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, including experience with small molecules, biologics, antibody-drug conjugates, radiopharmaceuticals, and immunotherapies, from early clinical stages through Phase III and regulatory approval.
The appointment comes as Helix prepares to enter 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 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.
“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,” said Thomas Mehrling, MD, PhD, Chief Executive Officer of Helix. “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 career includes 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,” said Dr. Loeffler. “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.”
Helix BioPharma’s 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 https://www.helixbiopharma.com/.
This appointment is significant as Helix advances its clinical programs toward key milestones. The addition of Dr. Loeffler, with his extensive experience in oncology drug development, is expected to strengthen the company's ability to execute its clinical strategy and potentially bring new treatment options to patients with difficult-to-treat cancers. The planned Phase Ib/II trial of L-DOS47 in combination with pembrolizumab represents a critical step in evaluating a novel approach for first-line NSCLC, while LEUMUNA could address an unmet need in post-transplant leukemia relapse. These developments underscore Helix’s commitment to advancing innovative therapies for underserved patient populations.
The forward-looking statements in this release involve risks and uncertainties, including those related to the company's ability to capitalize on the potential benefits of the appointment and the successful execution of its clinical programs. For more information, refer to the company's periodic reports on SEDAR+ at www.sedarplus.ca.
