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Ichnos Glenmark Innovation (IGI) and AbbVie Announce Exclusive Global Licensing Agreement for ISB 2001, a First-in-Class CD38×BCMA×CD3 Trispecific Antibody
GlobeNewswire News Room· 2025-07-10 11:35
Core Viewpoint - IGI Therapeutics and AbbVie have entered into an exclusive licensing agreement for ISB 2001, a novel trispecific T-cell engager targeting multiple myeloma, which is currently in Phase 1 clinical trials [1][2]. Company Overview - IGI Therapeutics is a clinical-stage biotechnology company focused on developing innovative biologics in oncology, utilizing its proprietary BEAT® technology platform to create first-in-class multispecific therapies [7]. - AbbVie is a global biopharmaceutical company dedicated to discovering and delivering innovative medicines across various therapeutic areas, including oncology [8]. Product Details - ISB 2001 is designed to target BCMA and CD38 on myeloma cells and CD3 on T cells, aiming to improve safety and efficacy compared to first-generation bispecific antibodies [3]. - The drug has shown a sustained overall response rate (ORR) of 79% and a complete/stringent complete response (CR/sCR) rate of 30% in a heavily pretreated patient population [3]. Licensing Agreement - Under the agreement, AbbVie will have exclusive rights to develop, manufacture, and commercialize ISB 2001 in North America, Europe, Japan, and Greater China [2]. - IGI will receive an upfront payment of $700 million and could earn up to $1.225 billion in milestone payments, along with tiered, double-digit royalties on net sales [2]. Regulatory Designations - ISB 2001 received Orphan Drug Designation from the U.S. FDA in July 2023 and Fast Track Designation for treating relapsed/refractory myeloma patients in May 2025 [4]. BEAT® Platform - The BEAT® platform enables the development of next-generation immune cell engagers with enhanced stability and function, addressing limitations of traditional bispecific antibody production [5]. - Key features include multispecific versatility, optimized engineering for precise modulation, and robust manufacturability [5].
Merus' Petosemtamab with Pembrolizumab Interim Data Demonstrates Robust Efficacy and Durability in 1L PD-L1+ r/m HNSCC
GlobeNewswire News Room· 2025-05-22 21:30
-  63% response rate observed among 43 evaluable patients -  79% overall survival rate at 12-months; 9 months median progression-free survival -  Conference Call on Thursday, May 22 at 5:30 p.m. ET UTRECHT, The Netherlands and CAMBRIDGE, Mass., May 22, 2025 (GLOBE NEWSWIRE) -- Merus N.V. (Nasdaq: MRUS) (Merus, the Company, we, or our), an oncology company developing innovative, full-length multispecific antibodies and antibody drug conjugates (Biclonics®, Triclonics® and ADClonics®), today announced interim ...
Zymeworks Presents Preclinical Data on ZW1528 at the American Thoracic Society International Conference
Globenewswire· 2025-05-19 20:15
Core Viewpoint - Zymeworks Inc. is advancing its clinical-stage pipeline with the presentation of new preclinical data for ZW1528, a bispecific molecule targeting IL-4Rα and IL-33, aimed at treating respiratory inflammation, particularly chronic obstructive pulmonary disease (COPD) [1][2]. Group 1: Product Development - ZW1528 demonstrates high affinity binding to IL-4Rα and IL-33, effectively blocking IL-4, IL-13, and IL-33 signaling pathways, which are critical in respiratory inflammation [5][6]. - The bispecific design of ZW1528 shows promising manufacturability and stability, supporting high dosing concentrations and subcutaneous administration [5][7]. - Zymeworks is also developing ZW1572, another bispecific inhibitor targeting IL-4Rα and IL-31 for atopic dermatitis, as part of its expanding IL-4Rα program portfolio [3][5]. Group 2: Preclinical Data and Findings - Preclinical data presented at the ATS conference indicate that ZW1528 can suppress both Type 2 and non-Type 2 immune responses in primary human immune cells from COPD patients [6][7]. - In vivo studies in murine models of lung inflammation show efficacy for ZW1528, with extended pharmacokinetics observed in rodent and non-human primate models [6][7]. - The bispecific antibody's blockade of cytokine-driven activation in human epithelial cells is superior to that achieved with monoclonal antibodies targeting either IL-4Rα or IL-33 [7]. Group 3: Company Overview - Zymeworks is a global biotechnology company focused on developing multifunctional biotherapeutics for difficult-to-treat conditions, including cancer and autoimmune diseases [8]. - The company has a robust pipeline of product candidates and has entered into strategic partnerships to enhance its therapeutic platforms [8].
Merus Announces the Journal Publication of Petosemtamab Mechanism of Action
Globenewswire· 2025-05-15 12:00
UTRECHT, The Netherlands and CAMBRIDGE, Mass., May 15, 2025 (GLOBE NEWSWIRE) -- Merus N.V. (Nasdaq: MRUS) ("Merus", "the Company", "we", or "our"), an oncology company developing innovative, full-length multispecific antibodies and antibody drug conjugates (Biclonics, Triclonics and ADClonics), today announced publication on the mechanism of action of petosemtamab, a bispecific antibody targeting Epidermal Growth Factor Receptor (EGFR) and Leucine-Rich G (LGR5), in the scientific journal "Cancers", a MDPI p ...
Zymeworks Provides Corporate Update and Reports First Quarter 2025 Financial Results
Globenewswire· 2025-05-08 20:05
Core Insights - Zymeworks Inc. reported financial results for Q1 2025, highlighting a significant increase in revenue and ongoing advancements in its clinical pipeline [1][15][20] Recent Developments - The appointment of Dr. Sabeen Mekan as Senior Vice President of Clinical Development is expected to enhance Zymeworks' oncology portfolio and regulatory strategy [3] - Six posters were presented at the AACR annual meeting, showcasing progress in the company's T cell engager and antibody-drug conjugate platforms [4][5] Financial Performance - Revenue for Q1 2025 was $27.1 million, a substantial increase from $10.0 million in Q1 2024, driven by milestone revenues from GSK and Daiichi Sankyo [15] - Research and development expenses rose to $35.7 million in Q1 2025 from $32.0 million in Q1 2024, primarily due to increased activities related to ZW251 and ZW209 [16] - The net loss for Q1 2025 was $22.6 million, down from $31.7 million in the same period last year, attributed to higher revenues [20] Cash Position - As of March 31, 2025, Zymeworks had $321.6 million in cash resources, expected to fund operations into the second half of 2027 [21] Pipeline and Collaborations - Zymeworks is advancing multiple clinical candidates, including ZW171 and ZW191, with an investigational new drug application for ZW251 planned by mid-2025 [22] - The company has strategic partnerships with BeiGene and Jazz Pharmaceuticals for the development and commercialization of zanidatamab [22][8]
Merus Announces Financial Results for the First Quarter 2025 and Provides Business Update
Globenewswire· 2025-05-07 20:11
- Petosemtamab in combination with pembrolizumab in 1L PD-L1+ r/m HNSCC phase 2 trial ongoing with clinical data update at 2025 ASCO® Annual Meeting - Based on the Company’s current operating plan, existing cash, cash equivalents and marketable securities expected to fund Merus’ operations into 2028 UTRECHT, The Netherlands and CAMBRIDGE, Mass., May 07, 2025 (GLOBE NEWSWIRE) -- Merus N.V. (Nasdaq: MRUS) (Merus, the Company, we, or our), an oncology company developing innovative, full-length multispecific an ...