505(b)(2)

LXP105

The LXP105 serves as a potent "combination backbone" for refractory breast cancer. Utilizing its small molecule’s superior tissue penetration, it synergizes with standard-of-care and immunotherapy to disrupt tumor signaling. This approach enhances therapeutic depth and mitigates resistance risks, establishing a more efficient and precise pathway for clinical combination regimens.

Therapeutic Area:

Triple-Negative Breast Cancer

Current Treatment Methods:

Chemotherapy ➡️ Surgery

Challenges with Current Treatment Methods:

Triple-negative breast cancer represents approximately 15-20% of breast cancer cases, with only 15% eligible for targeted therapies.
The objective response rate does not reach 100% (typically 60-90%).
Tumor shrinkage rate is relatively low (generally around 40-50%).

Development Value

Designed for aggressive tumors, this small-molecule therapy leverages strong tissue penetration to combine with standard or immunotherapies, enhancing efficacy and reducing resistance through synergistic mechanisms.

Latest Progress

Development Stage

Preclinical

IND

Phase I

Phase II

Phase III

NDA

Phase II (Proof of Concept)

Results

Better tumor reduction, Higher rate of pathological complete response

The LXP105+NACT group showed better tumor reduction, and a higher rate of pathological complete response compared to the NACT group alone.

Significant reduction observed in CT images

LXP105 combination therapy with NACT better than NACT only

Patents

Patents for cancer-related indications have been granted in Taiwan, the United States, Japan, Australia and European.