VANCOUVER, BC – Helix BioPharma Corp. (TSX: HBP, OTC PINK: HBPCF, FRANKFURT: HBP0), a clinical-stage oncology company developing novel therapies for difficult-to-treat cancers, announced today the appointment of Markus Loeffler, MD, MBA, as Chief Medical Officer (CMO). Dr. Loeffler's arrival marks a strategic move as the company prepares to enter a more execution-focused phase, with multiple programs approaching key regulatory and clinical milestones.
In his role, Dr. Loeffler will lead the strategy and execution of Helix's clinical programs, including the planned Phase Ib/II evaluation of L-DOS47 in combination with pembrolizumab for first-line non-small cell lung cancer (NSCLC). He will also guide LEUMUNA™ toward clinical development for leukemia relapse following allogeneic stem cell transplantation. This appointment underscores Helix's commitment to advancing its pipeline and achieving near-term clinical milestones.
Thomas Mehrling, MD, PhD, Chief Executive Officer of Helix, expressed confidence in Dr. Loeffler's abilities: “I’ve had the privilege of working with Markus before, and I have seen firsthand his ability to translate innovative science into well-executed clinical development programs. He is an outstanding clinical development leader with a strong track record of advancing innovative oncology therapies through the development pathway. His expertise will be instrumental as we advance L-DOS47 into its next stage of clinical development and prepare LEUMUNA to enter the clinic.”
Dr. Loeffler brings more than three decades of leadership in oncology drug development, with extensive experience advancing small molecules, biologics, antibody-drug conjugates (ADCs), radiopharmaceuticals, and immunotherapies from early clinical stages through Phase III and regulatory approval. He has held senior clinical development and CMO roles at leading companies including Roche, Advanced Accelerator Applications, Mundipharma, NH TherAguix, Corbus Pharmaceuticals, and SK Life Science. Notably, he led the pivotal Phase III clinical program for Lutathera®, which received approval for certain gastroenteropancreatic neuroendocrine tumors.
“I’m excited to join Helix at such an important stage in its evolution,” said Dr. Loeffler. “The Company’s pipeline combines strong scientific foundations with clear clinical development opportunities. I am particularly enthused by the opportunity to advance L-DOS47 in combination with checkpoint inhibition and to bring LEUMUNA toward its first clinical evaluation. I look forward to working alongside the team to translate these programs into meaningful new treatment options for patients with difficult-to-treat cancers.”
The appointment of a CMO with Dr. Loeffler's expertise is pivotal for Helix as it aims to navigate the complexities of clinical development and regulatory pathways. His experience in leading programs to approval, such as Lutathera, provides the company with leadership capable of driving its pipeline forward efficiently. The focus on L-DOS47, an antibody-enzyme conjugate for NSCLC, and LEUMUNA, a pre-IND oral immune checkpoint modulator, reflects Helix's strategy to address underserved patient populations.
Helix BioPharma is a clinical-stage oncology company with a pipeline that includes L-DOS47, LEUMUNA, and GEMCEDA, a pre-IND gemcitabine prodrug for advanced solid tumors. The company's shares are listed on the Toronto Stock Exchange (TSX: HBP), quoted on the OTC Pink Market (HBPCF), and listed on the Frankfurt Stock Exchange (FWB: HBP0). For more information, visit https://www.helixbiopharma.com/.
