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,MEDICAL DEVICES
Capterra | November 30, 2022
The rising adoption of connected medical devices is accelerating cyberattacks, according to Capterra’s new Medical IoT Survey of healthcare IT professionals. The survey also reveals that 67% of healthcare cyberattacks impact patient data and nearly half impact patient care, an indication that rising security risks in the industry are leading to severe consequences in patient outcomes and privacy.
The medical internet of things is helping to make healthcare more convenient, efficient, and patient-centric. However, connected devices with IoT sensors often have unprotected security vulnerabilities that endanger healthcare facilities, and even patients. In fact, medical practices with more than 70% of their devices connected are 24% more likely to experience a cyberattack than practices with 50% or fewer connected devices.
“As a healthcare organization connects more medical devices to its network, its attack surface expands. Connected medical devices often go unmonitored for security vulnerabilities, and because they run on a wide array of software and hardware platforms, it’s difficult to monitor with a single tool. This means that many connected medical devices are left wide open to cyberattacks.”
Zach Capers, senior security analyst at Capterra
More than half of healthcare IT staff rate the cybersecurity threat level in the industry as high or extreme, yet many healthcare organizations are not taking the necessary steps to protect medical IoT devices. Alarmingly, 57% do not always change the default username and password for each new connected medical device that is put into use. Additionally, 82% run connected medical devices on old Windows systems.
If a security vulnerability is discovered, organizations should patch the device or update its firmware as soon as possible. Unfortunately, 68% of healthcare organizations don’t always update connected devices when a patch is available. However, vulnerabilities and associated patches aren’t always well publicized, which means healthcare IT staff must stay up-to-date on emerging threats to medical IoT devices.
Medical IoT security requires proactive and ongoing vigilance. Healthcare practices should conduct routine vulnerability assessments before connecting medical devices to their IT network. They should also keep an up-to-date and accurate inventory of all connected devices plus associated software and firmware, and use software to monitor these devices.
Read the full report on Capterra.com to learn more about best practices for healthcare organizations to strengthen security for their medical IoT devices.
Capterra is the leading software reviews and selection platform that connects businesses to the right technology. Compare software, read and leave reviews, and access objective insights that empower business growth.
HEALTH TECHNOLOGY,MEDICAL DEVICES
Predictive Health Solutions | December 06, 2022
With the Predictive Health Solutions Patient No-Show Predictor, providers now have a new tool in combatting patient no-shows. By leveraging the power of predictive analytics, the PHS Patient No-Show Predictor can also help reduce patient backlogs and long waitlists, improve operational efficiencies, promote better patient health outcomes, increase potential revenues, enhance patient care, and minimize caregiver burnout.
Powered by SAS analytics software and co-developed by Pinnacle Solutions, the solution seamlessly integrates cutting edge technology into pre-existing daily operations, making it easy for healthcare staff to use. The solution identifies high-risk patients as well as potential key risk factors impacting a patient's ability to attend their appointment, such as weather, social determinants of health, or many other factors. Using the information provided, staff can quickly make informed decisions regarding intervention strategies that directly impact the patient's likelihood of attending their appointment and receiving the care they need. For example, staff may choose to offer alternative options to those with unreliable transportation or suggest afternoon appointments for those whose morning commute would be impacted by traffic delays. Teams may also choose to use the intelligence gathered to customize individual reminder protocols to maximize the impact and value of those existing tools. Data gathered can also be leveraged for strategic overbooking, as opposed to, for example, blindly scheduling same-day appointments.
Patient no-shows cost the US and Canadian healthcare systems more than $150 billion annually, and those numbers are likely higher as a result of the COVID-19 pandemic. The ensuing funding shortages not only impact the bottom line, but also directly affect healthcare systems' ability to provide the desired level of care, which in many cases creating even greater accessibility and availability issues. For instance, revenue lost as a result of no-shows could be used to fund additional medical staff or provide the latest medical technologies and therapy sessions for patients in need.
Predictive Health Solutions is a joint venture with Pinnacle Solutions, Inc. and the Center For Discovery, Innovation and Development an affiliate member of RWJBarnabas Health and a member of Children's Miracle Network Hospitals. PHS was established to improve access to healthcare, improve diagnostic algorithms, and enhance patient outcomes. PHS uses patient data and external sources to develop solutions that address healthcare needs better. Using machine learning algorithms and artificial intelligence, PHS helps organizations create optimal health for their communities.
Florence Healthcare | November 18, 2022
Florence Healthcare™, a clinical research technology company headquartered in Atlanta, Georgia, announced the completion of a year-long third-party study on the impact of Site Enablement Platforms™ on clinical research timelines and costs.
The study by Marketcap Consulting is the first to compare how traditional site management approaches differ from site-first Site Enablement Platforms. The study looked at the impact of traditional sponsor portals and new Site Enablement Platforms on research sponsor and Contract Research Organization study timelines and budgets.
“Pharma sponsors and CROs realize the importance of enabling sites to do their best work - but only recently have they discovered that traditional site portals are more hindrance than help. Yet, these organizations weren't able to measure the true impact of switching to a Site Enablement Platform. This year-long study aimed to fix that and highlight how linking fragmented workflows accelerates the full lifecycle of clinical trials.”
Ryan Jones, CEO of Florence Healthcare
Site enablement is a new technology category that prioritizes the needs of the site, a major shift from past technology that only looked at the experience of the sponsor. These platforms, including Florence Healthcare’s SiteLink™, insist on ease-of-use and ease-of-setup for the site, quality support, and simplified integrations. SiteLink works in conjunction with eBinders™, an electronic Investigator Site File solution used by over 12,000 research sites in 45 countries.
About the Study
Marketcap Consulting conducted interviews with clinical research operations leaders harnessing SiteLink, examined timelines and study costs, and analyzed the impact across the sites in the study. On average, the team found that SiteLink accelerated study start-up by four weeks and study close-out by two weeks at every site. For a 50-site study, this six-week acceleration reduced cash burn by one million dollars.
“We can see a clear positive impact on study timelines and cash burn when research sponsors and CROs implement Site Enablement Platforms,” said Joel White, founder of Marketcap Consulting. “This early study reveals that by enabling sites to do their best work, the clinical research industry unlocks value across the full research cycle.”
“While the financial impact of switching to SiteLink makes investing in site enablement an easy choice for sponsors and CROs, it’s really the acceleration of studies that gets our team at Florence Healthcare excited,” said Jones. “We aim to double the output of research teams by the end of the decade, and enabling sites is the way to do it.”
About Florence Healthcare
Florence Healthcare’s clinical trial software helps more than 12,000 research sites in 45 countries manage their documents, data, and workflows. The Florence Healthcare™ platform also provides remote access so sponsors and Contract Research Organizations can collaborate with their sites around the world. Florence Healthcare users now perform 5.8 million remote monitoring activities each month.