Antengene Corporation Limited | September 19, 2022
Antengene Corporation Limited a leading innovative, commercial-stage global biopharmaceutical company dedicated to discovering, developing and commercializing first-in-class and/or best-in-class medicines for hematology and oncology, announced that ATG-101, the company's in-house developed novel PD-L1/4-1BB bispecific antibody, has been granted an Orphan Drug Designation (ODD) by the U.S. Food and Drug Administration (FDA) for the treatment of pancreatic cancer. This ODD will help Antengene facilitate regulatory communication with the FDA, accelerate the clinical development and the future registration of ATG-101.
At present, no PD-L1/4-1BB bispecific antibody has been approved for the treatment of pancreatic cancer worldwide.
Orphan Drugs, also known as Rare Disease Drugs, refers to pharmaceutical products developed for the prevention, diagnosis, and treatment of rare diseases or conditions. Orphan Drug Designations by the U.S. FDA are meant to support the development of drug candidates that could potentially bring substantial therapeutic benefits to patients with rare diseases and to provide incentives to the subsequent development, registration and commercialization to designated drugs. Those incentives include tax credit on expenditures incurred in clinical studies, a waiver of the New Drug Application (NDA) fee, and 7-year market exclusivity in the U.S. regardless of the patent status of the designated drug.
Pancreatic cancer is a highly malignant type of gastrointestinal cancer. According to the statistics by the World Health Organization (WHO), pancreatic cancer was ranked 13th and 7th globally by its incidence and mortality rates in 2012. In 2018, the U.S. reported over 55,000 newly- diagnosed pancreatic cancer cases and 44,330 related deaths. Whereas still defined as an orphan disease currently, it is projected that by 2030, pancreatic cancer will become the second most common cause of cancer-related deaths.
ATG-101 is a novel PD-L1/4-1BB bispecific antibody that was designed to block the binding of immunosuppressive PD-1/PD-L1 and conditionally induce 4-1BB stimulation, thus activating anti-tumor immune effectors, while delivering enhanced anti-tumor activity, with an improved safety profile. In preclinical studies, ATG-101 demonstrated significant anti-tumor activity in animal models of resistant tumors as well as those that had progressed on anti-PD-1/L1 treatment. Furthermore, ATG-101 has also shown an excellent safety profile in Good Laboratory Practice (GLP) toxicology studies. ATG-101 is the first PD-L1/4-1BB bispecific antibody entering clinical development in Australia and is currently being evaluated in clinical studies in Australia, China, and the U.S.
"We are very encouraged by this Orphan Drug Designation from the U.S. FDA and are hopeful that ATG-101 will offer a novel therapeutic to patients with pancreatic cancer. As Antengene's first in-house developed asset with global rights, ATG-101 has already entered clinical development in Australia, China, and the U.S. We will strive to accelerate the global clinical development of ATG-101 in efforts to provide a new treatment option to patients around the world."
Dr. Bo Shan, Antengene's Chief Scientific Officer
Antengene Corporation Limited ("Antengene", SEHK: 6996.HK) is a leading commercial-stage R&D-driven global biopharmaceutical company focused on the discovery, development, manufacturing and commercialization of innovative first-in-class/best-in-class therapeutics for the treatment of hematologic malignancies and solid tumors, in realizing its vision of "Treating Patients Beyond Borders".
Since 2017, Antengene has built a broad and expanding pipeline of 15 clinical and preclinical assets, of which 10 are global rights assets, and 5 came with rights for Asia Pacific markets including the Greater China region. To date, Antengene has obtained 24 investigational new drug (IND) approvals in the U.S. and Asia, and submitted 6 new drug applications (NDAs) in multiple Asia Pacific markets, with the NDA for XPOVIO® already approved in mainland China, South Korea, Singapore and Australia.
FUTURE OF HEALTHCARE
Visionable and Verizon | September 22, 2022
Verizon Business and Visionable, a leading health technology company based in the U.K., announced that they are expanding their partnership which will enable both companies to work on a range of connected healthcare solutions, via Visionable’s patented technology powered by Verizon’s 5G Ultra Wideband and 5G Edge network, in the U.S.
Verizon and Visionable are working together on a secure next-generation digital healthcare collaboration platform that enables healthcare professionals to access data, collaborate and share resources within the APAC and EMEA regions. The partnership seeks to address some of healthcare’s biggest challenges including connecting frontline responders to specialist doctors during emergencies and enabling access to community-led care for patients needing long-term support.
“The healthcare industry generates a massive amount of data, but its ability to make good use of that data has long been hampered by network architectures that cannot handle it efficiently, securely, or cost-effectively. Through the combination of 5G and Edge computing, healthcare facilities and professionals will have access to secure near-real-time connectivity creating a new link between doctor and patient. As a result, illnesses could someday be diagnosed and treated more quickly, and medical costs could potentially decrease,”
Scott Lawrence, Senior Vice President for Verizon Global Solutions
Today’s announcement follows the launch of Visionable’s private-5G enabled Connected Healthcare Center in the U.K. in May. The center showcases the benefits of next-generation connectivity and collaboration across a patient’s care journey from urgent and emergency care to virtual wards to in-person care and rehabilitation, supported by Verizon private 5G.
“Our partnership provides real-time connectivity and productivity, when and where it counts and costs. Together with Verizon, we endeavor to support our healthcare teams by enabling them to bring healthcare to the patient wherever they are,“ said Alan Lowe, CEO and Co-Founder of Visionable.
This engagement is part of Verizon’s continued strategy to partner with customers, startups, universities, and large enterprises to explore how 5G can disrupt and transform nearly every industry. This includes Verizon’s strategic partnership with Emory Healthcare in Atlanta where Verizon is collaborating with Emory Healthcare to help spur the development of healthcare solutions powered by 5G Ultra Wideband.
Today’s announcement builds on the company’s network-as-a-service foundation and supports its growing private networks, mobile edge compute and business solutions.
Visionable is a UK company that is helping make connected healthcare a reality in the UK and around the world. Driven by the belief that affordable, high-quality, timely healthcare is a basic human right that should be accessible to all, Visionable’s patented, real-time & multi-streaming technology enables critical remote decision-making by clinicians wherever they are located have created their own proprietary clinical collaboration platform. This enables the hospital to come to the patient and for healthcare teams to collaborate freely across multiple locations. Visionable is trusted by 25% of the top 100 UK hospitals, 100 more than 90 NHS organisations, 46 and 34 NHS Trusts., over 16,000 NHS staff. Visionable’ s specialist advisory board includes Lord Victor Adebowale, previous NHS board member, Mike Farrar, ex-NHS Chief Executive and leader of the North West England Strategic Authority and Dr Junaid Bajwa, practising physician and MSD’s Digital Accelerator’s Global Lead for Strategic Alliances.
Verizon Communications Inc. (NYSE, Nasdaq: VZ) was formed on June 30, 2000 and is one of the world’s leading providers of technology and communications services. Headquartered in New York City and with a presence around the world, Verizon generated revenues of $133.6 billion in 2021. The company offers data, video and voice services and solutions on its award-winning networks and platforms, delivering on customers’ demand for mobility, reliable network connectivity, security and control.
Zynx Health | September 20, 2022
Zynx Health announced that it has published new order set and care plan guidelines to aid clinicians in the treatment of patients diagnosed with monkeypox. Created by the Zynx Clinical Team and based on recommendations from World Health Organization and the Centers for Disease Control and Prevention, the content is available as a single, downloadable PDF on the Zynx Health website. Given the public health emergency, this content is being made available at no cost.
“As monkeypox cases continue to rise, and with hospitals still facing shortfalls in the wake of the COVID-19 pandemic, our Zynx clinicians have developed and deployed this comprehensive order set and care plan bundle to alleviate the burden of researching the underlying evidence and then building the associated clinical decision support from scratch,” said Chuck Tuchinda, MD, president of Zynx Health. “The monkeypox content on the Zynx site is comprehensive, evidence-based, and ready for use.”
The Zynx Clinical Team will continue to update its monkeypox care guidance as new evidence emerges and best-practice recommendations evolve.
About Zynx Health
Zynx Health, a market leader in providing evidence- and experience-based clinical improvement solutions since 1996 and part of the Hearst Health network, provides healthcare professionals with vital information and processes that guide care decisions and reduce complexity across the entire patient journey in a way that leads to healthier lives for all. Named the “Best in KLAS” Category Leader for Clinical Decision Support – Care Plans and Order Sets in 2021 and 2022, Zynx is a pioneer and market leader in evidence- and experience-based clinical solutions that help health systems improve patient outcomes, financial outcomes, clinical engagement, and technology performance. With Zynx Health, healthcare organizations exceed industry demands for delivering high-quality care at lower costs under value-based reimbursement models.
About Hearst Health
The mission of Hearst Health is to help guide the most important care moments by delivering vital information into the hands of everyone who touches a person’s health journey. Each year in the U.S., care guidance from Hearst Health reaches 85% of discharged patients, 205 million insured individuals, 103 million home health visits, and 3.2 billion dispensed prescriptions. The Hearst Health network includes FDB Zynx Health, MCG, Homecare Homebase, and MHK. Hearst also holds a minority interest in the precision medicine and oncology analytics company M2Gen.
Paradigm Oral Health | September 23, 2022
Paradigm Oral Health a leading oral surgery and digital dentistry platform announced that BlackRock Long Term Private Capital has entered into a definitive agreement to acquire a majority interest in the company from shareholders including InTandem Capital Partners. LTPC will partner with Paradigm’s executive leadership team, led by founder and CEO Dr. David Rallis, to support the company’s continued expansion and strategic growth plans.
Founded in 2018, Paradigm has developed an industry-leading model designed to attract and retain best-in-class surgeons focused on delivering the highest quality of oral health care and dental implant surgery while fostering a medically-driven, patient-friendly culture of excellence. The company partners with leading oral surgery groups in markets across the United States, allowing them to maintain their unique brand identity while operating on the same platform. Paradigm’s proprietary practice management technology, Paragon, utilizes cutting-edge technology and data analytics to provide and store proprietary information and intelligence generated by the business, leading to enhanced performance as well as increased patient and provider satisfaction. Today, Paradigm and its team of over 100 surgeon partners provide patient care in 75 state-of-the-art facilities throughout the United States.
“We are pleased to invest in Paradigm, which has established itself as an industry defining platform for the development and delivery of next-generation oral health solutions. Through its focus on providing superior clinical care, advanced technology, and continued training and education to its surgeon partners, the company is well positioned for long-term growth. We look forward to partnering with Dr. David Rallis and the entire Paradigm team.”
Colm Lanigan, Head of BlackRock LTPC, Americas
David Rallis, DDS, MD, and CEO of Paradigm Oral Health, commented, “Paradigm is advancing oral surgical outcomes and patient experience through a culture that places the needs of the patient first. At Paradigm, we validate our clinical performance through a proprietary data ecosystem and use data to reinforce our culture of excellence and accountability. Through innovation, and the rapid adoption of technology, we continue to set the standard for dental implant surgery. Aligning our company with world-class partners, first InTandem Capital and now BlackRock LTPC, has allowed Paradigm to emerge as a leader. We are humbled by the opportunity to partner with BlackRock LTPC, and excited to work with Colm Lanigan and his team as we continue to advance Paradigm as the global leader in oral surgery.”
Elliot Cooperstone, Managing Partner of InTandem Capital Partners, Paradigm’s financial sponsor since 2019, commented, “InTandem Capital invests in healthcare companies that are local leaders with the ambition and potential to become a national powerhouse. Dr. David Rallis and the leadership team at Paradigm embraced our playbook for accelerated growth with amazing skill and dedication. Our deep trust in each other has allowed our partnership to flourish. My colleagues and I wish David and the Paradigm team the very best as they build on their well-deserved position as the country’s leading oral health company.”
Paradigm is BlackRock LTPC’s sixth investment to date and its fourth investment in North America.
Houlihan Lokey acted as financial advisor and Goodwin Procter acted as legal advisor to Paradigm. Simpson Thacher acted as legal advisor to Blackrock LTPC.
About Paradigm Oral Health
Paradigm Oral Health is the preeminent provider of oral surgery. Paradigm’s uniqueness comes from their ability to hire the most elite oral surgeons in the country and train them on their proprietary platform of excellence. Paradigm Oral Health continues to revolutionize and reinvent implant surgery through their ongoing technology and digital work-flow advancements. With a passion for excellence, Paradigm embraces every opportunity to meet the needs of their patients and referring dentists.
About BlackRock LTPC
BlackRock LTPC is an innovative private equity strategy focused on investing in high-quality businesses and value creation through active collaboration with management teams. The strategy's flexible duration and prudent approach to leverage preserve optionality for growth and help enable compounded capital appreciation. LTPC's team of 23 professionals are based in New York and London and invest across North America and Western Europe. LTPC is backed by BlackRock, Inc., which manages $320 billion in alternative investments and commitments on behalf of clients worldwide as of June 30, 2022.
About InTandem Capital Partners
InTandem Capital Partners is a private equity firm that invests in and helps accelerate the growth of select healthcare services companies. Its goal is to build excellent businesses of significant value working collaboratively with its management team partners. InTandem is comprised of former business executives and experienced investors, and is uniquely qualified to provide strategic, acquisition and operating expertise to help companies significantly increase their value over time. InTandem provides active support to the management of its portfolio companies directly and leverages its network of industry executives to augment its capabilities.