Ebola trial stopped early as Regeneron, Ridgeback therapies cut death risk; Merck inks deal to test Keytruda with Oncologie's antibody
→ As armed rebels conflict with containment efforts to thwart the deadly Ebola virus in the Congo, a trial testing the viability of four experimental therapies (from MappBio/ZMapp, Gilead $GILD/remdesivir, Regeneron $REGB/REGN-EB3, and Ridgeback Biotherapeutics/mAb114) in the region has been stopped early, because patients given REGN-EB3 or mAb114 were found to have a higher chance of survival versus the other two therapies, after interim mortality data from 499 patients was reviewed, the NIH said on Monday.
→ After admitting defeat for its anti-PD-1 Keytruda as a frontline monotherapy in advanced gastric or gastroesophageal cancer in late April, Merck is collaborating with Oncologie on a possible combination treatment. Oncologie “will conduct a Phase II single-arm open-label study to determine the efficacy and safety of bavituximab — an antibody that blocks the activity of phosphatidylserine — in combination with Keytruda” for patients who have failed at least one line of treatment. The study is expected to start enrollment in the second half of 2019 with around 80 patients in the US, UK, Korea and Taiwan. Back in June, Oncologie raised $80 million in Series B financing, which was led by Nan Fung Life Sciences and Pivotal BioVentures China.
→ A research fund created by former Conservative Prime Minister David Cameron is investing £6.5 million in a fresh biotech — AstronauTx — carved out of University College London. The company is working on resetting the behavior of astrocytes — crucial support cells in the brain — that typically help with nerve cell functioning but cause damage in Alzheimer’s patients. Cameron’s Dementia Discovery Fund is the world’s largest venture fund focused on a single disease area. Last year it raised $350 million in financing from a range of sources including Bill Gates and the US-based nonprofit AARP, formerly the American Association of Retired Persons.
→ After picking up a few million in cash to fund the Phase III program for its lead drug, rigosertib, back in May, Onconova is partnering with Mission Bio to utilize their Tapestri Platform — a single-cell DNA sequencing platform, enabling detection of heterogeneity in disease progression and treatment response — to study rigosertib in clinical trials. “In adding the Tapestri Platform to our research and development program, we are including the opportunity to study single cell clones in MDS and determine the sequence of genetic events and the influence of rigosertib on these events along with clinical outcomes,” said Steve Fruchtman, CEO of Onconova.
→ Women’s health company Daré Bioscience $DARE said its hydrogel, DARE-BV1, has been granted Qualified Infectious Disease Product (QIDP) designation by FDA for the treatment of bacterial vaginosis (BV) in women. In an investigator-initiated proof-of-concept study, the product conferred a an 86% cure rate in the evaluable subjects after a single administration — and the company expects to kick off a pivotal study in 250 women in the fourth quarter of 2019, it said on Monday.