Helix publishes article in Frontiers in Oncology

Executive Summary

• Helix BioPharma Corp. announced the publication of peer-reviewed results in Frontiers in Oncology regarding the Phase I/II monotherapy study of its lead candidate, L-DOS47, in patients with advanced non-small cell lung cancer (NSCLC).
• The study demonstrated that L-DOS47 was well-tolerated at doses up to 13.55 microgram/kg. While no complete or partial responses were observed, post-hoc analysis showed a statistically significant extension in progression-free survival (PFS) for patients in the highest dosing quartile.
• The company plans to advance L-DOS47 into a new Phase I/II combination study with the PD-1 inhibitor pembrolizumab, having received positive feedback from the FDA on the planned study design.

Key Details

• Publication Details: Peer-reviewed article titled "Safety of unconventional antibody-drug conjugate L-DOS47 in a Phase I/II monotherapy study targeting advanced NSCLC" published in Frontiers in Oncology.
• Study Design: Phase I/II open-label study evaluating L-DOS47 as a single agent in advanced NSCLC; initiated in 2012 with sites in Poland and Canada.
• Safety Profile: L-DOS47 was well tolerated at doses up to 13.55 microgram/kilogram.
• Efficacy Results (Post-hoc Analysis):
  • Patients in the highest dosing quartile experienced a median progression-free survival (PFS) of 4.1 months (approximately 16 weeks).
  • This result was statistically significant (P = 0.0203).
  • Over 90% of these patients had received two or more prior lines of therapy.
• Biomarker Findings: Immunohistochemical analysis of an unrelated cohort revealed that CEACAM6 was highly expressed in nearly half of NSCLC cases, supporting biomarker-driven patient selection for future trials.
• Comparative Context: Median PFS with pembrolizumab monotherapy in previously treated NSCLC populations typically ranges from 2 to 6.3 months, depending on PD-L1 expression levels.
• Future Development: Helix is advancing L-DOS47 into a new Phase I/II study in combination with pembrolizumab to neutralize tumor acidity and improve immunotherapy efficacy.
• Regulatory Status: The company has received positive feedback from the FDA regarding the planned Phase I/II combination study.

Notable Quotes

• "This study supports the safety profile of L-DOS47 and highlights the importance of CEACAM6 as a new biomarker for biologics for the treatment of lung cancer," said Brenda Lee, corresponding author and clinical director at Helix.
• "We're excited to build on these findings by advancing L-DOS47 into a new clinical study in combination with the PD-1 inhibitor pembrolizumab... We have just received positive feedback from the FDA on our planned phase I/II study in combination with pembrolizumab, and we are now laser-focused on executing this next crucial step in the development of L-DOS47 in NSCLC," said Thomas Mehrling, MD, PhD, chief executive officer of Helix BioPharma.