San Diego, USA 
Shanghai, China 
May 28, 2024

 

ABM Therapeutics, a clinical-stage biopharmaceutical company with a focus on treating brain cancers and cancer brain metastases, today announced Interim clinical data about its blood-brain barrier penetrant BRAF inhibitor ABM-1310 in the treatment of BRAF V600-mutated solid tumors will be presented at the upcoming American Society of Clinical Oncology (ASCO) Annual Meeting, taking place in Chicago, Illinois on June 1.

 
Poster Number: # 3107
Poster Session: Developmental Therapeutics-Molecularly Targeted Agents and Tumor Biology
Title：Interim analysis of ABM-1310, a blood-brain barrier penetrant BRAF inhibitor, in patients with BRAF V600-mutated solid tumors.
Presenter: Sarina A. Piha-Paul, MD | The University of Texas MD Anderson Cancer Center

 

Location: Location Hall A | On Demand
Date and Time: 6/1/2024, 9:00 AM-12:00 PM CDT

 

Abstract
Mutations in the BRAF gene (e.g. BRAF V600E) are among the most commonly identified cancer-causing mutations. ABM-1310 is a novel small-molecule BRAF inhibitor with high water solubility, high cell permeability, and high blood-brain barrier (BBB) penetration. This poster described the first-in-human, phase 1 study designed to evaluate safety, maximum tolerated dose (MTD), PK and preliminary efficacy of ABM-1310 in patients with advanced solid tumors who have BRAF V600 mutations.
This report included 53 patients (36 male; median age 56 years; 42 patients were refractory to prior BRAF ± MEK inhibitors). Of these, In ABM-1310 monotherapy part, 29 of 36 patients experienced treatment-related adverse events (TRAEs). Seven patients had G3 TRAEs. Two patients had treatment-related serious adverse event (SAE), including G3 nausea/vomiting and G2 renal failure. In part of ABM-1310 in combination with cobimetinib, all 17 patients had TRAEs. Four patients had G3 TRAEs. Two patients had SAE, including asymptomatic QT prolongation and diarrhea. No patient experienced G4 AE, no patient discontinued prematurely due to safety or tolerability reason and no treatment-related deaths. Among 34 efficacy-evaluable patients, 6 patients had partial response. 11 patients were at stable disease. Among 13 patients with primary CNS tumors treated with ABM-1310 monotherapy, the ORR was 30.8%, and PFS was 3.4 months and ongoing. In 6 patients with thyroid cancer, the ORR was 33.3%, and PFS was 6.0 months and ongoing. In 4 patients with pancreatic cancer, the ORR was 25%, DoR was 8.5 months. The MTD for ABM-1310 monotherapy or in combination with cobimetinib was 200 mg bid. Preliminary PK assessment of ABM-1310 drug exposure vs. dosages showed a linear dose-proportional relationship.
In summary, ABM-1310, either alone or in combination with cobimetinib, was generally tolerated without new or unknown side effects. Preliminary efficacy of ABM-1310 was evidenced in patients with BRAF V600-mutated solid tumors, including those who had primary CNS tumor and thyroid cancer and who were refractory to prior BRAF ± MEK inhibitor therapy.

 

The poster will be available online after presentation on June 1.
http:// www.abmtx.com/asco2024poster 

 
About ABM Therapeutics
ABM Therapeutics, a clinical-stage biopharmaceutical company with a mission to focus on the small molecule research and development of novel drugs for the treatment of cancer, and on brain cancer and cancer metastases. ABM has been building its broad and robust proprietary pipeline to construct a brain medicine R&D platform. ABM’s pipeline includes several programs in various stages of discovery and development, most of which have improved brain permeability to address the unmet needs of treating cancers and metastases in the brain.