Houston biotech company gets green light from FDA to test coronavirus-fighting drug

clinical trials bound

Pulmotect is headed to clinical trials to verify how its drug fights against COVID-19. Getty Images

Houston biotech company Pulmotect Inc. has embarked on two clinical drug trials that could create weapons for the battle against the novel coronavirus.

Pulmotect gained permission from the U.S. Food and Drug Administration to test its inhaled drug, PUL-042, as a way to prevent coronavirus infections and to slow the early progression of COVID-19, the potentially fatal disease caused by the novel coronavirus. Pulmotect developed PUL-042 to activate the lungs' front-line defense against respiratory infections, and now it's being enlisted in the race to devise coronavirus treatments and cures.

"We have demonstrated PUL-042's unique ability to stimulate the immune system in the lungs to protect against a wide range of pathogens in multiple animal models," Dr. Colin Broom, CEO of Pulmotect, says in a May 7 release. "Pulmotect is optimistic that its immune-stimulating technology could be useful in mitigating the threats of [the coronavirus] and future emerging pathogens, and protecting vulnerable populations."

Unlike a vaccine, which typically takes 10 to 15 years to bring to the market, PUL-042 promises much faster deployment as scientists and health care workers wage war against COVID-19.

Each of the two clinical trials, both in the second phase, is being conducted at 10 sites across the U.S., including locations in Houston. In all, 20 sites are participating. Money for the trials came from the company's recently completed $12 million round of series B funding.

Pulmotect's partner in the trials is Covington, Kentucky-based CTI Clinical Trial and Consulting Services Inc. PARI Respiratory Equipment Inc., whose North American headquarters is in Midlothian, Virginia, is supplying medical equipment known as nebulizers to administer Pulmotect's inhaled drug.

"Both clinical trials are placebo-controlled to objectively evaluate safety and efficacy," Broom says in a May 5 release.

"In the first study, up to four doses of PUL-042 or placebo will be administered to 200 subjects by inhalation over a 10-day period to evaluate the prevention of infection and reduction in severity of COVID-19. In the second study, 100 patients with early symptoms of COVID-19 will receive the treatment administered up to three times over six days. In both trials, subjects will be followed up for 28 days to assess the effectiveness and tolerability of PUL-042."

Previous experiments conducted by Pulmotect indicate PUL-042 effectively protects mice against severe acute respiratory syndrome (SARS) and Middle East respiratory syndrome (MERS), which are caused by coronaviruses that differ from the COVID-19 virus. Researchers performed those tests at the University of Texas Medical Branch at Galveston.

PUL-042 initially was developed to fight respiratory problems in cancer patients undergoing chemotherapy, which weakens the immune system. But the drug offers the potential to prevent or treat an array of respiratory infections caused by viruses, bacteria, or fungi.

"We have always considered PUL-042 to have the potential for the prevention and treatment of emerging epidemics and pandemics like the one we currently face," Broom says.

A separate trial of PUL-042 is underway in London. There, the drug is being tested on patients with chronic obstructive pulmonary disease (COPD) who are susceptible to lung infections. COPD is an inflammatory disease that blocks airflow from the lungs. People with COPD face a heightened risk of conditions like heart disease and lung cancer, the Mayo Clinic says.

Researchers at MD Anderson Cancer Center and Texas A&M University invented Pulmotect's PUL-042, which holds patents in 10 countries. Pulmotect, founded in 2007, emerged from Houston's Fannin Innovation Studio, which fosters early stage companies in the life sciences sector.

These Houston startups have created health care-related solutions amid the coronavirus outbreak. Getty Images

These 7 Houston health tech companies are providing COVID-19 solutions

startups to the rescue

It's all hands on deck in Houston in the battle against coronavirus — and local biotech startups have risen to the occasion.

From mental health solutions and online portals to virtual medicine and new treatments, these Houston companies have recently launched or pivoted to new options in health care.

Mental Health Match

Ryan Schwartz is offering free counseling to Texans. Photo courtesy of Mental Health Match

Mental Health Match, a Houston-based startup that uses tech to easily connect people to mental health professionals, has announced the opportunity for 100 Texas residents to get their first appointment free and remotely.

The company cites data that shows:

A 78 percent increase in Texans who are concerned about their marriage
A 71 percent increase in Texans concerned with their parenting or their children
A 35 percent spike in Texans feeling panicked

"You might be practicing social distancing, but you are not alone. It is easier to make it through this together if you can get support and guidance from a skilled professional. That's why we're working with therapists across Texas to provide a free session to individuals who need it most," says Ryan Schwartz, founder of Mental Health Match, in a news release.

Texans can apply for the free sessions online on a first-come, first-served basis.

Medical Informatics Corp.

Medical Informatics Corp.'s Sickbay platform can monitor patients from afar. Photo via michealthcare.com

Houston-based Medical Informatics has created a virtual ICU program, called Sickbay, and the tech tool is being used to remotely monitor patients in Houston Methodist. The program works around the clock from a control hub to use artificial intelligence and algorithms to monitor patients.

The company, which recently moved into its office in TMCx+, announced major growth in January, just ahead of the coronavirus outbreak.

"We designed our Sickbay platform to give lost data back to doctors, nurses and other members of the care team so they could save more lives," says Vincent Gagne, vice president of product for MIC, in a news release. "In fact, our apps are built in collaboration with our clients, such as Texas Children's Hospital and Houston Methodist. Having these facilities blocks away from our headquarters accelerates that collaboration and development."

MolecularMatch

MolecularMatch is bringing together COVID-19 information and trials. Photo via molecularmatch.com

MolecularMatch, a Houston startup focused on clinical informatics, has launched a free portal that accumulates research and clinical trials for COVID-19. The company is a tenant of TMCx+ and a portfolio company of Houston-based venture capital group GOOSE.

"The number of therapeutic cures and vaccines being tested are growing at an astounding rate," says Eric Pulaski, CEO at MolecularMatch, in a news release. "Our tools make it easier for clinicians and patients to find the help they need. Hopefully, we can help save lives by shortening the time it takes to get more patients into clinical trials and by speeding up research to find cures and vaccines."

The product uses the company's artificial intelligence-backed curation platform and is updated every two to three days.

Luminare

Luminare Inc. pivoted to quickly create an online COVID-19 screening tool, and local governments have tapped into the resource. Andriy Onufriyenko/Getty Images

Founded in 2014, Houston-based health care software startup Luminare Inc. seeks to prevent sepsis, a life-threatening reaction to a host of infections that causes about one-third of U.S. hospital deaths. Recently, though, Luminare pivoted to address another health concern — the threat of the novel coronavirus.

After the novel coronavirus surfaced, Luminare retooled its sepsis-detection platform to create a free online self-assessment test for people who suspect they've contracted the virus. The test, available at CheckForCorona.com, helps someone figure out whether they should seek a coronavirus test.

An online screening typically takes less than two minutes. The confidential, secure assessment complies with guidelines from the U.S. Centers for Disease Control and Prevention (CDC) and the World Health Organization (WHO). Based on your assessment results, you might be directed to contact your local health department or, in the worst-case scenario, call 911. Click here to read more.

Manatee

Manatee users can sign up for three months free. Photo via getmanatee.com

Denver-based Manatee was just announced to be selected for the 2020 TMCx cohort, and — while programming is beginning virtually — the startup will be enroute to Houston as soon as it's safe. Manatee focuses on providing connected, everyday therapy for kids.

In light of the effects of COVID-19 on both parents and children, Manatee has allowed users to register for three months free. Individuals can apply online.

Moleculin Biotech Inc.

Houston-based Moleculin, which works on oncology treatment, has filed a patent for its treatment to battle the coronavirus. Getty Images

Houston-based Moleculin Biotech Inc., a clinical stage pharmaceutical company that typically focuses on cancer treatment, announced that it has filed for a new patent for its use of one of its products to be used against the coronavirus and other potential viruses.

This patent application is for Moleculin's WP1122, and the company has entered into a partnership with a major Texas university to advance its research.

"We've actually been working on the antiviral potential of WP1122 for some time now," says Walter Klemp, Moleculin's chairman and CEO, in a news release, "but the rise of COVID-19 has obviously placed a new sense of urgency on what we are doing. We hope to be generating animal data on WP1122's antiviral potential in the near term."

Pulmotech Inc.

Pulmotect, a clinical-stage biotechnology company based in Houston, is testing a drug that could be useful in mitigating the threats of the coronavirus, which is currently been recognized as a global health emergency. Getty Images

Experiments conducted by clinical-stage, Houston-based biotechnology company Pulmotect Inc. show its PUL-042 inhaled drug has proven effective in protecting mice against two types of coronavirus: severe acute respiratory syndrome (SARS) and Middle East respiratory syndrome (MERS). Researchers performed those tests at the University of Texas Medical Branch at Galveston.

In the Galveston experiments, a single inhaled dose of PUL-042 protected lab mice from the SARS virus, and it greatly reduced the amount of virus in their lungs after the mice became infected with SARS or MERS.

"With the risks of virulent coronaviruses and other threats increasing, as shown by the recent outbreak in Wuhan that has already spread from China to other countries including the United States, Pulmotect is optimistic that its immune-stimulating technology could be useful in mitigating the threats of current and emerging pathogens and protecting vulnerable populations," says CEO Dr. Colin Broom in a news release. Click here to read more.

Houston biotech company is creating a drug that could fight the coronavirus

Med tech

A drug being developed by a Houston biopharmaceutical company eventually could help combat what the World Health Organization has proclaimed a global health emergency.

Experiments conducted by clinical-stage biotechnology company Pulmotect Inc. show its PUL-042 inhaled drug has proven effective in protecting mice against two types of coronavirus: severe acute respiratory syndrome (SARS) and Middle East respiratory syndrome (MERS). Researchers performed those tests at the University of Texas Medical Branch at Galveston.

The ability of PUL-042 to ward off the newest type of coronavirus, 2019-nCoV, hasn't been tested yet. However, the drug eventually could help prevent the new virus from spreading, says Broom, who joined Pulmotect as CEO last fall. A separate study would be required to evaluate PUL-042 in patients exposed to 2019-nCoV, he says.

"PUL-042 has the potential to prevent and treat respiratory complications in many high-risk patient populations, including those where no effective therapies are currently available, as is the case with the current coronavirus outbreak," Brenton Scott, president and chief operating officer of Pulmotect, says in the release.

Since its discovery in late December 2019 in Wuhan, China, nearly 9,800 people around the world were infected with 2019-nCoV as of January 31, The New York Times reported. Of those people, more than 200 died. On January 30, the World Health Organization (WHO) declared the virus outbreak a global health emergency.

No specific treatment or cure for 2019-nCoV virus is available. This virus is among seven known coronaviruses.

Symptoms of the Wuhan coronavirus include fever, cough, and shortness of breath, according to the U.S. Centers for Disease Control and Prevention (CDC). The virus can cause pneumonia, SARS, kidney failure, or even death, the Virginia Department of Health says.

PUL-042 "would be a great tool to have available for future outbreaks and epidemics, in addition to being used more routinely for more common infections," Broom says.

Fighting coronaviruses is a potential byproduct of PUL-042.

Initially, Pulmotect is focusing development of PUL-042 on the prevention and treatment of respiratory complications suffered by cancer patients with suppressed immune systems. Phase 1 clinical trials already have taken place in the U.S., and Phase 2 clinical trials are scheduled for later this year.

A separate trial of PUL-042 is underway in London. There, the drug is being tested on patients with chronic obstructive pulmonary disease (COPD) who are prone to lung infections. COPD is an inflammatory disease that blocks airflow from the lungs. People with COPD face a heightened risk of conditions like heart disease and lung cancer, the Mayo Clinic says.

Broom says PUL-042 is a few years away from being considered for approval by the U.S. Food and Drug Administration (FDA).

To date, Pulmotect has raised more than $28 million in outside funding. Founded in 2007, Pulmotect emerged from Houston's Fannin Innovation Studio, which nurtures early stage companies in the life sciences sector.

Patents for PUL-042, invented by MD Anderson Cancer Center and Texas A&M University, have been issued in nine countries.

A Houston biotech company has a new CEO and is ready for growth. Getty Images

Houston biopharmaceutical company brings on new CEO to grow company

Head honcho

With a veteran of the biopharmaceutical industry now aboard as its CEO and an executive at pharmaceutical giant AstraZeneca now serving on its board, Houston-based biopharmaceutical company Pulmotect Inc. is poised for progress.

In September, Dr. Colin Broom joined Pulmotect as CEO. He previously was CEO of Ireland-based Nabriva Therapeutics plc, a biopharmaceutical company that went public in 2015. During Broom's tenure at Nabriva, he helped develop the recently approved drug Xenleta, which treats bacterial pneumonia. Before that, he was chief scientific officer at Pennsylvania-based pharmaceutical company ViroPharma Inc., which Massachusetts-based Shire plc purchased for $4.2 billion in 2014.

Broom's hiring came on the heels of Kumar Srinivasan being named to Pulmotect's board of directors. Srinivasan is vice president of United Kingdom-based AstraZeneca and is its global head of business development and licensing for biopharmaceuticals R&D.

Researchers at MD Anderson Cancer Center and Texas A&M University invented Pulmotect's main product, PUL-042, which holds patents in nine countries. Pulmotect, founded in 2007, emerged from Houston's Fannin Innovation Studio, which nurtures early stage companies in the life sciences sector.

"Attracting such a highly regarded and proven CEO as Colin is a clear signal of the power and potential of Pulmotect's development program," Pulmotect's executive chairman, Leo Linbeck III, founder and chairman of Fannin, says in a release. "Under his leadership, I'm confident that we will advance our technology further into the clinic and closer to the marketplace. His addition is a real game-changer for the company."

Both Broom and Srinivasan are focusing on clinical trials for Pulmotect's PUL-042 product, an inhaled therapy that holds the potential to prevent or treat respiratory infections caused by bacteria, viruses, or fungi. The current Phase 2 trial is evaluating the effectiveness of PUL-042 in treating patients with mild chronic obstructive pulmonary disease (COPD) who've been exposed to a respiratory virus. The current trial is supposed to be followed by additional Phase 2 trials.

COPD, which affects 30 million Americans, is the No. 3 cause of death in the U.S., according to the COPD Foundation. Pulmotect says 40 percent of COPD-related costs could be avoided by preventing complications and hospitalizations, which typically result from COPD problems triggered by a bacterial or viral infection. PUL-042 could substantially decrease those complications, the company says.

Pulmotect seeks to gear PUL-042 toward patients with cancer who are undergoing chemotherapy, as their weakened immunity makes them highly susceptible to pneumonia, Broom says. If the product proves effective with those patients, then people at risk of developing respiratory infections also might benefit from it, including COPD patients and flu patients, he says.

To date, Pulmotect has raised more than $28 million in funding. That includes about $18 million in research grants, including a $7 million grant from the Cancer Prevention and Research Institute of Texas, as well as seven grants from the Small Business Innovation Research program.

Two of Pulmotect's three full-time employees work in Houston, and a team of consultants supports their work, Broom says. A small number of employees might be added during the current Phase 2 trial. Hiring would need to be ramped up if the Phase 2 trial demonstrates that PUL-042 works, he says.

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Houston startup raises $6M to scale home-based healthcare platform

fresh funding

As healthcare systems race to expand care beyond hospitals and into the home, investors are placing bigger bets on the infrastructure needed to make that shift possible.

This month, Rosarium Health announced it has raised $6 million in seed funding led by Kalos Ventures, with participation from ResilienceVC, Rock Health Capital, Symphonic Capital, Black Tech Nations Ventures and others.

The investment will help the Houston-based startup continue to build its platform, which features a national network of 800-plus clinicians and 3,000-plus contractors to coordinate home accessibility upgrades and modifications for seniors and people living with disabilities.

For founder and CEO Cameron Carter, the company’s mission grew out of firsthand caregiving experiences.

“From my own personal caregiving experiences, I realized that the benefits exist on paper, but not in reality,” Carter said in a news release. “Families are being left to figure out the paperwork and installations all on their own, which shouldn’t be how this works.”

While Medicare Advantage and Medicaid plans have expanded coverage for home-based services and accessibility modifications, the logistics behind delivering those services often remain fragmented.

Rosarium’s platform coordinates the entire process, from clinical assessments and referrals to contractor management, documentation, reimbursement and installation.

“A clinician can document that a home isn’t safe and a plan can approve a benefit, but there’s no one that’s responsible for making sure the work actually gets done,” Carter says. “We built the missing piece.”

The company was founded in 2021 as Rose Health and was a 2023 participant in the Texas Medical Center’s Accelerator for HealthTech program. It has scaled quickly, building a network of more than 800 clinicians and 3,000 contractors across 34 states.

Rosarium is currently in-network for 1.2 million Medicare and Medicaid lives, with projected coverage expected to reach nearly 4 million by the end of the year, according to the release.

“We’re excited to back Cameron because he and the team at Rosarium are building the infrastructure healthcare needs right now to make the home a safe and comfortable place of care,” Kate Ballinger, investor at Kalos Ventures, added in the release.

As part of the recent investment, Ballinger will join Rosarium’s board of directors.

With eyes on the future, Rosarium plans to grow its partnerships with Medicaid and Medicare Advantage plans, including CalViva and Community Health Plan of Imperial Valley, strengthening its presence in California while expanding access to underserved communities.

Additionally, Carter predicts that home-based healthcare will be part of a broader transformation happening across the industry.

“There’s a growing recognition that health outcomes are shaped by what happens in the home,” he said in the release. “The future of healthcare isn’t just treating people after something goes wrong. It’s creating environments that help prevent those problems in the first place.”

Houston business mogul Tilman Fertitta acquires Caesars in $17.6B deal

Money Moves

Houston billionaire Tilman Fertitta may currently be serving as America’s ambassador to Italy, but his company is as busy as ever. Fresh off its move to revive the Houston Comets WNBA franchise, his company, Fertitta Entertainment, has announced a $17.6 billion deal to acquire Caesars Entertainment, Inc.

Speculation about the deal has been circulating since at least March, according to various media reports. The deal combines Fertitta’s well-known Golden Nugget casino brand with all of the properties in the Caesars’ portfolio, including Las Vegas hotels Caesars Palace, Harrah's, Paris Las Vegas, Planet Hollywood, Horseshoe, The LINQ Hotel, Flamingo, and The Cromwell.

Overall, the combined company will include 60 domestic casino resorts and gaming facilities; online gaming including sports betting, iCasino, and Caesar’s online poker platform; retail sports betting at over 200 third-party locations through the William Hill brand; and over 550 Fertitta Entertainment outlets, including more than 450 Landry's full-service restaurants across America. The companies will combine their loyalty programs, Caesars Rewards, Golden Nugget's 24 Karat Select Club, and Landry's Select Club.

The terms will see Caesars’ shareholders receive $31 per share. Fertitta Entertainment will also acquire approximately $11.9 billion of Caesars' outstanding debt.

The transaction will be financed through a combination of equity contributed by Fertitta Entertainment, assumed Caesars' debt, and new committed debt financing arranged by a group consisting of 10 banks. It is subject to approval by Caesars’ shareholders and government regulators.

Fertitta Entertainment is the Houston-based company behind a diverse array of hospitality businesses, including The Golden Nugget, The Post Oak Hotel, River Oaks District, the Kemah Boardwalk, and Houston’s Downtown Aquarium.

It also operates a number of prominent restaurant brands, including Mastro's Restaurants, Del Frisco's Double Eagle Steakhouse, Morton's The Steakhouse, The Palm, McCormick & Schmick's, Landry's Seafood House, The Oceanaire Seafood Room, and Saltgrass Steak House.

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This article first appeared on CultureMap.com.

4 Houston-area institutions get $8M for cancer research facilities

fighting cancer

Cancer research capabilities in the Houston area just got an $8 million boost.

On Wednesday, May 20, the Cancer Prevention and Research Institute of Texas (CPRIT) awarded $8 million in grants to institutions in Houston and Bryan for the creation or expansion of so-called “core” cancer research facilities.

“Core facilities provide shared access to advanced technology, equipment, and scientific expertise that may not be available at every institution,” CPRIT says. “These core facilities are vital to not only cancer research but also to the study of diseases beyond cancer.”

Houston-area recipients of these $2 million grants are:

A facility at the University of Texas Health Science Center for preclinical support of cancer researchers in Texas to evaluate new safe, effective drugs and drug combinations.
The Accelerator for Cancer Therapeutics, operated by Houston’s Texas Medical Center Foundation. The accelerator helps researchers and startups move innovative cancer treatments from the lab to clinical trials.
Rice University’s Genetic Design & Engineering Center in Houston. The center enables researchers to collaborate on studies of custom DNA for cancer treatment.
A facility at the Texas A&M University System’s Health Science Center in Bryan that aims to speed up the development of cancer therapies.

In addition to those grants, the University of Texas M.D. Anderson Cancer Center, Methodist Hospital Research Institute, Baylor College of Medicine, and Rice University shared $21 million to recruit cancer researchers from other institutions.

The largest of those grants—totalling $4 million—went to M.D. Anderson for the recruitment of renowned cancer researcher Andre Nussenzweig from the National Institutes of Health. His research focuses on how DNA damage and faulty DNA repairs lead to cancer.

Here are the totals for the other CPRIT grants awarded in the Houston area:

$12.8 million to Houston-based Indapta Therapeutics for the development of an off-the-shelf therapy that naturally kills cancer cells, combined with an immunity-targeting agent for a type of leukemia.
$11.1 million to MD Anderson, including $5 million for a statewide platform to improve long-term health outcomes in adolescents and young adults who survived cancer.
$8.4 million to Baylor College of Medicine, including $4.8 million for two training programs for cancer researchers.
$6.25 million to UT Health Houston, including $4 million for a biomedical informatics and genomics training program for cancer researchers.
$4.4 million to the Texas A&M Health Science Center’s Houston campus, including $2.4 million for a cancer therapeutics training program.
$2.75 million to Rice, including $250,000 for a study of ovarian cancer.
$2 million to Houston-based March Biosciences for the development of a targeted therapy for treating T-cell lymphoma.
$1.15 million to the University of Houston, including $900,000 for a platform for detection of lung cancer.
$900,000 to Texas A&M in Bryan to conduct clinical drug trials in rural and underserved communities around the state.
$800,000 to Houston- and Israel-based Xerient Pharma for the development of an oral form of a cell-protecting drug called amifostine to protect the upper GI tract from radiation damage during pancreatic cancer treatment.
$659,000 to Missouri City-based OmniNano Pharmaceuticals for the development of a two-drug combination to treat the most common form of pancreatic cancer.
$250,000 to the University of Texas Medical Branch at Galveston for a novel therapeutic to prevent colitis-related colorectal cancer.

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