Latest news with #IL-1β
Yahoo
4 days ago
- Business
- Yahoo
Monte Rosa Therapeutics Announces FDA Clearance of IND Application for MRT-8102, a NEK7-Directed Molecular Glue Degrader for the Treatment of Multiple Inflammatory Diseases
MRT-8102, a highly selective NEK7-directed molecular glue degrader (MGD) developed to treat inflammatory conditions linked to NLRP3, IL-1β, and IL-6 dysregulation, expands Monte Rosa's clinical I&I portfolio Potency, selectivity, and long-lasting pharmacodynamics of MRT-8102 observed in preclinical studies create potential for clinical differentiation from competitive approaches for inflammatory diseases MRT-8102 Phase 1 clinical results, including data on safety, pharmacokinetics, NEK7 protein degradation, and key downstream pharmacodynamic markers, expected in H1 2026 BOSTON, June 10, 2025 (GLOBE NEWSWIRE) -- Monte Rosa Therapeutics, Inc. (Nasdaq: GLUE), a clinical-stage biotechnology company developing novel molecular glue degrader (MGD)-based medicines, today announced U.S. Food and Drug Administration (FDA) clearance of an Investigational New Drug (IND) application for MRT-8102, a NEK7-directed MGD being developed for the treatment of inflammatory diseases driven by the NLRP3 inflammasome and IL-1β. The Company plans to initiate a Phase 1 study of MRT-8102 in the coming weeks and anticipates sharing initial results in H1 2026. 'The IND clearance of MRT-8102 is another important milestone in our quest to broadly establish MGDs as a modality in immunology and inflammatory (I&I) indications. MRT-8102, following on the heels of our VAV1-directed MGD MRT-6160, is our second IND specifically for I&I indications, and represents the only clinical-stage MGD that selectively targets NEK7, with potential to address multiple inflammatory diseases, including cardio-immunology, rheumatology, and respiratory indications,' said Markus Warmuth, M.D., Chief Executive Officer of Monte Rosa Therapeutics. 'We believe MRT-8102 could provide a highly differentiated clinical profile compared to IL-1 antibodies and NLRP3 inhibitors in development based on its potency, selectivity, and long-lasting pharmacodynamics. We look forward to initiating a Phase 1 healthy volunteer study in the coming weeks, with clinical results expected in H1 2026, including data on safety, pharmacokinetics, NEK7 protein degradation, and downstream pharmacodynamic markers. As part of the Phase 1 study, we plan to establish initial proof-of-concept (POC) for cardio-immunology indications by evaluating changes in C-reactive protein (CRP) and other key inflammatory markers in a cohort of subjects with high CRP levels.' Monte Rosa believes its preclinical studies support MRT-8102's potential to address multiple inflammatory diseases driven by the NLRP3 inflammasome, IL-1β and IL-6. MRT-8102 has demonstrated nanomolar-level degradation of NEK7 in vitro with no off-target activity observed, including related NEK family proteins. In non-human primates (NHPs), oral administration of MRT-8102 resulted in near-complete inhibition of downstream inflammatory markers in ex vivo stimulation assays, as well as improvements in pathological measures in inflammatory disease models. Furthermore, in a rabbit gout model, daily oral dosing of MRT-8102 was observed to reduce pathogenic effects, including a reduction in joint swelling and histopathology scores. Preclinical GLP toxicology studies suggest a considerable safety margin for MRT-8102, with a greater than 200-fold exposure margin over the projected human efficacious dose in both rats and NHPs. In addition to MRT-8102, Monte Rosa is also working to advance a second-generation NEK7 program with enhanced CNS penetration with an IND submission expected in 2026. Monte Rosa retains full worldwide rights to MRT-8102 and its second-generation CNS-optimized NEK7 MGDs. About MRT-8102MRT-8102 is a potent, highly selective, and orally bioavailable investigational molecular glue degrader (MGD) that targets NEK7 for the treatment of inflammatory diseases linked to NLRP3, IL-1β, and IL-6 dysregulation. NEK7 has been shown to be required for NLRP3 inflammasome assembly, activation and IL-1β release both in vitro and in vivo. Aberrant NLRP3 inflammasome activation and the subsequent release of active IL-1β and interleukin-18 (IL-18) has been implicated in multiple inflammatory disorders, including cardiovascular disease, gout, osteoarthritis, neurologic disorders including Parkinson's disease and Alzheimer's disease, and metabolic disorders. In a non-human primate model, MRT-8102 was shown to potently, selectively, and durably degrade NEK7, and resulted in near-complete reductions of IL-1β and caspase-1 following ex vivo stimulation of whole blood. MRT-8102 has demonstrated a considerable safety margin (>200-fold exposure margin over projected human efficacious dose) in GLP toxicology studies. About Monte RosaMonte Rosa Therapeutics is a clinical-stage biotechnology company developing highly selective molecular glue degrader (MGD) medicines for patients living with serious diseases in the areas of oncology, autoimmune and inflammatory diseases, and more. MGDs are small molecule protein degraders that have the potential to treat many diseases that other modalities, including other degraders, cannot. Monte Rosa's QuEEN™ (Quantitative and Engineered Elimination of Neosubstrates) discovery engine combines AI-guided chemistry, diverse chemical libraries, structural biology, and proteomics to rationally design MGDs with unprecedented selectivity. Monte Rosa has developed the industry's leading pipeline of MGDs, which spans autoimmune and inflammatory diseases, oncology, and beyond. Monte Rosa has a global license agreement with Novartis to advance VAV1-directed molecular glue degraders and a strategic collaboration with Roche to discover and develop MGDs against targets in cancer and neurological diseases previously considered impossible to drug. For more information, visit Forward-Looking Statements This communication includes express and implied 'forward-looking statements,' including forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include all statements that are not historical facts and in some cases, can be identified by terms such as 'may,' 'might,' 'will,' 'could,' 'would,' 'should,' 'expect,' 'intend,' 'plan,' 'objective,' 'anticipate,' 'believe,' 'estimate,' 'predict,' 'potential,' 'continue,' 'ongoing,' or the negative of these terms, or other comparable terminology intended to identify statements about the future. Forward-looking statements contained herein include, but are not limited to, statements about our ability to grow our product pipeline, our ability to successfully complete research and further development and commercialization of our drug candidates in current or future indications, including the timing and results of our clinical trials and our ability to conduct and complete clinical trials, statements regarding our progress and speed of development of only-in-class and first-in-class molecular glue degrader therapeutics, statements around the Company's QuEEN™ discovery engine and the Company's view of its potential to rationally design MGDs with unprecedented selectivity, statements about the advancement and timeline of our preclinical and clinical programs, pipeline and the various products therein, including the ongoing development and progress of our NEK7-directed MGD, referred to as MRT-8102, our plans to initiate a Phase 1 study of MRT-8102 in the coming weeks and our expectations for the design and advancement of such Phase 1 study, including updates related to status, safety data, pharmacokinetics, NEK7 protein degradation, and key downstream pharmacodynamic markers and timing of data read-outs, including the planned readout in the first half of 2026, the Company's statements around the potential of MRT-8102 to address multiple inflammatory diseases driven by the NLRP3 inflammasome, IL-1β and IL-6, including cardio-immunology, rheumatology, and respiratory indications and the Company's belief that MRT-8102 could provide a highly differentiated clinical profile compared to IL-1 antibodies and NLRP3 inhibitors in development based on its potency, selectivity, and long-lasting pharmacodynamics, statements relating to MRT-8102's safety margin, as well as statements around the advancement and timeline of a second-generation NEK7 program and expectations to submit an IND to the FDA in 2026, the expected potential clinical benefit of any of our candidates, advancement and application of our platform, statements around our ability to capitalize on and potential benefits resulting from our research and translational insights, including announcements related to preclinical programs, statements regarding regulatory filings for our development programs, including the planned timing of such regulatory filings, such as IND applications, and potential review by regulatory authorities, as well as our expectations of success for our programs, among others. By their nature, these statements are subject to numerous risks and uncertainties, including those risks and uncertainties set forth in our most recent Annual Report on Form 10-K for the year ended December 31, 2024, filed with the U.S. Securities and Exchange Commission on March 20, 2025, and any subsequent filings, that could cause actual results, performance or achievement to differ materially and adversely from those anticipated or implied in the statements. You should not rely upon forward-looking statements as predictions of future events. Although our management believes that the expectations reflected in our statements are reasonable, we cannot guarantee that the future results, performance, or events and circumstances described in the forward-looking statements will be achieved or occur. Recipients are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date such statements are made and should not be construed as statements of fact. We undertake no obligation to publicly update any forward-looking statements, whether as a result of new information, any future presentations, or otherwise, except as required by applicable law. Certain information contained in these materials and any statements made orally during any presentation of these materials that relate to the materials or are based on studies, publications, surveys and other data obtained from third-party sources and our own internal estimates and research. While we believe these third-party studies, publications, surveys and other data to be reliable as of the date of these materials, we have not independently verified, and make no representations as to the adequacy, fairness, accuracy or completeness of, any information obtained from third-party sources. In addition, no independent source has evaluated the reasonableness or accuracy of our internal estimates or research and no reliance should be made on any information or statements made in these materials relating to or based on such internal estimates and research. InvestorsAndrew Funderburkir@ MediaCory Tromblee, Scient PRmedia@
Yahoo
26-05-2025
- Health
- Yahoo
Surprise Link Between Menthol And Alzheimer's Found in Mice
In recent years, scientists discovered something strange: When mice with Alzheimer's disease inhale menthol, their cognitive abilities improve. It seems the chemical compound can stop some of the damage done to the brain that's usually associated with the disease. In particular, researchers noticed a reduction in the interleukin-1-beta (IL-1β) protein, which helps to regulate the body's inflammatory response – a response that can offer natural protection but one that leads to harm when it's not controlled properly. The team behind the study, published in April 2023, says it shows the potential for particular smells to be used as therapies for Alzheimer's. If we can figure out which odors cause which brain and immune system responses, we can harness them to improve health. Watch the video below to see what the scientists discovered: "We have focussed on the olfactory system's role in the immune and central nervous systems, and we have confirmed that menthol is an immunostimulatory odor in animal models," said immunologist Juan José Lasarte from the Center for Applied Medical Research (CIMA) in Spain when the results were released. "But, surprisingly, we observed that short exposures to this substance for six months prevented cognitive decline in the mice with Alzheimer's and, what is most interesting, also improved the cognitive ability of healthy young mice." Having previously observed menthol inhalation boosting the immune response of mice, here the team showed that it could also improve the animals' cognitive abilities, as observed in a series of practical tests in the lab. In mice with Alzheimer's, the course of menthol for a six-month-long period was enough to stop the cognitive abilities and memory capabilities of the mice from deteriorating. In addition, it appears menthol pushed the IL-1β protein back to safe levels in the brain. When researchers artificially reduced the number of T regulatory (Treg) cells – known to help keep the immune system in check – some of the same effects were observed, opening a possible route that future treatments could take. "Both menthol exposure and Treg cell blockade caused a decrease in IL-1β, a protein that could be behind the cognitive decline observed in these models," said neuroscientist Ana Garcia-Osta from CIMA. "In addition, the specific blockade of this protein with a drug used in treating some autoimmune diseases also improved the cognitive capacity of healthy mice and mice with Alzheimer's." Scientists have already established numerous links between smells and our immune and nervous systems. These relationships are difficult to fully understand, but we know that our olfactory system can strongly influence the brain. Certain smells may trigger certain responses in the brain, leading to chemical reactions that affect memory, emotion, and more. Indeed, diseases related to the central nervous system – such as Alzheimer's, Parkinson's, and schizophrenia – often come with a loss of smell. This new research adds some promising data, but plenty more is needed in humans as well as mice. "This study is an important step toward understanding the connection between the immune system, the central nervous system, and smell," said immunologist Noelia Casares from CIMA. "The results suggest that odors and immune modulators may play an important role in the prevention and treatment of Alzheimer's and other diseases related to the central nervous system." The research was published in Frontiers in Immunology. An earlier version of this article was published in May 2023. Scientists Discover West Nile Virus in The UK For The First Time New Link Connects Herpes to Alzheimer's. Here's What We Know. Mesmerizing Video Shows Cardiac Cells Building a Heart
Yahoo
19-05-2025
- Health
- Yahoo
Cantargia Publishes Promising Preclinical Results Highlighting CAN10's Potential to Inhibit Vascular Inflammation
IL1RAP expression positively correlates with inflammatory markers in human atherosclerotic plaques. IL1RAP blocking antibodies inhibit endothelial activation and neutrophil adhesion induced by IL-1, IL-33 and IL-36. IL1RAP targeted therapy offers a novel strategy to mitigate vascular inflammation. LUND, SE / / May 19, 2025 / Cantargia (Cantargia AB (publ); Nasdaq Stockholm:CANTA) today announced the publication of preclinical results from IL1RAP targeting antibodies in models of vascular inflammation. Cytokines dependent on IL1RAP strongly affect human endothelial cells to induce release of proinflammatory mediators, attract immune cells and increase vascular permeability. These changes can be potently blocked by antibodies targeting IL1RAP. Also, IL1RAP levels in human atherosclerotic lesions correlate with various inflammatory markers, indicating translational possibility into human cardiovascular diseases (CVDs). The results are published in the Journal of the American Heart Association (JAHA). "IL1RAP and its ligands, IL-1, IL-33 and IL-36, are central for inflammation not only because of their effects on immune cells but also due to effects on other cells that respond to inflammation. The work now published show how IL1RAP-targeting antibodies can block inflammation by acting directly on endothelial cells and potentially reduce events important in several inflammatory diseases, including CVD"said David Liberg, CSO of Cantargia Vascular inflammation is a central part of several inflammatory diseases, including atherosclerosis. The current findings revealed that IL1RAP targeting antibodies inhibit the IL-1β, IL-33 and IL-36γ induced release of inflammatory and chemotactic mediators and genes related to endothelial activation and adhesion. Concordantly, endothelial permeability and neutrophil adhesion were inhibited by antibodies blocking IL1RAP. Analysis of human atherosclerotic plaques showed a correlation between the levels of IL1RAP and several of the inflammatory markers reduced by IL1RAP blockade, including interleukin-6 and -8 (IL-6 and IL-8). These data signify IL1RAP as a key regulator in vascular inflammation and in maintaining vascular integrity, which in turn implies targeting IL1RAP may have promising potential in several inflammatory diseases, including CVD. "Inflammation is a central hallmark of atherosclerosis, and our research shows that targeting IL1RAP inhibits important inflammatory markers central in atherosclerosis. The established collaboration with Cantargia is very valuable both for us and for development of therapeutic options within CVDs" said Associate Professor Karin H Franzén, Örebro University These data were generated in collaboration with Associate Professor Karin Franzén's research group at Örebro University. The article, titled "IL1RAP expression in human atherosclerosis - a target of novel antibodies to reduce vascular inflammation and adhesion", by Lindkvist et al., is available at Journal of the American Heart Associations website and at Cantargias website. For further information, please contactDamian Marron, Interim CEOTelephone: +46 (0)46-275 62 60E-mail: About CantargiaCantargia AB (publ), reg. no. 556791-6019, is a biotechnology company that develops antibody-based treatments for life-threatening diseases and has established a platform based on the protein IL1RAP, involved in a number of cancer forms and inflammatory diseases. Cantargia's oncology program, the antibody nadunolimab (CAN04), is being studied clinically, primarily in combination with chemotherapy with a focus on pancreatic cancer, non-small cell lung cancer and triple-negative breast cancer. Positive data for the combinations indicate stronger efficacy than would be expected from chemotherapy alone. Cantargia's second development program, the antibody CAN10, blocks signaling via IL1RAP in a different manner than nadunolimab and addresses treatment of serious autoimmune/inflammatory diseases, with initial focus on hidradenitis suppurativa and systemic sclerosis. Cantargia is listed on Nasdaq Stockholm (ticker: CANTA). More information about Cantargia is available at About CAN10The CAN10 antibody binds strongly to its target IL1RAP and has a unique capability to simultaneously inhibit signaling via IL-1, IL-33 and IL-36. Inhibition of these signals can be of significant value in the treatment of several inflammatory or autoimmune diseases. The initial focus of CAN10 will be on two severe diseases: hidradenitis suppurativa (HS) and treatment resistant atopic dermatitis (AD). In preclinical in vivo models of inflammatory diseases, such as systemic sclerosis, psoriasis, psoriatic arthritis, atherosclerosis, myocarditis and peritonitis, a CAN10 surrogate antibody significantly reduced the development of the disease. A clinical phase 1 study, investigating CAN10 in healthy volunteers and psoriasis patients, is ongoing. Good safety is shown at the completed dose levels, and additional data are expected continuously during 2025. AttachmentsCantargia publishes promising preclinical results highlighting CAN10's potential to inhibit vascular inflammation SOURCE: Cantargia View the original press release on ACCESS Newswire Error 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
30-04-2025
- Business
- Yahoo
Avalo Therapeutics to Participate in The Citizens Life Sciences Conference
WAYNE, Pa. and ROCKVILLE, Md., April 30, 2025 (GLOBE NEWSWIRE) -- Avalo Therapeutics, Inc. (Nasdaq: AVTX), a clinical stage biotechnology company focused on the treatment of immune dysregulation, today announced that Dr. Garry Neil, Chief Executive Officer of Avalo, will present at the Citizens Life Sciences Conference in New York on Thursday, May 8, 2025, at 3:00 pm ET. Live webcasts and replays, when available, can be found under "News / Events" in the Investors section of the Avalo Therapeutics website at The archived webcast will be available for replay for at least 30 days. About Avalo Therapeutics Avalo Therapeutics is a clinical stage biotechnology company focused on the treatment of immune dysregulation. Avalo's lead asset is AVTX-009, an anti-IL-1β mAb, targeting inflammatory diseases. For more information about Avalo, please visit About AVTX-009 AVTX-009 is a humanized monoclonal antibody (IgG4) that binds to interleukin-1β (IL-1β) with high affinity and neutralizes its activity. IL-1β is a central driver in the inflammatory process. Overproduction or dysregulation of IL-1β is implicated in many autoimmune and inflammatory diseases. IL-1β is a major, validated target for therapeutic intervention. There is evidence that inhibition of IL-1β could be effective in hidradenitis suppurativa and a variety of inflammatory diseases in dermatology, gastroenterology, and rheumatology. For media and investor inquiriesChristopher Sullivan, CFO Avalo Therapeutics, Inc. ir@ or Meru AdvisorsLauren Glaserlglaser@ 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
Associated Press
30-04-2025
- Business
- Associated Press
Avalo Therapeutics to Participate in The Citizens Life Sciences Conference
WAYNE, Pa. and ROCKVILLE, Md., April 30, 2025 (GLOBE NEWSWIRE) -- Avalo Therapeutics, Inc. (Nasdaq: AVTX), a clinical stage biotechnology company focused on the treatment of immune dysregulation, today announced that Dr. Garry Neil, Chief Executive Officer of Avalo, will present at the Citizens Life Sciences Conference in New York on Thursday, May 8, 2025, at 3:00 pm ET. Live webcasts and replays, when available, can be found under 'News / Events' in the Investors section of the Avalo Therapeutics website at The archived webcast will be available for replay for at least 30 days. About Avalo Therapeutics Avalo Therapeutics is a clinical stage biotechnology company focused on the treatment of immune dysregulation. Avalo's lead asset is AVTX-009, an anti-IL-1β mAb, targeting inflammatory diseases. For more information about Avalo, please visit About AVTX-009 AVTX-009 is a humanized monoclonal antibody (IgG4) that binds to interleukin-1β (IL-1β) with high affinity and neutralizes its activity. IL-1β is a central driver in the inflammatory process. Overproduction or dysregulation of IL-1β is implicated in many autoimmune and inflammatory diseases. IL-1β is a major, validated target for therapeutic intervention. There is evidence that inhibition of IL-1β could be effective in hidradenitis suppurativa and a variety of inflammatory diseases in dermatology, gastroenterology, and rheumatology. For media and investor inquiries Christopher Sullivan, CFO Avalo Therapeutics, Inc. [email protected] 410-803-6793 or Meru Advisors Lauren Glaser [email protected]
