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Monte Rosa Therapeutics Advances Second Development Candidate, MRT-6160, a Novel, Highly Selective Molecular Glue Degrader Targeting VAV1 for the Treatment of Autoimmune Diseases

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Monte Rosa Therapeutics has announced its second development candidate, MRT-6160, a novel molecular glue degrader (MGD) targeting VAV1 for the treatment of autoimmune diseases. The company plans to file an Investigational New Drug (IND) application for MRT-6160 in the first half of 2024.

Preclinical data show that MRT-6160 potently and selectively degrades VAV1, inhibiting disease progression in autoimmunity models. The molecule acts as an immune modulator, potentially avoiding broad immune suppression seen with other approaches. MRT-6160 is designed to attenuate multiple aspects of T- and B-cell function.

Monte Rosa (Nasdaq: GLUE) aims to develop MRT-6160 as a potential treatment for various autoimmune conditions, particularly those involving T- and B cell-mediated autoimmunity. The company expects it to be their second MGD to enter clinical trials, highlighting the productivity of their QuEEN™ platform.

Monte Rosa Therapeutics ha annunciato il suo secondo candidato per lo sviluppo, MRT-6160, un nuovo degradatore molecolare (MGD) che mira a VAV1 per il trattamento delle malattie autoimmuni. L'azienda prevede di presentare una domanda di Nuovo Farmaco Investigativo (IND) per MRT-6160 nella prima metà del 2024.

Dati preclinici mostrano che MRT-6160 degrada in modo potente e selettivo VAV1, inibendo la progressione della malattia nei modelli di autoimmunità. La molecola agisce come un modulatore immunitario, potenzialmente evitando la soppressione immunitaria globale osservata con altri approcci. MRT-6160 è progettato per attenuare molteplici aspetti della funzione delle cellule T e B.

Monte Rosa (Nasdaq: GLUE) mira a sviluppare MRT-6160 come un potenziale trattamento per varie condizioni autoimmuni, in particolare quelle coinvolgenti l'autoimmunità mediata dalle cellule T e B. L'azienda si aspetta che diventi il loro secondo MGD a entrare negli studi clinici, evidenziando la produttività della loro piattaforma QuEEN™.

Monte Rosa Therapeutics ha anunciado su segundo candidato en desarrollo, MRT-6160, un nuevo degradador de pegamento molecular (MGD) que se dirige a VAV1 para el tratamiento de enfermedades autoinmunes. La compañía planea presentar una solicitud de Nuevo Medicamento en Investigación (IND) para MRT-6160 en la primera mitad de 2024.

Los datos preclínicos muestran que MRT-6160 degrada de manera potente y selectiva VAV1, inhibiendo la progresión de la enfermedad en modelos de autoinmunidad. La molécula actúa como un modulador inmunitario, potencialmente evitando la supresión inmunológica amplia observada con otros enfoques. MRT-6160 está diseñado para atenuar múltiples aspectos de la función de células T y B.

Monte Rosa (Nasdaq: GLUE) tiene como objetivo desarrollar MRT-6160 como un tratamiento potencial para varias condiciones autoinmunes, particularmente aquellas involucrando la autoinmunidad mediada por células T y B. La compañía espera que sea su segundo MGD en entrar en ensayos clínicos, destacando la productividad de su plataforma QuEEN™.

몬테 로사 테라퓨틱스는 두 번째 개발 후보인 MRT-6160을 발표했습니다. 이 신약은 자가 면역 질환 치료를 위한 VAV1을 타겟으로 하는 새로운 분자 접착제 분해제(MGD)입니다. 회사는 2024년 상반기에 MRT-6160에 대한 임상 새 약물 조사(IND) 신청서를 제출할 계획입니다.

전임상 데이터는 MRT-6160이 VAV1을 강력하고 선택적으로 분해하여 자가 면역 모델에서 질병 진행을 억제한다는 것을 보여줍니다. 이 분자는 면역 조절제로 작용하여 다른 접근 방식에서 나타나는 광범위한 면역 억제를 피할 수 있습니다. MRT-6160은 T 세포와 B 세포 기능의 여러 측면을 감소시키도록 설계되었습니다.

몬테 로사(Nasdaq: GLUE)는 MRT-6160을 T 세포 및 B 세포 매개 자가 면역과 관련된 여러 자가 면역 질환의 잠재적인 치료제로 개발할 계획입니다. 이 회사는 MRT-6160이 임상 시험에 들어가는 두 번째 MGD가 될 것으로 예상하며, QuEEN™ 플랫폼의 생산성을 강조합니다.

Monte Rosa Therapeutics a annoncé son deuxième candidat en développement, MRT-6160, un nouvel agent d’élimination moléculaire (MGD) ciblant VAV1 pour le traitement des maladies auto-immunes. L'entreprise prévoit de soumettre une demande de Nouveaux Médicaments en Recherche (IND) pour MRT-6160 dans la première moitié de 2024.

Les données précliniques montrent que MRT-6160 dégrade puissamment et sélectivement VAV1, inhibant la progression de la maladie dans des modèles d'auto-immunité. La molécule agit comme un modulateur immunitaire, évitant potentiellement la suppression immunitaire large observée avec d'autres approches. MRT-6160 est conçu pour atténuer plusieurs aspects de la fonction des cellules T et B.

Monte Rosa (Nasdaq: GLUE) vise à développer MRT-6160 comme un traitement potentiel pour diverses conditions auto-immunes, en particulier celles impliquant une auto-immunité médiée par les cellules T et B. L'entreprise s'attend à ce qu'il soit leur deuxième MGD à entrer dans des essais cliniques, soulignant la productivité de leur plateforme QuEEN™.

Monte Rosa Therapeutics hat seinen zweiten Entwicklungskandidaten, MRT-6160, bekannt gegeben, einen neuartigen molekularen Klebe-Downloader (MGD), der auf VAV1 abzielt und zur Behandlung von Autoimmunerkrankungen eingesetzt werden soll. Das Unternehmen plant, im ersten Halbjahr 2024 einen Antrag auf einen neuen Prüfmedikament (IND) für MRT-6160 einzureichen.

Präklinische Daten zeigen, dass MRT-6160 VAV1 wirkungsvoll und selektiv degradiert und dadurch den Krankheitsverlauf in Modellen für Autoimmunität hemmt. Das Molekül wirkt als Immunmodulator, das potenziell eine weitreichende Immunsuppression, wie sie bei anderen Ansätzen beobachtet wird, vermeidet. MRT-6160 ist darauf ausgelegt, mehrere Aspekte der T- und B-Zellfunktion zu dämpfen.

Monte Rosa (Nasdaq: GLUE) hat das Ziel, MRT-6160 als mögliche Behandlung für verschiedene autoimmune Erkrankungen zu entwickeln, insbesondere solche, die T- und B-Zell-vermittelte Autoimmunität betreffen. Das Unternehmen erwartet, dass es der zweite MGD sein wird, der in klinische Studien eintritt, was die Produktivität ihrer QuEEN™-Plattform unterstreicht.

Positive
  • Development of MRT-6160, a novel molecular glue degrader targeting VAV1 for autoimmune diseases
  • Planned IND filing for MRT-6160 in the first half of 2024
  • Preclinical data shows potent and selective degradation of VAV1 by MRT-6160
  • Potential for MRT-6160 to avoid broad immune suppression seen in other approaches
  • MRT-6160 expected to be the company's second MGD to enter clinical trials
Negative
  • None.
  • Preclinical data establish MRT-6160’s ability to potently and selectively degrade VAV1 and inhibit disease progression in autoimmunity models, supporting potential applications across multiple autoimmune diseases
  • Planned IND filing in the first half of 2024

BOSTON, May 23, 2023 (GLOBE NEWSWIRE) -- Monte Rosa Therapeutics, Inc. (Nasdaq: GLUE), a clinical-stage biotechnology company developing novel molecular glue degrader (MGD)-based medicines, today announced its second development candidate, MRT-6160, a novel, potent, and selective molecular glue degrader (MGD) of VAV1. The Company plans to file an Investigational New Drug (IND) application for MRT-6160 in the first half of 2024 and to develop the molecule as a potential treatment for autoimmune diseases.

“MRT-6160 is a potent, orally bioavailable MGD designed to degrade VAV1, an important protein involved in the signaling pathways of T and B cells. Our in vitro studies have shown that MRT-6160 selectively degrades VAV1 without detectable effects on other proteins. By targeting VAV1, MRT-6160 attenuates multiple aspects of T- and B-cell function and inhibits disease progression in established in vivo models of autoimmunity,” said Owen Wallace, Ph.D., Chief Scientific Officer of Monte Rosa. “The underlying biology and our preclinical data both demonstrate that MRT-6160 acts as an immune modulator, which has the potential to avoid the broad immune suppression seen with other approaches. We look forward to progressing our clinical plan developed with the goal of providing early insights into safety, PK and PD, and proof of concept regarding differentiated effects on key immunomodulatory signaling pathways.”

“Our goal centers on pioneering therapeutically meaningful new drugs for patients with serious diseases. By addressing VAV1, a validated but previously undruggable target, we believe we've created a potentially groundbreaking therapy for patients suffering from a range of serious autoimmune conditions, particularly those involving both T- and B cell-mediated autoimmunity,” said Markus Warmuth, M.D., CEO of Monte Rosa. “MRT-6160 is expected to be our second MGD to enter clinical trials, showcasing the continued productivity of our QuEEN™ platform. We anticipate significant progress and milestones in our portfolio in the upcoming year, including initial clinical data from our GSPT1 MGD, MRT-2359, in the second half of this year and filing of an IND application for MRT-6160 in the first half of next year.”

About VAV1 and MRT-6160
VAV1, a Rho-family guanine nucleotide exchange factor, is a key signaling protein downstream of both the T-and B-cell receptors. VAV1 expression is restricted to blood and immune cells, including T and B cells. Preclinical studies have shown that targeted degradation of VAV1 protein via an MGD modulates both T- and B-cell receptor-mediated activity. This modulation is evident both in vitro and in vivo, demonstrated by a significant decrease in cytokine secretion, proteins vital for maintaining autoimmune diseases. Moreover, VAV1-directed MGDs have shown promising activity in preclinical models of autoimmune diseases and thus we believe have the potential to provide therapeutic benefits in multiple autoimmune indications, such as multiple sclerosis, rheumatoid arthritis, and dermatological disorders. MRT-6160 is a potent, highly selective, and orally bioavailable degrader of VAV1, which has shown deep degradation of its target with no detectable effects on other proteins. Preclinical studies demonstrate MRT-6160 inhibits disease progression in in vivo autoimmunity models.

About Monte Rosa
Monte Rosa Therapeutics is a biotechnology company developing novel molecular glue degrader (MGD) medicines for patients with serious diseases such as oncology, autoimmune and inflammatory diseases. MGDs are small molecule protein degraders that employ the body’s natural mechanisms to selectively eliminate therapeutically relevant proteins. The Company’s QuEEN™ (Quantitative and Engineered Elimination of Neosubstrates) platform enables it to rapidly identify protein targets and design highly selective degraders by combining diverse libraries of proprietary MGDs with in-house proteomics, structural biology, AI/machine learning, and computational chemistry capabilities. For more information, visit www.monterosatx.com

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 in herein include, but are not limited to, statements about our product development activities, including our expectations around the potential of molecular glue degraders, the potential of our pipeline of molecular glue degraders, including our molecular glue degrader for VAV1, known as MRT-6160, GSPT1, known as MRT-2159, NEK7, and CDK2, and our earlier stage, undisclosed molecular glue degraders, our expectations regarding the advancement, and timing thereof, of our pipeline and the various products therein, our ability to advance our development candidates, including MRT-6160, toward IND, our ability to initiate and the timing of initiation of additional lead optimization programs, and our expectations regarding our ability to nominate and the timing of our nominations of additional development candidates, our expectations regarding potential therapeutic opportunities for our molecular glue degraders, and our clinical development expectations therefor, our expectations regarding patient populations and medical needs for any potential therapeutic opportunities for our molecular glue degraders, our expectations for our ongoing clinical trial for MRT-2359 and the timing thereof, our expectations regarding our proprietary QuEEN™ platform and its potential for the discovery of product candidates, and the strength of our financial position, 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, 2022, filed with the U.S. Securities and Exchange Commission on March 16, 2023, 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.

Investors
Shai Biran
Monte Rosa Therapeutics
ir@monterosatx.com

Media
Cory Tromblee, Scient PR
media@monterosatx.com


FAQ

What is Monte Rosa Therapeutics' new development candidate for autoimmune diseases?

Monte Rosa Therapeutics' new development candidate is MRT-6160, a novel molecular glue degrader (MGD) targeting VAV1 for the treatment of autoimmune diseases.

When does Monte Rosa Therapeutics (GLUE) plan to file an IND for MRT-6160?

Monte Rosa Therapeutics plans to file an Investigational New Drug (IND) application for MRT-6160 in the first half of 2024.

What are the potential advantages of MRT-6160 in treating autoimmune diseases?

MRT-6160 acts as an immune modulator, potentially avoiding broad immune suppression seen with other approaches. It attenuates multiple aspects of T- and B-cell function and inhibits disease progression in autoimmunity models.

How does MRT-6160 target autoimmune diseases according to Monte Rosa Therapeutics (GLUE)?

MRT-6160 is designed to degrade VAV1, an important protein involved in the signaling pathways of T and B cells, which are key components in autoimmune diseases.

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