Pentixapharm Announces Advancement of PentixaTher to Fourth Dose Level in Acute Myeloid Leukemia Trial

EQS-News: Pentixapharm Holding AG / Key word(s): Study/Research Update Pentixapharm Announces Advancement of PentixaTher to Fourth Dose Level in Acute Myeloid Leukemia Trial (news with additional features) 26.09.2025 / 08:00 CET/CEST The issuer is solely responsible for the content of this announcement.  Achieves Key Milestone with CXCR4-based Radiotherapeutic

• Favorable safety profile enables advancement of radiolabeled PentixaTher to fourth of five planned activity dose levels in investigator-initiated PENTILULA Phase 1/2 trial
• Milestone marks important step for novel radiotherapeutic candidate in high unmet need indication with limited treatment options and poor prognosis

 Berlin, Germany, September 26, 2025 – Pentixapharm AG (Frankfurt Prime Standard: PTP), an advanced clinical-stage biotech, developing novel radiopharmaceuticals, today announced that its CXCR4-targeting radiolabeled candidate PentixaTher has advanced to the fourth dose level in the investigator-initiated PENTILULA Phase 1/2 study in acute myeloid leukemia (AML).

Based on favorable safety findings at the third dose level of 7.5 GBq, the investigator-initiated trial received approval from the independent Data Safety Monitoring Board (DSMB) to advance to the fourth of five planned dose levels at 10 GBq, underscoring PentixaTher’s tolerability to date. Importantly, this advancement not only reinforces the compound’s safety profile but also moves the study into a dose range with a higher likelihood for meaningful clinical efficacy. If favorable safety signals continue, the study is expected to escalate to a fifth and final dose level of 12.5 GBq.

AML is the most common acute leukemia in adults, with approximately 20,000 new cases annually in the U.S. and 17,000 new cases annually in Europe. Five-year survival rates range between approximately 32 and 37%, respectively.

“Advancing to higher dose levels marks a key step in validating the therapeutic potential and promise of PentixaTher,” said Dirk Pleimes, MD, CEO/CMO of Pentixapharm. “The encouraging results in this investor-led effort highlight the potential of CXCR4 as a powerful target for hematologic cancers and demonstrate the promise of radiopharmaceuticals to expand treatment options where medical need is greatest. The trial is expanding the clinical evidence base for CXCR4-targeted therapy to expand the boundaries of radiopharmaceuticals.”