Helix BioPharma Corp. (TSX: HBP, OTC PINK: HBPCF, FRANKFURT: HBP0), a clinical-stage oncology company, announced the appointment of Markus Loeffler, MD, MBA, as Chief Medical Officer (CMO). The move comes as the company prepares for a more execution-focused phase of clinical development, with several 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.
Thomas Mehrling, MD, PhD, CEO of Helix, said, "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 development through Phase III and regulatory approval. He has held senior clinical development and CMO roles at 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.
"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," said Dr. Loeffler.
Helix BioPharma is focused on developing therapies for underserved patient populations with difficult-to-treat cancers. Its pipeline is led by L-DOS47, a clinical-stage antibody-enzyme conjugate being developed as a combination therapy for non-small cell lung cancer. Additional candidates include LEUMUNA, a pre-IND oral immune checkpoint modulator for post-transplant leukemia relapse, and GEMCEDA, a pre-IND gemcitabine prodrug for advanced solid tumors. The company'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 Helix BioPharma's website.


