Accendatech's Phase 3 Trial of ACT001, an Oral Compound with Novel MoA, Begins Enrolling Patients with Small Cell Lung Cancer with Brain Metastasis in a Highly Competitive Research Field

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BOSTON--(BUSINESS WIRE)--Sep 29, 2025--

Accendatech Co., Ltd, a clinical-stage biotech company developing natural compound-based small molecule drugs with unique pharmacological properties announced the enrollment of first small cell lung cancer patient with brain metastasis this month for the pivotal phase 3 study in China (CTR20253399). The initiation of phase 3 trial is based on encouraging intracranial tumor response and overall survival signal from a phase 2b ACT001-CN-051 study which were released during 2025 SNO/ASCO conference held in Baltimore, MD in August, 2025. The topline data is expected to be published in a peer-reviewed journal.

ACT001 is the first study drug with the potential to enhance both chemoradiotherapy and immune therapy simultaneously that enters a phase 3 stage. It is also the first pivotal-stage study drug targeting NF-κB and STAT3 pathways since the cloning of gene involved in these two pathways approximately 39 and 33 years ago respectively. There have been numerous pre-clinical publications that proposed the pathways as therapeutic targets.

The kick-off of phase 3 ACT001 study is another evidence to reflect the increasingly dynamic nature of drug study in SCLC space since the approval of immune checkpoint inhibitors in 2019 and more recent approval of tarlatamab in 2024 as the first T cell engager ever approved in any solid tumor. The phase 3 ACT001 trial further diversify the drug development landscape in SCLC space that has now become a hot battle ground due to interesting efficacy data from studies on multiple novel modalities such as ADC and bi-specific antibodies.

About Accendatech Co., Ltd

The drug development strategy of Accendatech is focused on identifying and commercializing the unique pharmacological properties of natural compounds including, but not limited to, those form plants. The first such drug candidate/precursor is parthenolide that has attracted much attentions due to its impact on NF-κB and STAT3 signaling pathways that are involved in multiple disease processes. ACT001 was developed after proprietary structural engineering of parthenolide and formation optimization to overcome toxicity and PK issues, the two bottlenecks in this field. ACT001 has been systematically evaluated since then in multiple clinical indications in patients with cancer, inflammatory and tissue degenerative diseases. The phase 3 study is the first ever late-stage trial in SCLC space that solely enroll patients with brain metastasis which constitutes a huge unmet medical need. The rationale in SCLC study may also apply to other solid tumors with or without brain metastasis.

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CONTACT: Doug Cai

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KEYWORD: UNITED STATES NORTH AMERICA MASSACHUSETTS

INDUSTRY KEYWORD: SCIENCE OTHER SCIENCE BIOTECHNOLOGY RESEARCH PHARMACEUTICAL ONCOLOGY HEALTH CLINICAL TRIALS

SOURCE: Accendatech Co., Ltd

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PUB: 09/29/2025 01:09 PM/DISC: 09/29/2025 01:09 PM

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