ME Therapeutics talks pipeline and in vivo CAR plans

Executive Summary

• ME Therapeutics provided a strategic update on its pipeline, highlighting preclinical success with its STING activator in microsatellite stable (MSS) metastatic colorectal cancer, where it demonstrated synergy with PD-1 inhibitors.
• The company is advancing its in vivo CAR pipeline, optimizing constructs to target both myeloid and T cells to enhance efficacy in solid tumors, with plans to initiate in vivo testing in mouse models in the coming weeks.
• The company is actively pursuing a potential uplisting to the Nasdaq Capital Market or NYSE American, engaging with Luckosky Brookman LLP and specialized investment banks, though no guarantee of success or timeline was provided.

Key Details

• STING Activator Pipeline:
  • Target: Microsatellite stable (MSS) metastatic colorectal cancer, currently considered untreatable with standard immunotherapy.
  • Mechanism: Activates STING (stimulator of interferon genes) specifically in the tumor microenvironment.
  • Preclinical Data: Leads to specific recruitment of immune cells into the tumor and significantly reduces tumor growth.
  • Synergy: A single dose synergizes with PD-1 checkpoint inhibitors where the inhibitor is ineffective alone, potentially unlocking efficacy in unresponsive tumors.
  • Advantage: Targeted delivery into myeloid cells may reduce systemic side effects compared to previous STING-targeting drugs.
• In Vivo CAR Pipeline:
  • Strategy: Bypasses costly, complex ex vivo processes by delivering genetic instructions directly into the patient, allowing the body to engineer its own immune cells.
  • Potential Benefits: Off-the-shelf availability, reduced costs, and broader accessibility.
  • Technical Progress: Optimized CAR constructs are functional in both myeloid cells (for tumor killing) and T cells (for activation).
  • Pipeline Assets: Includes an in vivo CAR using a licensed CD22 nanobody, a CAR targeting a validated protein in most solid tumors, and a potentially universal CAR.
  • Next Steps: Initiate in vivo testing of optimized CARs using validated lipid nanoparticle (LNP) delivery systems in mouse cancer models in the coming weeks.
• Antibody Candidate:
  • Exploring use of lead antibody candidate targeting G-CSF to overcome resistance to current VEGF-inhibitors, capitalizing on renewed interest in VEGF targets in immunotherapy.
• Corporate Actions:
  • Working with Luckosky Brookman LLP to pursue a listing on Nasdaq Capital Market or NYSE American.
  • Met with specialized investment banks to assist in the uplisting process.
  • Assessing necessary steps to meet financial and regulatory requirements; no guarantee of approval or timing.

Notable Quotes

• "The excitement we are starting to see in the market for immune reprograming in vivo is not just a trend -- it is the necessary evolution of cancer care. By combining our deep expertise in the immune system with advanced LNP delivery from worldclass partners and validated targets such as CD22, ME Therapeutics is building a platform capable of reshaping the tumour microenvironment and democratizing cell therapy," said Salim Dhanji, PhD, chief executive officer.