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Sunday, July 1, 2018

Is waiting almost over with Geron?


Shares of Geron Corp. (NASDAQ:GERN), a clinical-stage oncology company, rose by as much as 14.9% around mid-June.
The spark? The drugmaker’s shares are responding positively to the company’s oral presentation over the weekend at the European Hematology Association meeting in Stockholm, Sweden. Specifically, Dr. David Steensma, from the Dana-Farber Cancer Institute, provided an update on the ongoing Part 1 portion of the combined Phase 2/3 trial known as “IMerge” that’s assessing the first-in-class telomerase inhibitor, imetelstat, in patients with lower risk myelodysplastic syndromes (MDS).

This conference presentation provided investors with a few key insights into imetelstat’s emerging clinical profile. First off, the company reported that a respectable 34% (11 of 32) of patients achieved red blood cell transfusion independence (TI) of greater than two months. That’s noteworthy because IT is the study’s primary endpoint, and over a third of the patients in this trial appear to be benefiting from imetelstat treatment. Normally, that sort of positive response in an experimental cancer trial is enough to warrant a larger, randomized trial.
Dr. Steensma also noted that a small sub-set of patients have now gone without blood transfusions for over a year at this point following imetelstat treatment. Although this initial part of the study lacks a control arm to put this intriguing result into the proper statistical context, this lengthy period of TI is impressive nonetheless, and suggests that this drug might even be a functional cure for a select few patients.

Looking ahead, Geron said it plans on unveiling the data from the expanded portion of the trial focusing on patients naïve to lenalidomide and hypomethylating agents and who lacked a certain mutation known as del(5q) at a future medical conference. While these particular data were arguably the main reason investors were tuning into this EHA presentation, the fact that the company expects to present additional data from this trial later on is a noteworthy development in and of itself.
In short, Geron and its shareholders are currently waiting on the all-important continuation decision by its partner Johnson & Johnson (NYSE:JNJ) regarding imetelstat’s fate. This decision is expected to come by the end of the third-quarter, but the next major hematology conference isn’t until December of this year. That’s not to say investors should read too much into this intriguing timeline, but this stated plan of action certainly implies that the two companies are indeed making plans that extend beyond the third-quarter of this year.

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