November 14, 2014
By Mark Terry, BioSpace.com Breaking News Staff
Menlo Park, Calif.-based Geron Corporation announced today that it has inked an exclusive global license and collaboration deal with Janssen Biotech, Inc .
The deal focuses on the development and commercialization of imetelstat, a telomerase inhibitor candidate for oncology developed by Geron. The compound is in early phase clinical studies for myelofibrosis (MF) and other hematologic myeloid malignancies such as myelodysplastic syndrome (MDS) and acute myelogenous leukemia (AML). Headquartered in Horsham, Penn., Janssen is a Johnson & Johnson Company .
Imetelstat (GRN163L) is administered by IV infusion. It is an engineered and modified short oligonucleotide that targets and binds to the active site of telomerase, the biochemical involved in chromosome elongation. In cancer and in aging cells, telomerase either stops functioning or functions improperly. The compound is not yet approved for marketing by regulatory agencies.
Under the agreement, Geron receives $35 million as an initial payment, with additional payments that could total $900 million for hitting various development, regulatory and commercial milestones, as well as royalties on worldwide net sales. The two companies will jointly handle regulatory, developmental, manufacturing and promotional activities.
“By leveraging Janssen’s ability to fully integrate and strategically align global oncology development and commercialization, we expect this collaboration to expand the development of imetelstat across a range of hematologic malignancies and potentially increase the speed with which imetelstat can be made available to patients with these serious, life-threatening diseases,” said Geron President and Chief Executive Officer John Scarlett in a statement.
Geron announced on Nov. 3 that the U.S. Food and Drug Administration had removed a full clinical hold on the company’s investigational new drug (IND) application for imetelstat. The FDA also indicated that Geron’s clinical development plan for the drug, which focuses on high-risk myeloid malignancies, is acceptable. The company does not plan to develop the drug for use in the treatment of essential thrombocythemia (ET) or polycythemia vera.
The full clinical hold centered on Geron getting follow-up data from patients treated with imetelstat who developed liver function test abnormalities. The company obtained the data from patients in Phase 2 trials in ET and multiple myeloma (MM), which was submitted to the FDA. According to the press statement, “The company’s analysis of these data concluded that in the ET trial LFT abnormalities resolved to normal or baseline in 14 of 18 follow-up patients. For the remaining four ET patients, at the time of the data cut-off, three patients showed improvement in LFT abnormalities and one patient had unresolved LFT abnormalities.”
