Texas Children Hospital | December 29, 2021
Texas Children's Hospital and Baylor College of Medicine announced today that CORBEVAX™, a protein sub-unit COVID-19 Vaccine, whose technology was created and engineered at its Center for Vaccine Development (CVD), has received Emergency Use Authorization (EUA) approval from the Drugs Controller General ofIndia(DCGI)to launch inIndiawith other underserved countries to follow.
Dubbed "The World's COVID-19 Vaccine", it uses a traditional recombinant protein-based technology that will enable its production at large scales making it widely accessible to inoculate the global population. The initial construct and production process of the vaccine antigen was developed at Texas Children's Hospital CVD, 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).
CORBEVAX™ after completing two Phase III clinical trials involving more than 3000 subjects was found to be safe, well tolerated and immunogenic:
CORBEVAX™ demonstrated superior immune response in comparison with COVISHIELD™ vaccine when assessed for Neutralizing Antibody (nAb) Geometric Mean Titers (GMT) against the Ancestral-Wuhan strain and the globally dominant Delta variant. CORBEVAX™ vaccination also generated significant Th1 skewed cellular immune response.
CORBEVAX™ nAb GMT against Ancestral-Wuhan strain is indicative of vaccine effectiveness of >90% for prevention of symptomatic infections based on the Correlates of Protection assessment performed during Moderna and Astra-Zeneca vaccine Phase III studies.
CORBEVAX™ nAb GMT against the Delta strain indicates a vaccine effectiveness of >80 percent for the prevention of symptomatic infections based on published studies.
While none of the subjects who took CORBEVAX™ or COVISHIELD™ had serious adverse events, CORBEVAX™ had 50 percent fewer adverse events than COVISHIELD™.
In the continuous monitoring of phase II studies, CORBEVAX™ showed high persistence of immune response as indicated by <30% drop in nAb GMT till 6 months second dose as compared to >80% drop observed with majority of the vaccines.
"Protein-based vaccines have been widely used to prevent many other diseases, have proven safety records, and use economies of scale to achieve low-cost scalability across the world," said Dr. Maria Elena Bottazzi, Professor and Associate Dean of the National School of Tropical Medicine at Baylor and Co-Director of the Texas Children's Hospital Center for Vaccine Development. "Our decade-long studies advancing coronavirus vaccine prototypes has led to the creation of this vaccine, which will fill the access gap created by the more expensive, newer vaccine technologies and that today are still not able to be quickly scaled for global production."
The need for safe, streamlined, low-cost vaccines for middle- to low-income countries is central to the world's fight against the COVID-19 pandemic. 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.
"This announcement is an important first step in vaccinating the world and halting the pandemic. 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," said Dr. Peter Hotez, Professor and Dean of the National School of Tropical Medicine at Baylor and Co-Director of the Texas Children's Hospital Center for Vaccine Development. "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."
"Over the years, we have worked to make quality vaccines and pharmaceutical products accessible to families around the world. With this as our backdrop, we resolved to develop an affordable and effective COVID-19 vaccine. It has now become a reality. We deeply appreciate Texas Children's Hospital Center for Vaccine Development, Baylor, CEPI, the Bill and Melinda Gates Foundation, and the government of India for their continuous support and cooperation during this journey. The combined efforts & unceasing support demonstrate that we can collectively overcome any challenge".
Mahima Datla, Managing Director, Biological E. Limited
ABOUT TEXAS CHILDREN'S HOSPITAL
Texas Children's Hospital, a not-for-profit health care organization, is committed to creating a healthier future for children and women throughout the global community by leading in patient care, education and research. Consistently ranked as the best children's hospital in Texas, and among the top in the nation, Texas Children's has garnered widespread recognition for its expertise and breakthroughs in pediatric and women's health. The hospital includes the Jan and Dan Duncan Neurological Research Institute; the Feigin Tower for pediatric research; Texas Children's Pavilion for Women, a comprehensive obstetrics/gynecology facility focusing on high-risk births; Texas Children's Hospital West Campus, a community hospital in suburban West Houston; and Texas Children's Hospital The Woodlands, the first hospital devoted to children's care for communities north of Houston. The organization also created Texas Children's HealthPlan, the nation's first HMO for children; has the largest pediatric primary care network in the country, Texas Children's Pediatrics; Texas Children's Urgent Care clinics that specialize in after-hours care tailored specifically for children; and a global health program that's channeling care to children and women all over the world. Texas Children's Global Health program leads efforts that advance health care equity through innovative collaboration in care, education and research for underserved populations globally. Texas Children's Hospital is affiliated with Baylor College of Medicine.
ABOUT TEXAS CHILDREN'S HOSPITAL CENTER FOR VACCINE DEVELOPMENT
Texas Children's Hospital Center for Vaccine Development is one of the leading vaccine development centers in the world. Established in Washington DC as the Sabin Vaccine Institute Product Development Partnership (PDP) in the year 2000 and after relocating to the Texas Medical Center in 2011, it rebranded as Texas Children's Center for Vaccine Development. For the past two decades it has acquired an international reputation as a non-profit PDP, advancing vaccines for poverty-related neglected tropical diseases (NTDs) and emerging infectious diseases of pandemic importance. In addition, it builds and strengthens capacity for vaccine development locally and with foreign nations and leads global efforts to guide and influence vaccine policy and advocacy through "vaccine diplomacy" as an international bridge for peace and vaccine development capacity.
ABOUT BCM VENTURES
Baylor College of Medicine Ventures is the commercial engine of the health sciences university, created to support the translation of academic knowledge and intellectual assets for the benefit of society. We do this by engaging university innovators, entrepreneurs and industry to fully develop ideas along their best commercial path. We foster a culture of commercialization and engage with industry to identify market opportunities for collaborative ventures.
ABOUT BIOLOGICAL E. LIMITED
Biological E. Limited (BE), a Hyderabad-based Pharmaceuticals & Biologics Company founded in 1953, is the first private sector biological products company in India and the first pharmaceutical company in Southern India. BE develops, manufactures and supplies vaccines and therapeutics. BE supplies its vaccines to over 100 countries and its therapeutic products are sold in India and the USA. BE currently has 8 WHO-prequalified vaccines in its portfolio. In recent years, BE has embarked on new initiatives for organisational expansion such as developing generic injectable products for the regulated markets, exploring synthetic biology and metabolic engineering as a means to manufacture APIs sustainably and developing novel vaccines for the global market.
FUTURE OF HEALTHCARE
Novant Health | March 29, 2022
Novant Health, one of the largest health care systems in the Southeast, today announced the launch of a new business division designed to innovate and support scalable solutions for some of the health care industry's biggest challenges. Operating as an independent business entity, Novant Health Enterprises will better enable partnerships with other health care organizations, create diversified growth and generate value for Novant Health's core business. Some of Novant Health's existing services will move over into this new division, and additional service offerings will be developed and acquired. NHE will accelerate the improvements Novant Health is making through its investments and partnerships focused on clinical, operational and technological advancements.
Envisioned as an incubator to accelerate the development of solutions that promise to unlock clinical, financial and patient value at scale, the health system's new venture will bring to market innovative solutions that empower all patients to live healthier lives – while enabling physicians to focus on delivering the best possible care. Novant Health Enterprises will build on the health system's considerable scale and prominence as well as the strength of its strategic partnerships and will focus on three core areas over the next five years: developing transformational clinical capabilities, continued expansion into non-acute settings, and commercializing differentiating digital solutions.
"Novant Health has long been at the forefront of innovation in health care, pioneering solutions internally and through unconventional partnerships to solve the industry's biggest challenges. This forward-thinking has enabled us to reimagine the patient experience, advance the quality and capability of care and be named the safest health care system in the region. I can't wait to see what a unique entity such as Novant Health Enterprises will incubate, innovate and accelerate as we leverage technological innovation to create better outcomes for our patients, providers and communities."
Carl S. Armato, president and CEO, Novant Health
Novant Health Enterprises will be led by Dean Swindle, who will serve as executive vice president of Novant Health and president of this new division. Swindle has over 30 years' experience as a financial and strategic executive in both national and regional health systems and has developed transformational growth activities and industry leading capabilities.
Angela Yochem will serve as chief operating officer and general manager of Novant Health Enterprises in addition to her current role as Novant Health executive vice president and chief transformation and digital officer. Yochem has over 25 years' experience in new business creation and operation, delivery of world-class consumer experiences and differentiating technologies, and development of advanced solutions for the competitive advantage of global companies at scale.
"Novant Health Enterprises convenes the industry's leading partnerships to deliver on our promise to make health care remarkable for all our patients, in every dimension, every time," said Swindle. "As most of us have witnessed in the health care industry, the events of the past two years have underscored the value that technology and transformational capabilities can bring to patient care. Novant Health Enterprises has never been more confident in the potential for technological innovation to alleviate the most pressing problems in health care and we are excited to get started."
"The creation of Novant Health Enterprises will maximize the power of innovation and partnerships, allowing us to better pursue our mission of making our communities healthier, one person at a time," said Yochem. "We'll not only have our finger on the pulse of what is needed to improve care, but we'll have the ability to foster, create, test and apply those solutions at an unprecedented rate. I look forward to uncovering new opportunities as we focus Novant Health Enterprises' initial priority areas in the coming months."
Novant Health Enterprises will continue to develop the operating framework and strategic plans over the course of the next year.
About Novant Health
Novant Health is an integrated network of physician clinics, outpatient facilities and hospitals that delivers a seamless and convenient healthcare experience to communities in North Carolina, South Carolina and Georgia. The Novant Health network consists of more than 1,800 physicians and over 35,000 employees who provide care at nearly 800 locations, including 15 hospitals and hundreds of outpatient facilities and physician clinics. In 2021, Novant Health was the highest-ranking healthcare system in North Carolina to be included on Forbes' Best Employers for Diversity list. Diversity MBA Magazine ranked Novant Health first in the nation on its 2021 list of "Best Places for Women & Diverse Managers to Work." In 2020, Novant Health provided more than $1.02 billion in community benefit, including financial assistance and services.
FUTURE OF HEALTHCARE
Prenosis | March 10, 2022
Prenosis, Inc., a precision medicine company,announced a venture investment from PACE Healthcare Capital, an early-stage investment firm committed to improving health outcomes. This investment brings total funding in the company to over$20 million, including partnerships with Foxconn, Roche Diagnostics, the Defense Threat Reduction Agency, and others.
Prenosisis leveraging machine learning algorithms trained on deep biological data and broad clinical data to create precise and comprehensive maps of acute disease. Using these maps, Prenosis develops and markets valuable navigational tools to improve patient care by illuminating the optimal treatment pathways for each patient.
"This capital will further accelerate our deep biological mapping of acute disease and to further grow the NOSIS™dataset/biobank, which is the largest such dataset/biobank ever created for sepsis," saidBobby Reddy, Jr., CEO and Co-Founder, Prenosis Inc. "Using our mapping technology, we are developing sophisticated methods to define, divide, and conquer diseases. The navigational guidance solutions based on our health state maps will address the critical challenge of sepsis by providing critical and actionable information tailored to each patient's health state."
Prenosis is pioneering a revolution in managing acute diseases that have previously eluded conventional methods, starting with sepsis. Sepsis occurs when the immune system reacts abnormally to an infection, setting off a chain of events that leads to tissue damage and organ failure. Sepsis is currently one of the leading causes of mortality in U.S. hospitals, and the WHO estimates that it causes 1 in 5 deaths worldwide1.
Prenosis has spent nearly a decade building fit-for-purpose biological and clinical datasets at an unprecedented level to better understand sepsis and other acute care conditions.
Using this information, Prenosis has developed patient maps and valuable navigational tools to empower physicians to administer optimal treatment to patients faster. Prenosis' first such tool, the Sepsis ImmunoScoreTM, is a Software-as-a-Medical Device (SaMD) digital diagnostic designed to aid in the risk assessment for progression to sepsis of patients admitted in the emergency department or hospital. Prenosis is currently seeking to obtain FDA clearance for the tool by the end of 2022. The test runs on Prenosis's Immunix™software platform, which interfaces with hospital Electronic Medical Records that hosts multiple products to improve patient care.
"Personalized medicine is the next frontier of healthcare. Complex acute diseases, such as sepsis, can only be conquered through a robust understanding of the biological response of each patient's immune system – one patient at a time. Prenosis brings our understanding of the disease patterns to a whole new level and enables physicians to make better decisions faster for their patients. We are excited to partner with Bobby and the whole Prenosis team as they continue to develop their technology and transform the way we understand and provide care for patients with complex acute diseases."
Julia Monfrini Peev, Founder and Managing Partner of PACE Healthcare Capital
The funding builds on a recent string of strategic partnerships and accolades for Prenosis, including being selected as part of the MedTech Innovator 2021 Showcase, being named the #2 Medtech Startup of 2021 by MDDI, and being asked to present its research at scientific meetings, including the forthcoming 2022 annual meetings for the Society of Critical Care Medicine and the American Thoracic Society.
"In addition to support from other investors and partners, PACE Healthcare Capital's involvement is a strong endorsement of our solutions and will help to accelerate our growth as we further expand our proprietary dataset and work towards commercialization of the Immunix™platform later this year," said Reddy. "As we use our technology to map acute disease, we hope to usher in a new age of data-driven treatment and medical discovery."
Prenosis is a health tech innovator devoted to ushering in a new era of precision diagnostics in acute care using artificial intelligence. Its Immunix™precision diagnostics platform leverages machine learning algorithms trained on deep biological data and broad clinical data designed to capture and illuminate the complex health states of patients more holistically. Its proprietary NOSISTMdataset is one of the largest and fastest-growing hybrid biomarker-clinical datasets for sepsis care. The Sepsis ImmunoScore™diagnostic on the Immunix™platform has the potential to save thousands of lives and billions of dollars in healthcare spending annually. The Sepsis ImmunoScore™is not yet approved for commercial use in the United States.
About PACE Healthcare Capital
PACE Healthcare Capitalis an early-stage venture capital firm focused on investing in companies that have developed high-impact solutions to critical healthcare challenges. With decades of combined experience and $1B+ of capital raised and deployed in healthcare, PACE applies institutional-grade investment processes to identify the best entrepreneurs and deploy financial and human capital to help them grow their business.
Health at Scale | February 01, 2022
Health at Scale today announced a collaboration with Walmart to provide personalized provider recommendations to Walmart associates and their families who work in locations where Health at Scale is offered and are enrolled in the company's health plan. This technology will be incorporated into Walmart's health plan administrator's search engine and virtual care referrals for associates in select geographies, making it easier for plan participants to find providers that match to their unique health needs and care history. Through this initiative, Walmart and Health at Scale will establish a more personalized healthcare experience that focuses on the needs of each individual in the moment and leverages industry-leading machine intelligence to identify providers who have successfully treated patients with similar characteristics and care needs.
"Finding the right provider is one of the most important health decisions a patient makes. It is also one of the hardest. What we really need to optimize is the patient-provider match. We're delighted to work with Walmart as the leader in employer health and benefits innovation and provide Walmart associates and their families in certain locations with smart, hyper-personalized provider matches that reflect a deep understanding and respect for their individual health needs."
Health at Scale CEOZeeshan Syed
Health at Scale's Precision Navigation™goes beyond non-personalized process-based star ratings, reputation rankings, and volume-based metrics and instead uses industry-leading AI and machine learning to model variations in provider outcomes across thousands of health factors. The service covers 25 different specialties as well as 34 procedures and imaging.
"Customizing services and treatments to individual needs is the next frontier in healthcare and is a major part of Walmart's commitmentto helping associates and their family members find great doctors who consistently deliver the best value and quality care in their community," saidLisa Woods, VP, Walmart US Benefits. "We are excited to launch this collaboration with Health at Scale and are eager to see the impact that another innovative benefit like this will have on associates' healthcare experience and outcomes."
About Health at Scale
Health at Scale is a healthcare machine intelligence company that uses proprietary advances in artificial intelligence and machine learning to match individuals managed by insurers, employers and providers to the next best action in real-time and when needed most: whether it's the ideal choice of treatment, an early intervention, or the right provider. Founded by machine learning and clinical faculty fromMIT,Harvard,Stanford, and theUniversity of Michigan, the company's mission is to bring precision delivery to healthcare, learning from thousands of health variables from over a hundred million lives to generate personalized and precise insights for individual patients. Health at Scale's machine intelligence is deployed at scale in real operational settings -- including with some of the largest healthcare organizations in the country, driving better health outcomes and affordability for its customers. The company's software solutions service a broad range of use cases: provider navigation and network design, early targeted prediction and prevention of adverse outcomes, optimized treatment planning; and fraud, waste, and abuse prevention.