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 mental health nonprofit expands platform statewide to connect more Texans with care

access granted

As mental health conversations evolve, the necessary pivot becomes how organizations across Texas navigate improved ways to help people access the care they need before their challenges become crises.

That’s why Mental Health America of Greater Houston recently announced that it is expanding its Care Connect platform statewide.

The expansion will address perhaps the most persistent barrier to behavioral healthcare—helping people find and navigate services that already exist.

Care Connect’s extended reach comes at a time when more than 3.5 million adults in the state live with some kind of mental health condition and scores of those in need continue to struggle with accessing care despite the growing awareness of mental health needs.

According to President and CEO Renae Vania Tomczak, Care Connect’s main goal was to remove as many obstacles as possible that Texans face when seeking mental health support.

“Care Connect was about a two-year planning process,” Tomczak says. “It really began with asking what challenges people in the Greater Houston Area were facing regarding mental health. It’s not just accessing care, but the difficulty in navigating the mental healthcare system.”

While provider shortages remain a challenge in some communities, Mental Health America of Greater Houston found that many individuals and families struggle simply to determine where to turn, how to identify the right provider and whether services are affordable.

“We wanted to make it easier for people who have questions, who may never have had a mental health challenge before, or they’re a caregiver for somebody who has a mental health issue,” Tomczak says. “We wanted to be the place that people can come to get their questions answered and be connected to care.”

Care Connect combines a vetted network of more than 1,000 providers and services across Texas with personalized navigation support.

Searches generate care results based on insurance coverage, language preferences, ZIP code and clinical specialties.

Additionally, one-on-one guidance and follow-up support are provided by bilingual resource specialists.

The platform also seeks to address affordability, one of the most significant barriers to mental healthcare access. Through participating providers, eligible individuals can receive six to eight counseling sessions at no cost.

“We have several providers who are willing to provide six to eight counseling sessions at no cost for people who do not have the means to pay for services themselves,” Tomczak says.

When provider matches are unavailable, the organization can connect individuals with master’s-level mental health professionals working under the supervision of licensed clinicians.

The statewide rollout builds on the platform’s early success in the Houston region, where it has helped thousands of individuals connect with mental health resources since launching last fall.

According to Tomczak, the decision to expand was driven in part by growing demand from outside the organization’s traditional service area.

“Last month we decided to take this program statewide,” she says. “It’s not just Houston that can use help in connecting to appropriate mental health services, but the whole state.”

The Care Connect program’s promotion through healthcare providers, community organizations and public-sector partners across Texas is now one of Mental Health America of Greater Houston’s top priorities.

Their goal is to create a stronger referral ecosystem that ultimately helps those who need access to mental health care more quickly.

To facilitate that, the organization has also added free mental health screenings to its website so that users will better identify any symptoms related to anxiety, depression and other conditions.

“Once they do that, then where do they go?” Tomczak says. “They’re not sure who to call and who can help them. At that point, we hope they’ll call us and talk to somebody live who can answer their questions and help them get started on the right path to improving their mental health.”

With eyes on the future, Tomczak believes public understanding of mental health has improved in recent years, particularly following the COVID-19 pandemic, which brought new attention to the effects of stress, isolation and uncertainty.

“The more we talk about it and have the opportunity to share that mental health conditions are traceable, the better,” she says.

According to Tomczak, long-term, Care Connect aims to reduce roadblocks that exist between recognizing the need for help and receiving it.

Ultimately, Care Connect hopes to create a robustly connected behavioral health system that gives Texans the ability to access mental health services swiftly and with confidence.

“No one should have to navigate mental health challenges alone,” Tomczak adds. “Care Connect is here to help connect people with resources, services and answers to ensure they get the care they need to take the next step toward better mental health.”

ExxonMobil sets date to make Texas its legal HQ

save the date

Energy giant Exxon Mobil Corp. has set a date to move its legal headquarters to Texas.

The Spring-based company announced this week that the redomiciliation from New Jersey to Texas is expected to be effective July 1. Exxon's board of directors unanimously recommended redomiciling in the Lone Star State in March, and shareholders approved the move to Texas at the company’s annual meeting in May.

As part of the move, ExxonMobil Holdings Corp. will replace Exxon Mobil Corp. of New Jersey and become the publicly traded parent company. Exxon reports that its shares will continue to trade on the New York Stock Exchange under the ticker symbol “XOM,” and that shareholders do not need to take action.

At the time of the recommendation, Exxon said the move would not affect business operations, management, strategy, assets or employee locations.

Exxon Chairman and CEO Darren Woods added that the redomiciliation was in part due to Texas' business-friendly environment and policies.

"Over the past several years, Texas has made a noticeable effort to embrace the business community. In doing so, it has created a policy and regulatory environment that can allow the company to maximize shareholder value,” Woods said in a news release. "Aligning our legal home with our operating home, in a state that understands our business and has a stake in the company’s success, is important.”

The Associated Press reports that about 30 percent of Exxon's employees work in Texas. Exxon's legal headquarters has been based in New Jersey since 1882, when it was Standard Oil Company.

Exxon moved its operational headquarters from Irving, Texas, to the Houston area in 2023.

Exxon was the highest-ranking Houston-area company on this year's Fortune 500 list, coming in at No. 9. Houston tied with Chicago for the second-most Fortune 500 headquarters on this year's list, with Texas leading the nation for the most Fortune 500 headquarters (57).

“Texas is the undisputed headquarters of headquarters,” Gov. Greg Abbott said in a news release. “The world’s leading businesses invest with confidence in Texas because of our welcoming business climate, predictable regulatory environment, and skilled and growing workforce. People and businesses are choosing Texas because Texas works.”

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

Axiom Space officially redomiciles its headquarters in Texas

space city

Axiom Space has claimed Houston as its operational home since 2016. And now it can call Texas its official legal headquarters, too.

The spacetech company, which is developing the first commercial space station, Axiom Station, has officially redomiciled its legal headquarters from Delaware to Texas, Axiom announced this week.

Axiom employs approximately 700 people, the majority of whom are in Texas, according to a news release. Its Assembly Integration and Test Facility was built as an anchor of the Houston Spaceport, and the company is also developing next-generation spacesuits at its Houston-based spacesuit lab.

“Texas has demonstrated, consistently and deliberately, that it wants innovative companies to thrive here and has built the policy and regulatory framework accordingly,” Jonathan Cirtain, CEO and president of Axiom Space, said in the release. “For Axiom Space, establishing Texas as both our operational and legal home puts us squarely in a state that understands our mission, supports our industry, and shares in what we are working to achieve.”

Axiom touts Texas's "financial and infrastructural commitments" to the space economy as reasons for the move, including programs and grants from organizations such as the Texas Space Exploration & Aeronautics Research Fund (SEARF), the Texas Space Commission, and the Texas A&M Space Institute.

Axiom was previously awarded a $5.5 million SEARF grant for the development of its orbital data center capabilities last year.

The news comes as energy giant ExxonMobil also announced concrete plans to redomicile its legal headquarters in Texas. Exxon's board of directors unanimously recommended redomiciling in the Lone Star State in March. The company announced this week that the move would become official July 1. The company's operational headquarters is based in Spring, Texas, a Houston-area suburb.

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