Pleco Therapeutics Reports Successful Pre-IND Meeting with FDA for PTX-252 in Acute Myeloid Leukemia

Nijmegen, The Netherlands – On March 26, 2025, Pleco Therapeutics, a biopharmaceutical company focused on developing new treatments for challenging cancer types, reported a successful Pre-Investigational New Drug (Pre-IND) meeting with the U.S. Food and Drug Administration (FDA). The discussion centered around the progress of PTX-252, an intravenous formulation aimed at treating Acute Myeloid Leukaemia (AML).

The Pre-IND meeting provided Pleco Therapeutics with the opportunity to present its Investigational New Drug (IND) development plan and receive valuable guidance from the FDA on the necessary nonclinical and clinical studies for PTX-252. Feedback from the Division of Hematologic Malignancies was particularly encouraging, as the FDA expressed support for the development strategy proposed by Pleco.

PTX-252 is a novel molecule engineered to eliminate toxic heavy metals from the microenvironment of tumors. This action aids in the enhancement of the tumor suppressor protein p53's functionality, consequently increasing cancer cells' responsiveness to chemotherapy. This innovative compound has been granted Orphan Drug Designation by the FDA in relation to its use in treating AML.

Ivo Timmermans, Founder and co-CEO of Pleco Therapeutics, expressed optimism regarding the feedback from the FDA, stating, "The FDA's constructive feedback supports our mission to bring PTX-252 to cancer patients with limited treatment options. The guidance provides a clear path forward to opening the IND to advance PTX-252 into the clinic as swiftly as possible."

Michael Stalhamer, President of Pleco Therapeutics USA, highlighted the importance of early collaboration with regulatory bodies, saying, "Collaborating with the US FDA and other Regulatory Bodies early in the development of a medicinal product is a key step. Pleco Therapeutics is grateful for the feedback which helps to define and streamline our clinical development program, while ensuring a safe and effective regulatory pathway to patients."

In their endeavor to bring PTX-252 to fruition, Pleco Therapeutics is working alongside Hyloris Pharmaceuticals, a Belgian-based specialty pharma company. This partnership is instrumental in progressing the development of PTX-252.

Pleco Therapeutics is committed to enhancing the survival rates of cancer patients by developing innovative Plecoid™ therapies that boost the efficacy of existing cancer treatments. The company is based in the Netherlands, with a subsidiary in Raleigh, North Carolina, USA.