Anti-Cancer Therapeutics

Project I: ABP1011T

Pre-Clinic: Against Various Tumors in the Nude Mice

Summary of the Inhibitory Efficacy Study of ABP1011T      

ABP1011T had achieved significant anticancer inhibitory effects in the antitumor efficacy studies of a dozen of tumors, including pancreatic cancer, glioma, small-cell lung cancer, squamous lung cancer, esophageal cancer, colorectal cancer, gastric cancer, hepatocellular carcinoma, sarcoma, bladder cancer, cervical cancer, ovarian cancer, bladder cancer, renal cancer, thyroid, prostate cancer, lymphoma, leukemia and other tumors in different kinds of pre-clinical animal studies.

    The clinical efficacy study of ABP1011T in multiple cancers will be further verified in clinical phase I-II trials by prioritizing 7-10 types of cancers mentioned above that are clinically unmet and in urgent need for different kinds of cancer patients.

Clinical Phase I Trial:

Summary of Clinical Phase I Trial Results 
    Safety:  The safety profile of ABP1011T TABLETS (4mg and 10mg) in this study was good and well tolerated, and the main adverse effects were the hypertension and thrombopenia, which were easily controllable and preventable.  RP2D : 20mg.
PK Characteristics:  Excellent linear dose-exposure correlation; rapid onset of action (its bioavailability in dogs: 90%).
    Efficacy Exploration:  The Phase I Climbing Trial had a total disease control rate (DCR) up to 61.5% in subjects with 12 different types of tumors.
    Effective Dose:  20 mg qd (for patients: ≥60 kg), 16 mg qd (for patients: <60 kg); two doses for different weight of patients.

 Based on the above results of the clinical phase I trial, Academician Xu Binghe, the Leading PI of the clinical I/II trial, discussed with relevant clinical experts and determined that the clinical phase IIa trial program would be officially launched on February 1, 2024, and 12 clinical centers are currently arranged.

    In the subsequent phase IIa trial, nine cancers (e.g., pancreatic cancer, sarcoma, small cell lung cancer, squamous lung cancer, esophageal squamous cancer, colorectal cancer, cervical cancer, ovarian cancer, bladder cancer, etc., which are clinically unmet and in urgent need of good drugs) will be prioritized to undergo a “single-arm” trial to validate the clinical efficacy of ABP1011T in a broad range of various cancers.

Project II: ABP1019A

Pre-Clinic: Against Various Tumors in the Nude Mice

Clinical Phase I Trial:

Summary of Clinical Phase I Trial Results 

Safety:  The safety of ABP1019A TABLETS (10mg and 25mg) in this clinical study was very good and well tolerated, and the main adverse effects were hypertension, which were easily controllable and preventable with medicines.   RP2D: 40mg.
PK Characteristics:  Excellent linear dose-exposure correlation; rapid onset of action (its bioavailability in dogs:  67%).
Efficacy Exploration:  The Phase I Trial had shown good efficacy for various cancers, especially for Pancreatic Cancer.
Effective Dose:  40 mg qd (for patients: ≥60 kg), 30 mg qd (for patients: <60 kg). 30-40mg qd for different weight of patients.
      Moreover, the safety of ABP1019A is very good (MRSD:  Dog, 87mg, and Rat, 393mg), and its permeability of blood-brain barrier is also quite high (233~522ng/g) for treatment of the glioma and various cancers metastasized into brain.
     

     Based on the above results of the clinical phase I trial, the clinical phase IIa trial program has been launched in December, 2024, and 12 clinical centers had been arranged in different cities of China. The phase IIa trial is ongoing, eight cancers (e.g., pancreatic cancer, glioma,  cholangio-carcinoma, SCLC and other lung cancer, esophageal squamous cancer, colorectal cancer, cervical cancer, and various cancers metastasized into brain, etc., which are clinically unmet and in urgent needs) have been prioritized to undergo a “single-arm trial” to validate the efficacy and tolerability of ABP1019A in various cancer patients.