ABM-1310

P1, N=15, Terminated, ABM Therapeutics Shanghai Company Limited | N=52 --> 15 | Trial completion date: May 2028 --> Aug 2024 | Recruiting --> Terminated | Trial primary completion date: May 2028 --> Aug 2024; Adjustment of the applicant's research and development strategy

P1, N=20, Terminated, ABM Therapeutics Shanghai Company Limited | N=72 --> 20 | Trial completion date: Aug 2025 --> Jun 2024 | Recruiting --> Terminated | Trial primary completion date: Aug 2025 --> Jun 2024; Adjustment of the applicant's research and development strategy

P1, N=53, Terminated, ABM Therapeutics Corporation | N=112 --> 53 | Trial completion date: Jan 2025 --> Apr 2024 | Active, not recruiting --> Terminated | Trial primary completion date: Sep 2024 --> Apr 2024; Not related to safety concerns or lack of efficacy

P1, N=112, Active, not recruiting, ABM Therapeutics Corporation | Recruiting --> Active, not recruiting

P1, N=52, Recruiting, ABM Therapeutics Shanghai Company Limited | Not yet recruiting --> Recruiting

P1, N=52, Not yet recruiting, ABM Therapeutics Shanghai Company Limited

In-vitro data showed the similar on-target enzyme activity of ABM-168 to marketed MEK inhibitors, as well as high anti-proliferation activities (IC50 <30nM) in multiple cancer cell lines with BRAF or RAS or NF1 mutation like A375, Colo-829, HT-29, MiaPaca-2, LN-229 etc. In vivo pharmacology studies demonstrated that ABM-168 had good potencies of tumor growth inhibitions with oral dose alone or combo with other drugs or compounds in multiple xenograft cancer models: In an A375-luc intracardiac melanoma metastatic model, ABM-168 at 2 mg/kg PO BID demonstrated an antitumor activity comparable to ABM-1310 (A highly BBB-permeable BRAF inhibitor developed by ABM Therapeutics) at different dose levels and frequencies. 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.

P1, N=112, Recruiting, ABM Therapeutics, Inc. | N=48 --> 112

P1, N=72, Recruiting, ABM Therapeutics Shanghai Company Limited | Not yet recruiting --> Recruiting

P1, N=72, Not yet recruiting, ABM Therapeutics Shanghai Company Limited

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.