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Preclinical development of ABM-168, a novel MEK Inhibitor to treat cancer with brain tumors (Section 17; Poster Board #6) - Mar 14, 2023 - Abstract #AACR2023AACR_2536; Single-dose, seven-day repeat dose non-GLP studies and four-week GLP toxicity studies in SD rats and beagle dogs were all completed. Based on these supportive preclinical study results, the IND of ABM-168 was submitted in 2022 Q3 to investigate its safety in human, which will be followed by further clinic development as a single agent, or in combination with other molecules to treat advanced cancers resulted from the abnormal MAPK signal pathway, particularly with brain tumors.
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Enrollment change, Combination therapy, Monotherapy, Metastases: Safety and Tolerability of ABM-1310 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - Jan 4, 2023 P1, N=112, Recruiting, Based on these supportive preclinical study results, the IND of ABM-168 was submitted in 2022 Q3 to investigate its safety in human, which will be followed by further clinic development as a single agent, or in combination with other molecules to treat advanced cancers resulted from the abnormal MAPK signal pathway, particularly with brain tumors. N=48 --> 112
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Trial completion date, Trial primary completion date, Combination therapy, Monotherapy, Metastases: Safety and Tolerability of ABM-1310 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - Sep 19, 2022 P1, N=48, Recruiting, Not yet recruiting --> Recruiting Trial completion date: Jun 2022 --> Jan 2025 | Trial primary completion date: Jun 2022 --> Sep 2024
- |||||||||| ABM-1310 / ABM Therap
Trial completion date, Trial primary completion date, Combination therapy, Monotherapy, Metastases: Safety and Tolerability of ABM-1310 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - Mar 23, 2022 P1, N=48, Recruiting, Trial completion date: Jun 2022 --> Jan 2025 | Trial primary completion date: Jun 2022 --> Sep 2024 Trial completion date: Dec 2021 --> Jun 2022 | Trial primary completion date: Dec 2021 --> Jun 2022
- |||||||||| ABM-1310 / ABM Therap, Erbitux (cetuximab) / Eli Lilly, EMD Serono
ABM-1310, A novel BRAF Inhibitor, combined with EGFR and MEK inhibitors, inhibits colorectal tumor growth and increases overall survival in vivo (Virtual Meeting II: E-Posters) - May 16, 2020 - Abstract #AACRII2020AACR-II_3818; In the HT-29 colon intracranial model, ABM-1310 also demonstrated significant tumor inhibition effect and increased animal overall survival. Compared with vehicle or marketed BRAF inhibitor vemurafenib, the median survival time of ABM-1310 group was >90 days vs 51 days (vemurafenib) and 38 days (vehicle), respectively.In Summary, ABM-1310, as a novel small molecule BRAF inhibitor, combined with EGFR and MEK inhibitors, has shown strong anti-tumor effect in preclinical in vivo models of colon cancer with BRAFv600 mutation, especially with brain metastasis.
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Preclinical development of ABM-1310, a novel BRAF Inhibitor to treat cancer with brain metastasis (Virtual Meeting II: E-Posters) - May 16, 2020 - Abstract #AACRII2020AACR-II_181; Non-clinical pharmacokinetics studies also shown ABM-1310 had a favorable ADME profile both in vitro and in vivo in animals. ABM-1310 demonstrated excellent brain penetration in animals.Single-dose, seven-day repeat dose non-GLP studies and four-week GLP toxicity studies in SD rats and beagle dogs all revealed that ABM-1310 had a good safety profile with NOAEL of 100mg/kg/day in SD rats and 30mg/kg/day in beagle dogs.Based on these supportive preclinical study results, IND of ABM-1310 was submitted in 2019 Q4 to investigate its safety in humans as signal reagent, which will be followed by further clinic development of ABM-1310, or combination with other molecules to treat cancers with BRAFv600 mutation, especially with brain metastasis.
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Enrollment open, Trial initiation date, Combination therapy, Monotherapy, Metastases: Safety and Tolerability of ABM-1310 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - May 7, 2020 P1, N=27, Recruiting, ABM-1310 demonstrated excellent brain penetration in animals.Single-dose, seven-day repeat dose non-GLP studies and four-week GLP toxicity studies in SD rats and beagle dogs all revealed that ABM-1310 had a good safety profile with NOAEL of 100mg/kg/day in SD rats and 30mg/kg/day in beagle dogs.Based on these supportive preclinical study results, IND of ABM-1310 was submitted in 2019 Q4 to investigate its safety in humans as signal reagent, which will be followed by further clinic development of ABM-1310, or combination with other molecules to treat cancers with BRAFv600 mutation, especially with brain metastasis. Not yet recruiting --> Recruiting | Initiation date: Jan 2020 --> May 2020
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