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Archive - Oct 11, 2015

Boehringer Ingelheim’s Investigational Biologic Cleared Skin Better, Faster, and for Longer Than Ustekinumab in Phase II Psoriasis Study

New results from a Phase II head-to-head psoriasis study showed superior efficacy of Boehringer Ingelheim’s investigational biologic compound BI 655066, over ustekinumab, Boehrninger Ingelheim announced on October 8, 2015. After nine months, 69 percent of patients with moderate-to-severe plaque psoriasis maintained clear or almost clear skin (PASI 90) with BI 655066 in the higher dose group compared to 30 percent of patients on ustekinumab. Patients also achieved this skin clearance significantly faster (approximately eight weeks versus approximately 16 weeks) and for more than two months longer (≥ 32 weeks versus 24 weeks) than those on ustekinumab. In addition, completely clear skin (PASI 100) was maintained after nine months in nearly triple the percentage of patients on BI 655066 compared with ustekinumab (43 percent versus 15 percent). "These results are striking. They further strengthen our understanding of the potential skin improvement that can be achieved with BI 655066, in moderate-to-severe plaque psoriasis. We saw a third more patients achieve clearer skin in a short time period. And this clearance was maintained longer compared to the commonly used treatment ustekinumab," commented Kim A. Papp, M.D., Ph.D., President of Probity Medical Research, Waterloo, Ontario, Canada. "Achieving clear skin quickly and maintaining clearance is an important goal for patients who have to deal with the daily impact of psoriasis." These meaningful 24-week findings from a Phase II study in psoriasis were presented on October 8, 2015 in an oral presentation by Dr. Papp at the 24th European Academy of Dermatology and Venereology (EADV) Congress in Copenhagen, Denmark.

FDA Approves Merck’s Keytruda (Ab to PD-1) for Treatment of Advanced Non-Small-Cell Lung Cancer (85% of All Lung Cancer); Companion Test to ID Patients Most Likely to Benefit Also Approved

Pembrolizumab (trade name Keytruda), a drug that has already been proven to extend the lives of people with advanced melanoma, was approved on October 2, 2015 by the U.S. Food and Drug Administration (FDA) to treat advanced non-small-cell lung cancer (NSCLC) in patients whose tumors express the protein PD-L1 (programmed cell death ligand 1). Keytruda is approved for use with a companion diagnostic, the PD-L1 IHC 22C3 pharmDx test, which is the first test designed to detect PD-L1 expression in NSCLC. Keytruda is marketed by Merck & Co., based in Whitehouse Station, New Jersey, and the PD-L1 IHC 22C3 pharmDx diagnostic test is marketed by Dako North America Inc. in Carpinteria, California. Richard Pazdur, M.D., Director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research said that the “approval of Keytruda gives physicians the ability to target specific patients who may be most likely to benefit from this drug.” The clinical trial study of Keytruda in advanced NSCLC represents the largest published research to date using immunotherapy to treat lung cancer, and the trial was conducted at UCLA and 29 other sites in the U.S., Europe, and Australia. “The approval of this drug and a test to identify patients most likely to benefit has the potential to transform the way that lung cancer is treated,” said Dr. Edward Garon, the study’s principal investigator and a researcher at UCLA’s Jonsson Comprehensive Cancer Center. “The quality and duration of disease response that was seen in the trial had previously been extremely rare in lung cancer.

mRNAs Coded by Most Complicated Gene Known in Nature Are Sequenced Using Hand-Held MinION Nanopore Sequencer; Single Dsc1 Gene in Drosphila Can Potentially Code for Over 38,000 Protein Isoforms

University of Connecticut (UConn) researchers have sequenced cDNA from the mRNA coded for by the most complicated gene known in nature (Dsc1 which controls brain wiring in Drosophila), using a hand-held sequencer no bigger than a cell phone. Genomicists Brenton Graveley, Ph.D., from the UConn Institute of Systems Genomics, postdoctoral fellow Mohan Bolisetty, Ph.D., and graduate student Gopinath Rajadinakaran teamed up with UK-based Oxford Nanopore Technologies to show that that company's MinION nanopore sequencer can sequence genes faster, better, and at a much lower cost than the standard technology. They published their findings online on September 30, 2015 in an open-access article in Genome Biology. The article is titled “Determining Exon Connectivity in Complex mRNAs by Nanopore Sequencing.” The scientists believe their published results demonstrate that nanopore sequencing can be used to deconvolute individual isoforms and that it has the potential to be a powerful method for comprehensive transcriptome characterization. If your genome were a library and each gene was a book, some genes would be straightforward reads, but some would be more like a "Choose Your Own Adventure" novel. Researchers often want to know which version of the gene is actually expressed in the body, but for complicated, choose-your-own-adventure genes, that has been impossible. Dr. Graveley, Dr. Bolisetty, and Rajadinakaran solved the puzzle in two parts. The first was to find a better gene-sequencing technology. In order to sequence a gene using the old, existing technology, researchers typically first make many copies of it, using the same chemistry our bodies use.