Drug Development

Geron survives, for now, but the jury at J&J is still out on the future of imetelstat

Geron has survived another scrape with disaster, but it’s still operating under a dark cloud.

This morning the biotech announced that J&J’s review of the data from two studies of its drug imetelstat warranted continued work in myelodysplastic syndromes and myelofibrosis. But the pharma giant $JNJ is still reserving the right to quit if the data don’t hold up later in the year.

That’s not a big vote of confidence.

Investors responded to the positive, though, sending shares of Geron up 17% in pre-market trading.

The studies for this drug include a Phase II/III study in low-risk myelodysplastic syndromes. Now Geron says that they’ll be sharing data with the FDA before deciding whether to launch the second part of that study, which is being tweaked.

Geron also isn’t likely to spur much excitement with the observation that the spleen volume response in myelofibrosis was less than that seen for other drugs. But Geron hurried on to note that there were several signs of clinical benefit to encourage researchers, adding that “the data suggest a potential overall survival benefit associated with imetelstat treatment in these patients.”

Enrollment in that second study, though, is still on hold — also not an encouraging sign. And the jury is still out:

Geron expects the longer-term data from the trial, potential health authority feedback, and the totality of imetelstat program information, including an assessment of the evolving treatment landscape in MF and the potential application of imetelstat in multiple hematologic malignancies, including MDS, will inform Janssen’s decision whether to continue development of imetelstat in relapsed or refractory MF.

Geron shares $GERN took a beating last fall after its drug, a telomerase inhibitor, ran into trouble during its key Phase II trial run by J&J. The low dose group — relapsed or resistant to JAK1 therapy — was not seeing an adequate response and investigators opted to shut that wing of the trial down, transferring patients over to the high dose. And new enrollment in the high dose arm was suspended so investigators could take a careful look at more mature data.

Geron reorganized back in 2011, dropping its work on stem cell therapies and remaking itself as a cancer drug developer. The biotech has gone more than two decades, though, without finding a drug that warrants approval.


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