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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Innovative Texas-based ride-share rolls into Houston with new cars and delivery service

Alto is a go

Houstonians who are interested in an alternative to Uber — and don't mind giving a Dallas-based company a shot — can now look for a new ride. Alto, the ride-share and delivery company based in Big D, has announced its expansion plans to Houston. The company is now offering pre-scheduled rides; Houston residents will be able to book on-demand rides starting October 1, according to a press release.

As CultureMap previously reported, Alto touts itself as a safer, more consistent approach to hailing a ride. Founded in 2018, Alto brands itself as "the first employee-based, on-demand ride-share company." Employees receive salaries and benefits, each company-owned car is branded with the Alto logo (so riders can be sure they're stepping into the right vehicle), and cloud-based cameras capture both interior and exterior videos of the ride.

The company offers ride memberships and also shops, purchases, and delivers from local brands directly to consumers with same-day delivery available.

For safety during the pandemic, all Alto drivers wear masks and gloves during every trip and each Alto vehicle is fitted with a HEPA cabin air filter which removes 99.9 percent of airborne particles, the company claims. Car interiors are also treated with PermaSafe, an EPA-registered hospital-grade sanitizing mist that is said to kill pathogens like COVID-19.

"Alto is thrilled to announce our expansion plans to Houston and offer the same clean, safe ride-share experience that's revolutionizing the industry to this new market," said Will Coleman, founder and CEO of Alto. "We're confident Houston residents will find Alto to be unlike any other ride-share experiences they've had to date, and find comfort in Alto's leading safety and health precautions, as well as elevated rider experience."

Locals who are interested in more information and getting on the Houston launch waitlist can the official site. The Alto app is available for download on the App Store and Google Play.

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This article originally ran on CultureMap.

3 crisis management tips for Houston business leaders

houston voices

The great pandemic of 2020 has brought to the surface the issue of crisis management. Especially with nationwide business shut downs in the last eight months, many companies are on a rocky road of uncertainty. Entrepreneurs are unsure of what the future holds after seeing revenues slow or halt in some cases. Layoffs, RIFs, budget cuts, departmental downsizing; all inevitable.

Way too many startup founders aren't equipped or experienced when it comes to crisis management. "In order to keep your startup going, you have to know how to identify a crisis before it spreads like a cancer and how to make big changes and big decisions fast and often," says Gael O'Brien, the ethics coach for Entrepreneur.com.

"Any time in which the world stops functioning in a way we're used to, a deviation from the norm, that might be the biggest early sign of a crisis about to rear its head," she continued.

Admitting you have a problem

O'Brien stresses that a leader should create an easy process whereby one can identify a crisis in its infancy. The key here, she says, is to make sure to recognize a crisis before it starts to consume your company. You'll have to learn how to contain the crisis by leading the charge in rapid decision making. Many entrepreneurs simply refuse to admit there's a problem at hand. Many times, admitting there's a crisis means admitting one was wrong. It also means they may have been wrong for years.

These entrepreneurs that refuse admitting there's a crisis often do so with common refrains like "I didn't want to scare anyone" or "if I admit I was wrong this whole time I'll lose respect."

"Great leaders aren't afraid to put their company first, even if it means a blow to the ego. These leaders are not afraid to inform everyone that might be affected know there is a crisis," O'Brien explained.

"They contain the problem and prevent it from becoming unmanageable. Good leaders don't opt for a temporary Band-Aid-like fix either. They aim for a permanent solution."

Casting for a crisis management team

There are two common mistakes startup leaders make when it comes to crisis management. The first is that they can miscast a crisis management team. Meaning, they put the wrong people in decision-making roles. You want people on your crisis management team who are not going to feel they will be blamed for a crisis or for controversial decisions.

When one is afraid of being blamed for something, they are more likely to obstruct and lie so that the team's focus is diverted. "These are people that will omit objective and relevant information if it means saving their own reputation or job. You want people that put the team first," said O'Brien.

Communication during a crisis

The second common mistake startup leaders make during a crisis is that they tend to under-communicate. It becomes habitual to keep things close to the chest. To become secretive during a crisis. Managers might feel that the less people know, the less chance there is of panic. However, doing this opens your company up to wild speculation among employees. Assumptions. And these assumptions are never good.

"You have to be forthright. It's not just that people have a right to know what's going on in their own company. It's also that if you leave yourself up to speculation, people will grow frustrated and worse, scared. Scared people make crises worse," said O'Brien.

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This article originally appeared on the University of Houston's The Big Idea. Rene Cantu, the author of this piece, is the writer and editor at UH Division of Research.

Cleantech incubator announces location in Houston, names newest partners

Greentown's moving in

After announcing its plans to expand to Houston in June, Boston-based Greentown Labs has selected its site for its cleantech startup and tech incubator.

Houston Mayor Sylvester Turner and the Greater Houston Partnership announced that Greentown Houston will be opening in the Innovation District, being developed by Rice Management Co. and home to The Ion. The site is located at 4200 San Jacinto St., which was Houston's last remaining Fiesta grocery story before it closed in July.

The facility is expected to open this coming spring and will feature 40,000 square feet of prototyping lab, office, and community space that can house about 50 startups, totaling 200 to 300 employees.

"We are thrilled to announce the selection of Greentown Labs' inaugural location in partnership with RMC, the City of Houston, the Partnership, and leading global energy and climate impact-focused companies," says Emily Reichert, CEO of Greentown Labs, in a press release. "In order to meet the urgent challenge of climate change, we must engage the talent and assets of major ecosystems around the country. We look forward to catalyzing the Houston ecosystem's support for climatetech startups as we work together toward a sustainable future for all."

Emily Reichert is the CEO of Greentown Labs. Photo courtesy of Greentown Labs

Greentown Labs launched in 2011 as community of climatetech and cleantech innovators bringing together startups, corporates, investors, policymakers, and more to focus on scaling climate solutions. Greentown Labs' first location is 100,000 square feet and located just outside of Boston in Somerville, Massachusetts. Currently, it's home to more than 100 startups and has supported more than 280 startups since the incubator's founding. According to the release, these startups have created more than 6,500 jobs and raised over $850 million in funding

"We are so pleased that Greentown Houston will locate in the heart of the Innovation District, where they will seamlessly integrate into the region's robust energy innovation ecosystem of major corporate energy R&D centers, corporate venture arms, VC-backed energy startups, and other startup development organizations supporting energy technology," says Susan Davenport, chief economic development officer at the Greater Houston Partnership, in the release. "Houston truly is the hub of the global energy industry, and Greentown Houston will ensure we continue to attract the next generation of energy leaders who will create and scale innovations that will change the world."

Greentown Houston, which previously announced several founding partners in June, has just named new partners, including: RMC, Microsoft, Saint-Gobain, and Direct Energy. According to the release, Greentown Houston is also looking for Grand Opening Partners. Naturgy and and FCC Environmental Services (FCC) are the first to join on as a grand opening partners, and startups and prospective partners can reach out for more information via this form.

Reichert previously told InnovationMap that it was looking for an existing industrial-type building that could be retrofitted to meet the needs of industrial startups that need lab space. She also said that this approach is very similar to how they opened their first location.

Rice Management Company is developing the Innovation District in the center of Houston. Screenshot via ionhouston.com

The new location will be in the 16-acre Innovation District that's being developed by RMC, which will be anchored by The Ion, a 270,000-square-foot hub that is being renovated from the former Sears building.

"What we love about Greentown Labs as much as its commitment to helping Houston become a leader in energy transition and climate change action is its proven track record of job creation through the support of local visionaries and entrepreneurs," says Ryan LeVasseur, managing director of Direct Real Estate at RMC, in the release. "Greentown Houston, like The Ion, is a great catalyst for growing the Innovation District and expanding economic opportunities for all Houstonians. We're thrilled Greentown Labs selected Houston for its first expansion and are honored it will be such a big part of the Innovation District moving forward."

Acquiring the new Greentown location is a big win for the mayor, who released the city's Climate Action Plan earlier this year. The plan lays out a goal to make Houston carbon neutral by 2050.

"We are proud to welcome Greentown Labs to Houston, and we are excited about the new possibilities this expansion will bring to our City's growing innovation ecosystem," says Turner in the release. "Organizations and partners like Greentown Labs will play a vital role in helping our City meet the goals outlined in the Climate Action Plan and will put us on the right track for becoming a leader in the global energy transition. The City of Houston looks forward to witnessing the innovation, growth, and prosperity Greentown Labs will bring to the Energy Capital of the World."

Greentown Labs will host a celebratory networking event on September 24 at 4 p.m. Registration for the EnergyBar is open here.

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