Moleculin Biotech has strengthened its strategic advisory team with the appointment of Adriano Treve, a pharmaceutical industry veteran with over four decades of experience at Roche, as the company prepares for critical data readouts from its Phase 3 acute myeloid leukemia trial.
The appointment comes at a pivotal time for the Houston-based late-stage pharmaceutical company, which is advancing toward the first unblinding of data for 45 patients in its Phase 2B/3 MIRACLE trial evaluating Annamycin (naxtarubicin) in combination with cytarabine as second-line treatment for acute myeloid leukemia.
Strategic Partnership Focus
Treve brings exceptional leadership credentials and deep understanding of global healthcare markets, having held senior executive roles across diverse regions including the U.S., Portugal, Brazil, Turkey, and most recently as Area Head for Turkey, Russia, Iran, Central Asia, the Caucasus, Eastern Europe, and the Indian Subcontinent. His expertise in international operations and market access is expected to be instrumental in advancing Moleculin's strategic partnerships.
"Adriano's extensive experience will be invaluable as we look to secure partnerships that optimize the value of Annamycin which we believe can potentially impact the global oncology drug market significantly," stated Walter Klemp, Chairman and CEO of Moleculin.
Treve expressed enthusiasm about joining the team, noting the promising trajectory of the MIRACLE trial. "I am excited to work closely with the Moleculin team to advance crucial solutions for patients with significant unmet medical needs. With the continued global expansion of the Phase 3 MIRACLE trial, positive feedback from investigators and the promising data demonstrated to date, I believe the Company is well positioned for strategic partnership opportunities."
MIRACLE Trial Progress
The Phase 3 MIRACLE trial (Moleculin R/R AML AnnAraC Clinical Evaluation) is a pivotal, multi-center, randomized, double-blind, placebo-controlled, adaptive design study evaluating the combination of Annamycin and cytarabine (AnnAraC) for adult patients with acute myeloid leukemia who are refractory to or relapsed after induction therapy. The global approval trial includes sites in the US, Europe and the Middle East.
The company expects to reach the first unblinding of 45 subjects in the second half of 2025, with the second unblinding expected in the first half of 2026. This timeline has reportedly increased interest from potential strategic partners significantly.
Regulatory Recognition
Annamycin has received substantial regulatory support, including Fast Track Status and Orphan Drug Designation from the FDA for the treatment of relapsed or refractory acute myeloid leukemia, as well as Orphan Drug Designation for soft tissue sarcoma. The European Medicines Agency has also granted Orphan Drug Designation for relapsed or refractory acute myeloid leukemia.
The drug is designed as a next-generation anthracycline that avoids multidrug resistance mechanisms while lacking the cardiotoxicity common with currently prescribed anthracyclines. Following a successful Phase 1B/2 study with FDA input, Moleculin believes it has substantially de-risked the development pathway toward potential approval.
Enhanced Advisory Team
Treve joins existing Business Advisor Dennis McNamara, who brings over 30 years of experience with strategic transactions for emerging life sciences companies. Klemp emphasized that this combination "should significantly expand opportunities for Moleculin going into 2026 and is intended to help accelerate the development of key partnerships that could create a significant value inflection for Moleculin shareholders."
Beyond its lead AML program, Moleculin is developing WP1066, an Immune/Transcription Modulator targeting brain tumors, pancreatic and other cancers, as well as a portfolio of antimetabolites including WP1122 for pathogenic viruses and certain cancer indications.
