Moleculin Biotech has entered into research and material transfer agreement with the University of North Carolina at Chapel Hill (UNC) for investigator-initiated preclinical research evaluating Annamycin for the treatment of pancreatic cancer.

Under the terms of the agreement, Moleculin will supply Annamycin and William C Zamboni, PharmD, PhD, Professor, UNC Eshelman School of Pharmacy, UNC Lineberger Comprehensive Cancer Center, and Carolina Institute of Nanomedicine, will conduct the planned preclinical research as part of a series of funded grants. The studies covered under this agreement will evaluate the ability of novel treatment agents and modalities to enhance the tumour delivery of liposomal Annamycin (L-Annamycin) and Free-Annamycin as compared to Doxil and Free-doxorubicin in the PDAC GEMM models.

Walter Klemp, Chairman and CEO, Moleculin, commented, “We are pleased to establish this agreement with the team at UNC-Chapel Hill, a leading institution in oncology innovation and translational research, and take another important step in our strategy to advance and develop Annamycin through multiple investigator-initiated studies to realise its full potential. Pancreatic cancer remains one of the most lethal and underserved cancers, with limited effective treatment options and a clear need for new therapeutic approaches. Evaluating Annamycin in collaboration with UNC’s world-class translational scientists dovetails well with our recently announced investigator-funded clinical trial in pancreatic cancer patients.”

Annamycin, also known by its non-proprietary name of naxtarubicin, currently has Fast Track Status and Orphan Drug Designation (ODD) from the US Food and Drug Administration (FDA) for the treatment of relapsed or refractory Acute Myeloid Leukemia (AML), in addition to ODD for the treatment of STS lung mets. Furthermore, Annamycin has ODD for the treatment of relapsed or refractory AML from the EMA.

 “Annamycin has a demonstrated high affinity for, and ability to concentrate in the pancreas, and recently published data reveals that the upregulation of topoisomerase II, the primary target of Annamycin, is highly correlated with poor survival in pancreatic cancer patients. This is why we believe targeting pancreatic cancer in addition to Acute Myeloid Leukemia and soft tissue sarcoma provides a critical strategic opportunity to expand the potential clinical applications of our technology into an indication with significant unmet need and market potential. We look forward to generating data that will help define Annamycin’s role in pancreatic cancer and further strengthen our oncology development pipeline as we work to deliver meaningful value for patients and shareholders,” continued Klemp.

Moleculin is currently conducting pivotal phase 2B/3, multi-centre, randomised, double-blind, placebo-controlled, adaptive design study of Annamycin in combination with cytarabine (also known as “Ara-C” and for which the combination of Annamycin and Ara-C is referred to as “AnnAraC”) for the treatment of adult patients with AML who are refractory to or relapsed (R/R) after induction therapy (R/R AML). This phase 3 “MIRACLE” trial (derived from Moleculin R/R AML AnnAraC Clinical Evaluation) is a global approval trial, including sites in the US, Europe and the Middle East.