505(b)(2)

LXPB5268

LXPB5268 was initially designed as a psychiatric medication, but it has been further developed for cancer treatment.

Indications

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%).

New Treatment NACT + LXPB5268

Standard Neoadjuvant Chemotherapy (NACT) combines LXPB5268

Clinical Trial

The proof-of-concept clinical trial for breast cancer has been conducted at a medical center in central Taiwan.

Expected Enrollment

18 people

Estimated completion of enrollment

September 2024

First participant enrollment date

February 2022

First participant completion date

August 2022

Latest Progress

Preclinical

IND

Phase 1

Phase 2

Phase 3

Market

Phase 2 (Proof of Concept)

Results

Better tumor reduction, Higher rate of pathological complete response

The LXPB5268+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

LXPB5268 combination therapy with NACT better than NACT only

Patents

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