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Geron poleaxed as partner J&J abandons only pipeline drug

Shares drop by two-thirds as questions raised on imetelstat’s potential

Johnson and Johnson logo Johnson & Johnson has dissolved its four-year-old partnership with Geron for cancer drug imetelstat, wiping two-thirds off the biotech’s share price at a stroke.

J&J’s Janssen Biotech unit said the decision was down to a “strategic portfolio evaluation and prioritisation of assets” in its pipeline, but nevertheless is a heavy blow to Geron, raising questions about imetelstat’s potential in particular and the emerging telomerase inhibitor class in general.

Imetelstat has been conspicuously absent from J&J’s R&D presentations for some months, raising eyebrows about the state of the programme, but despite this Geron’s share price has tripled since the start of the year on expectation that J&J would extend the $935m partnership, signed in 2014.

The shares continued to rise in the summer, even when the biotech revealed that the collaboration’s future rested on showing an overall survival benefit in a phase 2 trial (IMbark) of imetelstat in relapsed/refractory myelofibrosis (MF). It’s now emerged that study wasn’t an outright success, but according to Geron revealed “a potential improvement in survival” that it thinks is enough to support future development in that form of blood cancer.

Geron’s president and chief executive John Scarlett put a brave face on J&J’s decision in a conference call yesterday saying the company is “enthusiastic about taking imetelstat forward into further development in myeloid hematologic malignancies”.

Scarlett says the priority now is to push ahead with the second, phase 3 stage of its IMerge trial of the telomerase inhibitor in transfusion-dependent patients with low or Intermediate-risk myelodysplastic syndromes (MDS).

In the study imetelstat is being given to patients with anaemia who haven’t responded to a blood cell-boosting agent like EPO in the hope of removing their reliance on blood transfusions.

“Geron expects the transition of the complete imetelstat program to occur over approximately 12 months with operational support from Janssen,” said Scarlett. He also noted that the company has hired a contract research organisation (CRO) to help ensure IMerge and an extended IMbark trial can continue without interruption.

“While we expect to fund the future development of imetelstat through phase III in MDS and possibly MF, we also expect to initiate discussions with…possible strategic partners after the programme has been fully transferred back to us, in particular seeking to identify companies who would be interested in ex-US commercialisation rights.”

Analysts have suggested that might be a tough call given the increasingly competitive markets for MF and MDS, with firmly entrenched therapies such as Incyte and Novartis’ Jakafi (ruxolitinib) and Celgene’s broad portfolio headed by Revlimid (lenalidomide), and a clutch of new candidates coming through mid- to late-stage clinical development.

A lot will rest on data from the two trials that Geron hopes to present at the American Society of Haematology (ASH) meeting in November.

Article by
Phil Taylor

28th September 2018

From: Research



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