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

clinical trials bound

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

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.

These Houston startups have created health care-related solutions amid the coronavirus outbreak. Getty Images

These 7 Houston health tech companies are providing COVID-19 solutions

startups to the rescue

It's all hands on deck in Houston in the battle against coronavirus — and local biotech startups have risen to the occasion.

From mental health solutions and online portals to virtual medicine and new treatments, these Houston companies have recently launched or pivoted to new options in health care.

Mental Health Match

Ryan Schwartz is offering free counseling to Texans. Photo courtesy of Mental Health Match

Mental Health Match, a Houston-based startup that uses tech to easily connect people to mental health professionals, has announced the opportunity for 100 Texas residents to get their first appointment free and remotely.

The company cites data that shows:

A 78 percent increase in Texans who are concerned about their marriage
A 71 percent increase in Texans concerned with their parenting or their children
A 35 percent spike in Texans feeling panicked

"You might be practicing social distancing, but you are not alone. It is easier to make it through this together if you can get support and guidance from a skilled professional. That's why we're working with therapists across Texas to provide a free session to individuals who need it most," says Ryan Schwartz, founder of Mental Health Match, in a news release.

Texans can apply for the free sessions online on a first-come, first-served basis.

Medical Informatics Corp.

Medical Informatics Corp.'s Sickbay platform can monitor patients from afar. Photo via michealthcare.com

Houston-based Medical Informatics has created a virtual ICU program, called Sickbay, and the tech tool is being used to remotely monitor patients in Houston Methodist. The program works around the clock from a control hub to use artificial intelligence and algorithms to monitor patients.

The company, which recently moved into its office in TMCx+, announced major growth in January, just ahead of the coronavirus outbreak.

"We designed our Sickbay platform to give lost data back to doctors, nurses and other members of the care team so they could save more lives," says Vincent Gagne, vice president of product for MIC, in a news release. "In fact, our apps are built in collaboration with our clients, such as Texas Children's Hospital and Houston Methodist. Having these facilities blocks away from our headquarters accelerates that collaboration and development."

MolecularMatch

MolecularMatch is bringing together COVID-19 information and trials. Photo via molecularmatch.com

MolecularMatch, a Houston startup focused on clinical informatics, has launched a free portal that accumulates research and clinical trials for COVID-19. The company is a tenant of TMCx+ and a portfolio company of Houston-based venture capital group GOOSE.

"The number of therapeutic cures and vaccines being tested are growing at an astounding rate," says Eric Pulaski, CEO at MolecularMatch, in a news release. "Our tools make it easier for clinicians and patients to find the help they need. Hopefully, we can help save lives by shortening the time it takes to get more patients into clinical trials and by speeding up research to find cures and vaccines."

The product uses the company's artificial intelligence-backed curation platform and is updated every two to three days.

Luminare

Luminare Inc. pivoted to quickly create an online COVID-19 screening tool, and local governments have tapped into the resource. Andriy Onufriyenko/Getty Images

Founded in 2014, Houston-based health care software startup Luminare Inc. seeks to prevent sepsis, a life-threatening reaction to a host of infections that causes about one-third of U.S. hospital deaths. Recently, though, Luminare pivoted to address another health concern — the threat of the novel coronavirus.

After the novel coronavirus surfaced, Luminare retooled its sepsis-detection platform to create a free online self-assessment test for people who suspect they've contracted the virus. The test, available at CheckForCorona.com, helps someone figure out whether they should seek a coronavirus test.

An online screening typically takes less than two minutes. The confidential, secure assessment complies with guidelines from the U.S. Centers for Disease Control and Prevention (CDC) and the World Health Organization (WHO). Based on your assessment results, you might be directed to contact your local health department or, in the worst-case scenario, call 911. Click here to read more.

Manatee

Manatee users can sign up for three months free. Photo via getmanatee.com

Denver-based Manatee was just announced to be selected for the 2020 TMCx cohort, and — while programming is beginning virtually — the startup will be enroute to Houston as soon as it's safe. Manatee focuses on providing connected, everyday therapy for kids.

In light of the effects of COVID-19 on both parents and children, Manatee has allowed users to register for three months free. Individuals can apply online.

Moleculin Biotech Inc.

Houston-based Moleculin, which works on oncology treatment, has filed a patent for its treatment to battle the coronavirus. Getty Images

Houston-based Moleculin Biotech Inc., a clinical stage pharmaceutical company that typically focuses on cancer treatment, announced that it has filed for a new patent for its use of one of its products to be used against the coronavirus and other potential viruses.

This patent application is for Moleculin's WP1122, and the company has entered into a partnership with a major Texas university to advance its research.

"We've actually been working on the antiviral potential of WP1122 for some time now," says Walter Klemp, Moleculin's chairman and CEO, in a news release, "but the rise of COVID-19 has obviously placed a new sense of urgency on what we are doing. We hope to be generating animal data on WP1122's antiviral potential in the near term."

Pulmotech Inc.

Pulmotect, a clinical-stage biotechnology company based in Houston, is testing a drug that could be useful in mitigating the threats of the coronavirus, which is currently been recognized as a global health emergency. Getty Images

Experiments conducted by clinical-stage, Houston-based biotechnology company Pulmotect Inc. show its PUL-042 inhaled drug has proven effective in protecting mice against two types of coronavirus: severe acute respiratory syndrome (SARS) and Middle East respiratory syndrome (MERS). Researchers performed those tests at the University of Texas Medical Branch at Galveston.

In the Galveston experiments, a single inhaled dose of PUL-042 protected lab mice from the SARS virus, and it greatly reduced the amount of virus in their lungs after the mice became infected with SARS or MERS.

"With the risks of virulent coronaviruses and other threats increasing, as shown by the recent outbreak in Wuhan that has already spread from China to other countries including the United States, Pulmotect is optimistic that its immune-stimulating technology could be useful in mitigating the threats of current and emerging pathogens and protecting vulnerable populations," says CEO Dr. Colin Broom in a news release. Click here to read more.

Houston biotech company is creating a drug that could fight the coronavirus

Med tech

A drug being developed by a Houston biopharmaceutical company eventually could help combat what the World Health Organization has proclaimed a global health emergency.

Experiments conducted by clinical-stage biotechnology company Pulmotect Inc. show its PUL-042 inhaled drug has proven effective in protecting mice against two types of coronavirus: severe acute respiratory syndrome (SARS) and Middle East respiratory syndrome (MERS). Researchers performed those tests at the University of Texas Medical Branch at Galveston.

The ability of PUL-042 to ward off the newest type of coronavirus, 2019-nCoV, hasn't been tested yet. However, the drug eventually could help prevent the new virus from spreading, says Broom, who joined Pulmotect as CEO last fall. A separate study would be required to evaluate PUL-042 in patients exposed to 2019-nCoV, he says.

"PUL-042 has the potential to prevent and treat respiratory complications in many high-risk patient populations, including those where no effective therapies are currently available, as is the case with the current coronavirus outbreak," Brenton Scott, president and chief operating officer of Pulmotect, says in the release.

Since its discovery in late December 2019 in Wuhan, China, nearly 9,800 people around the world were infected with 2019-nCoV as of January 31, The New York Times reported. Of those people, more than 200 died. On January 30, the World Health Organization (WHO) declared the virus outbreak a global health emergency.

No specific treatment or cure for 2019-nCoV virus is available. This virus is among seven known coronaviruses.

Symptoms of the Wuhan coronavirus include fever, cough, and shortness of breath, according to the U.S. Centers for Disease Control and Prevention (CDC). The virus can cause pneumonia, SARS, kidney failure, or even death, the Virginia Department of Health says.

PUL-042 "would be a great tool to have available for future outbreaks and epidemics, in addition to being used more routinely for more common infections," Broom says.

Fighting coronaviruses is a potential byproduct of PUL-042.

Initially, Pulmotect is focusing development of PUL-042 on the prevention and treatment of respiratory complications suffered by cancer patients with suppressed immune systems. Phase 1 clinical trials already have taken place in the U.S., and Phase 2 clinical trials are scheduled for later this year.

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 prone 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.

Broom says PUL-042 is a few years away from being considered for approval by the U.S. Food and Drug Administration (FDA).

To date, Pulmotect has raised more than $28 million in outside funding. Founded in 2007, Pulmotect emerged from Houston's Fannin Innovation Studio, which nurtures early stage companies in the life sciences sector.

Patents for PUL-042, invented by MD Anderson Cancer Center and Texas A&M University, have been issued in nine countries.

A Houston biotech company has a new CEO and is ready for growth. Getty Images

Houston biopharmaceutical company brings on new CEO to grow company

Head honcho

With a veteran of the biopharmaceutical industry now aboard as its CEO and an executive at pharmaceutical giant AstraZeneca now serving on its board, Houston-based biopharmaceutical company Pulmotect Inc. is poised for progress.

In September, Dr. Colin Broom joined Pulmotect as CEO. He previously was CEO of Ireland-based Nabriva Therapeutics plc, a biopharmaceutical company that went public in 2015. During Broom's tenure at Nabriva, he helped develop the recently approved drug Xenleta, which treats bacterial pneumonia. Before that, he was chief scientific officer at Pennsylvania-based pharmaceutical company ViroPharma Inc., which Massachusetts-based Shire plc purchased for $4.2 billion in 2014.

Broom's hiring came on the heels of Kumar Srinivasan being named to Pulmotect's board of directors. Srinivasan is vice president of United Kingdom-based AstraZeneca and is its global head of business development and licensing for biopharmaceuticals R&D.

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

"Attracting such a highly regarded and proven CEO as Colin is a clear signal of the power and potential of Pulmotect's development program," Pulmotect's executive chairman, Leo Linbeck III, founder and chairman of Fannin, says in a release. "Under his leadership, I'm confident that we will advance our technology further into the clinic and closer to the marketplace. His addition is a real game-changer for the company."

Both Broom and Srinivasan are focusing on clinical trials for Pulmotect's PUL-042 product, an inhaled therapy that holds the potential to prevent or treat respiratory infections caused by bacteria, viruses, or fungi. The current Phase 2 trial is evaluating the effectiveness of PUL-042 in treating patients with mild chronic obstructive pulmonary disease (COPD) who've been exposed to a respiratory virus. The current trial is supposed to be followed by additional Phase 2 trials.

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 preventing complications and hospitalizations, which typically result from COPD problems triggered by a bacterial or viral infection. PUL-042 could substantially decrease those complications, the company says.

Pulmotect seeks to gear PUL-042 toward patients with cancer who are undergoing chemotherapy, as their weakened immunity makes them highly susceptible to pneumonia, Broom says. If the product proves effective with those patients, then people at risk of developing respiratory infections also might benefit from it, including COPD patients and flu patients, he says.

To date, Pulmotect has raised more than $28 million in funding. That includes about $18 million in research grants, including a $7 million grant from the Cancer Prevention and Research Institute of Texas, as well as seven grants from the Small Business Innovation Research program.

Two of Pulmotect's three full-time employees work in Houston, and a team of consultants supports their work, Broom says. A small number of employees might be added during the current Phase 2 trial. Hiring would need to be ramped up if the Phase 2 trial demonstrates that PUL-042 works, he says.

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Houston founders launch edtech startup, pilot to pinpoint why students are struggling

learning gaps

Early detection. It sounds simple enough: identify a problem before it has the chance to become a bigger one.

But in practice, early detection is much more difficult to navigate, especially in education, when it comes to identifying the reasons behind a student's academic struggles.

That’s why co-founders Alapati “Al” Ware and Estela Montanez launched Progress Report, a Houston-built K-12 learning-intelligence platform designed to go beyond identifying that a student is struggling.

The platform recently began its pilot program with 35 educators and more than 200 students in Texas and Arizona.

“It’s a micro-learning school that works with children with disabilities, primarily dyslexia and nonverbal students,” Ware tells InnovationMap.

The platform is also being used by homeschool parents, home teachers and Houston educators, including those at SWPS College & Career Preparatory Academy, a Houston charter school.

Ware says Progress Report was designed to fill a gap he and Montanez saw in existing edtech. Some platforms cater almost entirely to students, leaving teachers with little insight into if and how a child is learning. Others focus heavily on district data, where “the student is just a number,” leaving teachers to navigate disconnected tools.

“Our goal was [to] focus purely on the teacher because the teacher is the backbone,” Ware says.

Progress Report traces student performance to learning gaps and prerequisite skills, helping educators understand not only where a student is struggling, but what may be causing it.

The platform then helps teachers build individualized instruction for general education students, students with special education and Individualized Education Program (IEP) needs, and Spanish-speaking learners—all within one educator-controlled system.

The goal is to reduce the guesswork and hours of manual work educators can spend developing individualized lesson plans.

Progress Report helps idenitify learning gaps and common roadblocks for each student. Image courtesy Progress Report

For Ware and Montanez, the mission is also personal.

The concept dates back to around 2023, when the co-founders first had to navigate and address their children’s educational needs.

Ware, Progress Report’s CEO and CTO with a background in edtech, built the platform end-to-end after watching his daughter, who had an IEP related to speech, struggle to get the support she needed.

Montanez, the company’s COO, brought another perspective. Her son is on the autism spectrum. She now leads Progress Report’s operations, partnerships and pilot execution while helping carry its focus on bilingual families from Puerto Rico to Houston.

Together, they began researching ways to personalize their children’s learning and help them progress academically. Montanez’s son went on to become an AP student and high school athlete, while Ware’s daughter began reading more than two grade levels above her grade, they tell InnovationMap.

But Progress Report isn’t designed simply to give a struggling student more work.

Take a student who appears to have difficulty with math.

The problem may not actually be math, the founders share. The student could understand the calculations but struggle to comprehend complex words used in a math problem.

Progress Report is designed to trace those performance patterns back to learning gaps, prerequisite skills or other instructional barriers. From there, it can recommend a next instructional step while leaving the educator in control.

The same concept applies to accommodations.

The system can read IEPs, 504 Plans, Present Levels of Academic Achievement and Functional Performance (PLAAFPs), evaluations and other special education records. Approved IEP goals can then be mapped into the student’s learning graph, while accommodations can carry over into lesson planning and question delivery.

The founders say that approach separates Progress Report from simply adding another artificial intelligence chatbot to a classroom. And still, they believe teachers have to remain at the center.

Teachers, in fact, helped build Progress Report.

The founders began meeting with Houston-area educators months before the pilot. Their feedback helped shape the platform before testing began.

“We’ve been building alongside these educators,” Ware says.

Parents are another piece.

Progress Report can give parents access to their child’s learning record so they can see learning gaps as they develop. Teachers can also see information on work being completed at home when the parent and educator are working together.

After the pilot wraps, Ware and Montanez plan to introduce a $29.99 monthly subscription for homeschool parents, teachers and other educators. They say the price was intentionally kept relatively low to help make the tools more accessible.

They are also exploring ways to work with organizations that could help families who can’t afford the platform.

Moving forward, the goal is considerably bigger.

Over the next five years, Ware and Montanez want Progress Report to become what they describe as a “gold standard” in every state. They know getting there will require building relationships with educators, technology leaders, policymakers and school board members.

For now, they’re starting with a few hundred students and a question that sounds simple but can be remarkably difficult to answer: Why is this student struggling?

If Progress Report works the way its founders envision, teachers and parents will have a clearer answer.

Pioneering cohousing development opens in Houston's historic 2nd Ward

Housing in Hou

An experimental, multi-generational building in the East End is now open and accepting residents. Only 10 of the 33 units remain available at East End Commons, the first project from CoHousing Houston.

Located at 115 Lenox, East End Commons was first conceived in 2017 and is designed to combine the security of home ownership with the community aspect of apartment life, essentially a condominium but with added focus on bringing neighbors together.

Units range from 900-2,000 square feet, offering ample private home space, but with a large Common House area and central courtyard for gatherings, working, and interaction. Large front porches encourage people to spend time outside where they can meet their neighbors, as do extensive foot paths for casual meetings.

"At East End Commons, you know your neighbors before you move in — so you have a network of people and spaces that are immediately there for you," said founding resident Kelli Soika. "We designed for larger shared spaces versus larger personal spaces in order to foster the breakdown of the barriers that lead to loneliness."

Combating loneliness and isolation is certainly necessary. A 2025 survey conducted by the American Psychological Association shows that most Americans feel a sense of societal division and lonely. A loss of "third spaces," where people gather outside the home or work, is a prime factor. East End Commons aims to alleviate some of that disconnectedness.

"I wanted to live in a neighborhood that is imbued with a sense of community above the individual, like we have all experienced in Houston during times of disaster recovery," said Lynn Morstead, one of East End Commons‘ founding residents. "In those instances, such as Hurricane Harvey, we surface from our separateness and come together in new and unexpected ways. With East End Commons, the goal is to translate that notion beyond a set period of time and make it a fixture of everyday life. I call it 'disaster-free neighborliness.'"

East End Commons was designed by Kathleen English of English + Associates. Sustainability is part of the project's design, with amenities such as geothermal heating and cooling exchange HVAC, pre-heated water systems, low-energy use air conditioning and heating, and native landscaping.

Prices for units range from $300,000 to the $900,000s, which can be more than double the home price in the rapidly gentrifying East End. HOA fees not only help maintain communal areas, they also cover shared internet, water, and other communal expenses. Similarly, government of the building is handled democratically via a community board that aims to make decisions by building consensus.

For more information, email info@cohousinghouston.com or call 832-900-2919.

MD Anderson president to retire after nine years, interim successor named

retirement plan

An era is ending at The University of Texas MD Anderson Cancer Center.

On Aug. 26, Dr. Peter WT Pisters announced his plans to retire from his role as president of the comprehensive cancer center. He will work on a smooth transition of leadership with interim president Dr. Jeffrey E. Lee throughout September.

“I first arrived at UT MD Anderson 32 years ago with a passion for doing everything I could to advance our mission to end cancer. Serving as the only faculty member to become president, and now marking nine years in the role, I can say with great pride and gratitude that there is no better place than UT MD Anderson to turn hope into healing for patients and families everywhere,” Pisters said in a news release. “With a timeless strategy, a strong leadership team, unprecedented levels of financial health, and a priceless culture anchored in our deeply held Core Values, now is the right time for me to transition to other opportunities. UT MD Anderson has never been stronger, and its future has never been brighter.”

Pisters assumed the presidency in 2017 and helped launch some of the most cutting-edge new clinics in MD Anderson history. One of those was the James P. Allison Institute, named for the Nobel Laureate scientist who discovered a way to suppress immune response on tumors so that immune cells would attack cancer cells instead. As head of his titular clinic, Allison pioneered several new immunotherapies against cancer.

Pisters also oversaw the creation of the Institute for Data Science in Oncology in 2024, an innovative consortium of scientists dedicated to enhancing single-cell imaging to improve precision in cancer treatments. The institute also brought together teams to use data-driven analytics regarding safety, quality and access.

The UT System Board of Regents praised the leadership and work of Pisters in a statement, wishing him well in the next phase of his career.

“The Board of Regents and I are profoundly grateful to Dr. Pisters for his exceptional presidency over the past nine years and for thoughtfully concluding his service when UT MD Anderson is thriving at its best position of peak performance, strength and impact. We wish him our very best with his retirement and in his next chapter,” Kevin P. Eltife, chairman of the UT System Board of Regents, added in the release.

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