On August 19, 2025 AbbVie (NYSE: ABBV) reported that it has completed its acquisition of Capstan Therapeutics (Press release, AbbVie, AUG 19, 2025, View Source [SID1234655379]). With the completion of the acquisition, Capstan is now a part of AbbVie.

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Capstan’s lead asset CPTX2309, currently in Phase 1 for the treatment of B cell-mediated autoimmune diseases, is a tLNP that generates CD19-specific, CD8+ in vivo CAR-T cells. The CAR-T cells are designed to achieve rapid and deep B cell depletion with the aim of achieving durable, drug-free remission. This can be accomplished without the need for lymphodepleting chemotherapy, while also avoiding other challenges associated with conventional ex vivo CAR-T therapies.

"With the acquisition now complete, we are excited to work together with the talented team at Capstan to advance our mission of transforming patient care," said Jonathon Sedgwick, Ph.D., senior vice president and global head of discovery research, AbbVie. "The addition of CPTX2309 and Capstan’s tLNP platform strengthens our ability to deliver new treatments aimed at resetting the immune system and enables application of Capstan’s proprietary technology more broadly for in vivo programming of cells."

On August 19, 2025 Mabwell (688062.SH), an innovative biopharmaceutical company with entire industry chain, reported that its self-developed CDH17-targeting ADC (R&D code: 7MW4911) received IND clearance from the U.S. Food and Drug Administration (FDA) (Press release, Mabwell Biotech, AUG 19, 2025, View Source [SID1234655378]). The clearance enables the initiation of Phase I/II study of 7MW4911 to evaluate the safety, pharmacokinetics, and efficacy in patients with advanced colorectal cancer and other advanced gastrointestinal tumors.

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7MW4911 is an investigational CDH17-targeting ADC developed using Mabwell’s proprietary IDDC platform. Its highly optimized structure integrates three key elements:

Mab0727: A highly specific CDH17 monoclonal antibody with rapid internalization properties, cross-species (human/monkey) moderate affinity, and minimal off-target binding.
Novel cleavable linker: Ensures precise payload release in tumor tissues.
MF-6 payload: A proprietary DNA topoisomerase I inhibitor designed to overcome multidrug resistance (MDR), exhibiting superior plasma stability, controlled drug release, and potent bystander effects.
In July 2025, Mabwell published preclinical data in Cell Reports Medicine ("Overcoming multidrug resistance in gastrointestinal cancers with a CDH17-targeted ADC conjugated to a DNA topoisomerase inhibitor"), demonstrating 7MW4911’s tumor-selective cytotoxicity via CDH17-mediated internalization. Key advantages include:

Optimized molecular design: Homogeneous drug-to-antibody ratio (DAR=4, >95%) and stable linker confer exceptional plasma stability, while membrane-permeable MF-6 drives potent bystander killing.
Broad Antitumor Efficacy: Demonstrates robust tumor regression in colorectal, gastric, and pancreatic cancer PDX/CDX models, including tumors with RAS/BRAF mutations and diverse Consensus Molecular Subtypes (CMS).
MDR resistance: Outperforms MMAE/DXd-based ADCs in ABC transporter-mediated MDR models and reverses tumor progression post-ADC treatment.
Target versatility: Active even in tumors with low-to-moderate CDH17 expression, expanding potential patient eligibility.
Favorable safety profile: Limited tissue distribution in mice, controllable pharmacokinetics (moderate half-life, no accumulation), and a wide therapeutic window in cynomolgus monkeys, with no significant toxicity signals.
With this profile, 7MW4911 emerges as a promising therapeutic candidate for advanced gastrointestinal cancers. IND application of 7MW4911 has been accepted by China’s National Medical Products Administration (NMPA).

About CDH17

CDH17 is a pan-cancer validated target with restricted expression in normal intestinal epithelium but marked overexpression in gastrointestinal cancers (e.g., colorectal, gastric, pancreatic). Its aberrant expression correlates with tumor metastasis and poor prognosis, positioning it as an ideal therapeutic target.

On August 19, 2025 Myosin Therapeutics, a biotechnology company developing novel therapies for aggressive cancers, reported it has been awarded a $4.5M Phase IIB Bridge Award from the National Cancer Institute’s (NCI) Small Business Innovation Research (SBIR) program (Press release, Myosin Therapeutics, AUG 19, 2025, View Source [SID1234655377]).

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The funding will support Myosin Therapeutic’s Phase I STAR-GBM dose escalation and expansion trial of MT-125, a first-in-class novel small molecule therapeutic being evaluated in patients with newly diagnosed, MGMT unmethylated glioblastoma. Glioblastoma remains among the most lethal cancers, with median survival measured in months. MT-125 targets non-muscle myosin II, a critical driver of tumor cell invasion, proliferation and treatment resistance, representing a novel therapeutic approach that is distinct from existing standards of care.

The STAR-GBM trial will assess the safety, tolerability, and pharmacokinetics of MT-125 in this patient population with significant unmet need. Exploratory endpoints include measures of efficacy, including progression-free survival and overall survival.

The NCI SBIR program is one of the most competitive federal funding mechanisms for cancer-focused innovation, providing support to small businesses with technologies that have strong scientific merit, commercial potential, and a clear path to clinical impact. Bridge Awards, which require that matching funds from private capital be raised first, are reserved for companies with promising, later-stage projects that have already demonstrated significant technical progress and the potential to attract substantial private investment.

"The NCI Bridge Award was perfectly timed to support our STAR-GBM trial, for which patient enrollment is set to begin in November," said Dr. Courtney Miller, co-founder and CEO of Myosin Therapeutics. "It will enable us to generate the data needed to position the program for later-stage development, potential partnerships, and future expansion into a wider range of patients. Our ultimate goal is to deliver a transformative treatment option for patients who currently face limited or inadequate therapeutic choices."

On August 19, 2025 XtalPi reported that it signed a Memorandum of Understanding (MOU) with Korea’s leading pharmaceutical company Dong-A ST, to jointly develop therapeutics for immunological and inflammatory diseases (Press release, XtalPi, AUG 19, 2025, View Source [SID1234655376]).

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This collaboration will be based on XtalPi’s intelligent and automated drug discovery platform, which integrates artificial intelligence (AI), quantum physics, and large-scale automated robotic experiments. The two companies plan to co-identify targets and discover first-in-class or best-in-class drug candidates using XtalPi’s proprietary AI-driven drug discovery platform. The XtalPi platform combines the speed and generative power of AI with the accuracy of its robotic lab-in-the-loop to accelerate drug discovery and vastly expand the explorable chemical space. This integrated workflow spans deep-learning-based molecule design, quantum physics and molecular dynamics simulations for predicting drug-target interactions, automated chemical synthesis, and experimental validation of candidate compounds’ key pharmaceutical properties.

Leveraging its expertise in immunology and inflammation as well as its experience in small molecule drug development, Dong-A ST will actively participate throughout the entire R&D process—including candidate validation, efficacy and safety testing, and the formulation of preclinical and clinical development strategies. The company also plans to explore strategies for pipeline expansion and assess commercialization potential.

Through this partnership, Dong-A ST aims to strengthen its pipeline in the immunology and inflammation space and expand its R&D scope beyond small molecule therapeutics into areas such as targeted protein degradation (TPD), biologics, antibody-drug conjugates (ADC), and gene therapies.

John Wang, Senior Vice President of Drug Discovery at XtalPi, stated: "The combination of Dong-A ST’s extensive expertise and XtalPi’s proven AI-robotics platform is well-positioned to translate scientific innovation into competitive precision medicines. Together, we aim to rapidly discover and rigorously validate novel drug candidates across multiple modalities to unlock unique market opportunities, and deliver transformative therapies for global patients."

Jae-Hong Park, Head of R&D at Dong-A ST, remarked, "This collaboration marks a pivotal step in expanding Dong-A ST’s R&D capabilities," adding, "By leveraging synergies with XtalPi’s AI platform, we expect to accelerate the development of next-generation treatments for immune and inflammatory diseases."

Meanwhile, both Dong-A ST and XtalPi operate open innovation offices in Boston, USA. This geographic proximity will facilitate closer and more efficient collaboration throughout the drug discovery process.

On August 19, 2025 Agenus Inc. ("Agenus") (Nasdaq: AGEN), a leader in immuno-oncology, reported that the Company will host a virtual Stakeholder Briefing on August 27, 2025 at 4:00 p.m. ET (Press release, Agenus, AUG 19, 2025, View Source [SID1234655375]). The event will feature presentations from senior management and industry thought leaders, offering insights into transformative developments that could shape the future of cancer treatment. The agenda includes a strategic and financial overview, achievements tied to the Zydus partnership closing, patient needs fueling interest in colorectal cancer (CRC) studies, recent data from the botensilimab (BOT) and balstilimab (BAL) program, and an overview of the Phase 3 BATTMAN study in metastatic CRC—plus highlights of upcoming milestones and potential breakthroughs in immuno-oncology. The session will conclude with a live Q&A.

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Speakers to Include:

Garo H. Armen, PhD
Founder, Chairman, CEO of Agenus

Jennifer Buell, PhD
CEO of MiNK Therapeutics/ Chair of Executive Committee of Agenus

Richard M. Goldberg, MD
Chief Development Officer of Agenus (joined May 2025)
GI oncology expert with 40+ years in CRC research

Nicholas C. DeVito, MD
Assistant Professor of Medical Oncology at Duke University
Primarily treats patients with CRC and gastroesophageal cancers
Research focused on tumor immune evasion and immunotherapy

Chris O’Callaghan, DVM, MSc, PhD, & Jonathan Loree, MD, MS, FRCPC (CCTG):
Senior Investigators at Canadian Cancer Trials Group (CCTG)

Stakeholder Briefing Details:

Webcast Link | View Source

Audience Conference Call Registration Link | View Source

Conference ID: 73242