Latest news with #INTERACT
Yahoo
08-08-2025
- Business
- Yahoo
Sana Biotechnology Announces Publication in New England Journal of Medicine of Groundbreaking Clinical Data from Transplantation Without Immunosuppression of Hypoimmune-Modified, Insulin-Producing Islet Cells in Patient with Type 1 Diabetes
Data Demonstrate that Sana's Hypoimmune (HIP)-Modified Pancreatic Islet Cells, Transplanted with No Immunosuppression, Persist and Function Over Time in Patient with Type 1 Diabetes Study Establishes Ability to Genetically Modify and Transplant Pancreatic Islet Cells Without Immunosuppression and Overcome Both Allogeneic and Autoimmune Rejection Six-Month Patient Follow-up Results Presented at the 85th Annual American Diabetes Association (ADA) Scientific Sessions Further Demonstrate that Sana's HIP-Modified Pancreatic Islet Cells are Safe and Well-tolerated, Survive, Evade Detection by the Immune System, and Continue to Produce Insulin in the Patient Sana Is Incorporating its HIP Technology to Develop SC451, a HIP-Modified, Stem Cell-Derived Therapy as a One-Time Treatment for Patients with Type 1 Diabetes, with a Goal of Normal Blood Glucose with No Insulin and No Immunosuppression Recent FDA INTERACT Meeting Increases Confidence in Moving Forward with GMP Master Cell Bank for SC451 and in Filing SC451 Investigational New Drug Application (IND) as Early as 2026 Sana Expects Study Data to Be Generalizable across Multiple Cell Types and Patient Populations SEATTLE, Aug. 04, 2025 (GLOBE NEWSWIRE) -- Sana Biotechnology, Inc. (NASDAQ: SANA), a company focused on changing the possible for patients through engineered cells, today announced that the New England Journal of Medicine (NEJM) has published a journal article titled 'Survival of Transplanted Allogeneic Beta Cells with No Immunosuppression' (DOI: 10.1056/NEJMoa2503822). The article discusses 12-week results from an investigator-sponsored trial, conducted at Uppsala University Hospital, evaluating the transplantation of UP421, a primary human pancreatic islet cell therapy engineered with Sana's hypoimmune (HIP) technology, without the use of immunosuppressive medications in a 42-year-old patient living with type 1 diabetes for over three decades. The intramuscular transplantation of HIP-modified pancreatic islet cells is safe and well-tolerated and demonstrates that these cells evade autoimmune and allogeneic immune recognition, persist, and secrete insulin in a glucose-dependent manner over the 12-week evaluation period reported in the article. 12-week PET-MRI scanning also confirmed islet cells at the transplant site. Six-month data, described below, were recently presented at the ADA meeting and presented today at the World Transplant Congress 2025 concurrently with the publication of the NEJM article. 'We are thrilled to have the results of this study, which we believe represent both a scientific and medical breakthrough, recognized in the New England Journal of Medicine,' said Per-Ola Carlsson, MD, Study Principal Investigator, Senior Physician and Professor at the Clinic for Endocrinology and Diabetology at Uppsala University Hospital. 'Type 1 diabetes is a disease in which the immune system destroys the beta cells in pancreatic islets, requiring the patient to receive lifelong insulin therapy to control glucose levels. Although it is well established that pancreatic islet cell transplantation at a target therapeutic dose can predictably allow patients with type 1 diabetes to live without insulin therapy, until now these patients must take lifelong, significant immunosuppression, which is frequently toxic and difficult to tolerate. This study shows that Sana's novel HIP-modified pancreatic islets restore insulin production without the need for immunosuppression, a transformative outcome and significant step toward a broadly accessible, functional cure for patients with type 1 diabetes. The patient is making his own insulin for the first time in over 35 years.' 'These peer-reviewed results, built upon the extensive preclinical and translational studies of Dr. Sonja Schrepfer and the team at Sana, reinforce our belief that Sana has the capability to develop a functional cure for the broad population of individuals living with type 1 diabetes,' said Steve Harr, MD, Sana's President and Chief Executive Officer. 'The data, together with recent FDA feedback regarding our HIP-edited master cell bank for GMP manufacturing and our non-clinical testing plan for SC451, increase our confidence in our goal for treating type 1 diabetes—a single treatment with no immunosuppression that leads to long-term normal blood glucose without exogeneous insulin. We expect to file an IND for SC451, a next generation HIP-modified, stem cell-derived pancreatic islet therapy, as early as 2026 and begin Phase 1 testing shortly thereafter. I want to thank the entire Sana team, the investigators at Uppsala, and the patient who volunteered for this transformative, first-in-human study.' James Shapiro, M.D., Professor of Surgery, Medicine, and Surgical Oncology at the University of Alberta and leader of the clinical team that developed the Edmonton Protocol for islet cell transplantation, added 'Exogenous insulin therapy remains a lifesaving therapy in the short term, but it falls short of replicating the precise and dynamic glucose regulation of a healthy pancreas, leaving patients susceptible to both short- and long-term medical complications. This limitation motivated my team and me to pioneer a protocol for islet cell transplantation with immunosuppression and to continue innovating in this field. The data presented in the NEJM article—demonstrating that transplanted, engineered islet cells can both evade immune-mediated destruction and respond appropriately to insulin demands—represent a significant advancement in the ongoing pursuit of a definitive cure for type 1 diabetes and support my long-held belief that the future of type 1 diabetes treatment is in stem cell-based therapies.' Key Findings from Ongoing Study No serious adverse events or adverse events possibly or probably related to UP421 were identified in the study. HIP-modified pancreatic islet cells, transplanted with no immunosuppressive medicines, including no glucocorticoids, evade immune detection and rejection. Pancreatic islet cells survive and function post-transplantation. The survival and function of the HIP-modified pancreatic beta cells was confirmed at each blood draw, as measured by the presence of circulating C-peptide, a biomarker indicating that transplanted beta cells are producing insulin. C-peptide levels increase during monthly mixed meal tolerance tests (MMTT), showing increased insulin secretion in response to a meal. Of note, prior to transplant, the patient had undetectable C-peptide both when fasting and during an MMTT. MRI scans at each month show a sustained and consistent signal at the site of cell transplantation, consistent with graft survival. A PET-MRI scan with a tracer targeting pancreatic beta cells confirms that the surviving cells are, in fact, pancreatic beta cells. Sign in to access your portfolio
Campaign ME
03-07-2025
- Business
- Campaign ME
The future of marketing is intelligent, integrated and inspiring
The media and advertising industry is experiencing a significant change, driven by artificial intelligence (AI), changing consumer expectations, regulatory developments and rapid advancements in technology. We are entering a new era where marketing is not just automated; it is truly intelligent, integrated and inspiring. Breaking the data barrier The modern marketing landscape has a critical flaw: data fragmentation. Enterprise-level insights remain trapped across martech stacks, customer relationship management (CRM) tools and media platforms, slowing decisions and reducing effectiveness. The solution: intelligent, cloud-based systems that centralise disparate data sources. Enhanced with AI and machine learning, these platforms deliver real-time, actionable intelligence at scale. INTERACT is a prime example of this transition – an AI-powered marketing platform that serves as the core system for modern marketing. It brings together identity resolution, real-time segmentation, analytics and activation into one integrated environment, enabling faster, smarter and more precise campaign execution. From spray-and-pray to precision According to Acxiom's Top 5 Customer Experience (CX) Trends for 2025, while 77 per cent of consumers value the convenience that AI delivers, the fundamental human need for authentic connection remains strong. Brands that prioritise community-led experiences are witnessing retention increases of up to 67 per cent. Today's AI and machine learning unlock granular audience insights, predictive modelling, and personalised content. As brands pivot to audience-first, identity-based strategies, we're witnessing a decisive shift from third-party cookie dependency to privacy-focused systems. By blending deterministic and probabilistic data signals, forward-thinking brands across diverse industries now identify high-value audience segments and engage them with precision across every customer touchpoint. Marketing in the moment The traditional marketing funnel has become obsolete in today's dynamic marketplace. Contemporary consumer journeys are fluid and nonlinear, requiring real-time decision-making. Leading brands are now deploying comprehensive, AI-powered frameworks that: Integrate first-party data from customer data platforms (CDPs), CRMs and digital platforms. Leverage predictive modelling to create lookalike and high-value segments. Incorporate real-time behavioural signals to evaluate purchase intent and optimise engagement timing. Enable dynamic, cross-channel activation spanning paid, owned, and earned media. This agile approach transcends operational efficiency – it enables brands to maintain competitive agility, responding swiftly and intelligently to platform changes, evolving consumer behaviours, and regulatory compliance requirements. Augmented creativity: where art meets algorithm Creativity remains marketing's cornerstone, yet AI has become its most powerful catalyst. Generative AI tools such as ChatGPT, Sora and DALL-E are transforming content creation – from automated copywriting to localised video production and adaptive design. These tools enable teams to rapidly test creative variations, scale personalisation and adapt brand storytelling whilst maintaining strategic coherence and creative excellence. When AI, predictive analytics and creative insight converge, static campaigns become dynamic, self-optimising ecosystems where messaging continuously adapts based on real-time audience engagement and behavioural insights. Navigating a regulated world As technological innovation accelerates, regulatory frameworks and ethical standards are evolving with equal urgency. Across the Middle East, North Africa and Turkey (MENAT) region, data protection legislation – including the UAE's DIFC Data Protection Law and Saudi Arabia's Personal Data Protection Law – is advancing rapidly. Yet a critical disconnect persists: whilst 98 per cent of consumers know their data is collected, only 57 per cent understand how it's used. This trust gap demands action. Brands demonstrating transparency and responsible data stewardship build deeper consumer confidence. Research reveals that 78 per cent of users trust brands that provide clear, accessible communication about their data policies and practices. Success requires robust data governance, privacy-centric design, and ethical AI implementation. Addressing the talent gap in data science and AI demands sustained investment in skills development and organisation-wide AI literacy programmes. The intelligent future of marketing isn't waiting – it's already here Success will no longer be defined by who possesses the most data, but by who leverages it most strategically. To lead in this transformative era, brands must act now: embed AI into the core of their strategy, build connected ecosystems, and equip teams with the advanced tools and specialised talent necessary to drive meaningful change. This is not a time for incremental shifts – it's a moment for bold transformation. The future of marketing isn't merely automated – it's intelligent, interconnected, and genuinely inspiring. By Karthik Kumar, Managing Director, KINESSO – MCN MENAT
Medscape
19-06-2025
- Health
- Medscape
Early, Aggressive BP Lowering Tied to Better ICH Outcomes
Initiating intensive blood pressure (BP) lowering within a few hours of intracerebral hemorrhage (ICH) was associated with better neurologic outcomes, fewer serious adverse events, and better mortality compared to the more conservative standard treatment, new research confirmed. Best results were found when treatment was administered within 3 hours of ICH symptoms, a pooled analysis of the four Intensive BP Reduction in Acute Cerebral Hemorrhage Trials (INTERACT1-4) showed. While current guidelines set a target systolic BP of < 180 mm Hg within 1 hour of ICH symptom onset, the intensive treatment systolic target is < 140 Hg within 1 hour. The new findings were published online on June 18 in The Lancet Neurology . Timing Dependent? In addition to evaluating the safety and efficacy of early intensive treatment for ICH, the investigators also aimed to assess the impact of treatment timing. The INTERACT1-3 studies included 10,269 adults with acute ACH who presented within 6 hours of symptom onset and had a systolic BP of > 150 mm Hg. INTERACT4 included 1043 patients with suspected acute stroke who had a systolic BP of ≥ 150 mm Hg within 2 hours of symptom onset. In addition, 1029 study participants had a hemorrhagic form of stroke. All were randomly assigned to receive either intensive or guideline recommended BP-lowering treatment with locally available BP drugs within 1 hour. Scores on the modified Rankin scale were used to determine functional recovery, the primary outcome measure for the pooled analysis. Additionally, a CT substudy of nearly 3000 INTERACT participants was conducted to measure hematoma volume. Mean systolic BP rates at 1 hour were significantly lower for the intensive treatment group compared to the guideline group (149.6 mm Hg vs 158.8 mm Hg, respectively; P < .0001). Poor physical function, defined as a modified Rankin scale score of 3-6 at the end of follow-up, was significantly less likely after intensive BP lowering (odds ratio [OR], .85; P = .0001). The intensive group also had reduced odds of neurologic deterioration within 7 days compared to the guideline group (OR, .76; P = .0002), as well as lower odds of any serious adverse event (OR, .84; P = .0003) or death (OR, .83; P = .002). CT substudy results showed no significant effect on either relative or absolute hematoma growth in the first 24 hours from intensive vs guideline treatment. However, when intensive BP lowering was initiated within 3 hours of symptom onset, functional recovery was improved and hematoma growth was reduced in almost 25% of the patients with serial CT scans, investigators noted. Patients with mild-to-moderate severity, as measured by ICH scores, had even greater reductions in hematoma growth after early intensive BP-lowering treatment. The new pooled analysis of all four INTERACT trials confirms findings from INTERACT4, presented at the 2024 European Stroke Organization Conference Annual Meeting and reported by Medscape Medical News . 'Time Is Brain' In an accompanying editorial, David J. Werring, PhD, Department of Translational Neuroscience and Stroke, University College London Queen Square Institute of Neurology, London, noted that several previous studies showed no benefit of BP lowering in acute ischemic stroke, 'probably because acutely elevated blood pressure has a role in maintaining brain perfusion.' However, the pathophysiology of stroke from ICH 'is different, with a major role for hematoma expansion within the first few hours, a therapeutic target which might be reduced' by intensive BP lowering, he wrote. Still, Werring noted that possible benefits need to be weighed against possible risks; and he pointed out several study limitations, such as the low severity of ICH overall and the inclusion of INTERACT3 data, which may have introduced confounding from BP lowering being just one component of its treatment 'bundle,' alongside strict glucose control and anticoagulant reversal. 'Notwithstanding these important limitations, the data presented make a compelling case for ultra-early intensive blood pressure reduction as a potentially useful intervention to improve outcomes in people with acute ICH,' he wrote, adding that more research is needed. 'Meanwhile, the clear message from this meta-analysis is that earlier treatment is better, meaning that, once again, time is brain for patients with ICH,' Werring concluded.
