Helix BioPharma Appoints Dr. Markus Loeffler as Chief Medical Officer to Drive Next Phase of Clinical Development

Helix BioPharma Corp. (TSX: HBP, OTC PINK: HBPCF, FRANKFURT: HBP0), a clinical-stage oncology company developing therapies for difficult-to-treat cancers, has announced the appointment of Markus Loeffler, MD, MBA, as Chief Medical Officer (CMO). The appointment 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. Thomas Mehrling, MD, PhD, Chief Executive Officer 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 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.

In response to his appointment, Dr. Loeffler said, “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 a CMO with such extensive experience is a significant step for Helix BioPharma as it seeks to advance its pipeline. The company's lead candidate, L-DOS47, is an antibody-enzyme conjugate being developed as a combination therapy for NSCLC. LEUMUNA™ is a pre-IND oral immune checkpoint modulator for post-transplant leukemia relapse, and GEMCEDA™ is a pre-IND gemcitabine prodrug for advanced solid tumors. Helix'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/.

This appointment underscores Helix's commitment to advancing its clinical programs and bringing new treatment options to patients with difficult-to-treat cancers. With Dr. Loeffler's leadership, the company is well-positioned to navigate the complexities of clinical development and regulatory approval, potentially accelerating the timeline for these promising therapies.