Core Insights - ModeX Therapeutics has initiated a Phase 1/2a clinical trial for MDX2004, a first-in-class trispecific antibody-fusion protein aimed at treating advanced cancers and immune disorders [1][3] - MDX2004 is designed to stimulate T cells through three signaling pathways, enhancing immune activation and potentially rejuvenating cellular immunity [2][5] - The drug targets patients with advanced solid tumors, addressing the limited treatment options and low long-term survival rates associated with current therapies [3] Company Overview - ModeX Therapeutics is a clinical-stage biopharmaceutical company focused on developing innovative multispecific biologics for cancer and infectious diseases [7] - The company utilizes a platform called ModeX Synergistic Targeting of Antibody Receptors (MSTAR) to create unique multispecific medicines that target multiple disease pathways simultaneously [6] - ModeX is a subsidiary of OPKO Health, which is a multinational biopharmaceutical and diagnostics company aiming to establish leading positions in rapidly growing markets [8] Product Details - MDX2004 is a trispecific antibody-fusion protein that targets CD3, CD28, and 4-1BB on human T cells, promoting the expansion of stem and memory T cell populations [5] - The drug aims to restore immune function in patients with underlying immune impairments due to aging, chronic diseases, infections, or chemotherapy [5] - Preclinical proof-of-concept data and clinical dose selection analyses for MDX2004 will be presented at the SITC Annual Meeting in November 2025 [4]

Core Viewpoint - Zymeworks Inc. has appointed Dr. Sabeen Mekan as Senior Vice President of Clinical Development, enhancing its leadership team to advance its clinical-stage oncology portfolio and diversify into autoimmune and inflammatory diseases [1][2]. Company Overview - Zymeworks Inc. is a clinical-stage biotechnology company focused on developing novel biotherapeutics for difficult-to-treat diseases, including cancer, inflammation, and autoimmune diseases [1][4]. - The company utilizes proprietary technologies to engineer and develop differentiated antibody-based therapeutic candidates, including zanidatamab, a HER2-targeted bispecific antibody [4][5]. Leadership Changes - Dr. Sabeen Mekan, with 18 years of experience in hematology and oncology, will play a crucial role in formulating the clinical development strategy for Zymeworks' oncology portfolio [2][3]. - Dr. Jeff Smith continues as Executive Vice President & Chief Medical Officer, focusing on R&D in autoimmune and inflammatory diseases [1][2]. - Barbara Schaeffler has been promoted to Senior Vice President, Clinical Development Operations, reporting to Dr. Smith [1]. Clinical Development Focus - The expanded clinical development team aims to enhance the focus on progressing Zymeworks' clinical-stage solid tumor portfolio while diversifying into autoimmune and inflammatory diseases [2]. - Dr. Mekan expressed commitment to addressing unmet needs in various cancer types through next-generation antibody-drug conjugates and multispecific antibody therapeutics [2][3]. Pipeline and Regulatory Progress - Zymeworks has received FDA accelerated approval for Ziihera® (zanidatamab-hrii) for treating adults with previously-treated, unresectable or metastatic HER2-positive biliary tract cancer [4]. - The company is advancing a robust pipeline, with Phase 1 studies for ZW171 and ZW191 actively recruiting and an investigational new drug application for ZW251 planned for mid-2025 [5].