Aduro Biotech Inc., of Berkeley, Calif., launched a collaboration with the University of California (UC) Berkeley to establish the Immunotherapeutics and Vaccine Research Initiative, combining UC Berkeley's research capabilities with the company's expertise in immunotherapy discovery and development to identify and advance new treatment options and preventive modalities for cancer, infectious disease and autoimmune disease. Terms were not disclosed.
Alexion Pharmaceuticals Inc., of New Haven, Conn., said Japan's Ministry of Health, Labor and Welfare has approved Kanuma (sebelipase alfa) for the treatment of patients of all ages in Japan with lysosomal acid lipase deficiency (LAL-D). Kanuma, an enzyme replacement therapy, is the first therapy approved in Japan for the treatment of patients with LAL-D, a genetic and progressive ultra-rare metabolic disease in which patients suffer multi-organ damage and premature death. Alexion said it expects that initial patients with LAL-D in Japan will start commercial treatment with Kanuma in the third quarter.
Aralez Pharmaceuticals Inc., of Milton, Ontario, said the FDA acknowledged acceptance of the new drug application for its investigational candidate, Yosprala (PA32540/PA8140), for the secondary prevention of cardiovascular disease in patients at risk for aspirin-induced gastric ulcers. The PDUFA date is Sept. 14. The company has developed an investigational aspirin therapy, known as Yosprala 81/40, containing 81 mg of aspirin, and Yosprala 325/40, containing 325 mg of aspirin. Both products are a coordinated-delivery tablet combining immediate-release omeprazole (40 mg), a proton pump inhibitor, layered around a pH-sensitive coating of an aspirin core developed with the goal of significantly reducing gastrointestinal (GI) ulcers and other GI complications compared to taking enteric-coated or plain aspirin alone.
Eagle Pharmaceuticals Inc., of Woodcliff Lake, N.J., entered an agreement with the National Institute on Drug Abuse (NIDA) to explore the use of Ryanodex (dantrolene) in the treatment of hyperthermia related to 3,4-methylenedioxy-methamphetamine (Ecstasy) and methamphetamine intoxication, a life-threatening condition mostly affecting adolescents and young adults. The preclinical studies will be conducted by NIDA beginning in the summer of 2016 utilizing a well-characterized animal model, the company said. Initial results of the focused studies are anticipated in late 2016 or early 2017. The drug was approved for malignant hyperthermia in 2014.
Eiger Biopharmaceuticals Inc., of Palo Alto, Calif., said ubenimex, its oral, small-molecule, dual-inhibitor of aminopeptidase and leukotriene A4 hydrolase, gained orphan status from the EMA for the treatment of pulmonary arterial hypertension (PAH). The company will soon begin enrolling LIBERTY, a phase II, randomized, double-blind, placebo-controlled study of ubenimex in PAH patients. (See BioWorld Today, July 23, 2015.)
Emulate Inc., of Cambridge, Mass., said it secured $28 million of its series B financing to accelerate translation of its Organs-on-Chips technology into a commercially available Human Emulation System, a lab-ready automated system designed to enable researchers and product development teams to work with a human-relevant system in their existing R&D workflows. The Organs-on-Chips technology aims to offer greater precision and control than cell culture or animal-based experimental methods. Existing investors Hansjörg Wyss, Nanodimension and Cedars-Sinai Medical Center participated in the financing, as well as new investors OS Fund, Atel Ventures, ALS Finding a Cure and a fourth unnamed investor. (See BioWorld Today, June 22, 2015.)
Forge Therapeutics Inc., of San Diego, and Carlsbad, Calif.-based Active Motif Inc., formed a research collaboration aimed at advancing epigenetic research related to the family of iron-containing lysine demethylases known as Jumonji KDMs. The companies aim to validate emerging epigenetic targets for oncology indications and demonstrate the "druggability" of Jumonji KDMs.
Kamada Ltd., of Ness Ziona, Israel, submitted an EMA marketing authorization application for the company's inhaled alpha-1 antitrypsin (AAT) therapy as a treatment for AAT deficiency.
Ligand Pharmaceuticals Inc., of San Diego, entered a global license agreement allowing Abba Therapeutics AG, of Basel, Switzerland, to use its Omnirat, Omnimouse and Omniflic platforms to generate fully human mono- and bispecific antibodies. Ligand is set to receive an undisclosed initial access payment and will be eligible for clinical milestone payments and royalties on each successful Omniab antibody. Abba will be responsible for costs related to the program.
Medicortex Finland Oy, of Turku, Finland, a start-up focused on the diagnosis and treatment of neurodegenerative conditions, said it launched a funding round, seeking investors to support R&D for a therapeutic and companion diagnostic test for traumatic brain injury.
Monosol Rx, of Warren, N.J., said it completed a pilot pharmacokinetic study and, following a pre-investigational new drug application meeting with the FDA, plans to continue its efforts to develop Pharmfilm tadalafil to treat erectile dysfunction.
Oxis Biotech Inc., of Los Angeles, a wholly owned subsidiary of Oxis International Inc., said it continues to focus on a cure for the Zika virus, based on the work of Sean Xie, a research scientist, professor of pharmacology at the University of Pittsburgh and a member of the company's scientific advisory board, who identified small-molecule chemical inhibitors that target nonstructural proteins with the potential to block Zika virus replication.