Latest news with #MonteRosa
Yahoo
3 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
28-05-2025
- Business
- Yahoo
Monte Rosa Therapeutics to Participate in the Jefferies Global Healthcare Conference
BOSTON, May 28, 2025 (GLOBE NEWSWIRE) -- Monte Rosa Therapeutics, Inc. (Nasdaq: GLUE), a clinical-stage biotechnology company developing novel molecular glue degrader (MGD)-based medicines, today announced that Markus Warmuth, M.D., Chief Executive Officer, will participate in a fireside chat at the Jefferies Global Healthcare Conference on Wednesday, June 4, 2025, at 12:50 p.m. EDT. A webcast of the fireside chat will be accessible via the 'Events & Presentations' section of Monte Rosa's website at and an archived version will be made available for 30 days following the presentation. 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 InvestorsAndrew Funderburk ir@ MediaCory Tromblee, Scient PRmedia@
Forbes
03-05-2025
- Forbes
Why This ‘Secret' Italian Riviera City Should Be On Your Must-See List
The city of Chiavari is located between Portofino and Cinque Terre. The eastern coast of Italy's Riviera, beginning in Genoa and ending at the Tuscan border, ranks among the most famous seasides in the world, with wildly popular resorts like Portofino and Cinque Terre. While there are still uncrowded hamlets to explore, there's also a remarkable, lesser-known Riviera city, Chiavari, that you should add to your must-see list. It's so delightful, authentic and complete as a holiday destination you can't help but wonder why it hasn't yet exploded with international travelers (but are grateful for the fact it hasn't). If your checklist for an ideal summer spot includes a place without mobs of tourists, ample beaches, a variety of cultural attractions, locavore restaurants free of tourist menus, indie boutiques, plus a better-than-average chance of sunny weather (in July and August), head to Chiavari. For centuries this quietly prosperous city—Napoleon made it the capital of the Apeninnes in the early 1800s—relied on maritime commerce, agriculture and furniture production (the Chiavarina chair often used at weddings or for ballroom galas was created here) to swell its coffers. Post-World War II seaside tourism was added to the mix, but without the jet-set flash. Families came to rent apartments or book extended hotel stays during warm-weather months, and somehow managed to keep the destination a 'secret' for themselves. A building facade with trompe l'oeil decorative detail in Chiavari. Olga Bacigalupo, whose family founded and owns one of the principal hotels in town, the Monte Rosa, says her guests are mostly Italian and European, a blend of vacationers that have typically been drawn to Chiavari. While Cinque Terre and Portofino attract the lion's share of international travelers this may be starting to change. Bacigalupo points to events like Chiavari in Fiore (a flower festival) in May and the annual Economic Forum Giannini in April attracting new visitors to the city. But Chiavari seems to be choosing its modern-day tourism path carefully, avoiding situations that can lead to overcrowding, and focusing on cultural events like jazz and theater festivals for peak summer months. In contrast to many tourist-centric destinations, Chiavari lets you feel connected to the city and immersed in its native rhythms simply by strolling the main shopping street, Via Martiri della Liberazione, an arcaded walkway reminiscent of Bologna's porticoed corridors. The arcaded walkways of Via Martiri della Liberazione. (Photo by Paolo Picciotto/REDA/Universal Images Group via Getty Images) Although it can be quiet in the evening (a lot of the restaurant action is along the side streets, like Via Bighetti, and by the sea), Via Martiri is the prime gathering spot come morning whether for shopping or a coffee meet-up, as Chiavarians go about their day-to-day, which includes a mandatory stop at the large open-air food market in the Piazza Mazzini. Here you'll find an exceptional bounty of fruits and vegetables, a good selection of local cheeses and connoisseur vendors who can tell you a thing or two (and do) about selecting the best fennel or asparagus. The last weekend of the month there's a bonus market to visit on the historic Via Rivarola, called Tipicamente Chiavari, with artisanal and DOP produce. The food market in Piazza Mazzini. Beaches face the Gulf of Tigullio. At 1 PM, Via Martiri becomes quiet, a majority of shops close for an hour or more, another sign that even in high season the city remains in sync with the traditions and habits of its year-rounders. Many Chiavarians head home for lunch, although the twenty-ish crowd tends to linger at local bars or caffès for an insalatone or large slice of foccacia. A couple of hours later the town buzzes to life again, and as you get closer to the waterfront, you see people with umbrellas and rolled up mats walking to the sea. A long lungomare flanks a scenic coastline with a mix of public beaches and private lidos (Chiavari beaches have earned Bandiera Blu status). The marina, with 459 moorings, is where you can catch a ferry to Portofino or Cinque Terre. Chiavari is known for its many gracious villas. As you walk around the city, you become aware of its quiet wealth, rooted in other centuries. Set out for the Via Enrico Millo, in a residential area outside the centro storico, where you'll come across gracious Liberty-Style villas, the legacy of the Chiavarians who sailed to South America in the 19th-century to seek their fortunes, and when they found them, came back to enjoy the good life in their hometown. If you look for botteghe storiche (historic shops) when you travel in Italy, Chiavari has a number of them, which like the Liberty villas date from the 19th century, that period of notable prosperity in the city's history. Fans of Caffè Greco in Rome should go to the Gran Caffè Defilla, a place that Rita Hayworth once visited, located on Corso Garibaldi in another arcaded passageway. You can while away the early evening hours outdoors with a Negroni or Spritz (or when the weather is cool, inside in the Art Nouveau-style salon). But you could spend your entire day here: as per its name, Defilla is a caffè with plenty of local pastries to get you started in the morning or revived in the afternoon, but there's also a restaurant and wine store that can have you at Defilla from morning to dusk. The Pasticceria Coppello, in business since 1826 and specializing in local sweets, is another requisite stop. Try the hometown cookie, dolcezze di Chiavari, or pandolce, Liguria's answer to panettone. Visit the historic Panarello for more artisanal sweets; a favorite is the almond cake named after the shop. Inside the Palazzo Rocca, with two important Chiavari museums. (Photo by Isabella Pino/REDA/Universal Images Group via Getty Images) Perhaps because Chiavari is still under-the-radar for many, there's a sense of discovery when seeking out the city's cultural attractions. At the Palazzo Rocca, you can take in thousands of years of Chiavari history at the archaeological museum, which includes Iron Age artifacts excavated from nearby burial grounds. The palazzo has another museum, the Civic Gallery, that provides more recent insights into local history with period rooms and Genovese and Flemish paintings dating from the 17th century. Other highlights include the Palazzo Ravaschieri Museum with a wide-ranging art collection that reaches from the 15th century to the present, and the Risorgimento Museum, one of the country's most important centers for memorabilia from Italy's unification period. Both are located in the the palazzo that's home to Chiavari's Società Economica, a cultural institution founded in 1791 that's long played an important role in the city's artistic and civic life. The Palazzo di Giustizia in Chiavari. The Cattedrale di Nostra Signora dell'Orto dates from the 1600s, and is noted for an ornate frescoed and marble interior. Chiavari's annual celebration honoring its patron saint, Madonna dell'Orto (July 1-3), is a major event in the city with a program of special masses at the cathedral, a heavily attended city-wide procession, and a lavish fireworks display over the sea. The Cattedrale di Nostra Signora dell'Orto. Lodging: In town, the four-star Hotel Monte Rosa is in an ideal location, a short walk from the main shopping street, Via Martiri. This is a welcoming family-run property, with the grandchildren of the founders, Luigia Rocca and Luigi Bacigalupo who started as restaurateurs in 1909, running the 59-room hotel today. The Monte Rosa has a swimming pool and provides a shuttle twice a day to a private beach club. For those who want to stay on the beach there's the Grand Hotel Torre Fara with a swimming pool facing the seaside promenade. A historic gate, once part of the estate of a local marquess, leads to the terrace and pool area at the Hotel Monte Rosa. Dining: Luchin, in business since 1907, is an essential stop for authentic Ligurian cooking. Farinata, minestrone Genovese, vegetable pies and pansotti are among their specialties with many dishes prepared in an ancient wood-fired oven. For fresh fish from the Ligurian Sea and and homemade pastas, there's Da Felice, known for its carefully sourced locavore ingredients. Another restaurant on the water is Ostaia Ca Da Gurpe Al Mare, with well-curated seafood options and great seaside views.
Yahoo
24-02-2025
- Business
- Yahoo
Monte Rosa Therapeutics to Present at the TD Cowen 45th Annual Health Care Conference
BOSTON, Feb. 24, 2025 (GLOBE NEWSWIRE) -- Monte Rosa Therapeutics, Inc. (Nasdaq: GLUE), a clinical-stage biotechnology company developing novel molecular glue degrader (MGD)-based medicines, today announced that Markus Warmuth, M.D., Chief Executive Officer, will present at the TD Cowen 45th Annual Health Care Conference on Monday, March 3, 2025, at 2:30 p.m. EST. A webcast of the presentation will be accessible via the 'Events & Presentations' section of Monte Rosa's website at and an archived version will be made available for 30 days following the presentation. 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 identify degradable protein targets and rationally design MGDs with unprecedented selectivity. The QuEEN discovery engine enables access to a wide-ranging and differentiated target space of well-validated biology across multiple therapeutic areas. Monte Rosa has developed the industry's leading pipeline of MGDs, which spans oncology, autoimmune and inflammatory disease 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 InvestorsAndrew Funderburk ir@ MediaCory Tromblee, Scient PRmedia@ in to access your portfolio
