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ONX-1006

ONX-1006 Efficacy test (preliminary)

Study for Determination of ONX-1006 Concentration in AsPC-1 Pancreatic Cancer Xenograft Model

Group Dose(mg/kg) PTX loading(mg/kg)
G1 Negative control 0 0
G2 ONX-1006 (low dose) 20 1.84
G3 ONX-1006 (mid dose) 50 4.6
G4 ONX-1006 (high dose) 100 9.2
G5 Paclitaxel group 20 20

Figure 1. Tumor volume.

Test substance IV injection on Day 8, 15, 22, 29 and 36

Significant difference from the Negative control group by Dunnett's t-test: ** p < 0.01

Data presented mean ± S.E. (n=4)

Test institute : KFDA Certified Company, Dt&CRO Co., Ltd

Test Results : Breakthrough results and efficacy demonstrated in efficacy tests conducted by injections ( G3&G4 ).
                         → Proven much superior efficacy even when administered at a dose of less than 1/2 to ¼ compared to the single dose of paclitaxel

During clinical observation No significant adverse symptoms, No significant adverse symptoms in clinical chemistry. No change in weight and coagulation.

ONX-1006 administered animals are normal - No harmful or toxic side effects observed.

ONX-1006 Efficacy test

ONX-1006 AsPC-1 Pancreatic Xenograft Test, 2021

Group Dose(mg/kg) PTX loading(mg/kg)
G1 Negative control(Vehicle) 0 0
G2 Test substance 1 (low dose) 68 10
G5 Test substance 1 (low dose) 68 10
G7 nab-paclitaxel 20 20
G8 paclitaxel 10 10
Figure 1. Tumor volume Test substances were injected into mice (i.v) from 8th day after inoculation of AsPC-1 cell All data expressed mean ± S.E. (n=8). Test substance IV injection on Day 8, 15, 22, 29, 36 and 42

Test institute : KFDA Certified Company, Dt&CRO Co., Ltd

Test Results: Breakthrough results and efficacy demonstrated in efficacy tests conducted by injections ( G2&G5 ).
                     → Proven superior anticancer effect than nab-paclitaxel, which is more advanced than existing anticancer drugs.

During clinical observation No significant adverse symptoms, No significant adverse symptoms in clinical chemistry, No change in weight and coagulation.

ONX-1006 administered animals are normal-No harmful or toxic side effects observed.

ONX-1006: PANC-1 Pancreatic cancer Xenograft Test 2020

Data were expressed as mean ±S.E.
The results were statistically analyzed by ONE-WAY ANOVA * : Significantly different from G1 p<0.05 ** : Significantly different from G1 p<0.01 G1 : Vehicle control (n=9) G2 : Test article 1200 mg/kg (n=9) G3 : Test article 1900 mg/kg (n=9)

Test institute : KFDA Certified Company, ChemOn Inc.

Results: Breakthrough efficacy results

G2: Paclitaxel 42mg/kg: x4 RAT lethal dose

G3: Paclitaxel 67mg/kg: 6x RAT lethal dose
※ Paclitaxel (PTX) RAT lethal dose:10~12mg/kg

During clinical observation No significant adverse symptoms, No significant adverse symptoms in clinical chemistry. No change in weight and coagulation.

ONX-1006 administered animals are normal - No harmful or toxic side effects observed.

ONX-1006: MDA-MB-231 Breast Xenograft Efficacy test in 2021

Figure 2. Tumor volumes (mm³) Data were expressed as mean ±S.E.
The results were statistically analyzed by Student’s t-test. * : Significantly different from G1, p<0.05 ** : Significantly different from G1, p<0.01 G1 : Vehicle control (Saline, n=10) G2 : Test article (ONX-1006, 100mg/kg, n=10) G3 : Test article (ONX-1006, 400mg/kg, n=10)

Test institute : KFDA Certified Company, ChemOn Inc.

Results: G3 Breakthrough efficacy results

During clinical observation No significant adverse symptoms, No significant adverse symptoms in clinical chemistry, No change in weight and coagulation.

ONX-1006 administered animals are normal - No harmful or toxic side effects observed.