Drs. Maria Elena Bottazzi and Peter Hotez at the Center for Vaccine Development. Photo courtesy of Texas Children's Hospital

With the U.S. logging its highest single-day total of new COVID-19 cases (441,278 infections) and some 281, 808, 270 cases documented worldwide, new treatments worldwide are in major demand — especially in emerging nations.

To that end, Texas Children’s Hospital and Baylor College of Medicine announced a new COVID vaccine ready to deploy in India and soon, other underserved countries.

Corbevax, which is dubbed “The World’s COVID-19 Vaccine,” utilizes a traditional recombinant protein-based technology that will enable production at large scales, per a press release. That means the inoculation will be widely accessible to inoculate the global population.

This new vaccine was developed at Texas Children’s Hospital CVD and led by co-directors Drs. Maria Elena Bottazzi and Peter Hotez — and in-licensed from BCM Ventures, Baylor College of Medicine’s integrated commercialization team, to Hyderabad-based vaccine and pharmaceutical company Biological E. Limited (BE).

After completing two Phase III clinical trials involving more than 3000 subjects the vaccine was found to be safe, well tolerated, and immunogenic. Current research shows Corbevax notably effective against the Ancestral-Wuhan strain and the globally dominant Delta variant, press materials note.

Safe, streamlined, low-cost vaccines for middle- to low-income countries are central to the world’s fight against the COVID-19 pandemic, the two Houston organizations note. Indeed, without widespread vaccination of populations in the Global South, additional virus variants will arise, hindering the progress achieved by currently available vaccines in the United States and other Western countries, per research.

“This announcement is an important first step in vaccinating the world and halting the pandemic,” said Hotez in a statement. “Our vaccine technology offers a path to address an unfolding humanitarian crisis, namely the vulnerability the low- and middle-income countries face against the delta variant. Widespread and global vaccination with our Texas Children’s-Baylor-BE vaccine would also forestall the emergence of new variants. We have previously missed that opportunity for the alpha and delta variant. Now is our chance to prevent a new global wave from what might follow.”

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This article originally ran on CultureMap.

Texas Children's Hospital and Baylor College of Medicine are working on a new COVID-19 vaccine candidate. Photo by Dwight C. Andrews/Greater Houston Convention and Visitors Bureau

Houston health care organizations team up for the 'people's vaccine'

COVID Collaboration

Two major health care institutions in Houston — Texas Children's Hospital and the Baylor College of Medicine — are a step closer to rolling out what they dub the "people's vaccine" for COVID-19.

The two institutions, along with India-based vaccine and pharmaceutical company Biological E Ltd., have gained approval to move ahead this month with Phase III clinicals trials in India of a COVID-19 vaccine candidate called Corbevax. The Texas Children's Hospital Center for Vaccine Development developed the vaccine's protein antigen, which was licensed from the Baylor College of Medicine's BCM Ventures commercialization arm.

Unlike COVID-19 vaccines in the U.S., Corbevax contains the so-called "spike protein" from the surface of the novel coronavirus. Once that protein is injected via a vaccine, the body is supposed to begin building immunity against the protein and thereby prevent serious illness.

Experts envision Corbevax being a readily available weapon in the global fight against the COVID-19 pandemic, thanks to the simple vaccine platform (like the one used to prevent Hepatitis B) and the ability to store the vaccine in normal refrigerated settings. The targets of this vaccine are children and mothers.

"In the midst of India's public health crisis, it is our hope that our Texas Children's and Baylor COVID-19 vaccine can be released for emergency authorization in India and in all countries in need of essential COVID-19 vaccinations," Dr. Peter Hotez, co-director of the Texas Children's Hospital Center for Vaccine Development, says in a June 9 news release.

India has reported more than 29 million cases of COVID-19, causing 354,000 deaths. The country's COVID-19 surge reached its peak in May.

"The vaccines currently available cannot be manufactured quick enough to meet supply shortages in low-income countries," Hotez says. "Our vaccine is truly 'the people's vaccine,' created to serve the most marginalized and underserved populations that are hardest hit by this pandemic. This is the vaccine that could be used to vaccinate the world."

In the Phase III trial, the two-dose Corbevax vaccine will be administered to about 1,200 people age 18 to 80 at 15 sites in India. A larger global study of Corbevax is in the works.

According to India.com, Corbevax could be the most affordable COVID-19 vaccine available in the nation of nearly 1.37 billion people, costing close to $7 for a two-dose regimen. The Indian government already has preordered 300 million doses of Corbevax, which has shown promise in Phase I and Phase II trials. The Phase II trial ended in April.

If the Phase III trial goes as planned, doses could be widely administered as soon as August. Biological E initially plans to produce 75 million to 80 million doses per month, according to media reports. The Indian company foresees manufacturing at least 1 billion doses by the end of 2022.

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Houston doctor wins NIH grant to test virtual reality for ICU delirium

Virtual healing

Think of it like a reverse version of The Matrix. A person wakes up in a hospital bed and gets plugged into a virtual reality game world in order to heal.

While it may sound far-fetched, Dr. Hina Faisal, a Houston Methodist critical care specialist in the Department of Surgery, was recently awarded a $242,000 grant from the National Institute of Health to test the effects of VR games on patients coming out of major surgery in the intensive care unit (ICU).

The five-year study will focus on older patients using mental stimulation techniques to reduce incidences of delirium. The award comes courtesy of the National Institute on Aging K76 Paul B. Beeson Emerging Leaders Career Development Award in Aging.

“As the population of older adults continues to grow, the need for effective, scalable interventions to prevent postoperative complications like delirium is more important than ever,” Faisal said in a news release.

ICU delirium is a serious condition that can lead to major complications and even death. Roughly 87 percent of patients who undergo major surgery involving intubation will experience some form of delirium coming out of anesthesia. Causes can range from infection to drug reactions. While many cases are mild, prolonged ICU delirium may prevent a patient from following medical advice or even cause them to hurt themselves.

Using VR games to treat delirium is a rapidly emerging and exciting branch of medicine. Studies show that VR games can help promote mental activity, memory and cognitive function. However, the full benefits are currently unknown as studies have been hampered by small patient populations.

Faisal believes that half of all ICU delirium cases are preventable through VR treatment. Currently, a general lack of knowledge and resources has been holding back the advancement of the treatment.

Hopefully, the work of Faisal in one of the busiest medical cities in the world can alleviate that problem as she spends the next half-decade plugging patients into games to aid in their healing.

Houston scientists develop breakthrough AI-driven process to design, decode genetic circuits

biotech breakthrough

Researchers at Rice University have developed an innovative process that uses artificial intelligence to better understand complex genetic circuits.

A study, published in the journal Nature, shows how the new technique, known as “Combining Long- and Short-range Sequencing to Investigate Genetic Complexity,” or CLASSIC, can generate and test millions of DNA designs at the same time, which, according to Rice.

The work was led by Rice’s Caleb Bashor, deputy director for the Rice Synthetic Biology Institute and member of the Ken Kennedy Institute. Bashor has been working with Kshitij Rai and Ronan O’Connell, co-first authors on the study, on the CLASSIC for over four years, according to a news release.

“Our work is the first demonstration that you can use AI for designing these circuits,” Bashor said in the release.

Genetic circuits program cells to perform specific functions. Finding the circuit that matches a desired function or performance "can be like looking for a needle in a haystack," Bashor explained. This work looked to find a solution to this long-standing challenge in synthetic biology.

First, the team developed a library of proof-of-concept genetic circuits. It then pooled the circuits and inserted them into human cells. Next, they used long-read and short-read DNA sequencing to create "a master map" that linked each circuit to how it performed.

The data was then used to train AI and machine learning models to analyze circuits and make accurate predictions for how untested circuits might perform.

“We end up with measurements for a lot of the possible designs but not all of them, and that is where building the (machine learning) model comes in,” O’Connell explained in the release. “We use the data to train a model that can understand this landscape and predict things we were not able to generate data on.”

Ultimately, the researchers believe the circuit characterization and AI-driven understanding can speed up synthetic biology, lead to faster development of biotechnology and potentially support more cell-based therapy breakthroughs by shedding new light on how gene circuits behave, according to Rice.

“We think AI/ML-driven design is the future of synthetic biology,” Bashor added in the release. “As we collect more data using CLASSIC, we can train more complex models to make predictions for how to design even more sophisticated and useful cellular biotechnology.”

The team at Rice also worked with Pankaj Mehta’s group in the department of physics at Boston University and Todd Treangen’s group in Rice’s computer science department. Research was supported by the National Institutes of Health, Office of Naval Research, the Robert J. Kleberg Jr. and Helen C. Kleberg Foundation, the American Heart Association, National Library of Medicine, the National Science Foundation, Rice’s Ken Kennedy Institute and the Rice Institute of Synthetic Biology.

James Collins, a biomedical engineer at MIT who helped establish synthetic biology as a field, added that CLASSIC is a new, defining milestone.

“Twenty-five years ago, those early circuits showed that we could program living cells, but they were built one at a time, each requiring months of tuning,” said Collins, who was one of the inventors of the toggle switch. “Bashor and colleagues have now delivered a transformative leap: CLASSIC brings high-throughput engineering to gene circuit design, allowing exploration of combinatorial spaces that were previously out of reach. Their platform doesn’t just accelerate the design-build-test-learn cycle; it redefines its scale, marking a new era of data-driven synthetic biology.”