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Geron Corporation GERN shares have risen 55% so far this year compared with the industry’s increase of 2.1%, riding on the development of its sole pipeline candidate, imetelstat.
Imetelstat is being evaluated as a treatment for hematologic myeloid malignancies like myelofibrosis (“MF”) in a phase II IMbark study and myelodysplastic syndromes (“MDS”) in a phase II/III IMerge study.
Notably, both the studies are being conducted by Geron, following the termination of the collaboration related to imetelstat development by Johnson & Johnson JNJ. The candidate enjoys orphan drug designation for both the indications.
Pipeline Progress
Geron is progressing well with the development of imetelstat. Earlier this month, the company completed the transfer of the sponsorship of the investigational new drug (“IND”) related to imetelstat from Janssen. Geron now holds the full responsibility for the development of imetelstat.
Enrollment has been stopped in the phase II portion of IMerge study and the company anticipates top-line data from it by the end of 2019. Preliminary data presented last year had shown that the benefit/risk profile of imetelstat in treated patients, including the expansion arm, supports continued development in lower risk MDS indication. Based on this data, the company expects to initiate the phase III portion of the IMerge study in mid-2019.
Geron has also added new leaders to its development team with vast experience in oncology and drug development to support the progress of imetelstat.
Meanwhile, the company postponed the date of the end of phase II meeting related to IMbark study to the first quarter of 2020 from the third quarter of this year. The extended period is likely to be used for further analysis of data from the IMbark study, which may support the regulatory application seeking approval of imetelstat in relapsed/refractory MF.
However, operating expense is set to increase as Geron will bear all costs of imetelstat development following the termination of collaboration with J&J. Geron has sufficient funds to start the phase III portion of IMerge studies. However, it may face difficulties with the progress of the study, if the company fails to raise funds or find a suitable partner for funding the continuation of the study.
Moreover, the single pipeline candidate is also a concern. Any hiccups in development may lead to share price decline. Meanwhile, Acceleron Pharma Inc. XLRN and its partner Celgene Corporation’s CELG luspatercept, which is being developed for MDS in a phase III study, may give competition to imetelstat.