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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Rice University launches hub in India to drive education, tech innovation abroad

global mission

Rice University is launching Rice Global India, which is a strategic initiative to expand India’s rapidly growing education and technology sectors.

“India is a country of tremendous opportunity, one where we see the potential to make a meaningful impact through collaboration in research, innovation and education,” Rice President Reginald DesRoches says in a news release. “Our presence in India is a critical step in expanding our global reach, and we are excited to engage more with India’s academic leaders and industries to address some of the most pressing challenges of our time.”

The new hub will be in the country’s third-largest city and the center of the country’s high-tech industry, Bengaluru, India, and will include collaborations with top-tier research and academic institutions.

Rice continues its collaborations with institutions like the Indian Institute of Technology (IIT) Kanpur and the Indian Institute of Science (IISc) Bengaluru. The partnerships are expected to advance research initiatives, student and faculty exchanges and collaborations in artificial intelligence, biotechnology and sustainable energy.

India was a prime spot for the location due to the energy, climate change, artificial intelligence and biotechnology studies that align with Rice’s research that is outlined in its strategic plan Momentous: Personalized Scale for Global Impact.

“India’s position as one of the world’s fastest-growing education and technology markets makes it a crucial partner for Rice’s global vision,” vice president for global at Rice Caroline Levander adds. “The U.S.-India relationship, underscored by initiatives like the U.S.-India Initiative on Critical and Emerging Technology, provides fertile ground for educational, technological and research exchanges.”

On November 18, the university hosted a ribbon-cutting ceremony in Bengaluru, India to help launch the project.

“This expansion reflects our commitment to fostering a more interconnected world where education and research transcend borders,” DesRoches says.

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

funds granted

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."

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