Bio Green Med Solution (BGMS) H.C. Wainwright 26th Annual Global Investment Conference 2024 summary

Key program updates and clinical progress

• FADRA, a next-generation CDK2/9 inhibitor, is in phase 2 proof-of-concept studies targeting patients with CDKN2A/B abnormalities and T-cell lymphoma.

• Daily oral dosing of FADRA at 100 mg BID has shown improved clinical benefit and durable responses in both solid and liquid tumors.

• Safety profile for FADRA is favorable, with mostly mild, reversible side effects and minimal hematologic toxicity.

• Early efficacy signals include partial and complete responses in multiple cancer types, with notable activity in patients with relevant genetic alterations.

• Pharmacokinetic and pharmacodynamic data confirm comprehensive target engagement and biological activity at recommended doses.

Scientific rationale and precision medicine approach

• FADRA targets loss-of-function CDKN2A/B mutations, common in various solid tumors and lymphomas, aiming to restore tumor suppressor pathways.

• Dual inhibition of CDK2 and CDK9 may overcome resistance seen with single-target agents and silence key oncogenes like MYC.

• Biomarker-driven patient selection is central to ongoing and future registration strategies.

• Durable responses and broad activity in both solid and hematologic malignancies support the precision medicine hypothesis.

Pipeline expansion and future plans

• PLOGO, a selective PLK-1 inhibitor, is advancing through phase 1 with no dose-limiting toxicities and promising preclinical biomarker data.

• Plans include pausing PLOGO to improve formulation for higher exposure and longer patent life, with future trials targeting ARID1A or TP53 mutant tumors.

• Upcoming milestones: initial phase 2 FADRA data in CDKN2A/B and T-cell lymphoma cohorts, completion of tablet manufacturing, and clinical supply of new PLOGO formulation.