Incyte (INCY +6.7%) and Merck (MRK +0.4%) expand their collaboration investigating the combination of epacadostat and Keytruda (pembrolizumab) in solid tumors and blood cancers. The companies now plan to initiate pivotal studies in four additional tumor types: non-small cell lung cancer, renal cell carcinoma, bladder cancer and squamous cell carcinoma.
Epacadostat is a small molecule inhibitor of IDO1, an immunosuppressive enzyme that has been shown to induce regulatory T cell generation and activation thereby allowing cancer cells to avoid detection by the immune system. Pembrolizumab helps the immune system fight tumor cells by blocking the interaction between PD-1, a cell surface receptor expressed on T cells and pro-B cells, and its ligands PD-L1 and PD-L2. PD-1 is an immune checkpoint which down regulates the immune system. Blocking its action activates the immune system to attack cancer cells.
The good news has apparently spread to NewLink Genetics (NLNK +17.1%) who inked a development deal in October 2014 with Roche's (OTCQX:RHHBY) Genentech for IDO candidate GDC-0919.
Thinly traded micro cap NewLink Genetics (NLNK +8%) perks up on increased volume in response to a Bloomberg report that its experimental Ebola vaccine, rVSV-ZEBOV, licensed to Merck (MRK +0.2%) in 2014, showed promising efficacy in an 11,000-person study in Guinea. The results were just published in The Lancet.
Of the people who received the vaccine (one shot) in the final stage of the trial, no cases of Ebola were recorded after a 10-day incubation period. An earlier study showed rVSV-ZEBOV to be 100% effective in people who were in close contact with Ebola patients in Guinea.
The vaccine candidate has Breakthrough Therapy status in the U.S. which is designed to accelerate the regulatory review process.
The Ebola outbreak from 2013 - 2016 in West Africa claimed 11,300 lives before exhausting itself.
Merck (MRK -0.4%) announces that its experimental Ebola vaccine, V920 (rVSVdeltaG-ZEBOV-GP, live attenuation) has received accelerated review status in the U.S. and EU.
The FDA has tagged V920 a Breakthrough Therapy which provides for more intensive guidance from the FDA review team, the involvement of more senior agency personnel and a rolling review of the New Drug Application (NDA).
The European Medicines Agency (EMA) has granted PRIME status to V920 which provides early and proactive support from the regulator, including the appointment of a liaison called a rapporteur, with the aim of optimizing clinical trial design as well as accelerated review of the Marketing Authorization Application (MAA).
Merck licensed V920 from NewLink Genetics (NLNK +1.6%) in late 2014.
NewLink Genetics (NASDAQ:NLNK) -32.1% AH after announcing that its investigational immunotherapy for resected pancreatic cancer did not achieve its primary endpoint.
Patients in one part of the study received the investigational immunotherapy called algenpantucel L along with a standard-of-care treatment, compared with the traditional treatment alone; NLNK says there was no statistical difference between the two groups for overall survival time or for long-term survival.