Launxp (6876), a company dedicated to the development of innovative drugs for cancer and metabolic diseases, announced on the 18th that an exploratory clinical study of its drug candidate LXP105, applied as a neoadjuvant therapy for Phase II Triple-Negative Breast Cancer (TNBC), has been accepted for publication by the international oncology journal Frontiers in Oncology.

This study combined LXP105 with standard neoadjuvant chemotherapy (NACT) to explore its clinical feasibility, safety, imaging-based tumor changes, and changes in immune biomarkers related to the tumor microenvironment (TME). The findings provide preliminary scientific evidence for LXP105’s role in TME modulation and its subsequent clinical development in TNBC. As a single-center exploratory study, the results demonstrated that adding LXP105 to standard NACT has favorable clinical feasibility. No unexpected safety signals were observed during the study period, and no patients required dose modification or treatment discontinuation due to LXP105-related adverse reactions.

In terms of radiographic tumor response, all 7 patients who received the LXP105 combination therapy exhibited measurable primary tumor shrinkage, ranging from 45.0% to 100%, with a median tumor shrinkage of 77.3%. In contrast, the median shrinkage observed in the NACT-alone group was 43.4%. Furthermore, 2 patients in the LXP105 combination group achieved a pathological complete response (pCR), while the remaining 5 showed varying degrees of pathological regression; no pCR was observed in the NACT-alone group. These results should be interpreted as an exploratory efficacy signal rather than conclusive evidence of comparative efficacy for LXP105, which will require further validation through larger, prospective, and controlled clinical studies.

Triple-negative breast cancer is highly aggressive, and its tumor microenvironment involves complex immunosuppression, vascular abnormalities, and cellular stress responses. In recent years, research in Cancer Neuroscience has increasingly indicated that monoamine neurotransmitters, such as serotonin and norepinephrine, may be involved in tumor vascular dynamics, immune cell migration, and TME regulation.

LXP105 is a Serotonin-Norepinephrine Reuptake Inhibitor (SNRI). Unlike traditional cytotoxic drugs that directly kill tumor cells, the working hypothesis proposed in this study is that LXP105 may influence the vascular, immune, and cellular stress response environment within the tumor by modulating monoamine signaling, thereby serving as a potential adjunctive strategy to standard anti-cancer treatments. This mechanism remains a research hypothesis and awaits further verification through subsequent translational research and prospective clinical trials.

Chiu-Hung Chen, General Manager of Launxp, stated that the acceptance of this study by Frontiers in Oncology is a significant milestone in the clinical development of LXP105. “The most important significance of this research lies not only in the observation of radiographic tumor shrinkage signals but also in establishing—for the first time using clinical patient data—a scientific link between LXP105 and TME- and immune-related biomarkers that merits further investigation,” Chen said.

Chen also pointed out that while the combination of immunotherapy and chemotherapy has shifted the treatment paradigm for high-risk early TNBC, some patients still fail to achieve an adequate treatment response. Therefore, finding ways to further improve the tumor microenvironment and enhance the efficacy of existing anti-cancer therapies remains a crucial research direction. The “neuro-vascular-immune axis” regulation concept represented by LXP105 offers a novel research pathway distinct from traditional cytotoxicity or single immune checkpoint inhibition.

In addition to the scientific foundation for early TNBC neoadjuvant therapy established by this study, Launxp will evaluate the development potential of LXP105 in various TNBC treatment settings. This includes its integration with current immunotherapy strategies and future clinical development targeting patients with suboptimal responses to immunotherapy or those who experience disease progression post-treatment.

The relevant clinical positioning, trial design, and development timelines will be carefully mapped out based on subsequent scientific evidence, regulatory strategies, and the company’s overall R&D resource allocation, aiming to further confirm the clinical value of LXP105 and maximize the R&D and commercial potential of Launxp’s broader pipeline.

Launxp noted that at this stage, the company’s core R&D resources will remain focused on advancing the clinical development of its lead product, LXP103. Regarding LXP105, the company will continue to deepen its research on the mechanism of action, translational medicine, and biomarkers based on the outcomes of this TNBC exploratory clinical study.