Nippon Kayaku PhII breast cancer candidate misses endpoint

Lab work
Clinical work

Tokyo-based Nippon Kayaku said a Phase III study of in-licensed breast cancer candidate NK105 missed its primary endpoint--with the specialty chemical and niche pharmaceutical and diagnostics firm slated to provide efficacy and safety details of the study at an unspecified, future scientific congress.

The micellar candidate was compared in the late-stage trial against paclitaxel (Taxol, Onxal) and was licensed from Tokyo-based NanoCarrier--which said in a separate statement that this would not impact its pipeline. Both firms are listed on the Tokyo exchange.

NanoCarrier said: "The basic technology used in NK105 is physically entrapping drugs into the nanomicelles. It was known that retention of paclitaxel itself in human plasma half-life was approximately 30 minutes. By contrast, the human plasma half-life could be prolonged more than 10 hours by slower release effect of the miceller technologies licensed to Nippon Kayaku. Therefore, it was placed an expectation on NK105 for clinical contribution.

"On the other hand, our current pipeline such as NC-6004, NC-4016 and NC-6300 has been developed by using the second generation of NanoCarrier’s technology, in which drug was chemically conjugated in polymer inside micelles. This technology is extremely innovative for the performance of control release and shows superiorly prolonged the human plasma half-life more than 100 hours in the case of NC-6004 and NC-4016. We strongly believe that the controlled drug release exerts a significant degree of impact on the drug efficacy and the reduction of side effects in cancer patients."

Nippon Kayaku has a wide-ranging portfolio of oncology drugs, including related therapies in pain relief. It's also a significant active pharmaceutical ingredient (API) supplier with plans to develop biosimilars in cancer and autoimmune therapies.

- here's the release from Nippon Kayaku
- and one from NanoCarrier