TME Pharma N.V. announced the unanimous approval of all resolutions at its 2025 annual general meeting of shareholders, including the appointment of Diede van den Ouden as Chief Executive Officer, succeeding Aram Mangasarian. The leadership change positions the clinical-stage biotechnology company to advance its tumor microenvironment-targeting therapies, particularly its lead candidate NOX-A12 in glioblastoma.
The shareholders representing 16.67% of the total issued and outstanding share capital participated in the AGM held on June 25, 2025, approving van den Ouden's appointment as sole member of the board of directors and CEO.
Strategic Leadership Transition
"On behalf of the Board and the entire TME Pharma team I would like to welcome Diede van den Ouden as our new CEO. Diede's commitment to TME Pharma, demonstrated both as a significant shareholder and an active supporter, gives us great confidence as we enter this next chapter," said Maurizio PetitBon, Chairman of TME Pharma.
Van den Ouden brings unique alignment to the role as both CEO and major shareholder. "I am honored to join TME Pharma at such a pivotal moment in the company's journey. Thanks to the dedication and vision of the entire team, TME Pharma has reached a critical inflection point, marked by robust clinical progress and a strengthened financial position, with reduced cash burn and a secured 12-month runway," said the newly elected CEO.
Clinical Progress in Challenging Oncology Indications
Under outgoing CEO Aram Mangasarian's leadership, TME Pharma achieved significant clinical milestones, particularly in glioblastoma - one of the most challenging areas in oncology. The company has delivered industry-leading clinical data for NOX-A12 (olaptesed pegol), an anti-CXCL12 L-RNA aptamer designed to target the tumor microenvironment.
In the GLORIA Phase 1/2 clinical trial, TME Pharma has observed consistent tumor reductions and objective tumor responses from NOX-A12 combined with radiotherapy in newly diagnosed brain cancer patients with unmethylated MGMT promoter who will not benefit clinically from standard chemotherapy. The expansion arms evaluating NOX-A12 in triple combination with radiotherapy and bevacizumab have shown even deeper and more durable responses, with improved survival outcomes.
Regulatory Recognition and Fast Track Designation
The clinical progress has earned significant regulatory recognition. The US FDA and German BfArM have approved the design of a randomized Phase 2 trial in glioblastoma, and TME Pharma received fast track designation from the FDA for NOX-A12 in combination with radiotherapy and bevacizumab for treating glioblastoma. The combination had previously received orphan drug designation for glioblastoma in the United States and glioma in Europe.
Expanding Pipeline and Strategic Partnerships
Beyond glioblastoma, TME Pharma has demonstrated NOX-A12's potential across multiple cancer types. The company published encouraging overall survival and safety data from its NOX-A12 combination trial with Keytruda in metastatic colorectal and pancreatic cancer patients in the Journal for ImmunoTherapy of Cancer in October 2021.
The company has entered its second collaboration with MSD/Merck for the Phase 2 OPTIMUS study, evaluating NOX-A12 combined with pembrolizumab and two different chemotherapy regimens as second-line therapy in patients with metastatic pancreatic cancer. The trial design has received approval in the United States.
Dual-Asset Strategy
TME Pharma's pipeline includes a second clinical-stage candidate, NOX-E36 (emapticap pegol), an L-RNA aptamer inhibiting CCL2 and related chemokines. This asset shows potential to address fibrosis and inflammation and is being evaluated in ophthalmic diseases requiring well-tolerated therapies with anti-fibrotic effects.
Future Strategic Focus
Van den Ouden outlined her strategic priorities: "Building on this solid foundation, my focus will be on leading the company through its next phase of transformation, accelerating our strategic initiatives for both NOX-A12 and NOX-E36. As a major shareholder myself, my interests are fully aligned with those of our shareholders, and I am committed to delivering long-term value for all stakeholders."
The Supervisory Board expressed confidence in the new leadership's ability to continue driving strategic objectives, including securing funding and partnerships for both NOX-A12 and NOX-E36. Mangasarian will remain involved with TME R&D programs in an advisory capacity, ensuring continuity in the company's scientific direction.
