S*BIO Pte Ltd and Onyx Pharmaceuticals, Inc has expanded their development collaboration and option and license commercialisation agreement for the former's novel Janus kinase 2 (JAK2) inhibitors, SB1518 and SB1578, also known as ONX 0803 and ONX 0805, respectively. The expanded agreement builds upon the development and commercialization collaboration between the two companies announced in January 2009.
Onyx will provide US$ 20 million in funding to broaden and accelerate the existing development programme for both compounds. The programme will be expanded to include new indications for haematologic malignancies and myeloproliferative disorders. S*BIO will continue to perform the clinical development of SB1518 (ONX 0803) and preclinical through clinical development of SB1578 (ONX 0805).
“We have made significant progress in the development of our novel JAK2 inhibitors and the new funding by Onyx further validates the strength of our collaboration and underscores the success of our joint programs,” said Dr Jan-Anders Karlsson, CEO of S*BIO. “Advancing SB1518 and SB1578 into new indications will generate greater value in our assets and is expected to expedite future commercialization.”
“We believe these JAK2 inhibitors have potential as important cancer therapeutics, and it is to the advantage of patients affected by these diseases to accelerate and broaden their clinical testing into multiple haematologic and myeloproliferative disorders,” said N Anthony Coles, president and CEO of Onyx. “Expanding our collaboration with S*BIO on these programs fits with Onyx’s vision to invest in novel therapies and strengthens our position as an emerging oncology leader.”
JAK2 inhibitors are implicated across a broad range of difficult-to-treat illnesses, including cancer and autoimmune diseases, in which patients have mutations and rearrangements of the JAK2 gene. SB1518 (ONX 0803) is a small molecule JAK2-selective kinase inhibitor, which has demonstrated activity against both the wild type JAK2 kinase and the JAK2 kinase with the V617F mutation. The V617F mutation is found in high frequencies in myeloproliferative disorders such as myelofibrosis (MF). It is estimated that approximately 50 per cent of patients with MF possess the JAK2 mutation. SB1518 (ONX 0803) also provides new development pathways for other hematologic malignancies with mutations and rearrangements in the JAK2 gene. At the recent American Society of Haematology annual meeting, investigators reported encouraging data for SB1518 (ONX 0803) in early stage clinical trials in myeoloproliferative and other haematologic disorders, such as leukaemia and lymphoma.
Onyx can elect to exercise its exclusive options for SB1518 (ONX 0803) and SB1578 (ONX 0805) separately and independently at certain predetermined stages of development for each compound in all indications in the United States, Canada and Europe. S*BIO would retain rights to develop and commercialize SB1518 and SB1578 in the rest of the world.
S*BIO is a privately-held biotech company focused on the research and clinical development of novel targeted small molecule drugs for the treatment of cancer with leading programs around histone deacetylases (HDAC) and kinases.
Onyx Pharma is a biopharmaceutical company committed to improving the lives of people with cancer. The company, in collaboration with Bayer HealthCare Pharmaceuticals, Inc, is developing and marketing Nexavar (sorafenib) tablets, a small molecule drug that is currently approved for the treatment of liver cancer and advanced kidney cancer.