In November 2014, Janssen signed an exclusive worldwide collaboration and license agreement with Geron for the development and commercialization of imetelstat in oncology, including hematologic myeloid malignancies.
Janssen took the latest decision after portfolio assessment and prioritization of assets within its portfolio.
Geron has reclaimed the global rights to develop and commercialize imetelstat, as a result of Janssen’s decision.
As per terms of the CLA, Gerom has regained the licensed rights of the imetelstat program, including intellectual property rights generated under the collaboration, without any continuing economic obligations from Janssen.
Janssen will also not have any further obligations to fund any of the current ongoing imetelstat clinical trials.
With operational support from Janssen, the transition of imetelstat program to Geron is expected to be completed in around one year, including the orderly transfer of all ongoing clinical, regulatory, medical affairs, manufacturing and preclinical activities.
Janssen will also supply imetelstat to Geron for up to two years, during a transition period for clinical manufacturing.
The current patients in the ongoing imetelstat clinical trials, including IMbark study in myelofibrosis and IMerge study in myelodysplastic syndromes, will continue to be supported across the respective trial protocols.
IMerge is a two-part clinical trial designed to assess imetelstat in transfusion dependent patients with Low or Intermediate-1 risk myelodysplastic syndromes (MDS) ) who have relapsed after or are refractory to prior treatment with an erythropoiesis stimulating agent (ESA).
IMbark is a phase 2 clinical trial designed to assess two starting dose levels of imetelstat(either 4.7 mg/kg or 9.4 mg/kg administered by intravenous infusion every three weeks) in around 200 patients with Intermediate-2 or High-risk myelofibrosis (MF) who have relapsed after or are refractory to prior treatment with a JAK inhibitor.
Geron president and CEO John Scarlett said: “We believe the clinical results from IMbark provide valuable insights into the potential future development of imetelstat for an underserved relapsed and refractory myelofibrosis patient population.
“We also believe the combined data of 38 patients from the initial and expansion cohorts for the target patient population from the Phase 2 portion of IMerge support further development of imetelstat, and we are therefore prioritizing the initiation of the Phase 3 portion of IMerge.”