Helix BioPharma Corp. (TSX: HBP, OTC PINK: HBPCF, FRANKFURT: HBP0), a clinical-stage oncology company developing novel therapies for difficult-to-treat cancers, announced today the appointment of Markus Loeffler, MD, MBA, as Chief Medical Officer (CMO). Dr. Loeffler’s appointment comes at a pivotal time as the company 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 in first-line non-small cell lung cancer (NSCLC). He will also guide LEUMUNA™ toward clinical development for leukemia relapse following allogeneic stem cell transplantation. This appointment underscores Helix’s commitment to advancing its pipeline and bringing innovative therapies to patients with difficult-to-treat cancers.
“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 LEUUMUNA to enter the clinic.”
Dr. Loeffler brings more than three decades of leadership in oncology drug development. He is a physician-scientist with extensive experience advancing oncology therapeutics, including small molecules, biologics, antibody-drug conjugates (ADCs), radiopharmaceuticals, and immunotherapies, from early clinical development through Phase III and regulatory approval. Throughout his career, he has held senior clinical development and CMO roles at leading biotechnology and pharmaceutical companies, including Roche, Advanced Accelerator Applications, Mundipharma, NH TherAguix, Corbus Pharmaceuticals, and SK Life Science. Notably, Dr. Loeffler 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 is focused on developing therapies for underserved patient populations with difficult-to-treat cancers. Its pipeline is led by L-DOS47, a clinical-stage antibody-enzyme conjugate being developed as a combination therapy for NSCLC. Additional pipeline 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/.
The appointment of Dr. Loeffler is expected to strengthen Helix’s clinical development capabilities as it moves toward key milestones. The planned Phase Ib/II trial of L-DOS47 in combination with pembrolizumab represents a significant step in the company’s strategy to combine its novel antibody-enzyme conjugate with checkpoint inhibition, a promising approach in oncology. Additionally, advancing LEUMUNA toward the clinic could address a significant unmet need in post-transplant leukemia relapse. Dr. Loeffler’s proven track record in leading successful clinical programs, including the approval of Lutathera, brings valuable expertise to Helix as it navigates the complexities of drug development and regulatory approval.
This announcement reflects Helix’s ongoing commitment to advancing its pipeline and delivering innovative therapies to patients. With Dr. Loeffler’s leadership, the company is well-positioned to execute its clinical development plans and potentially bring new treatment options to those with difficult-to-treat cancers.
