Helix BioPharma Corp., 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). This strategic hire comes as Helix prepares to enter a more execution-focused phase of clinical development, with multiple programs approaching key regulatory and clinical milestones.
Dr. Loeffler brings over three decades of leadership in oncology drug development, with extensive experience advancing therapeutics ranging from small molecules and biologics to antibody-drug conjugates and immunotherapies. He has held senior clinical development and CMO roles at prominent companies such as 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 his new role at Helix, Dr. Loeffler will lead the strategy and execution of the company'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, 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.”
Helix BioPharma's pipeline is led by L-DOS47, a clinical-stage antibody-enzyme conjugate being developed as a combination therapy for NSCLC. 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).
This appointment is pivotal for Helix as it advances its lead candidate L-DOS47 into combination therapy trials with checkpoint inhibitors, a strategy that could enhance treatment efficacy for NSCLC patients. The addition of Dr. Loeffler, with his proven track record in bringing oncology drugs to regulatory approval, underscores Helix's commitment to moving its pipeline forward. For leaders in the biotech and pharmaceutical industry, this move signals Helix's intent to strengthen its clinical development capabilities and potentially accelerate the path to market for its novel therapies.
The company also noted that its forward-looking statements involve risks and uncertainties, including the ability to capitalize on potential benefits of its programs and the risk factors disclosed in its periodic reports available on SEDAR+ at www.sedarplus.ca.
