505(b)(1)

LXPA1788

LXPA1788 is a new chemical entity, and in our plan, it will treat carcinoma related to the digestive system.

Indications

Solid Tumor

Science

Multi-target Kinase Inhibitor

LXPA1788 is a multi-target kinase inhibitor that simultaneously inhibits multiple signaling pathways essential for cancer cell proliferation.

Benefits of multi-target kinase inhibitor:

  1. More effectively inhibits cancer cell growth
  2. Reduces side effects
  3. Overcomes drug resistance
 
Clinically, multi-target drugs have been proven to inhibit tumor cell growth more effectively than single-target drugs, showing better and broader anti-cancer effects.

Lates Progress

  • Enter Phase 1 Clinical Trial in 2024
  • FDA and TFDA IND Application

Preclinical

IND

Phase 1

Phase 2

Phase 3

Market

Phase1

Pre-clinical Results

LXPA1788 can effectively inhibit pancreatic and liver cancer (animal studies)

Pancreatic Cancer

Liver Cancer

Compare to other drug​

LXPA1788 has better inhibitory effect

Cell lines:

Acute Monocytic Leukemia Cell Line

The cell line was established from the peripheral blood of a patient at relapse of acute monocytic leukemia which had evolved from myelodysplastic syndrome (MDS).

Acute Monocytic Leukemia Cell Line

The cell line was established from the peripheral blood of a patient at relapse of acute monocytic leukemia which had evolved from myelodysplastic syndrome (MDS).

Acute Monocytic Leukemia Cell Line
A lymphoblast cell line that was isolated from the marrow of a White, 32 years old, female patient with acute lymphoblastic leukemia.

Non-Small Cell Lung Cancer Cell Line
An epithelial cell that was isolated from the lung of a White, 39-year-old female patient with adenocarcinoma.

Non-Small Cell Lung Cancer Cell Line
The cell line was isolated from the lungs of a nonsmoking female with non-small cell lung cancer.

Non-Small Cell Lung Cancer Cell Line
The cell line was isolated from a lung adenocarcinoma derived from a female nonsmoker with non-small cell lung cancer.

Colon Cancer Cell Line
The cell line was isolated from the colon of an adult male with colon cancer.

Pancreatic Cancer Cell Line
An epithelial cell line that was derived from tumor tissue of the pancreas obtained from a 65-year-old, White male.

Comparison of competitor

Linifanib

  • It’s a inhibitor of receptor tyrosine kinase (RTK), vascular endothelial growth factor (VEGF) and platelet-derived growth factor (PDGF) receptor families.
  • It’s still on phase III clinical trial.
  • Indication(s):
    Hepatocellular Carcinoma

Sorafenib

  • It’s a inhibitor of Raf kinase, PDGF (platelet-derived growth factor), VEGF receptor 2 & 3 kinases and c Kit the receptor for Stem cell factor.
  • First approved by FDA in December 20, 2005.
  • Indication(s):
    2005 Advanced Renal Cell Carcinoma
    2007 Unresectable Hepatocellular Carcinoma
    2013 Metastatic Differentiated Thyroid Cancer

Midostaurin

  • It’s a inhibitor of protein kinase C alpha, VEGFR2, KIT, PDGFR and WT and/or mutant FLT3 tyrosine kinases.
  • First approved by FDA in April 28, 2017.
  • Indication(s):
    2017 FLT3-Mutated Acute Myeloid Leukemia and Systemic Mastocytosis

Clinical Study Design

Phase I clinical trial is planned to be conducted in 2024 Q2

Hospital

3 Taiwan Hospitals

Participants

Patients with solid tumors

Expected Enrollment

30-40 clinical trial participants

Research Method

Adaptive 3+3

Treatment Duration

stimated once every six months

Drug Administration Frequency

Estimated once weekly injection

Patents

Patents have been granted in Taiwan, the United States, Korea, China and Europe.