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.
Alkem Laboratories Ltd. | January 13, 2022
Alkem Laboratories Ltd. (Alkem) hereby announces to launch a unique patented technology for the treatment of Diabetic Foot Ulcer (DFU) in India. The solution would be based on disruptive 4D Bioprinting technology, which would be used to treat deep, non-healing chronic wounds and is expected to be launched in the Indian market in the latter half of 2022 post regulatory approval. This advanced technology for DFU management has a high scope of preventing amputations in diabetic patients. This technology will be available at affordable rates to Indian patients at a time when there is no definitive treatment for DFU in India.
India currently has approximately 77 mn diabetes patients, the second highest in the world. A diabetic foot ulcer is one of the most significant and devastating complications of diabetes and is defined as a foot affected by ulceration that is associated with neuropathy and/or peripheral arterial disease of the lower limb in a patient with diabetes. Approximately, 12-15% with diabetes suffer from DFU at least once in a lifetime. 5–24% of them will finally lead to limb amputation within 6–18 months after the first evaluation. The risk of foot ulceration and limb amputation increases with age and the duration of diabetes. Alkem has collaborated with Rokit Healthcare Inc. to commercialize the technology in India to help reduce amputation amongst DFU patients considering the negative impact of amputation on a patient's quality of life and the associated economic burden on the healthcare system.
"In India, Diabetes is one of the major healthcare challenges. The challenge in itself is so huge that diabetic foot ulcers often get ignored. Approximately 1 lac people have to undergo amputation every year and compromise on their quality of life. To address the problem, Alkem has collaborated with Rokit Healthcare Inc., a global regenerative solutions company, to bring out novel solutions for the management of diabetic foot ulcers."
Mr. Sandeep Singh, Managing Director, Alkem Laboratories Ltd
Adding further, Mr. Sandeep asserted, "Alkem, over the years, has always been at the forefront in delivering high-quality patient care, through its innovation and patient-centric initiatives."
About Alkem Laboratories Ltd
Established in 1973 and headquartered in Mumbai, Alkemis a leading Indian pharmaceutical company with global operations, engaged in the development, manufacture, and sale of pharmaceutical and nutraceutical products. The Company produces branded generics, generic drugs, active pharmaceutical ingredients (APIs), and nutraceuticals, which it markets in India and International markets. With a portfolio of more than 800 brands in India, Alkem is ranked the fifth largest pharmaceutical company in India in terms of domestic sales. The Company also has presence in more than 40 international markets, with the United States being its key focus market.
Graham Healthcare Group | December 21, 2021
Graham Healthcare Group, a leader in homecare, palliative and hospice services, today announced its acquisition of InTeliCare Health Services, a provider of home health services in central Florida. The agreement was finalized on December 15th, 2021, and marks Graham's first expansion into Florida.
Graham will integrate InTeliCare into its Residential Home Health division to accelerate access to personalized home health care throughout Florida. Residential is a leading post-acute home care network serving communities in Michigan, Illinois and Pennsylvania.
Integrating InTeliCare into Residential Home Health will bring together industry-leading, patient-centered home health services to strengthen the continuum of care for patients across central Florida.
"More than one-fifth of Florida's population is over 65, and that number continues to grow. With the baby boomer generation doubling in size and an increase in comorbidities, this is an ideal time for Graham Healthcare Group to begin serving people in the state of Florida in their own homes with high-quality post-acute and end-of-life care."
David Curtis, Chief Executive Officer of Home Health at Graham Healthcare Group
"With the addition of InTeliCare, we're poised for growth as we continue our mission to transform home care and improve patient experiences," Curtis said. "This agreement expands the ability of Graham Healthcare Group to deliver consistent, high-quality care across the spectrum of home health and further strengthens our foundation for success."
Irene Tuttle, InTeliCare Founder and Chief Executive Officer, will serve in an advisory role following the deal's close. Toni Walker, InTeliCare's longstanding Vice President of Operations, will maintain leadership over day-to-day operations.
"We strongly align with Residential's values of care and community," Tuttle said. "This is an extraordinary opportunity to join forces with an organization that shares our employee- and patient-driven approach to care."
"We are confident that the powerful synergies and added strength this partnership creates will continue to elevate the value and experience of post-acute care and advance the continuum of home health care in central Florida," Tuttle added.
Residential Home Health intends to retain InTelicare's workforce and will support them with enhanced operational efficiencies and advanced clinical and technology innovations.
Both Residential Home Health and InTeliCare are known for strong, employee-friendly cultures. Residential has been recognized as a top workplace for 11 consecutive years in the Detroit market and was recognized in the Chicago and St. Louis markets in 2021.
About Graham Healthcare Group
A subsidiary of Graham Holdings Company, Graham Healthcare Group has designed business and technology solutions to drive better care, outcomes and productivity in home health and hospice services for more than 20 years. Itincludes Residential Healthcare Group, Allegheny Health Network-Healthcare @ Home, Mary Free Bed at Home, Clarus, and CSI Pharmacy. Itis deeply committed to radically changing the home care model by putting patients and their families at the top of the paradigm, while enhancing the quality and consistency of healthcare in the most convenient and cost-effective setting possible: at home.
About Residential Home Health
Based in Troy, Michigan, Residential Home Health is a leading provider of home health, palliative and hospice services in Michigan, Illinois and Pennsylvania. Residential is one of the fastest growing home health networks with 2,500 dedicated care professionals.
About InTeliCare Health Services
Based in Boca Raton, InTeliCare is a leading provider of home health services in central Florida. The company has 80 employees serving nearly 300 patients from three offices.
FUTURE OF HEALTHCARE
Ensemble Health Partners | December 15, 2021
Ensemble Health Partners, in partnership with Caduceus Capital Partners, led the $8 million Series A capital raise for Janus Health, a revenue cycle automation and decision support platform.
Billions of dollars are left uncollected annually by healthcare providers due to poor methods and inconsistent human decision making in the revenue cycle process. Janus Health studies end-user behavior within the revenue cycle and uses advanced AI to determine the optimal path for each workflow. Janus then automates processes and end-to-end workflows using its scalable platform and delivers real-time predictive recommendations to guide human worker performance.
“I invest in people first. I’ve known Brendan for a long time, and he has assembled an incredible team who are experts in the field. We see a lot of technology fads in healthcare, but I am always most concerned with delivering value and creating a meaningful impact for our clients and associates. As someone deeply entrenched in the revenue cycle world, I see tremendous potential for Janus to deliver on both fronts.”
Judson Ivy, Founder, President and CEO, Ensemble Health Partners
“Several factors, including labor shortages, shrinking reimbursements and more stable IT environments, are creating a ripe opportunity to transform the revenue cycle with artificial intelligence and automation,” said Brendan Downing, co-founder and CEO of Janus Health. “Janus Health offers a timely service that can have a significant impact for health systems struggling with these rising costs-to-collect and reimbursement challenges.”
Health systems continue to struggle with a workforce shortage and lack of resources. A recent McKinsey & Company study showed that $180 billion could be saved in healthcare administration and finance costs with automated technology. Many health systems do not currently have revenue cycle automation, but plan to implement this technology in the next year. With Janus Health, managers and executives receive actionable insights into people, productivity and practices, allowing them to optimally allocate and manage resources.
“The revenue cycle in healthcare is notoriously challenging. Billing and collections are especially complicated when you consider the various payors and parties involved in a transaction,” said Dave Vreeland, senior managing partner at Caduceus Capital Partners. “This area is one of the most labor-intensive in healthcare, and there is a huge opportunity for Janus to make a difference in the industry.”
Jim Gaffney, EVP, strategy and corporate development at Ensemble Health Partners and Sue Tyler, venture partner at Caduceus Capital Partners will serve on the Janus Health board of directors.
About Ensemble Health Partners
Ensemble Health Partners is a leading provider of technology-enabled revenue cycle management solutions for health systems, including hospitals and affiliated physician groups. The company offers end-to-end revenue cycle solutions as well as a comprehensive suite of point solutions to clients across the country.
About Caduceus Capital Partners, LLC
Caduceus Capital Partners is a venture capital and private equity company focused on early-stage digital health investments. The Caduceus Capital Partners investment model actively supports portfolio companies from the first check to the exit phase with operational expertise and network access to potential customers and partners.
About Janus Health Technologies
Janus Health is leapfrogging the automation solutions of today by developing the only end-to-end process improvement platform that studies a revenue cycle operation to determine the optimal path of each workflow and rapidly builds intelligent automation and decision support with a single-click.