Helix BioPharma Corp. (TSX: HBP, OTC PINK: HBPCF, FRANKFURT: HBP0), a clinical-stage oncology company focused on developing therapies for difficult-to-treat cancers, announced today the appointment of Markus Loeffler, MD, MBA, as Chief Medical Officer (CMO). Dr. Loeffler brings over three decades of leadership in oncology drug development, having held senior roles at Roche, Advanced Accelerator Applications, Mundipharma, NH TherAguix, Corbus Pharmaceuticals, and SK Life Science. He also led the pivotal Phase III clinical program for Lutathera®, a radiopharmaceutical approved for certain gastroenteropancreatic neuroendocrine tumors.
The appointment comes as Helix prepares for a more execution-focused phase of clinical development, with multiple programs approaching key regulatory and clinical milestones. As CMO, 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 in first-line non-small cell lung cancer (NSCLC). He will also guide LEUMUNA™, a pre-IND oral immune checkpoint modulator, toward clinical development for leukemia relapse following allogeneic stem cell transplantation.
Thomas Mehrling, MD, PhD, Chief Executive Officer of Helix, commented, “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 expressed his enthusiasm, stating, “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.”
The appointment of Dr. Loeffler underscores Helix's commitment to advancing its pipeline, which includes L-DOS47, an antibody-enzyme conjugate being developed as a combination therapy for NSCLC, and LEUMUNA™, a pre-IND oral immune checkpoint modulator for post-transplant leukemia relapse. Additionally, the company is developing GEMCEDA™, a pre-IND gemcitabine prodrug for advanced solid tumors.
Helix BioPharma is a clinical-stage oncology company focused on developing therapies for underserved patient populations with difficult-to-treat cancers. Its 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/.
The addition of a seasoned CMO with experience in late-stage development and regulatory approvals is a significant step for Helix as it moves toward key clinical milestones. Dr. Loeffler's leadership is expected to enhance the company's ability to execute its clinical trials and potentially bring new treatment options to patients with difficult-to-treat cancers.

