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Monte Rosa Therapeutics Announces Closing of Global License Agreement With Novartis to Advance T and B Cell-modulating VAV1-directed Molecular Glue Degraders

Monte Rosa Therapeutics Announces Closing of Global License Agreement With Novartis to Advance T and B Cell-modulating VAV1-directed Molecular Glue Degraders

Monte Rosa Therapeutics宣佈與諾華公司達成全球貨幣許可協議,以推進針對t和b電芯調節的VAV1導向分子膠水降解劑。
GlobeNewswire ·  12/11 20:00

BOSTON, Dec. 11, 2024 (GLOBE NEWSWIRE) -- Monte Rosa Therapeutics, Inc. (Nasdaq: GLUE), a clinical-stage biotechnology company developing novel molecular glue degrader (MGD)-based medicines, today announced the closing of the Company's previously announced global exclusive development and commercialization license agreement with Novartis to advance VAV1-directed MGDs, including MRT-6160.

波士頓,2024年12月11日(環球新聞稿) -- 蒙特羅莎治療公司。 (納斯達克: GLUE),一家臨床階段的生物技術公司,正在開發新型的分子膠退化劑(MGD)基礎的藥物,今天宣佈與諾華公司達成此前宣佈的全球獨佔開發和商業化許可協議,以推進針對VAV1的MGD,包括MRt-6160。

Under the terms of the agreement, Novartis will obtain exclusive worldwide rights to develop, manufacture, and commercialize MRT-6160 and other VAV1 MGDs and will be responsible for all clinical development and commercialization, starting with Phase 2 clinical studies. Monte Rosa remains responsible for completing the ongoing Phase 1 clinical study of MRT-6160.i Novartis has agreed to pay Monte Rosa $150 million up front. Monte Rosa is eligible to receive up to $2.1 billion in development, regulatory, and sales milestones, beginning upon initiation of Phase 2 studies, as well as tiered royalties on ex-U.S. net sales. Monte Rosa will co-fund any Phase 3 clinical development and will share any profits and losses associated with the manufacturing and commercialization of MRT-6160 in the U.S.

根據協議條款,諾華將獲得全球獨家開發、製造和商業化MRt-6160及其他VAV1 MGD的權利,並將負責所有臨床開發和商業化,首個階段是進行第二階段臨床研究。蒙特羅莎仍負責完成MRt-6160的正在進行的第一階段臨床研究。諾華已同意提前支付蒙特羅莎15000萬美元。蒙特羅莎有資格在第二階段研究開始後,獲得高達21億美元的開發、監管和銷售里程碑款項,以及美國以外淨銷售的分級特許權使用費。蒙特羅莎將共同資助任何第三階段臨床開發,並將分享與MRt-6160在美國的製造和商業化相關的任何利潤和損失。

MRT-6160 is a potent, highly selective, and orally bioavailable investigational degrader of VAV1, a key signaling protein downstream of both the T- and B-cell receptors. Preclinical studies have demonstrated deep degradation of VAV1, resulting in a significant decrease in cytokines linked to immune-mediated conditions, with no detectable effects on other proteins. MRT-6160 has shown promising activity in preclinical models of multiple immune-mediated conditions.ii,iii

MRt-6160是一種強效、高選擇性且口服生物利用度良好的VAV1研究性降解劑,VAV1是t細胞和b細胞受體下游的一個關鍵信號蛋白。臨床前研究表明,VAV1的深度降解導致與免疫介導的病症相關的細胞因子的顯著減少,對其他蛋白沒有可檢測的影響。MRt-6160在多種免疫介導病症的臨床前模型中顯示出良好的活性。

About Monte Rosa
Monte 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 .

About Monte Rosa
Monte 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 .

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 the future development and commercialization of VAV1 MGDs, including MRT-6160 , our expectations regarding the potential clinical scope and benefit for the MRT-6160 program, including results of preclinical studies, and our expectations of timing for the program, statements around the advancement and application of our pipeline, statements about the obligations under the agreement with Novartis, as well as regarding the receipt of the development, regulatory, and sales milestones and other payments under the agreement , 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, 2023, filed with the U.S. Securities and Exchange Commission on March 14, 2024, 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.

前瞻性聲明
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 the future development and commercialization of VAV1 MGDs, including MRt-6160 , our expectations regarding the potential clinical scope and benefit for the MRt-6160 program, including results of preclinical studies, and our expectations of timing for the program, statements around the advancement and application of our pipeline, statements about the obligations under the agreement with Novartis, as well as regarding the receipt of the development, regulatory, and sales milestones and other payments under the agreement , 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, 2023, filed with the U.S. Securities and Exchange Commission on March 14, 2024, 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.

Investors
Andrew Funderburk
ir@monterosatx.com

投資者
安德魯·芬德巴克
ir@monterosatx.com

Media
Cory Tromblee, Scient PR
media@monterosatx.com
___________________________

媒體
科裏·湯布利,科學公關
media@monterosatx.com
___________________________

i Details about the study, MRT-6160 in a First-in-human Study in Healthy Subjects, can be found at ClinicalTrials.gov under the identifier NCT06597799.
ii Cartwright A et al. MRT-6160, a VAV1-Directed Molecular Glue Degrader, Reduces Joint Inflammation
and Autoantibody Production in a Collagen-Induced Arthritis Autoimmune Disease Model. Poster presented at: Digestive Disease Week 2024; May 21, 2024; Washington, DC.
iii Cartwright A et al. MRT-6160, a VAV1-Directed Molecular Glue Degrader, Inhibits Disease Progression in a T-cell Transfer Mediated Colitis Model Concomitant with Reduced Calprotectin Expression. Poster presented at: EULAR 2024 – Annual European Congress of Rheumatology; June 14, 2024; Vienna, Austria.

有關該研究的詳細信息,MRt-6160在健康受試者中的首次人類研究,可在ClinicalTrials.gov網站上查找,標識符爲NCT06597799。
Cartwright A 等。MRt-6160,作爲VAV1靶向分子膠水降解劑,減少關節炎症
和在膠原誘導的關節炎自身免疫疾病模型中減少自身抗體產生。海報展示於:2024年消化疾病周;2024年5月21日;華盛頓特區。
Cartwright A 等。MRt-6160,作爲VAV1靶向分子膠水降解劑,抑制t細胞轉移介導的結腸炎模型中的疾病進展,同時降低鈣保護素表達。海報展示於:2024年EULAR - 歐洲風溼病年會;2024年6月14日;維也納,奧地利。


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