An increasing number of anticancer agents has been proposed in recent years with the attempt to overcome treatment-resistant cancer cells and particularly cancer stem cells (CSC), the major culprits for tumour resistance and recurrence. However, a huge obstacle to treatment success is the ineffective delivery of drugs within the tumour environment due to limited solubility, short circulation time or inconsistent stability of compounds that, together with concomitant dose-limiting systemic toxicity, contribute to hamper the achievement of therapeutic drug concentrations. The synthetic retinoid Fenretinide (4-hydroxy (phenyl)retinamide; 4-HPR) formerly emerged as a promising anticancer agent based on pre-clinical and clinical studies. However, a major limitation of fenretinide is traditionally represented by its poor aqueous solubility/bioavailability due to its hydrophobic nature, that undermined the clinical success of previous clinical trials. Here, we developed a novel nano-micellar fenretinide formulation called bionanofenretinide (Bio-nFeR), based on drug encapsulation in an ion-pair stabilized lipid matrix, with the aim to raise fenretinide bioavailability and antitumour efficacy. Bio-nFeR displayed marked antitumour activity against lung, colon and melanoma CSC both in vitro and in tumour xenografts, in absence of mice toxicity. Bio-nFeR is suitable for oral administration, reaching therapeutic concentrations within tumours and an unprecedented therapeutic activity in vivo as single agent. Altogether, our results indicate Bio-nFeR as a novel anticancer agent with low toxicity and high activity against tumourigenic cells, potentially useful for the treatment of solid tumours of multiple origin.

The Developing Countries Vaccine Manufacturing Network coordinated a multi-laboratory study funded by the US National Institute for Innovation in Manufacturing Biopharmaceuticals to assess the performance of the Pertussis Serological Potency Test (PSPT) in the laboratories of seven whole-cell pertussis vaccine (wP) manufacturers and three National Control Laboratories based in Southeast Asian countries. To this end, common protocols for the immunization of mice and serological testing by ELISA were shared with all laboratories. Each laboratory used their own wP vaccines and the reference vaccine routinely used in the regulatory required mouse protection test (MPT) and assayed the products both in the MPT and PSPT. Whereas in all laboratories the PSPT showed decreased serum IgG levels after immunization with sub-potent compared to potent final batches, some issues were encountered during execution of the assay, which prevented drawing of definitive conclusions on assay performance. Nevertheless, the study provided the participants with the opportunity to familiarize themselves with the PSPT protocols and revealed the next steps to be addressed for implementation of the method.