clinical trials bound

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

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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Allterum Therapeutics Inc., a portfolio company of Fannin Innovation Studio, is using the funds to prepare for clinical trials. Photo via Getty Images

Allterum Therapeutics Inc. has built a healthy launchpad for clinical trials of an immunotherapy being developed to fight a rare form of pediatric cancer.

The Houston startup recently collected $1.8 million in seed funding through an investor group associated with Houston-based Fannin Innovation Studio, which focuses on commercializing biotech and medtech discoveries. Allterum has also brought aboard pediatric oncologist Dr. Philip Breitfeld as its chief medical officer. And the startup, a Fannin spinout, has received a $2.9 million grant from the Cancer Prevention Research Institute of Texas.

The funding and Breitfeld's expertise will help Allterum prepare for clinical trials of 4A10, a monoclonal antibody therapy for treatment of cancers that "express" the interleukin-7 receptor (IL7R) gene. These cancers include pediatric acute lymphoblastic leukemia (ALL) and some solid-tumor diseases. The U.S. Food and Drug Administration (FDA) has granted "orphan drug" and "rare pediatric disease" designations to Allterum's monoclonal antibody therapy.

If the phrase "monoclonal antibody therapy" sounds familiar, that's because the FDA has authorized emergency use of this therapy for treatment of COVID-19. In early January, the National Institute of Allergy and Infectious Diseases announced the start of a large-scale clinical trial to evaluate monoclonal antibody therapy for treatment of mild and moderate cases of COVID-19.

Fannin Innovation Studio holds exclusive licensing for Allterum's antibody therapy, developed at the National Cancer Institute. Aside from the cancer institute, Allterum's partners in advancing this technology include the Therapeutic Alliance for Children's Leukemia, Baylor College of Medicine, Texas Children's Hospital, Children's Oncology Group, and Leukemia & Lymphoma Society.

Although many pediatric patients with ALL respond well to standard chemotherapy, some patients continue to grapple with the disease. In particular, patients whose T-cell ALL has returned don't have effective standard therapies available to them. Similarly, patients with one type of B-cell ALL may not benefit from current therapies. Allterum's antibody therapy is designed to effectively treat those patients.

Later this year, Allterum plans to seek FDA approval to proceed with concurrent first- and second-phase clinical trials for its immunotherapy, says Dr. Atul Varadhachary, managing partner of Fannin Innovation Studio, and president and CEO of Allterum. The cash Allterum has on hand now will go toward pretrial work. That will include the manufacturing of the antibody therapy by Japan's Fujifilm Diosynth Biotechnologies, which operates a facility in College Station.

"The process of making a monoclonal antibody ready to give to patients is actually quite expensive," says Varadhachary, adding that Allterum will need to raise more money to carry out the clinical trials.

The global market for monoclonal antibody therapies is projected to exceed $350 billion by 2027, Fortune Business Insight says. The continued growth of these products "is expected to be a major driver of overall biopharmaceutical product sales," according to a review published last year in the Journal of Biomedical Science.

One benefit of these antibody therapies, delivered through IV-delivered infusions, is that they tend to cause fewer side effects than chemotherapy drugs, the American Cancer Society says.

"Monoclonal antibodies are laboratory-produced molecules engineered to serve as substitute antibodies that can restore, enhance or mimic the immune system's attack on cancer cells. They are designed to bind to antigens that are generally more numerous on the surface of cancer cells than healthy cells," the Mayo Clinic says.

Varadhachary says that unlike chemotherapy, monoclonal antibody therapy takes aim at specific targets. Therefore, monoclonal antibody therapy typically doesn't broadly harm healthy cells the way chemotherapy does.

Allterum's clinical trials initially will involve children with ALL, he says, but eventually will pivot to children and adults with other kinds of cancer. Varadhachary believes the initial trials may be the first cancer therapy trials to ever start with children.

"Our collaborators are excited about that because, more often than not, the cancer drugs for children are ones that were first developed for adults and then you extend them to children," he says. "We're quite pleased to be able to do something that's going to be important to children."

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