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Pipeline

ONX-1006

ONX-1006 Efficacy Study

Study to Determine the Efficacy of ONX-1006 in an 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 substances were administered intravenously on Days 8, 15, 22, 29, and 36.

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

Data are expressed as mean ± S.E. (n=4).

Test Institute: Dt&CRO Co., Ltd. (KFDA-certified CRO)

Test Results: ONX-1006 demonstrated substantial anticancer efficacy following intravenous administration (G3 & G4).
→ ONX-1006 demonstrated greater tumor growth inhibition despite delivering approximately one-half to one-quarter of the paclitaxel dose.

During clinical observation, no significant adverse clinical signs were observed. No significant changes were noted in clinical chemistry or body weight.

ONX-1006 Efficacy Study

ONX-1006 AsPC-1 Pancreatic Xenograft Test

Group Dose(mg/kg) PTX loading(mg/kg)
G1 Negative control(Vehicle) 0 0
G2 ONX-1006 (low dose) 68 10
G5 ONX-1006 (low dose) 68 10
G7 nab-paclitaxel 20 20
G8 paclitaxel 10 10
ONX-1006 AsPC-1 pancreatic cancer xenograft tumor volume
Figure 1. Tumor Volume Test substances were administered intravenously to mice beginning on Day 8 after inoculation with AsPC-1 cells. All data are expressed as mean ± S.E. (n=8). Test substances were administered intravenously on Days 8, 15, 22, 29, 36, and 42.
14-day detailed view of ONX-1006 tumor volume
Figure 1A. 14-Day Detailed View of Tumor Volume Over Time AsPC-1 xenograft model. Treatment was initiated on Day 8 after inoculation of cancer cells. * p < 0.05, ONX-1006 (G5) vs. Abraxane (G7).

Test Institute: Dt&CRO Co., Ltd. (KFDA-certified CRO)

Test Results: ONX-1006 demonstrated substantial anticancer efficacy in the AsPC-1 pancreatic cancer xenograft model (G2 & G5).
→ ONX-1006 demonstrated greater tumor growth inhibition than nab-paclitaxel under the study conditions.

The 14-day detailed view further showed that ONX-1006 administered twice weekly achieved statistically significant tumor suppression 14 days after treatment initiation compared with Abraxane.

During clinical observation, no significant adverse clinical signs were observed. No significant changes were noted in clinical chemistry, body weight, or coagulation parameters.

ONX-1006: PANC-1 Pancreatic cancer Xenograft Test

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 Co., 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 clinical signs were observed. No significant changes were noted in clinical chemistry, body weight, or coagulation parameters.

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