CAMBRIDGE, U.K. – “I have trained a large dog to bite anyone who says the words ‘personalized medicine.’ We are a long way from that.” So said George Poste, chief scientist at Complex Adaptive Systems and professor of health innovation at Arizona State University, opening a discussion on the state of play in the field, at the Gap Summit in Cambridge. Read More
CHICAGO – Following last year’s Checkmate-238 data showing that PD-1 inhibitor Opdivo (nivolumab, Bristol Myers Squibb Co.) was better at improving relapse-free survival (RFS) than CTLA-4 inhibitor Yervoy (ipilimumab, BMS) in melanoma patients after surgery, Kenilworth, N.J.-based Merck & Co. Inc. presented data for its own PD-1 inhibitor, Keytruda (pembrolizumab), in the melanoma adjuvant setting at the American Association for Cancer Research Annual Meeting 2018. (See BioWorld, Sept. 12, 2017.) Read More
PARIS – Several prominent studies featured at the 2018 International Liver Congress (ILC), the annual meeting of the European Association for the Study of the Liver (EASL), made clear that the industry has made progress but not yet found the silver bullet against one of its biggest foes: nonalcoholic steatohepatitis (NASH). If anything, ILC participants likely left Paris with more questions than answers about future directions for NASH study and treatment. Read More
CHICAGO – PD-1 drugs in lung cancer took over the second day of the American Association for Cancer Research meeting with a trio of presentations of clinical trials in patients with non-small-cell lung cancer (NSCLC), which were all concurrently published in The New England Journal of Medicine. Read More
PARIS – Nonalcoholic steatohepatitis (NASH), along with its forerunner conditions, and the constellation of viral hepatitis infections – A, B, C, D and, for some regions of the world, E – seemed to generate the most attention at the 2018 International Liver Congress (ILC), the annual meeting of the European Association for the Study of the Liver (EASL). However, rare liver indications garnered their share of the spotlight, included several presentations singled out by EASL for potentially high impact. Read More
CHICAGO – Despite all the focus on immuno-oncology, targeted therapy is still alive and well, albeit with a focus on small populations of patients. During a session at the American Association for Cancer Research meeting, principal investigators testing precision medicine therapies highlighted the drugs’ ability to hone in on patients in most need of additional treatments. Read More
Celldex Therapeutics Inc. is discontinuing its lead program, the antibody-drug conjugate glembatumumab vedotin (glemba), after it failed to help women with tough-to-treat metastatic triple-negative breast cancers (TNBC) stay both alive and progression-free for longer than Roche Holding AG’s Xeloda (capecitabine), missing the primary endpoint of a phase IIb study. The hard blow, which will also bring an end to a phase II combination study in melanoma, precipitated plans for restructuring and re-evaluation at the company as its shares (NASDAQ:CLDX) tumbled 64.6 percent to close at 76 cents on Monday. Read More
DUBLIN – Shire plc is offloading its oncology business to Les Laboratoires Servier SAS for $2.4 billion in cash, which represents a multiple of 9.2 times its 2017 revenue of $261.7 million. Read More
Polarityte Inc., of Salt Lake City, closed its public offering of about 2 million shares, plus an additional 304,687 shares sold to cover the full overallotment option, with net proceeds expected to total about $34.2 million. Read More
Humanigen Inc., of Brisbane, Calif., signed an agreement with the University of Texas MD Anderson Cancer Center to begin investigator-led research on lenzilumab and its potential to support chimeric antigen receptor T-cell therapy. Read More
A new U.S. study has discovered for the first time in human neurons the cause of – and a potential solution for – the primary genetic risk factor for developing Alzheimer’s disease (AD), a gene called apolipoprotein E4 (ApoE4). Read More