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.

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UH-backed project secures $3.6M to transform CO2 into sustainable fuel with cutting-edge tech

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A University of Houston-associated project was selected to receive $3.6 million from the U.S. Department of Energy’s Advanced Research Projects Agency-Energy that aims to transform sustainable fuel production.

Nonprofit research institute SRI is leading the project “Printed Microreactor for Renewable Energy Enabled Fuel Production” or PRIME-Fuel, which will try to develop a modular microreactor technology that converts carbon dioxide into methanol using renewable energy sources with UH contributing research.

“Renewables-to-liquids fuel production has the potential to boost the utility of renewable energy all while helping to lay the groundwork for the Biden-Harris Administration’s goals of creating a clean energy economy,” U.S. Secretary of Energy Jennifer M. Granholm says in an ARPA-E news release.

The project is part of ARPA-E’s $41 million Grid-free Renewable Energy Enabling New Ways to Economical Liquids and Long-term Storage program (or GREENWELLS, for short) that also includes 14 projects to develop technologies that use renewable energy sources to produce sustainable liquid fuels and chemicals, which can be transported and stored similarly to gasoline or oil, according to a news release.

Vemuri Balakotaiah and Praveen Bollini, faculty members of the William A. Brookshire Department of Chemical and Biomolecular Engineering, are co-investigators on the project. Rahul Pandey, is a UH alum, and the senior scientist with SRI and principal investigator on the project.

Teams working on the project will develop systems that use electricity, carbon dioxide and water at renewable energy sites to produce renewable liquid renewable fuels that offer a clean alternative for sectors like transportation. Using cheaper electricity from sources like wind and solar can lower production costs, and create affordable and cleaner long-term energy storage solutions.

Researchers Rahul Pandey, senior scientist with SRI and principal investigator (left), and Praveen Bollini, a University of Houston chemical engineering faculty, are key contributors to the microreactor project. Photo via uh.edu

“As a proud UH graduate, I have always been aware of the strength of the chemical and biomolecular engineering program at UH and kept myself updated on its cutting-edge research,” Pandey says in a news release. “This project had very specific requirements, including expertise in modeling transients in microreactors and the development of high-performance catalysts. The department excelled in both areas. When I reached out to Dr. Bollini and Dr. Bala, they were eager to collaborate, and everything naturally progressed from there.”

The PRIME-Fuel project will use cutting-edge mathematical modeling and SRI’s proprietary Co-Extrusion printing technology to design and manufacture the microreactor with the ability to continue producing methanol even when the renewable energy supply dips as low as 5 percent capacity. Researchers will develop a microreactor prototype capable of producing 30 MJe/day of methanol while meeting energy efficiency and process yield targets over a three-year span. When scaled up to a 100 megawatts electricity capacity plant, it can be capable of producing 225 tons of methanol per day at a lower cost. The researchers predict five years as a “reasonable” timeline of when this can hit the market.

“What we are building here is a prototype or proof of concept for a platform technology, which has diverse applications in the entire energy and chemicals industry,” Pandey continues. “Right now, we are aiming to produce methanol, but this technology can actually be applied to a much broader set of energy carriers and chemicals.”

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This article originally ran on EnergyCapital.

Houston innovator drives collaboration, access to investment with female-focused group

HOUSTON INNOVATORS PODCAST EPISODE 262

After working in technology in her home country of Pakistan, Samina Farid, who was raised in the United States, found her way to Houston in the '70s where business was booming.

She was recruited to work at Houston Natural Gas — a company that would later merge and create Enron — where she rose through the ranks and oversaw systems development for the company before taking on a role running the pipelines.

"When you're in technology, you're always looking for inefficiencies, and you always see areas where you can improve," Farid says on the Houston Innovators Podcast, explaining that she moved on from Enron in the mid-'80s, which was an exciting time for the industry.

"We had these silos of data across the industry, and I felt like we needed to be communicating better, having a good source of data, and making sure we weren't continuing to have the problems we were having," she says. "That was really the seed that got me started in the idea of building a company."

She co-founded Merrick Systems, a software solutions business for managing oil and gas production, with her nephew, and thus began her own entrepreneurial journey. She came to another crossroads in her career after selling that business in 2014 and surviving her own battle with breast cancer.

"I got involved in investing because the guys used to talk about it — there was always men around me," Farid says. "I was curious."

In 2019, she joined an organization called Golden Seeds. Founded in 2005 in New York, the network of angel investors funding female-founded enterprises has grown to around 280 members across eight chapters. Suzan Deison, CEO of the Houston Women's Chamber, was integral in bringing the organization to Houston, and now Farid leads it as head of the Houston Chapter of Golden Seeds.

For Farid, the opportunity for Houston is the national network of investors — both to connect local female founders to potential capital from coast to coast and to give Houston investors deal flow from across the country.

"It was so hard for me to get funding for my own company," Farid says. "Having access to capital was only on the coasts. Software and startups was too risky."

Now, with Golden Seeds, the opportunity is there — and Farid says its an extremely collaborative investor network, working with local organizations like the Houston Angel Network and TiE Houston.

"With angel investing, when we put our money in, we want these companies to succeed," she says."We want more people to see these companies and to invest in them. We're not competing. We want to work with others to help these companies succeed."

Building a biotech workforce: How this Houston program is shaping the next generation

future focused

Houston is currently in need of biomanufacturing professionals to keep up with the ever-growing industry. That's what Saniya Mansuri, health care consultant for BioPath @ TMC, says.

“Houston has lost out on a big biopharmaceutical company. And when there was a feasibility study that was done, it was identified that one of the reasons that Houston wasn't chosen was the lack of a workforce and a lack of workforce development programs,” she explains.

Mansuri and the TMC Innovation team are doing just that with the introduction of the new program. She moved from Toronto in 2023. When she applied for a role at TMC Innovation, she was handpicked to help shepherd the BioPath program, thanks to her background that included starting a nonprofit for underserved youth in Canada.

The goal of the BioPath program is to attract young people considering going into the trades to learn the skills to become biomanufacturing professionals. According to BioPath’s website, 42 percent of TMC institutions anticipate a great need for biotechnicians in the near future, but there’s a lack of places for workers to train that aren’t part of a four-year degree. BioPath not only helps to recruit youths to careers that only require two years of training, but educates them for success in their newly chosen jobs.

“For the role of biomanufacturing technician, you can do a certificate program, get certified and enter into an entry level career that pays upwards of $50,000 — a stable career where there is a lot of development and job mobility involved,” says Mansuri.

This school year saw the debut of a pilot program that began with marketing and awareness to begin to get kids excited. Working with the organization Bridge Year, BioPath has created a booth for career fairs at which there’s a simulation of the skills involved in column chromatography that potential technicians would be learning. The booth is currently touring HISD high schools.

BioPath is also partnering with the national nonprofit, Learning Undefeated, to create a mobile STEM lab that will park at schools starting in January.

“Instead of students going to a biology class, you would swap it out for a class on this mobile STEM lab, and we have a biomanufacturing activity and curriculum that the students would learn,” explains Mansuri.

But that’s only the beginning. BioPath is looking at securing internships for the students, as well as sponsoring interested students in attending a biomanufacturing summer camp run by Texas A&M. Once educated, Mansuri and her team will help their charges with certification, mentorship and finding jobs post-certification.

Mansuri says she’s already received emails from interested students who have taken part in the “Career Test Drive” booth, but expects more after a soft launch in February in which 200 high school students will come to the TMC to learn more. The future for biomanufacturing in Houston is looking more promising already.

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