A partnership to battle epidemics, a biomarker for immunotherapies, draft rules for gene-edited animals, and NIH director will remain for now.
(GEN, 1/16/17, David Fabrizio)
A cancer biomarker can often be as important as the therapies they guide, because they can help to match patients with the right treatment. However, some biomarkers have limitations based on the way they are measured and analyzed. A new, more quantitative biomarker called tumor mutational burden (TMB) could be the answer for immunotherapies. TMB predicts responses to immunotherapy in a range of advanced cancers. Unlike protein-based biomarkers, TMB is a quantitative measure of the total number of mutations per coding area of a tumor genome. Tumors that have higher levels of TMB are believed to express more neoantigens – a type of cancer-specific antigen – that may allow for a more robust immune response and therefore a more durable response to immunotherapy.
(The New York Times, 1/18/17, Don McNeil)
With memories of the tragic Ebola outbreak still fresh, and a Zika epidemic that rages on, foundations and governments announced this week the creation of a partnership to combat epidemics before they spiral out of control. The Coalition for Epidemic Preparedness Innovations, unveiled at the World Economic Forum in Davos this week, has already raised US$500 million from the Bill & Melinda Gates Foundation—the largest donor—Norway, Japan and the UK’s Wellcome Trust. Six major vaccine makers have joined as partners rather than donors, as did the World Health Organization and Doctors without Borders. The partnership will initially develop and stockpile vaccines against three known viral threats, and also push the development of technology to brew large amounts of vaccine quickly when new threats, like the mosquito-borne Zika virus, arise.
(Nature, 1/19/17, Amy Maxmen)
The US Food and Drug Administration issued three proposed regulations on Jan. 18 addressing CRISPR and other cutting-edge technologies being used to transform animals. It is not clear how the administration of incoming president Donald Trump will carry the proposals forward, however. The most controversial of three proposed regulations declares that all animals whose genomes have been intentionally altered will be examined for safety and efficacy in a process similar to that for new drugs.
(Nature, 1/19/17, Sara Reardon)
Geneticist Francis Collins, appointed in 2009 by President Obama to run the US National Institutes of Health, has been held over by the Trump administration, NIH spokesperson Renate Myles said in a statement this week. Collins had submitted a pro forma resignation letter offering to leave his post on Jan. 20, but he emerged as a candidate by the Trump revision team to continue leading the NIH and met with the president-elect on Jan. 11.
—Compiled by Senior Scientific Writer Regina McEnery