Company: APM
Filing Date: 2025-10-06
Form Type: S-4
Source: 0001213900-25-096656
Chunk: 253

Company: Aptorum Group Ltd
Filing Date: 2025-10-06
Form: S-4
Chunk 253
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ctal cancer, leukemia and lymphoma, etc. Similar to our previous findings against neuroblastoma cell lines, SACT -1exhibits similar anti -tumorefficacy across one or more other major cancer types, including but not limited to colorectal cancer, leukemia and lymphoma cell lines. As a result, in addition to treating neuroblastoma, SACT -1may have potential applications in the treatment of other cancers. Based on this discovery, we plan to carry out further in vivostudies to study the efficacy of SACT -1 130 over other types of cancers to maximize the potential of SACT -1. Based on the initial 22 day data of a recent study we conducted in a xenograft mouse model of neuroblastoma, SACT -1was orally administered daily at 60mg/kg in combination of SOC chemotherapy brought a statistically significant tumor shrinkage (unpaired student’s t -test, p<0.01) from Day 15 to Day22, compared to the control group which received SOC only. The combination reduced the tumor size by up to 54.2% in the first 22 days compared with the control (SOC only). SACT -1appears to be effective in accelerating the effect of the SOC in early time points (from Day 1 – 7 vs control). This further supports our earlier in vitroobservation that SACT -1promotes tumor DNA damage and tumor cell death. Figure 5 Figure 5: 22 days data of in vivostudies in a xenograft mouse model of neuroblastoma ____________ **Unpaired student’s t -test, p<0.01, n=8 (based on initial 22 days period) In September 2021, we announced that we received clearance from the US FDA regarding the IND application to initiate clinical trials of SACT -1. In January 2022, we further announced that the completion of our Phase I clinical trial for assessing relative bioavailability and food effect of SACT -1, and no serious adverse events were observed. SACT -1’s Phase 1 clinical trial is an Open -labelRandomized, Single Cross Over Bioavailability and Food Effect Study of SACT -1in healthy adult volunteers. In additions, the US FDA has granted Orphan Drug Designation to SACT -1in January 2022. In March 2023, we further announced the completion of the End of Phase 1 (EOP1) meeting with the US FDA