much promise,” she says. “The promise of AI, big data, all the engineering tools that we have available, the promise of CRISPR — all of that is going to bring what we've learned from biology, from basic science, together to help us make the cell therapies that are going to be safe and and also very effective for our patients.”

From Your Site Articles
VenoStent's innovative medical device is officially enrolling subjects in a clinical trial. Image courtesy of VenoStent

Houston startup with unique vascular innovation enrolls subjects in new trial

medical device momentum

A Houston-based company has enrolled the initial subjects in a first-of-its-kind trial.

VenoStent was created to improve vascular surgery outcomes for patients undergoing arteriovenous fistula (AVF) creation surgery.

“When a vein is connected to an artery, as in AVF creation, the vein experiences a 10x increase in pressure and flow that is traumatizing to veins. Many fail to become usable for dialysis,” Geoffrey Lucks, VenoStent COO and co-founder, says in a news release.

Enter VenoStent’s SelfWrap Bioabsorbable Perivascular Wrap, better known as simply SelfWrap. In May 2023, SelfWrap gained FDA approval to begin its US IDE Study, SAVE-FistulaS: The SelfWrap-Assisted ArterioVEnous Fistula Study.

Roughly half a million Americans need hemodialysis just to survive another day. Nearly all of those patients require a vascular access creation surgery, but the procedure has a 50-percent failure rate in its first year. VenoStent and SelfWrap are aimed at improving those odds. It works by using the body’s own healing mechanism.

SelfWrap is a flexible, bioabsorbable vascular wrap that helps to recreate the arterial environment in veins. Over time, the body replaces the SelfWrap with venous tissue.

The company has begun to enroll patients for what will eventually be a 200-subject study. Some of those people have radiocephalic fistulas, others have brachiocephalic ones. This is important, because it will likely prove that the technology works for most types of AVFs. The sites for this clinical trial are at the Surgical Specialists of Charlotte, P.A. in Charlotte, NC, and the Cardiothoracic and Vascular Surgeons in Austin.

“While it’s ambitious and sets a high bar for FDA Approval, we owe it to the chronic kidney disease (CKD) patient community to provide the highest level of clinical evidence,” Timothy Boire, CEO and cofounder, says in the release. “We’re confident based on years of preclinical and clinical data that we’ll demonstrate superiority to standard of care with this breakthrough technology.”

VenoStent recently completed a $16 million Series A, financed by Good Growth Capital and IAG Capital. This is the first-ever randomized controlled trial of a medical device designed to improve outcomes from arteriovenous fistula (AVF) creation surgery in the United States.

A Houston-based biotech company has completed early testing for its groundbreaking insulin alternative and is headed toward clinical trials. Photo via Getty Images

Houston startup completes testing, prepares biosimilar insulin drug for clinical trials

next steps

A Houston biotech startup is one step closer to releasing its marquee drug for the global insulin market, which is projected to break the $90 billion threshold by 2029.

rBIO says it recently completed testing of the properties of R-biolin, an insulin drug that’s biologically identical to Novo Nordisk’s Novolin drug. The patent for Novolin about two decades ago. In March 2023, the Dutch drugmaker announced it was slashing the list price of Novolin by 65 percent to $48.20 per vial and $91.09 per FlexPen.

Executives at rBIO are now pursuing a partnership with a contract research organization to manage clinical trials of R-biolin. If those trials go well, R-biolin will seek approval to supply its insulin therapy to diabetes patients around the world.

Washington University in St. Louis is rBIO’s academic partner for the R-biolin project.

The rBIO platform produces insulin at greater yields that traditional manufacturing techniques do. The company is striving to drive down the cost of insulin by 30 percent.

About 38 million Americans have diabetes, with the vast majority being treated for type 2 diabetes, according to the U.S. Centers for Disease Control and Prevention (CDC). Many people with diabetes must take insulin to control their blood sugar levels.

Research company iHealthcareAnalyst predicts the global market for insulin will surpass the $90 billion mark in 2029.

“There has been a lot of talk in the media about reducing the cost of insulin for diabetic patients, but what is often overlooked is that the domestic demand for insulin will soon outpace the supply, leading to a new host of issues,” Cameron Owen, co-founder and CEO of rBIO, says in a news release.

“We’re dedicated to addressing the growing demand for accessible insulin therapies, and … we’re thrilled to announce the viability of our highly scalable manufacturing process.”

Professionals from the University of California San Diego and Johns Hopkins University established rBIO in 2020. The startup moved its headquarters from San Diego to Houston in 2022.

CEO Cameron Owen and Chief Scientific Officer Deenadayalan Bakthavatsalam work on insulin purification in the Houston lab. Photo courtesy

Sieve Health is an AI cloud-based SaaS platform designed to automate and accelerate matching patients with clinical trials. Photo via Getty Images

Houston-based health tech startup is revolutionizing patient selection for clinical trials

working smarter

On many occasions in her early career, Dr. Arti Bhosale, co-founder and CEO of Sieve Health, found herself frustrated with having to manually sift through thousands of digital files.

The documents, each containing the medical records of a patient seeking advanced treatment through a clinical trial, were always there to review — and there were always more to read.

Despite the tediousness of prescreening, which could take years, the idea of missing a patient and not giving them the opportunity to go through a potentially life-altering trial is what kept her going. The one she didn’t read could have slipped through the cracks and potentially not given someone care they needed.

“Those stories have stayed with me,” she says. “That’s why we developed Sieve.”

When standard health care is not an option, advances in medical treatment could be offered through clinical trials. But matching patients to those trials is one of the longest standing problems in the health care industry. Now with the use of new technology as of 2018, the solution to the bottleneck may be a new automated approach.

“Across the globe, more than 30 percent of clinical trials shut down as a result of not enrolling enough patients,” says Bhosale. “The remaining 80 percent never end up reaching their target enrollment and are shut down by the FDA.”

In 2020, Bhosale and her team developed Sieve Health, an AI cloud-based SaaS platform designed to automate and accelerate matching patients with clinical trials and increase access to clinical trials.

Sieve’s main goal is to reduce the administrative burden involved in matching enrollments, which in turn will accelerate the trial execution. They provide the matching for physicians, study sponsors and research sites to enhance operations for faster enrollment of the trials.

The technology mimics but automates the traditional enrollment process — reading medical notes and reviewing in the same way a human would.

“I would have loved to use something like this when I was on the front lines,” Bhosale says, who worked in clinical research for over 12 years. “Can you imagine going through 10,000 records manually? Some of the bigger hospitals have upwards of 100,000 records and you still have to manually review those charts to make sure that the patient is eligible for the trial. That process is called prescreening. It is painful.”

Because physicians wear many hats and have many clinical efforts on their plates, research tends to fall to the bottom of the to-do list. Finding 10-20 patients can take the research team on average 15-20 months to find those people — five of which end up unenrolling, she says.

“We have designed the platform so that the magic can happen in the background, and it allows the physician and research team to get a jumpstart,” she says.” They don’t have to worry about reviewing 10,000 records — they know what their efforts are going to be and will ensure that the entire database has been scanned.”

With Sieve, the team was able to help some commercial pilot programs have a curated data pool for their trials – cutting the administrative burden and time spent searching to less than a week.

Sieve is in early-stage start up mode and the commercial platform has been rolled out. Currently, the team is conducting commercial projects with different research sites and hospitals.

“Our focus now is seeing how many providers we can connect into this,” she says. “There’s a bigger pool out there who want to participate in research but don’t know where to start. That’s where Sieve is stepping in and enabling them to do this — partnering with those and other groups in the ecosystem to bring trials to wherever the physicians and the patients are.”

Arti Bhosale is the co-founder and CEO of Sieve Health. Photo courtesy of Sieve

Houston-based Pulmotect announced a grant from the U.S. Department of Defense that will fund two COVID-19 drug trials. Photo via Getty Images

Houston biotech receives up to $6M federal grant for COVID-19 treatment

DOD delivered

The Pentagon is putting its financial power behind two COVID-19 clinical trials led by Houston-based biotech company Pulmotect Inc.

The U.S. Department of Defense is pumping as much as $6 million into the pair of Phase 2 trials, which involve a total of 300 U.S. participants, according to a January 27 news release from Pulmotect. When it's inhaled, Pulmotect's drug, PUL-042, stimulates the lungs' immune system to fight bacteria, viruses, or fungi that cause respiratory illnesses.

Pulmotect joins a number of Houston organizations that have tapped into Department of Defense funding for research into COVID-19 therapies.

In January, for instance, researchers at the University of Texas Health Science Center at Houston (UTHealth) collected $5.1 million from the department to evaluate whether an investigational oral drug, vadadustat, can help prevent acute respiratory distress syndrome (ARDS) in COVID-19 patients.

"It's wonderful that we have COVID-19 vaccinations available now, but they won't directly help patients who are already sick in the hospital or who will become sick in the future," Dr. Holger Eltzschig, chairman of Department of Anesthesiology at UTHealth's McGovern Medical School, says in a news release.

Also in January, Houston-based clinical research organization Pharm-Olam LLC sealed a $36.3 million deal with the Department of Defense to conduct a clinical trial of an antibody treatment for inflammatory problems associated with COVID-19.

So far, Pulmotect's PUL-042 has shown promise in battling the coronaviruses that trigger MERS (Middle East respiratory syndrome) and SARS (severe acute respiratory syndrome). The current trials related to the coronavirus that causes COVID-19 are evaluating PUL-042's effect on prevention of infections and reducing the severity of the disease.

Pulmotect initially designed PUL-042 to treat and prevent respiratory complications in cancer patients. But once the coronavirus pandemic set in, the company pivoted to testing the effectiveness of its drug in combatting the virus that causes COVID-19. Last May, the U.S. Food and Drug Administration (FDA) approved Pulmotect's COVID-19 trials.

Pulmotect says PUL-042 someday could be a therapy that's deployed during pandemics, epidemics, and bioterrorism attacks.

Invented at Houston's MD Anderson Cancer Center and at Texas A&M University, PUL-042 has earned patents in 10 countries. The National Institutes of Health, the Cancer Prevention and Research Institute of Texas, and other organizations have supported R&D for PUL-042.

Founded in 2007, Pulmotect emerged from Houston's Fannin Innovation Studio, which nurtures early stage companies in the life sciences sector. In September 2019, the company brought aboard Dr. Colin Broom as CEO. He previously was CEO of an Irish biopharmaceutical company.

Thus far, Pulmotect has garnered about $18 million in equity and about $20 million in other funding.

Before the pandemic, Pulmotect was evaluating the effectiveness of PUL-042 in treating patients with mild chronic obstructive pulmonary disease (COPD) who've been exposed to a respiratory virus.

COPD, which affects 30 million Americans, is the No. 3 cause of death in the U.S., according to the COPD Foundation. Pulmotect says 40 percent of COPD-related costs could be avoided by heading off complications and hospitalizations, which usually result from COPD problems caused by a bacterial or viral infection. In this context, the drug is meant to treat cancer patients undergoing chemotherapy whose weakened immune systems make them susceptible to pneumonia.

Pulmotect is headed to clinical trials to verify how its drug fights against COVID-19. Getty Images

Houston biotech company gets green light from FDA to test coronavirus-fighting drug

clinical trials bound

Houston biotech company Pulmotect Inc. has embarked on two clinical drug trials that could create weapons for the battle against the novel coronavirus.

Pulmotect gained permission from the U.S. Food and Drug Administration to test its inhaled drug, PUL-042, as a way to prevent coronavirus infections and to slow the early progression of COVID-19, the potentially fatal disease caused by the novel coronavirus. Pulmotect developed PUL-042 to activate the lungs' front-line defense against respiratory infections, and now it's being enlisted in the race to devise coronavirus treatments and cures.

"We have demonstrated PUL-042's unique ability to stimulate the immune system in the lungs to protect against a wide range of pathogens in multiple animal models," Dr. Colin Broom, CEO of Pulmotect, says in a May 7 release. "Pulmotect is optimistic that its immune-stimulating technology could be useful in mitigating the threats of [the coronavirus] and future emerging pathogens, and protecting vulnerable populations."

Unlike a vaccine, which typically takes 10 to 15 years to bring to the market, PUL-042 promises much faster deployment as scientists and health care workers wage war against COVID-19.

Each of the two clinical trials, both in the second phase, is being conducted at 10 sites across the U.S., including locations in Houston. In all, 20 sites are participating. Money for the trials came from the company's recently completed $12 million round of series B funding.

Pulmotect's partner in the trials is Covington, Kentucky-based CTI Clinical Trial and Consulting Services Inc. PARI Respiratory Equipment Inc., whose North American headquarters is in Midlothian, Virginia, is supplying medical equipment known as nebulizers to administer Pulmotect's inhaled drug.

"Both clinical trials are placebo-controlled to objectively evaluate safety and efficacy," Broom says in a May 5 release.

"In the first study, up to four doses of PUL-042 or placebo will be administered to 200 subjects by inhalation over a 10-day period to evaluate the prevention of infection and reduction in severity of COVID-19. In the second study, 100 patients with early symptoms of COVID-19 will receive the treatment administered up to three times over six days. In both trials, subjects will be followed up for 28 days to assess the effectiveness and tolerability of PUL-042."

Previous experiments conducted by Pulmotect indicate PUL-042 effectively protects mice against severe acute respiratory syndrome (SARS) and Middle East respiratory syndrome (MERS), which are caused by coronaviruses that differ from the COVID-19 virus. Researchers performed those tests at the University of Texas Medical Branch at Galveston.

PUL-042 initially was developed to fight respiratory problems in cancer patients undergoing chemotherapy, which weakens the immune system. But the drug offers the potential to prevent or treat an array of respiratory infections caused by viruses, bacteria, or fungi.

"We have always considered PUL-042 to have the potential for the prevention and treatment of emerging epidemics and pandemics like the one we currently face," Broom says.

A separate trial of PUL-042 is underway in London. There, the drug is being tested on patients with chronic obstructive pulmonary disease (COPD) who are susceptible to lung infections. COPD is an inflammatory disease that blocks airflow from the lungs. People with COPD face a heightened risk of conditions like heart disease and lung cancer, the Mayo Clinic says.

Researchers at MD Anderson Cancer Center and Texas A&M University invented Pulmotect's PUL-042, which holds patents in 10 countries. Pulmotect, founded in 2007, emerged from Houston's Fannin Innovation Studio, which fosters early stage companies in the life sciences sector.

Ad Placement 300x100
Ad Placement 300x600

CultureMap Emails are Awesome

Property Showcase

Rice University's edtech company receives $90M to lead NSF research hub

major collaboration

An educational technology company based out of Rice University has received $90 million to create and lead a research and development hub for inclusive learning and education research. It's the largest research award in the history of the university.

OpenStax received the grant funding from the U.S. National Science Foundation for a five-year project create the R&D hub called SafeInsights, which "will enable extensive, long-term research on the predictors of effective learning while protecting student privacy," reads a news release from Rice. It's the NSF's largest single investment commitment to national sale education R&D infrastructure.

“We are thrilled to announce an investment of $90 million in SafeInsights, marking a significant step forward in our commitment to advancing scientific research in STEM education,” NSF Director Sethuraman Panchanathan says in the release. “There is an urgent need for research-informed strategies capable of transforming educational systems, empowering our nation’s workforce and propelling discoveries in the science of learning.

"By investing in cutting-edge infrastructure and fostering collaboration among researchers and educators, we are paving the way for transformative discoveries and equitable opportunities for learners across the nation.”

SafeInsights is funded through NSF’s Mid-scale Research Infrastructure-2 (Mid-scale RI-2) program and will act as a central hub for 80 partners and collaborating institutions.

“SafeInsights represents a pivotal moment for Rice University and a testament to our nation’s commitment to educational research,” Rice President Reginald DesRoches adds. “It will accelerate student learning through studies that result in more innovative, evidence-based tools and practices.”

Richard Baraniuk, who founded OpenStax and is a Rice professor, will lead SafeInsights. He says he hopes the initiative will allow progress to be made for students learning in various contexts.

“Learning is complex," Baraniuk says in the release. "Research can tackle this complexity and help get the right tools into the hands of educators and students, but to do so, we need reliable information on how students learn. Just as progress in health care research sparked stunning advances in personalized medicine, we need similar precision in education to support all students, particularly those from underrepresented and low-income backgrounds.”

OpenStax awarded $90M to lead NSF research hub for transformational learning and education researchwww.youtube.com

2 Houston startups selected by US military for geothermal projects

hot new recruits

Two clean energy companies in Houston have been recruited for geothermal projects at U.S. military installations.

Fervo Energy is exploring the potential for a geothermal energy system at Naval Air Station Fallon in Nevada.

Meanwhile, Sage Geosystems is working on an exploratory geothermal project for the Army’s Fort Bliss post in Texas. The Bliss project is the third U.S. Department of Defense geothermal initiative in the Lone Star State.

“Energy resilience for the U.S. military is essential in an increasingly digital and electric world, and we are pleased to help the U.S. Army and [the Defense Innovation Unit] to support energy resilience at Fort Bliss,” Cindy Taff, CEO of Sage, says in a news release.

A spokeswoman for Fervo declined to comment.

Andy Sabin, director of the Navy’s Geothermal Program Office, says in a military news release that previous geothermal exploration efforts indicate the Fallon facility “is ideally suited for enhanced geothermal systems to be deployed onsite.”

As for the Fort Bliss project, Michael Jones, a project director in the Army Office of Energy Initiatives, says it’ll combine geothermal technology with innovations from the oil and gas sector.

“This initiative adds to the momentum of Texas as a leader in the ‘geothermal anywhere’ revolution, leveraging the robust oil and gas industry profile in the state,” says Ken Wisian, associate director of the Environmental Division at the U.S. Bureau of Economic Geology.

The Department of Defense kicked off its geothermal initiative in September 2023. Specifically, the Army, Navy, and Defense Innovation Unit launched four exploratory geothermal projects at three U.S. military installations.

One of the three installations is the Air Force’s Joint Base San Antonio. Canada-based geothermal company Eavor is leading the San Antonio project.

Another geothermal company, Atlanta-based Teverra, was tapped for an exploratory geothermal project at the Army’s Fort Wainwright in Alaska. Teverra maintains an office in Houston.

------

This article originally ran on EnergyCapital.

Houston investor calls for all angels to move the ecosystem forward

houston innovators podcast episode 233

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."



HAN, a nonprofit, provides a unique opportunity for its members, as Miller explains. The group consists of around 100 individuals from all business backgrounds, so evaluating companies together brings more than just a wealth of capital — but also a wealth of knowledge.

"What HAN provides is access to investments," Miller says, adding that members have the benefit in evaluating companies together with people from different backgrounds. "Inside a group like HAN, we have extraordinary expertise."

In addition to educating both founders and investors in the process, Miller has dedicated herself to providing opportunities for students in low-income parts of Houston to learn about the startup world. Eight years ago, she founded Eagle Investors, an organization that provides a year-long program that culminates in a group of students participating as judges for the Rice Business Plan Competition.

"They spend a year learning about innovation, entrepreneurship, and investing by meeting local investors, entrepreneurs, and service providers. They go around Houston to get to visit and ... experience all of the ecosystem," Miller says.

At RBPC, the cohort of high school students evaluate the pitches and select a company to provide a $5,000 prize.

Miller herself has been a judge at RBPC for 20 years now, and she's had a front row seat for watching Houston develop as an ecosystem. She's seen the city make real progress, but has one major call to action.

"The piece that I am most aware of that I would like to see grow is activating more accredited investors who are interested in this asset class of early-stage companies and plugging in," Miller says. "They can also invest their time and knowledge to help companies in our region grow and scale."

View All Listings