Helix BioPharma Corp., a clinical-stage oncology company focused on developing therapies for difficult-to-treat cancers, has announced the appointment of Markus Loeffler, MD, MBA, as Chief Medical Officer (CMO). The move comes as the company prepares to enter a more execution-focused phase of clinical development, with multiple programs approaching key regulatory and clinical milestones.
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. His appointment is seen as a critical step in advancing the company's pipeline, which includes L-DOS47, LEUMUNA, and GEMCEDA™.
Thomas Mehrling, MD, PhD, Chief Executive Officer of Helix, expressed confidence in Dr. Loeffler's ability to translate innovative science into well-executed clinical programs. "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," Mehrling said. "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 in advancing small molecules, biologics, antibody-drug conjugates (ADCs), radiopharmaceuticals, and immunotherapies from early clinical development 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 was subsequently approved for the treatment of certain gastroenteropancreatic neuroendocrine tumors.
Dr. Loeffler expressed enthusiasm about joining Helix at this pivotal stage. "I’m excited to join Helix at such an important stage in its evolution. 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," he said.
The appointment underscores Helix's commitment to advancing its lead candidate L-DOS47, an antibody-enzyme conjugate being developed as a combination therapy for NSCLC. The company is also progressing LEUMUNA, a pre-IND oral immune checkpoint modulator for post-transplant leukemia relapse, and GEMCEDA, a pre-IND gemcitabine prodrug for advanced solid tumors. With Dr. Loeffler's expertise, Helix aims to navigate the complexities of clinical development and regulatory pathways, potentially bringing new treatment options to patients in need.
Helix BioPharma's common 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/.
