Group awaiting approval of Summa purchase shares extensive vision for using AI
The venture capital firm bankrolling Health Assurance Transformation Company's purchase — pending regulatory approval — of Summa Health has been lobbying U.S. government officials for new health care policies espousing greater use of artificial intelligence in medical settings.
HATCo owner General Catalyst has published a range of materials advocating for policies encouraging health care providers to use AI while delivering care and equip patients with AI to monitor vital signs in their daily lives.
In 2024, General Catalyst launched an initiative called the General Catalyst Institute. The institute published a March report that said AI could be implemented throughout the entire health care system — with the federal government getting rid of regulations that General Catalyst and its allies see as burdensome.
The integration of AI into health care is among the chief concerns opponents of the Summa deal have expressed about the potential HATCo ownership, with fears that it will result in less attentive care and the elimination of jobs.
One of the proposals in the GCI paper — which General Catalyst spokesperson Molly Gillis said via email was "drafted in collaboration with over two dozen healthcare experts and entrepreneurs" — is for the U.S. Food and Drug Administration to "create an expedited pathway for reviewing and approving AI-driven healthcare solutions."
The paper also shares the firm's vision of the U.S. Department of Health and Human Services broadly supporting the "Make America Healthy Again" movement championed by President Donald Trump and Robert F. Kennedy Jr. For example, the paper said the department can create "regional healthcare innovation sandboxes" that would test "interventions that address root causes of chronic disease, including environmental factors and food additives, while maintaining rigorous scientific standards."
Gillis, partner and chief of staff at General Catalyst, said the General Catalyst Institute is nonpartisan. She did not directly answer a Beacon Journal reporter's question about whether General Catalyst is concerned about Kennedy, the HHS secretary — opposing vaccines, questioning antidepressants and advocating for the removal of fluoride from public water.
The effectiveness of multiple vaccines and antidepressants has been thoroughly tested and is widely agreed upon in the medical community, while new drugs go through multi-tiered government approval processes. Fluoride is added to water to prevent cavities, according to the U.S. Centers for Disease Control and Prevention.
"Our engagement in Washington reflects our belief that healthcare transformation requires input from leaders across the public and private sectors, regardless of who is in office," Gillis said.
More broadly, Gillis said, "General Catalyst's commitment to fulfilling and accelerating the promise of Health Assurance, which prioritizes and incentivizes keeping people well, remains steadfast. We strongly believe that accelerating innovation and advancing value-based care through patient-centered solutions will create better health outcomes for all Americans."
Summa spokesman Mike Bernstein said via email that Summa is fully aligned with General Catalyst and HATCo's vision of creating a new health care model "that transforms the current sick care system into a resilient, proactive system designed to help people stay well, reduce cost through innovation and make quality care more affordable and accessible for everyone. We view this work as non-partisan and we seek feedback from people throughout the public and private sectors, regardless of who is in office or what political affiliations they hold."
Summa leaders could not directly address the GCI report, Bernstein said.
General Catalyst Institute also praised decisions surrounding AI by the Trump administration in a March 14 letter to the National Coordination Office at the U.S. government's Networking and Information Technology Research and Development Program.
"President Trump has demonstrated his commitment — and that of his administration — to strengthening American leadership in the global AI race in a variety of ways, including prioritizing the appointment of the first ever White House AI Czar in David Sacks, and nominating and appointing many qualified individuals to shape and implement his administration's policies across this important topic," the letter said.
While the March 14 letter was not fully focused on health care as the GCI report was, it cited health care as an area where AI could be applied, stating that AI can "analyze medical data, help with diagnostic tools, predict disease outbreaks, and personalize treatment plans."
Matthew Charlebois, who is opposed to the proposed Summa-HATCo deal and a member of the Summa Is Not For Sale coalition, said it was "not surprising at all" to him that General Catalyst would try to curry favor with the Trump administration.
"If Kamala Harris won the election, they would do something similar with her administration in terms of trying to win their support," Charlebois said.
But as far as General Catalyst's proposals themselves, he said, "It very much sounds like Akron and Summa in particular is being used as an experimental guinea pig subject to test out these largely unproven scientific experiments with regards to implementing AI technology into health care."
Charlebois said General Catalyst wants "less regulations on the health care industry so they can extract more profits from patients and they can work their workers even harder."
The General Catalyst Institute wrote in the March 14 letter, "The adoption of intelligent AI agents allows humans to focus on work that requires creativity, emotional intelligence, and complex decision-making. As this trend continues, managing AI agents will likely become a new function, or part of an expanded role."
Summa's Bernstein said, "Importantly, technology will be used to support and empower our workforce, not replace it, so that clinicians and staff can focus fully on what matters most: delivering compassionate, high-quality care.
"As part of this transformation, we remain committed to investing in our people through workforce development, clinical training and enhanced engagement, recognizing that they are vital to our long-term success."
Hemant Taneja, General Catalyst's CEO, and Dr. Stephen Klasko, an adviser to the firm and former president and CEO of Thomas Jefferson University and Jefferson Health, in 2020 wrote a book called "UnHealthcare." In it, they proposed that a new "health assurance" system could replace the "sick care" system.
"Building health assurance is one of the greatest business opportunities in history," they wrote. "How often in any generation does a multi-trillion-dollar global industry go through a reinvention?"
Many of the proposals listed in the book focus on using technology to detect symptoms so physical health assurance locations don't get crowded, consumers can make more choices about their health to improve their wellbeing and hospitals can lower costs.
"Failure to take medications is one of the chief reasons patients end up back at a doctor's office or emergency room," the authors wrote. "Soon, pills will contain a tiny ingestible chip that can tell an app whether you're following through."
Later in the book, Taneja and Klasko wrote, "AI-driven chat bots will 'talk' to mental health patients — we already know that many younger people are more likely to be honest with a chat bot than a psychologist. AI will help keep an eye on seniors 24/7, enabling them to live at home longer."
In its March report, the General Catalyst Institute addressed concerns about privacy, safety and security as it proposed the rollout of AI throughout the health care system. Ensuring privacy, for instance, would be done in part through data encryption and anonymization, the paper said.
A document signed by Summa and HATCo leaders said HATCo and its affiliates will encourage portfolio companies to "locate their headquarters in the Summa Community." The Beacon Journal obtained the report from the Ohio Attorney General's Office, which is reviewing the proposed sale.
Charlebois said he doesn't see how patients, workers and the community would benefit from General Catalyst's AI push.
"None of these are proposals that are about meeting the needs of Akronites," Charlebois said. "All these are proposals about, 'How can we profit our portfolio companies and ourselves and take over the health care industry and run it like a for-profit corporation?'"
Meanwhile, Summa is already using AI for multiple services, Bernstein said, citing "sepsis detection, transcription, radiology interpretation and lung cancer screening."
The hospital system uses a "comprehensive vetting process" before implementing new technologies, Bernstein said, adding that these are technologies from various companies, including some in General Catalyst's investment portfolio. He declined to name specific General Catalyst portfolio companies that provide the technologies, citing that "we are still in the early stages of this work and still in regulatory review" with the acquisition deal.
Other Northeast Ohio hospital systems are using similar technologies, too. University Hospitals radiologists interpret results with AI, and Cleveland Clinic uses AI to transcribe provider-patient interactions. Providers from both hospital systems have talked positively of the technologies.
Charlebois said Summa employees in inpatient and outpatient patient care settings have joined the Summa Is Not For Sale coalition. He declined, however, to share how many Summa employees have joined the group — saying they all want to remain anonymous.
Gillis said General Catalyst's work over the past several years has had a priority of "making healthcare more accessible and affordable for all Americans."
"As we work towards finalizing our transaction with Summa Health, which includes maintaining its charity care policy, community benefit, and essential services, our vision is to reimagine and evolve healthcare to work better for patients, providers, and communities in the Greater Akron region and across America — through partnership, innovation, and an unwavering focus on health outcomes for all people," Gillis said.
Patrick Williams covers growth and development for the Akron Beacon Journal. He can be reached by email at pwilliams@gannett.com or on X, formerly known as Twitter, @pwilliamsOH. Sign up for the Beacon Journal's business and consumer newsletter, "What's the deal?," at bit.ly/42LtqbS
This article originally appeared on Akron Beacon Journal: HATCo owner General Catalyst would bring heavy AI focus to Summa
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Inflammation Link Allergy, Asthma, and Depression?
The prevalence of depression is consistently higher in persons with asthma than in persons without it, according to experts, and a review of 24 studies also found that allergic rhinitis was associated with higher odds of depression or anxiety. Over the past two decades, multiple investigators have looked beyond emotional or lifestyle triggers of depression in chronic airway or allergic conditions, focusing instead on eco-biological ones. This has led to inflammation being identified as the common denominator in all three — allergies, asthma, and depression. As the understanding of how inflammation, as measured by an increase in immune cells, cytokines, and other biomarkers, affects neural signaling continues to improve; potential implications for clinical practice are beginning to emerge, experts say. Evolutionary 'Mismatch' One line of inquiry that implicates inflammation in depression, chronic airway trouble, and allergies, involves the microbiome and how modern living has altered it. 'There's essentially an evolutionary mismatch in the modern world,' Charles Raison, MD, professor of psychiatry and human ecology at the University of Wisconsin - Madison, told Medscape Medical News in an interview. 'We've made the world so clean we deprive ourselves — especially in early life when allergies and asthma tend to develop — of contact with microorganisms that train the immune system not to fire off at things they don't need to fire off about.' In a review of literature published in 2013 on immune function titled, Inflammation, Sanitation, and Consternation , Raison and his coauthors concluded that measured exposure to certain microorganisms and their antigens could offer both prevention and intervention for depression. 'Our current challenge is to determine who among those with allergies is at highest risk of developing depression, and why,' Christopher Lowry, PhD, a coauthor on the paper with Raison, told Medscape Medical News . Lowry is a professor of integrative physiology and associate chair of faculty affairs at the University of Colorado Boulder. 'Old Friends' Raison and Lowry's collaboration follows on from the 'Old Friends' work of Graham Rook, a coauthor of their review study, and an emeritus professor of medical microbiology at the University College London in London, England. 'The association between allergies and depression is embedded in the 'Old Friends' or Biodiversity Hypothesis which posits that reduced exposures to diverse microbial environments, which is typical of modern urban lifestyles, increases risk of allergies, anxiety disorders, and depression,' Lowry told Medscape Medical News . Because the commensal microorganisms in the gut are one of the major types of microbial 'Old Friends' that can induce anti-inflammatory and immunoregulatory responses, Lowry said, 'Those who lack diverse microbial exposures, including diverse microbial exposures in the gut microbiome, are thought to be at higher risk of inflammatory disease and inflammation-associated conditions.' Similarly, 'we have shown that this response is greater in persons who grow up in an urban environment, without daily exposure to pets, relative to persons who grow up on a farm, with daily exposure to farm animals,' said Lowry, whose research on the immune effects of exposure to animals was published in the Proceedings of the National Academies of Science . Other categories of microbial 'Old Friends,' according to Lowry, are environmental saprophytes found in soil, mud, and unpurified water, and so-called 'Old Infections' such as the hepatitis A virus or Salmonella . Rook has gone so far as to say that these microbial inputs, 'are absolutely crucial in early life, but continue to be important in adulthood and old age.' Raison added, 'These microbes don't cause illnesses, they are the teachers of tolerance, is how we used to say it. When we began to institute a bunch of modern sanitation and medical practices, on the plus side people stopped dying in youth. Huge win. But we didn't see we were tossing out the good with the bad, and we've lost our exposure to these environmental immunoregulatory organisms that suppress inflammation.' In the past 40 years, incident rates for asthma in the US have doubled according to federal data. A third of persons in the US now have an allergy of some kind, these data also showed. Rates of depression are also at their highest, according to a probability-based Gallup survey of 100,000 adults in the US. In 2023, the survey found that 29% of US adults had been given a diagnosis of depression in their lifetime. Microbial Population Health Initiative The 'Old Friends' theory was tested in Finland for the decade between 2008 and 2018, when a population health initiative to increase exposures to diverse microbial environments led to a reduction in hospitalizations for asthma by half nationally and a 50% drop in the number of food allergies reported in Finnish schools and daycares. The results were published in 2021 in The Journal of Allergy and Clinical Immunology . Depression rates for this time period in Finland are not currently available. 'This was hot, sexy stuff back 20 years ago, but nobody figured out the magic bullet to end all allergies and asthma, so like a lot of things in mental health, it didn't come too much,' Raison said. 'It's gone through fads, like the probiotic fad. But another question would be, what if you were to re-expose kids to these kinds of microbes that train the immune system not to be so agitated, would you lower rates of depression and suicide in adults? Those studies were never done.' Lowry, however, now studies whether the microorganism, Mycobacterium vaccae ATCC 15483, which has been identified as having anti-inflammatory, immunoregulatory, and stress-resilience properties, can be leveraged to protect humans from the effects of inflammation. In a study that was published earlier this year in Brain, Behavior and Immunity , Lowry and his colleagues found M vaccae reduced biomarkers of neuroinflammation and anxiety-like behavior in animals. It also reduced several indicators of obesity such as plasma leptin concentrations and adipose tissue. 'We hope to conduct clinical trials in the next 2-5 years to determine if treatment with mycobacteria can reduce inflammation and promote stress resilience in humans,' Lowry said. 'Future studies should evaluate if mycobacteria or other 'Old Friends' can prevent or treat anxiety and depression.' Inflammation Is Bidirectional If depression in asthma and allergies is at least partially biological, then there are implications for clinical practice, according to one expert. 'The default for physicians is usually that it's hard to have a chronic disease, and that's why their patients are depressed,' Melissa Rosenkranz, PhD, told Medscape Medical News . 'But if they understand that there is a biology that underlies it, that the immune dysregulation that's giving rise to the disease is also contributing to the depression, and that they can do something about that — if we can target those signaling pathways, then we can be treating both simultaneously.' Rosenkranz is an associate professor of psychiatry at the University of Wisconsin - Madison and is the distinguished chair of contemplative neuroscience at the Center for Healthy Minds. Her field is psycho-neuroimmunology, which focuses on interactions between the mind, brain, and immune system. Whether inflammation is the mechanism of action or a symptom in both asthma and depression is something she and her colleagues have studied. 'It goes in both directions,' Rosenkranz said. 'We've done that research.' Alterations in Neural Signaling Their first and second studies involved scanning study patients' brains before and after their airways were challenged with an inflammatory antigen and comparing those results to the before and after scans of the brains of participants exposed to methacholine, which does not irritate, but does constrict, the bronchial passages, making it difficult to breathe. A third study introduced an inflammatory agent to a micro region of the bronchial passages. 'All three studies showed what was happening in the brain was different in the inflammatory context,' Rosenkranz said in the interview. Specifically, Rosenkranz and her colleagues discovered that the brain's salience network — the part that prioritizes which stimuli, both internal and external to the body, require the brain's attention most — responded differently to emotional information when the immune system had been activated. They found that the more the salience network was engaged during psychological stress, the more the inflammatory response in the airway was activated, even without exposure to allergy triggers. 'Our results identify a specific inflammatory pathway linking asthma-related airway inflammation and emotion-related neural function,' Rosenkranz and her coauthors wrote in their study, published in The Journal of Allergy and Clinical Immunology . An immune pathway common to both depression and the airway inflammatory response in asthma is the T helper cell 17 (TH17) response, according to Rosenkranz, whose work has shown that the TH17 response is amplified in the lung during stress. Activity in the TH17 pathway is also elevated in people with depression, according to Rosenkranz, and TH17 is also less responsive to common asthma medications and is associated with treatment-resistant depression. 'There are probably multiple pathways through which [inflammation] happens, so I don't want to claim that this is the only one, but I think it's one among a few that may provoke inflammation in the brain,' Rosenkranz said. 'And inflammation has been shown to be part of the pathophysiology of depression. It's also part of the cascade that gives rise to Alzheimer's disease and other forms of dementia.' Rosenkranz's latest study is on how an asthma exacerbation can lead to inflammation in the brain, and whether those changes might set the stage for dementia. 'It's possible that depression is along the same trajectory as dementia,' Rosenkranz said. 'As you get on later in life, you see the cognitive decline. With nearly 10% of the population having asthma, this is a really important public health question.' Rosenkranz said she doesn't want to be an alarmist. 'I'm not suggesting that everybody who has depression has inflammation in their brain,' she said. As the field searches for an immune-signaling pathway that, if targeted with drugs, could improve asthma, allergies, prevent asthma-related depression, and possibly protect the brain, Rosenkranz said that for now, 'Physicians should evaluate the emotional well-being of their patients and work closely with mental health professionals to address mental and physical symptoms in tandem, so that they can best serve their patients.' They need to understand that depression in patients with asthma or allergy could be a symptom of, not a reaction to their diagnosis, she said.
Yahoo
an hour ago
- Yahoo
Early data suggest Roche's NXT007 may have the potential to provide haemostatic normalisation in people with haemophilia A
Positive phase I/II data presented at the 2025 International Society on Thrombosis and Haemostasis (ISTH) Congress show NXT007 achieved no bleeds requiring treatment in the highest dose groups in people with haemophilia A1 The NXT007 clinical development programme aims to normalise haemostasis and minimise treatment burden2,3 Three phase III clinical studies on NXT007, a next-generation bispecific antibody, set to begin in 20261 Basel, 23 June 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today positive phase I/II data on NXT007 in people with haemophilia A, supporting its progression into phase III clinical development. NXT007 is a next-generation investigational bispecific antibody, engineered by Chugai, a member of the Roche Group. Early data from the NXTAGE study suggest that NXT007 may have the potential to provide haemostatic normalisation in people with haemophilia A (without factor VIII inhibitors). NXT007 showed a tolerable safety profile with no thromboembolic events reported so far.1 These results were featured as an oral presentation at the 2025 International Society on Thrombosis and Haemostasis (ISTH) Congress, 21-25 June, Washington D.C., United States.1 'These NXT007 data are promising for people with haemophilia A and underscore our ongoing commitment to advancing care and addressing the real-world challenges faced by this community,' said Levi Garraway, MD, PhD, Roche's Chief Medical Officer and Head of Global Product Development. 'Hemlibra established a new standard of care, and our focus is to continue to deliver breakthrough innovation that might ultimately help people with haemophilia to live their lives in a manner unaffected by this condition.' NXT007 leverages the Roche Group's expertise in haemophilia A and bispecific antibody development. Our goal is to bring a next generation prophylactic to our portfolio, offering greater therapeutic choice, sustained, elevated bleed protection and reduced treatment burden with factor independence - to allow patients to experience freedom from constant vigilance and have confidence in bleed protection. NXT007 will be further evaluated in a robust clinical development programme, including ongoing phase I/II clinical trials, with additional phase II data expected later this year. There are also three phase III studies currently planned for 2026, including a phase III head-to-head study with Roche's Hemlibra, the first available prophylactic treatment that can be administered subcutaneously and with flexible dosing options (every week, two weeks or four weeks).4,5 Part B of the phase I/II NXTAGE study, conducted by Chugai, in Japan, Taiwan and South Korea, is evaluating the safety, pharmacokinetics, pharmacodynamics and efficacy of prophylaxis with NXT007 in people with haemophilia A without factor VIII inhibitors who had not been previously treated with Hemlibra® (emicizumab).1 Thirty participants (from 12 to 65 years of age) were enrolled in four cohorts (B-1 to B-4) to receive ascending doses of subcutaneous NXT007 every two-to-four weeks during the maintenance period (following four-to-six weeks of loading doses). In presented data from the primary analysis, no treated bleeds were observed with NXT007 in the highest dose cohorts (B-3 and B-4). NXT007 was well tolerated, with no thromboembolic events observed so far.1 About NXT007NXT007 is a next-generation investigational bispecific antibody, being investigated as a prophylactic (preventive) treatment option for people with haemophilia A.1,2,3 NXT007 was engineered by Chugai – a member of the Roche Group – built on Hemlibra® (emicizumab)'s framework, with the aim of optimising factor VIII-mimetic activity and half-life, to further enhance potency, efficacy, dosing and administration convenience. NXT007 brings together factor IXa and factor X, proteins required to activate the natural coagulation cascade.1,2,3 NXT007 is being studied in a robust clinical development programme exploring its potential to achieve sustained elevated bleed protection equivalent to people who do not have haemophilia A (sustained haemostatic normalisation), and reduced treatment burden with factor independence, offering people living with haemophilia A greater therapeutic choice.1,2,3 About haemophilia AHaemophilia A is an inherited, serious disorder in which a person's blood does not clot properly, leading to uncontrolled and often spontaneous bleeding. Haemophilia A affects around 900,000 people worldwide.6,7 People with haemophilia A either lack or do not have enough of a clotting protein called factor VIII. In a healthy person, when a bleed occurs, factor VIII brings together the clotting factors IXa- and X, which is a critical step in the formation of a blood clot to help stop bleeding. Depending on the severity of their symptoms, people with haemophilia A can bleed frequently, especially into their joints or muscles.8 These bleeds can present a significant health concern as they often cause pain and can lead to chronic swelling, deformity, reduced mobility and long-term joint damage.9 A serious complication of treatment is the development of inhibitors to factor VIII replacement therapies. Inhibitors are antibodies developed by the body's immune system that bind to and block the efficacy of replacement factor VIII, making it difficult, if not impossible, to obtain a level of factor VIII sufficient to control bleeding.6 About Roche in haematologyRoche has been developing medicines for people with malignant and non-malignant blood diseases for more than 25 years; our experience and knowledge in this therapeutic area runs deep. Today, we are investing more than ever in our effort to bring innovative treatment options to patients across a wide range of haematologic diseases. Our approved medicines include MabThera®/Rituxan® (rituximab), Gazyva®/Gazyvaro® (obinutuzumab), Polivy® (polatuzumab vedotin), Venclexta®/Venclyxto® (venetoclax) in collaboration with AbbVie, Hemlibra® (emicizumab), PiaSky® (crovalimab), Lunsumio® (mosunetuzumab) and Columvi® (glofitamab). Our pipeline of investigational haematology medicines includes T-cell engaging bispecific antibody cevostamab, targeting both FcRH5 and CD3 and Tecentriq® (atezolizumab). Our scientific expertise, combined with the breadth of our portfolio and pipeline, also provides a unique opportunity to develop combination regimens that aim to improve the lives of patients even further. About Roche Founded in 1896 in Basel, Switzerland, as one of the first industrial manufacturers of branded medicines, Roche has grown into the world's largest biotechnology company and the global leader in in-vitro diagnostics. The company pursues scientific excellence to discover and develop medicines and diagnostics for improving and saving the lives of people around the world. We are a pioneer in personalised healthcare and want to further transform how healthcare is delivered to have an even greater impact. To provide the best care for each person we partner with many stakeholders and combine our strengths in Diagnostics and Pharma with data insights from the clinical practice. For over 125 years, sustainability has been an integral part of Roche's business. As a science-driven company, our greatest contribution to society is developing innovative medicines and diagnostics that help people live healthier lives. Roche is committed to the Science Based Targets initiative and the Sustainable Markets Initiative to achieve net zero by 2045. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit All trademarks used or mentioned in this release are protected by law. References[1] 1. Shima M, et al. NXT007 Prophylaxis in Emicizumab-Naive Persons with Hemophilia A without Inhibitor: Phase I/II Study (NXTAGE) Presented at International Society on Thrombosis and Haemostasis (ISTH) congress; 2025 June. Abstract OC.20.3.[2] Shima M, et al. Safety, Pharmacokinetics, and Pharmacodynamics of Single Subcutaneous Injection of NXT007, an Emicizumab-Based Next-Generation Bispecific Antibody, in Healthy Volunteers (NXTAGE Study). Presented at: International Society on Thrombosis and Haemostasis (ISTH) Congress; 2023 July 28. Abstract OC 69.4. [3] Teranishi-Ikawa Y., et al. A bispecific antibody NXT007 exerts a hemostatic activity in hemophilia A monkeys enough to keep a non-hemophiliac state. Journal of Thrombosis and Haemostasis. 2023; doi: 10.1016/ Hemlibra SmPC [Internet; cited 2025 June] Available from: [5] FDA Prescribing Information [Internet; cited 2025 June]. Available from: [6] Srivastava A, et al. WFH guidelines for the management of hemophilia, 3rd edition. Haemophilia. 2020;26 (Suppl 6): 1-158.[7] Iorio A, et al. Establishing the Prevalence and Prevalence at Birth of Hemophilia in Males. Ann Intern Med. 2019;171(8):540-546.[8] NHS. Symptoms of haemophilia [Internet; cited 2025 June]. Available from: [9] Franchini M, et al. Haemophilia A in the third millennium. Blood Rev. 2013; 179-84. Roche Global Media RelationsPhone: +41 61 688 8888 / e-mail: Hans Trees, PhDPhone: +41 79 407 72 58 Sileia UrechPhone: +41 79 935 81 48 Nathalie AltermattPhone: +41 79 771 05 25 Lorena CorfasPhone: +41 79 568 24 95 Simon GoldsboroughPhone: +44 797 32 72 915 Karsten KleinePhone: +41 79 461 86 83 Nina MählitzPhone: +41 79 327 54 74 Kirti PandeyPhone: +49 172 6367262 Yvette PetillonPhone: +41 79 961 92 50 Dr Rebekka SchnellPhone: +41 79 205 27 03 Roche Investor Relations Dr Bruno EschliPhone: +41 61 68-75284e-mail: Dr Sabine BorngräberPhone: +41 61 68-88027e-mail: Dr Birgit MasjostPhone: +41 61 68-84814e-mail: Investor Relations North America Loren KalmPhone: +1 650 225 3217e-mail: Attachment Media Investor Release phase I_II data on NXT007 EnglishError in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
an hour ago
- Yahoo
Early data suggest Roche's NXT007 may have the potential to provide haemostatic normalisation in people with haemophilia A
Positive phase I/II data presented at the 2025 International Society on Thrombosis and Haemostasis (ISTH) Congress show NXT007 achieved no bleeds requiring treatment in the highest dose groups in people with haemophilia A1 The NXT007 clinical development programme aims to normalise haemostasis and minimise treatment burden2,3 Three phase III clinical studies on NXT007, a next-generation bispecific antibody, set to begin in 20261 Basel, 23 June 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today positive phase I/II data on NXT007 in people with haemophilia A, supporting its progression into phase III clinical development. NXT007 is a next-generation investigational bispecific antibody, engineered by Chugai, a member of the Roche Group. Early data from the NXTAGE study suggest that NXT007 may have the potential to provide haemostatic normalisation in people with haemophilia A (without factor VIII inhibitors). NXT007 showed a tolerable safety profile with no thromboembolic events reported so far.1 These results were featured as an oral presentation at the 2025 International Society on Thrombosis and Haemostasis (ISTH) Congress, 21-25 June, Washington D.C., United States.1 'These NXT007 data are promising for people with haemophilia A and underscore our ongoing commitment to advancing care and addressing the real-world challenges faced by this community,' said Levi Garraway, MD, PhD, Roche's Chief Medical Officer and Head of Global Product Development. 'Hemlibra established a new standard of care, and our focus is to continue to deliver breakthrough innovation that might ultimately help people with haemophilia to live their lives in a manner unaffected by this condition.' NXT007 leverages the Roche Group's expertise in haemophilia A and bispecific antibody development. Our goal is to bring a next generation prophylactic to our portfolio, offering greater therapeutic choice, sustained, elevated bleed protection and reduced treatment burden with factor independence - to allow patients to experience freedom from constant vigilance and have confidence in bleed protection. NXT007 will be further evaluated in a robust clinical development programme, including ongoing phase I/II clinical trials, with additional phase II data expected later this year. There are also three phase III studies currently planned for 2026, including a phase III head-to-head study with Roche's Hemlibra, the first available prophylactic treatment that can be administered subcutaneously and with flexible dosing options (every week, two weeks or four weeks).4,5 Part B of the phase I/II NXTAGE study, conducted by Chugai, in Japan, Taiwan and South Korea, is evaluating the safety, pharmacokinetics, pharmacodynamics and efficacy of prophylaxis with NXT007 in people with haemophilia A without factor VIII inhibitors who had not been previously treated with Hemlibra® (emicizumab).1 Thirty participants (from 12 to 65 years of age) were enrolled in four cohorts (B-1 to B-4) to receive ascending doses of subcutaneous NXT007 every two-to-four weeks during the maintenance period (following four-to-six weeks of loading doses). In presented data from the primary analysis, no treated bleeds were observed with NXT007 in the highest dose cohorts (B-3 and B-4). NXT007 was well tolerated, with no thromboembolic events observed so far.1 About NXT007NXT007 is a next-generation investigational bispecific antibody, being investigated as a prophylactic (preventive) treatment option for people with haemophilia A.1,2,3 NXT007 was engineered by Chugai – a member of the Roche Group – built on Hemlibra® (emicizumab)'s framework, with the aim of optimising factor VIII-mimetic activity and half-life, to further enhance potency, efficacy, dosing and administration convenience. NXT007 brings together factor IXa and factor X, proteins required to activate the natural coagulation cascade.1,2,3 NXT007 is being studied in a robust clinical development programme exploring its potential to achieve sustained elevated bleed protection equivalent to people who do not have haemophilia A (sustained haemostatic normalisation), and reduced treatment burden with factor independence, offering people living with haemophilia A greater therapeutic choice.1,2,3 About haemophilia AHaemophilia A is an inherited, serious disorder in which a person's blood does not clot properly, leading to uncontrolled and often spontaneous bleeding. Haemophilia A affects around 900,000 people worldwide.6,7 People with haemophilia A either lack or do not have enough of a clotting protein called factor VIII. In a healthy person, when a bleed occurs, factor VIII brings together the clotting factors IXa- and X, which is a critical step in the formation of a blood clot to help stop bleeding. Depending on the severity of their symptoms, people with haemophilia A can bleed frequently, especially into their joints or muscles.8 These bleeds can present a significant health concern as they often cause pain and can lead to chronic swelling, deformity, reduced mobility and long-term joint damage.9 A serious complication of treatment is the development of inhibitors to factor VIII replacement therapies. Inhibitors are antibodies developed by the body's immune system that bind to and block the efficacy of replacement factor VIII, making it difficult, if not impossible, to obtain a level of factor VIII sufficient to control bleeding.6 About Roche in haematologyRoche has been developing medicines for people with malignant and non-malignant blood diseases for more than 25 years; our experience and knowledge in this therapeutic area runs deep. Today, we are investing more than ever in our effort to bring innovative treatment options to patients across a wide range of haematologic diseases. Our approved medicines include MabThera®/Rituxan® (rituximab), Gazyva®/Gazyvaro® (obinutuzumab), Polivy® (polatuzumab vedotin), Venclexta®/Venclyxto® (venetoclax) in collaboration with AbbVie, Hemlibra® (emicizumab), PiaSky® (crovalimab), Lunsumio® (mosunetuzumab) and Columvi® (glofitamab). Our pipeline of investigational haematology medicines includes T-cell engaging bispecific antibody cevostamab, targeting both FcRH5 and CD3 and Tecentriq® (atezolizumab). Our scientific expertise, combined with the breadth of our portfolio and pipeline, also provides a unique opportunity to develop combination regimens that aim to improve the lives of patients even further. About Roche Founded in 1896 in Basel, Switzerland, as one of the first industrial manufacturers of branded medicines, Roche has grown into the world's largest biotechnology company and the global leader in in-vitro diagnostics. The company pursues scientific excellence to discover and develop medicines and diagnostics for improving and saving the lives of people around the world. We are a pioneer in personalised healthcare and want to further transform how healthcare is delivered to have an even greater impact. To provide the best care for each person we partner with many stakeholders and combine our strengths in Diagnostics and Pharma with data insights from the clinical practice. For over 125 years, sustainability has been an integral part of Roche's business. As a science-driven company, our greatest contribution to society is developing innovative medicines and diagnostics that help people live healthier lives. Roche is committed to the Science Based Targets initiative and the Sustainable Markets Initiative to achieve net zero by 2045. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit All trademarks used or mentioned in this release are protected by law. References[1] 1. Shima M, et al. NXT007 Prophylaxis in Emicizumab-Naive Persons with Hemophilia A without Inhibitor: Phase I/II Study (NXTAGE) Presented at International Society on Thrombosis and Haemostasis (ISTH) congress; 2025 June. Abstract OC.20.3.[2] Shima M, et al. Safety, Pharmacokinetics, and Pharmacodynamics of Single Subcutaneous Injection of NXT007, an Emicizumab-Based Next-Generation Bispecific Antibody, in Healthy Volunteers (NXTAGE Study). Presented at: International Society on Thrombosis and Haemostasis (ISTH) Congress; 2023 July 28. Abstract OC 69.4. [3] Teranishi-Ikawa Y., et al. A bispecific antibody NXT007 exerts a hemostatic activity in hemophilia A monkeys enough to keep a non-hemophiliac state. Journal of Thrombosis and Haemostasis. 2023; doi: 10.1016/ Hemlibra SmPC [Internet; cited 2025 June] Available from: [5] FDA Prescribing Information [Internet; cited 2025 June]. Available from: [6] Srivastava A, et al. WFH guidelines for the management of hemophilia, 3rd edition. Haemophilia. 2020;26 (Suppl 6): 1-158.[7] Iorio A, et al. Establishing the Prevalence and Prevalence at Birth of Hemophilia in Males. Ann Intern Med. 2019;171(8):540-546.[8] NHS. Symptoms of haemophilia [Internet; cited 2025 June]. Available from: [9] Franchini M, et al. Haemophilia A in the third millennium. Blood Rev. 2013; 179-84. 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