ABM-168 / ABM Therap, Mosaica Medicines - LARVOL DELTA

ABM Therapeutics Inc. announced a licensing agreement granting Mosaica Medicines global rights to ABM‑168, an in‑house developed allosteric MEK1/2 inhibitor currently in Phase I clinical trials for advanced solid tumors with a focus on brain metastases and primary brain tumors (flcube.com) - "Next Milestone: Phase I data expected Q3 2026 to support dose‑expansion cohorts."

Licensing / partnership • P1 data • Brain Cancer • CNS Tumor • Solid Tumor

Safety and Effectiveness of ABM-168 in Adults with Advanced Solid Tumors. (clinicaltrials.gov) - P1 | N=12 | Terminated | Sponsor: ABM Therapeutics Corporation | N=112 ➔ 12 | Trial completion date: Oct 2025 ➔ Jun 2024 | Recruiting ➔ Terminated | Trial primary completion date: Oct 2025 ➔ Jun 2024; Due to development strategy change.

Enrollment change • Metastases • Trial completion date • Trial primary completion date • Trial termination • Brain Cancer • Colon Cancer • Colorectal Cancer • Lung Cancer • Oncology • Solid Tumor • CD4

Safety and Effectiveness of ABM-168 in Adults With Advanced Solid Tumors. (clinicaltrials.gov) - P1 | N=112 | Recruiting | Sponsor: ABM Therapeutics Corporation

Metastases • New P1 trial • Brain Cancer • Colon Cancer • Colorectal Cancer • Gastrointestinal Cancer • Lung Cancer • Oncology • Solid Tumor • CD4

ABM-1310 has significant improved BBB-penetration and intracranial tumor growth inhibition compared to FDA approved BRAF inhibitors (AACR 2023) - "Also, in the A375-luc intracranial model, ABM-1310 alone or combo with ABM proprietary, BBB-penetrable MEK inhibitor ABM-168, demonstrated significant improved antitumor activity and animal medial survival time (MST) compared with combination regimens of other BRAF/MEK inhibitors (vemurafenib + cobimetinib, dabrafenib + trametinib, or encorafenib + binimetinib). Either ABM-1310 as a single agent or the combination of ABM-1310 and ABM-168 showed a BLI decrease (%) > 99% on Day 26 and MST of > 69 days, while MST for vehicle was 27 days, and MST for the combo of Dabrafenib and Trametinib was 33 days. In a primary GBM model (DBTGR-05MG, a BRAFv600 mutant GBM cell line), the similar result was demonstrated."

FDA event • Brain Cancer • CNS Tumor • Colon Cancer • Colorectal Cancer • Endocrine Cancer • Gastrointestinal Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Ovarian Serous Adenocarcinoma • Solid Tumor • Thyroid Gland Anaplastic Carcinoma • Thyroid Gland Carcinoma • Thyroid Gland Papillary Carcinoma

Preclinical development of ABM-168, a novel MEK Inhibitor to treat cancer with brain tumors (AACR 2023) - "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..."

Preclinical • Brain Cancer • CNS Tumor • Glioblastoma • Melanoma • Oncology • Solid Tumor • NF1