Bionor Pharma ASA, of Oslo, Norway, said it assembled a clinical study advisory board to design a proof-of-principle study of T-cell vaccine candidate Vacc-4x together with a latency reversing agent. It was determined the company should plan a randomized, double-blind, placebo-controlled phase II study aimed at investigating the contribution of Vacc-4x as a component in a functional cure for HIV. The study will be conducted as an international trial that may include multiple sites in Europe, the U.S. and Australia.

Circadian Technologies Ltd., of Melbourne, Australia, presented preclinical data at the annual Association for Research in Vision and Ophthalmology conference in Denver demonstrating efficacy with targeted therapy OPT-302 (VGX-300). The data demonstrate that OPT-302 reduced blood vessel growth and vessel leakage in a mouse model of wet age-related macular degeneration, either as a monotherapy or in combination with the VEGF-A inhibitor Eylea (aflibercept, Regeneron Pharmaceuticals Inc.).

Novogen Ltd., of Sydney, said preclinical data suggested that its cancer drug candidate, TRXE-009, killed diffuse intrinsic pontine glioma, or DIPG, cells at therapeutically relevant concentrations by inducing caspase-dependent apoptosis. TRXE-009 showed a high therapeutic index and was able to target cancer cells at concentrations having little effect on normal cells. The data were presented at the Biennial Conference on Pediatric Neuro-Oncology Basic and Translational Research in San Diego. Novogen plans to advance the candidate into the clinic in 2016 to treat solid tumors.

Scientists from the Japanese Osaka University have gained new insights into signaling mechanisms that drive pulmonary arterial hypertension (PAH), a life-threatening disease that develops when the arteries in the lungs narrow and blood pressure rises, forcing the heart into overtime work. Previous work had implicated the proinflammatory cytokine interleukin-6 (IL-6) in PAH, but the processes set off by IL-6 signaling had not been worked out. The authors showed that IL-6 recruited proinflammatory immune system cells to the arteries, a process that could be prevented by treating animals with an anti-IL-6 antibody. Downstream signaling from IL-6 included IL-21, TH17 T cells and M2 macrophages, and the authors showed that "these findings suggest promising therapeutic strategies for PAH targeting IL-6/IL-21– signaling axis." Their findings appeared in the May 4, 2015, online issue of the Proceedings of the National Academy of Sciences.

Plexxikon Inc., of Berkeley, Calif., a member of Tokyo-based Daiichi Sankyo Group, and Merck & Co. Inc., of Kenilworth, N.J., said they are collaborating on a clinical trial to evaluate the combination of PLX3397, Plexxikon's CSF-1R inhibitor, with Keytruda (pembrolizumab), Merck's anti-PD-1 therapy. The phase I/II trial will enroll patients with advanced melanoma and multiple other solid tumors with the goal of determining the safety and tolerability of the combination therapy. The trial is expected to begin enrollment by midyear.

Prima Biomed Ltd., of Sydney, disclosed a collaboration with Nec Corp., of Tokyo, and Yamaguchi University in Yamaguchi, Japan, for Orsay, France-based Immutep SA's IMP321 in combination with a peptide vaccine developed by Nec and Yamaguchi University. The study, to be conducted at Yamaguchi University and supported by Nec, will investigate the use of antigen presenting cell activator IMP321 as an adjuvant, together with peptide antigens believed to be involved in hepatocellular cancer.

Specialised Therapeutics Australia, of Melbourne, Australia, and Helsinn Group, of Lugano, Switzerland, said the Therapeutic Goods Administration approved Akynzeo (netupitant/palonosetron) to prevent acute and delayed nausea and vomiting associated with initial and repeat courses of moderately and highly emetogenic cancer chemotherapy (CINV). The companies said the drug is the first approved fixed-dose combination oral agent to target two signaling pathways associated with CINV by combining an NK1 receptor antagonist and a 5-HT3 receptor antagonist in a single capsule.

Sumitomo Dainippon Pharma Co. Ltd., of Osaka, Japan, and Takeda Pharmaceutical Co. Ltd., also of Osaka, said their license agreement, inked in 2011 for the joint development and exclusive commercialization of pharmaceutical products containing lurasidone hydrochloride (Latuda), an atypical antipsychotic agent, in Europe, will be terminated. Takeda's right to develop and commercialize Latuda within 26 member states of the European Union (excluding the UK), Switzerland, Norway, Turkey and Russia, will transfer back to Sumitomo Dainippon upon the effective date of the termination. The companies said the move is based on market and business considerations of Takeda and is not the result of new safety or efficacy information on Latuda, an atypical antipsychotic designed to have an affinity for dopamine D2, serotonin 5-HT2A and serotonin 5-HT7 receptors where it has antagonist effects.