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.

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

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.

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.

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 team’s discovery brings solid-state batteries closer to EV use

A Better Battery

A team of researchers from the University of Houston, Rice University and Brown University has uncovered new findings that could extend battery life and potentially change the electric vehicle landscape.

The team, led by Yan Yao, the Hugh Roy and Lillie Cranz Cullen Distinguished Professor of Electrical and Computer Engineering at UH, recently published its findings in the journal Nature Communications.

The work deployed a powerful, high-resolution imaging technique known as operando scanning electron microscopy to better understand why solid-state batteries break down and what could be done to slow the process.

“This research solves a long-standing mystery about why solid-state batteries sometimes fail,” Yao, corresponding author of the study, said in a news release. “This discovery allows solid-state batteries to operate under lower pressure, which can reduce the need for bulky external casing and improve overall safety.”

A solid-state battery replaces liquid electrolytes found in conventional lithium-ion cells with a solid separator, according to Car and Driver. They also boast faster recharging capabilities, better safety and higher energy density.

However, when it comes to EVs, solid-state batteries are not ideal since they require high external stack pressure to stay intact while operating.

Yao’s team learned that tiny empty spaces, or voids, form within the solid-state batteries and merge into a large gap, which causes them to fail. The team found that adding small amounts of alloying elements, like magnesium, can help close the voids and help the battery continue to function. The team captured it in real-time with high-resolution videos that showed what happens inside a battery while it’s working under a scanning electron microscope.

“By carefully adjusting the battery’s chemistry, we can significantly lower the pressure needed to keep it stable,” Lihong Zhao, the first author of this work, a former postdoctoral researcher in Yao’s lab and now an assistant professor of electrical and computer engineering at UH, said in the release. “This breakthrough brings solid-state batteries much closer to being ready for real-world EV applications.”

The team says it plans to build on the alloy concept and explore other metals that could improve battery performance in the future.

“It’s about making future energy storage more reliable for everyone,” Zhao added.

The research was supported by the U.S. Department of Energy’s Battery 500 Consortium under the Vehicle Technologies Program. Other contributors were Min Feng from Brown; Chaoshan Wu, Liqun Guo, Zhaoyang Chen, Samprash Risal and Zheng Fan from UH; and Qing Ai and Jun Lou from Rice.

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This article originally appeared on EnergyCaptialHTX.com.

Rice biotech accelerator appoints 2 leading researchers to team

Launch Pad

The Rice Biotech Launch Pad, which is focused on expediting the translation of Rice University’s health and medical technology discoveries into cures, has named Amanda Nash and Kelsey L. Swingle to its leadership team.

Both are assistant professors in Rice’s Department of Bioengineering and will bring “valuable perspective” to the Houston-based accelerator, according to Rice. 

“Their deep understanding of both the scientific rigor required for successful innovation and the commercial strategies necessary to bring these technologies to market will be invaluable as we continue to build our portfolio of lifesaving medical technologies,” Omid Veiseh, faculty director of the Launch Pad, said in a news release.

Amanda Nash

Nash leads a research program focused on developing cell communication technologies to treat cancer, autoimmune diseases and aging. She previously trained as a management consultant at McKinsey & Co., where she specialized in business development, portfolio strategy and operational excellence for pharmaceutical and medtech companies. She earned her doctorate in bioengineering from Rice and helped develop implantable cytokine factories for the treatment of ovarian cancer. She holds a bachelor’s degree in biomedical engineering from the University of Houston.

“Returning to Rice represents a full-circle moment in my career, from conducting my doctoral research here to gaining strategic insights at McKinsey and now bringing that combined perspective back to advance Houston’s biotech ecosystem,” Nash said in the release. “The Launch Pad represents exactly the kind of translational bridge our industry needs. I look forward to helping researchers navigate the complex path from discovery to commercialization.”

Kelsey L. Swingle

Swingle’s research focuses on engineering lipid-based nanoparticle technologies for drug delivery to reproductive tissues, which includes the placenta. She completed her doctorate in bioengineering at the University of Pennsylvania, where she developed novel mRNA lipid nanoparticles for the treatment of preeclampsia. She received her bachelor’s degree in biomedical engineering from Case Western Reserve University and is a National Science Foundation Graduate Research Fellow.

“What draws me to the Rice Biotech Launch Pad is its commitment to addressing the most pressing unmet medical needs,” Swingle added in the release. “My research in women’s health has shown me how innovation at the intersection of biomaterials and medicine can tackle challenges that have been overlooked for far too long. I am thrilled to join a team that shares this vision of designing cutting-edge technologies to create meaningful impact for underserved patient populations.”

The Rice Biotech Launch Pad opened in 2023. It held the official launch and lab opening of RBL LLC, a biotech venture creation studio in May. Read more here.

University of Houston archaeologists make history with Mayan tomb discovery

History in the Making

Two University of Houston archaeologists have made scientific history with the discovery of a Mayan king's tomb in Belize.

The UH team led by husband and wife scientists Arlen F. Chase and Diane Z. Chase made the discovery at Caracol, the largest Mayan archeological site in Belize, which is situated about 25 miles south of Xunantunich and the town of San Ignacio. Together with Belize's Institute of Archeology, as well as support from the Geraldine and Emory Ford Foundation and the KHR Family Fund, they uncovered the tomb of Caracol's founder, King Te K’ab Chaak. Their work used airborne light detection and ranging technology to uncover previously hidden roadways and structures that have been reclaimed by the jungle.

The tomb was found at the base of a royal family shrine. The king, who ascended the throne in 331 AD, lived to an advanced enough age that he no longer had teeth. His tomb held a collection of 11 pottery vessels, carved bone tubes, jadeite jewelry, a mosaic jadeite mask, Pacific spondylus shells, and various other perishable items. Pottery vessels found in the chamber depict a Maya ruler wielding a spear as he receives offerings from supplicants represented as deities; the figure of Ek Chuah, the Maya god of traders, surrounded by offerings; and bound captives, a motif also seen in two related burials. Additionally, two vessels had lids adorned with modeled handles shaped like coatimundi (pisote) heads. The coatimundi, known as tz’uutz’ in Maya, was later adopted by subsequent rulers of Caracol as part of their names.

 Diane Chase archaeologist in Mayan tomb Diane Z. Chase in the Mayan tomb. Photo courtesy of University of Houston

During the Classical Period, Caracol was one of the main hubs of the Mayan Lowlands and covered an area bigger than that of present-day Belize City. Populations survived in the area for at least 1,000 years before the city was abandoned sometime around 900 AD. The royal dynasty established by Te K’ab Chaak continued at Caracol for over 460 years.

The find is also significant because this was roughly when the Mexican city of Teotihuacan made contact with Caracol, leading to a long relationship of trade and cultural exchange. Cremation sites found in Caracol contain items that would have come from Teotihuacan, showing the relationship between the two distant cities.

"Both central Mexico and the Maya area were clearly aware of each other’s ritual practices, as reflected in the Caracol cremation," said Arlen F. Chase, professor and chair of Comparative Cultural Studies at the University of Houston.

“The connections between the two regions were undertaken by the highest levels of society, suggesting that initial kings at various Maya cities — such as Te K’ab Chaak at Caracol — were engaged in formal diplomatic relationships with Teotihuacan.”

The Chases will present their findings at a conference on Maya–Teotihuacan interaction hosted by the Maya Working Group at the Santa Fe Institute in New Mexico in August 2025.

 UH professors Chase make Mayan Discovery UH archaeologists Arlen F. Chase and Diane Z. Chase Photo courtesy of University of Houston

 

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This story originally appeared on CultureMap.com.

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