Privately held Syndax Pharmaceuticals is pairing its breakthrough-designated cancer drug with an in-development immunotherapy from Merck KGaA and Pfizer, hoping to hit upon a winning clinical combination.
The companies say that these two Phase III studies bring the late-stage program up to 6 studies, meeting their goal for 2015.
Threshold Pharmaceuticals, whose Merck KGaA-partnered oncology therapy failed in a pair of trials this month, is laying off the majority of its workers and rallying around a midstage cancer drug.
Fresh off its latest major setback in R&D, Merck KGaA is marshaling the big euros in an attempt to make 2016 its long-awaited turnaround year in drug development. And it's reserving most of its chips for a big gamble on immuno-oncology.
The clinical misery at Merck KGaA is continuing unabated this week. The German pharma company reported early today that its cancer therapy TH-302 failed both Phase III studies, forcing it to abandon two indications while reconsidering its commitment to a drug that has long been hailed as a top program in their pipeline.
Merck KGaA and Pfizer have bagged FDA breakthrough therapy designation for avelumab, the pair's anti-PD-L1 monoclonal antibody. And while the immunotherapy is lagging behind rivals' PD-1 and PD-L1 drugs in some indications, Merck KGaA and Pfizer think the breakthrough status could help them steal a lead in metastatic Merkel cell carcinoma.
Partners Merck KGaA and Pfizer are looking to prove their 5th-place immuno-oncology treatment can contend with the leaders in the field, launching a late-stage lung cancer study to establish the antibody's promise.
Merck KGaA has teamed up with Selvita to discover small molecule drugs against multiple oncology indications. The alliance builds on an earlier two-year research collaboration into the discovery of enzyme inhibitors to regulate metabolic processes in cancer cells.
Merck KGaA, long troubled by pipeline setbacks, said it's back on track thanks to some high-profile partnerships and a particular focus on immuno-oncology.
Merck KGaA and Pfizer, playing catch-up among drug companies using the immune system to fight cancer, picked up the FDA's fast-track designation for their in-development therapy, designed to expedite its eventual review.