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Mabwell’s CDH17-targeting ADC 7MW4911 Receives IND Clearance from FDA

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.

Myosin Therapeutics Awarded $4.5 Million NCI Bridge Grant to Advance Phase I Trial of MT-125 in Glioblastoma

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]).

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."

XtalPi Signs MOU with Dong-A ST for Joint Research and Development of Immunology and Inflammation Therapies

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]).

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.

Agenus to Unveil BOT/BAL Strategic Advancements, Key Milestones, and Future Outlook in Virtual Stakeholder Briefing on August 27, 2025

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.

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

BerGenBio First half results 2025

On August 19, 2025 BerGenBio ASA (OSE: BGBIO reported financial results for the first half 2025 (Press release, BerGenBio, AUG 19, 2025, View Source [SID1234655374]).

Highlights, including post period:

In February, following a preliminary analysis of response data, BerGenBio decided to close its lead clinical study, BGBC016, in bemcentinib in combination with standard of care therapy in first line (1L) non-squamous Non-Small Cell Lung Cancer (NSCLC) patients with a mutation in the STK11 gene.
The company has implemented significant cost-containment and cash-conservation measures. The Board of Directors has also decided to halt all remaining development activities for bemcentinib.
In June, the company entered into a merger agreement with Oncoinvent ASA.
The transaction combines BerGenBio’s capital resources and listing with Oncoinvent’s late-stage oncology pipeline, strengthening the combined company’s ability to advance innovative radiopharmaceutical cancer therapies.
The merger was approved by an Extraordinary General Meeting 4 August 2025 and is expected to be completed by end of September.
In connection with the merger, the EGM approved a fully underwritten rights issue of NOK 130 million. The funding has been committed by existing investors in Oncoinvent ASA and external investors and is expected to be completed in October after completion of the merger. All shareholders in the combined company will receive equal rights to participate in the rights issue depending on their shareholdings.
At time of the completion of the merger the Board of Directors and management will change. The Board of Directors will exist of the current Board of Directors in Oncoinvent ASA with the addition of Olav Hellebø and the executive management will consist of the current Oncoinvent ASA management. The current Board of Directors and Executive management of BerGenBio will leave their position at the same time.
The EGM also approved changing the name of BerGenBio ASA to Oncoinvent ASA, effective upon completion of the merger and the rights issue.

Olav Hellebø, Chief Executive Officer of BerGenBio stated:

"The first half of 2025 has been one of the most defining periods in BerGenBio’s history. After the decision to discontinue the BGBC016 trial, we conducted a comprehensive strategic review to identify the best way forward for our shareholders. This resulted in the proposed merger with Oncoinvent, a company with an exciting trajectory in radiopharmaceutical cancer therapies, experienced leadership, and strong growth prospects."

"As part of the transaction approved after the end of the first half, a fully underwritten rights issue was also approved, open to all shareholders on equal terms and offering the opportunity to participate in this next stage. The proposed merger and rights issue marks the closure of an important chapter in BerGenBio’s journey and the beginning of a new phase for its shareholders."

"Biotechnology is a unique industry. It demands optimism, courage, and years of dedicated effort, yet ultimately everything depends on clinical results and patient benefit. I would like to sincerely thank our shareholders for their support over the years, and particularly those who have been with us for a long time. Your commitment has been essential in enabling BerGenBio to pursue bold scientific ambitions, even in the knowledge that success is never guaranteed."

First half 2025 Financial Highlights

The operating loss for the first half was NOK 54.6 million (first half 2024: NOK 90.5 million).
Net cash flow for the first half was negative by NOK 73.9 million (first half 2024: negative by NOK 89.3 million).
Cash and cash equivalents amounted to NOK 65.9 million as of 30 June 2025 (140.2 million as of 31 December 2024).

Financial Report

The H1 2025 Financial report is attached to this stock exchange announcement and will be available at the Company’s website: View Source