Geron, Janssen Link To Develop Blood Cancer Drug Imetelstat

Clinical stage biopharmaceutical firm Geron reported that it has signed into an exclusive global license and collaboration with Janssen Biotech to jointly develop and market its drug Imetelstat for hematologic malignancies and other therapeutic uses.

Imetelstat is an intravenous, specific, first-in-class telomerase inhibitor discovered by Geron. The drug is a modified short oligonucleotide that directly targets and binds with high affinity to the active site of telomerase. The company said that initial data suggests Imetelstat’s disease-modifying activity influences the malignant clone associated with hematologic tendencies.

The drug is undergoing early phase clinical development for myelofibrosis (MF) and is being considered for development for other hematologic myeloid malignancies, such as myelodysplastic syndrome (MDS) and acute myelogenous leukemia (AML). Earlier this November, Geron reported that the FDA has lifted its clinical hold on Imetelstat’s investigational new drug (IND).

Under the terms of the agreement, Janssen Biotech will pay Geron an upfront fee of $35 million. Geron will also be eligible to receive additional payments of up to $900 million upon achievement of certain development, regulatory, production, and marketing activities to be accomplished under a joint governance structure. Janssen will take the lead in the operational implementation of the aforementioned activities and will be responsible for booking of all sales.

Dr. John Scarlett, Geron's President and CEO, said, “We expect this collaboration to expand the development of imetelstat across a range of hematologic malignancies and potentially increase the speed with which imetelstat can be made available to patients with these serious, life-threatening diseases.”

The agreement will include initial Phase 2 studies and additional registrational trials in MF and MDS. The collaboration is also expected to include exploratory and potential follow-up late-stage studies in AML. Geron said it expects to begin Phase 2 studies in MF in mid-2015. Janssen and Geron will equally share the development costs for the clinical development trials.

Earlier this month, Janssen also signed up Genmab to investigate the human CD38 monoclonal antibody daratumumab in Phase 3 studies as treatment for frontline multiple myeloma.