Helix BioPharma Corp. (TSX: HBP, OTC PINK: HBPCF, FRANKFURT: HBP0), a clinical-stage oncology company developing novel therapies for difficult-to-treat cancers, has announced the appointment of Markus Loeffler, MD, MBA, as Chief Medical Officer (CMO). Dr. Loeffler brings over three decades of leadership in oncology drug development, including pivotal roles at Roche, Advanced Accelerator Applications, Mundipharma, NH TherAguix, Corbus Pharmaceuticals, and SK Life Science. His extensive experience spans small molecules, biologics, antibody-drug conjugates, radiopharmaceuticals, and immunotherapies, from early development through regulatory approval.
The appointment comes as Helix prepares to enter a more execution-focused phase, 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), and will guide LEUMUNA™ 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’s background includes leading the pivotal Phase III clinical program for Lutathera®, which was subsequently approved for the treatment of certain gastroenteropancreatic neuroendocrine tumors. This experience is expected to be invaluable as Helix advances its pipeline. “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.
The strategic significance of this appointment is underscored by the advancement of L-DOS47, a clinical-stage antibody-enzyme conjugate being developed as a combination therapy for NSCLC. The planned Phase Ib/II trial with pembrolizumab represents a critical step in potentially expanding treatment options for patients with this challenging disease. Additionally, LEUMUNA, a pre-IND oral immune checkpoint modulator for post-transplant leukemia relapse, and GEMCEDA, a pre-IND gemcitabine prodrug for advanced solid tumors, are also progressing. Dr. Loeffler’s leadership will be crucial in navigating these programs through the regulatory and clinical development landscape.
Helix BioPharma is a clinical-stage oncology company focused on developing therapies for underserved patient populations. The company’s pipeline is led by L-DOS47, with additional candidates including LEUMUNA and GEMCEDA. 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/.
This appointment reflects Helix’s commitment to strengthening its clinical development capabilities as it approaches critical milestones. With Dr. Loeffler’s proven track record, the company is well-positioned to advance its promising oncology pipeline and potentially bring new treatment options to patients in need.
