Akaal Pharma Pty Ltd., of Melbourne, Australia, published positive preclinical studies of safety and efficacy of its AKP-11 in comparison with Gilenya (fingolimod, Novartis AG). Gilenya is FDA-approved to treat relapsing-remitting multiple sclerosis. Efficacy and safety of the Sphingosine 1-phosphate receptor-1 modulator AKP-11 was determined using in vitro cell culture and animal model experimental autoimmune encephalomyelitis, a rat model.
Arqule Inc., of Burlington, Mass., and Daiichi Sankyo Co. Ltd., of Tokyo, reported that the phase III METIV-HCC trial for tivantinib in second-line hepatocellular carcinoma (HCC) has completed accrual. In addition, the planned interim analysis, which is triggered when 60 percent of events occur, is expected to take place early in the second quarter of 2016, the companies said. The trial is conducted under a special protocol assessment and has accrued more than 300 HCC patients with MET-high tumors, as determined by an immunohistochemistry test.
Astellas Pharma Inc., of Tokyo, said results from the pivotal phase III SECURE trial evaluating Cresemba (isavuconazonium sulfate) in adult patients with invasive aspergillosis were published in The Lancet. The article, "Isavuconazole versus voriconazole for primary treatment of invasive mould disease caused by Aspergillus and other filamentous fungi (SECURE): a phase 3, randomised-controlled, non-inferiority trial," appears in the Dec. 9 online issue. Data showed Cresemba demonstrated noninferiority to voriconazole on the primary endpoint of all-cause mortality through day 42 in patients with proven, probable or possible invasive fungal disease. All-cause mortality through day 42 in the intent-to-treat population was 18.6 percent in the Cresemba group and 20.2 percent in the voriconazole group. Cresemba is co-developed with Basilea Pharmaceutica Ltd., of Basel, Switzerland, and was launched in the U.S. by Astellas in 2015.
Bellicum Pharmaceuticals Inc., of Houston, and Astellas Pharma Inc., of Tokyo, said Astellas affiliate Agensys Inc. and Bellicum entered a global license agreement, granting Bellicum rights to develop and commercialize adoptive cell therapies, including CAR T cells, for tumors expressing prostate stem cell antigen (PSCA) using PSCA technology, both in-licensed and developed at Agensys. Terms were not disclosed.
Bionomics Ltd., of Adelaide, Australia, said it identified an additional market opportunity for its anxiety drug, BNC210, to treat post-traumatic stress disorder, which will be evaluated in a phase II trial funded by a $12 million private placement from four U.S. institutional investors. The trial is expected to begin in the first half of 2016, with patients to be recruited at several sites in Australia and New Zealand.
Dimerix Ltd., of Melbourne, Australia, said the FDA granted orphan designation to propagermanium and irbesartan, the constituent parts of its drug candidate, DMX-200, for the treatment of focal segmental glomerulosclerosis (FSGS), a leading cause of chronic kidney disease. A progressive form of kidney cancer, FSGS is estimated to account for 2.3 percent of patients with end-stage renal disease. DMX-200 is in a single-arm, open-label phase II trial in adults with chronic kidney disease, with proteinuria, with primary endpoints evaluating the incidence and severity of adverse events and the clinically significant changes in the safety profile of participants.
Hutchison China Meditech Ltd., of Hong Kong, reported that its subsidiary, Hutchison Medipharma Ltd., initiated FALUCA, a phase III registration study for fruquintinib (HMPL-013) in third-line nonsquamous non-small-cell lung cancer patients in China. Fruquintinib is an investigational small molecule which selectively inhibits vascular endothelial growth factor receptors (VEGFR). FALUCA is a randomized, double-blind, placebo-controlled experiment designed to treat patients who have failed two lines of systemic chemotherapy. Patients will be randomized at a 2-to-1 ratio to receive either 5 mg of fruquintinib orally once per day, on a three-weeks-on/one-week-off cycle, plus best supportive care (BSC); or placebo plus BSC. The primary endpoint is overall survival. HMP plans to enroll approximately 520 patients in China with top-line results expected in 2017.In other news, Shanghai Hutchison Pharmaceuticals Ltd. (SHPL), its 50-50 joint venture with a subsidiary of Shanghai Pharmaceuticals Holding Co. Ltd., entered an agreement with the Shanghai government for the surrender of SHPL's remaining 36 years land-use rights on its approximately 58,000-square-meter old factory site in Shanghai. Under the terms, SHPL will receive cash compensation of $105 million, in three stages over a period of about one year.
Prima Biomed Ltd., of Sydney, said a preclinical collaboration with Tokyo-based NEC Corp. and Yamaguchi University to combine Prima's IMP321 antigen-presenting cell activator with a therapeutic vaccine to treat various forms of carcinoma produced favorable safety data, resulting in a decision to move the vaccine into development. Under a material transfer agreement, Yamaguchi will begin to design a clinical program in cancer patients, which is expected to be initiated in Japan in the first quarter of 2016. NEC will provide support for the proof-of-concept research.
S1 Biopharma Inc., of New York, and Chong Kun Dang Pharmaceutical Corp. (CKD), of Seoul, South Korea, entered a commercialization agreement for Lorexys (S1P-104), S1 Biopharma's investigational therapy currently positioned to advance to a phase IIb trial for treatment of hypoactive sexual desire disorder (HSDD) in women. Under terms of the deal, CKD acquires rights to commercialize Lorexys throughout South Korea. The terms include an undisclosed up-front payment to S1 Biopharma and additional payments based on milestones as well as royalties on future product sales. CKD also has right of first refusal for commercialization agreements related to additional potential indications for Lorexys.
Sinovac Biotech Ltd., of Beijing, said it received approval to start human trials of its Sabin Inactivated Polio Vaccine, or sIPV, candidate, and is currently finalizing the clinical trial protocol based on the clinical trial license. The trials, aimed at selecting the dosage and evaluating safety and immunogenicity of the vaccine, are set to start in the first half of 2016 and are expected to be completed by 2018.
Starpharma Holdings Ltd., of Melbourne, Australia, said it raised A$32 million (US$23.1 million) via a private placement to domestic and international institutional investors. Eligible shareholders will also have the opportunity to participate, at the same price, through a share purchase plan to will raise up to a further A$3 million. The placement was conducted at A73 cents per share. Proceeds will be used to support advancement of the business, including the DEP docetaxel phase II program and the acceleration of further DEP drug delivery candidates into the clinic. Funds also will support the licensing, approvals and launches of the Vivagel BV symptomatic relief product and the completion of the phase III studies of Vivagel for prevention of recurrent bacterial vaginosis. Bell Potter Securities Ltd. and Canaccord Genuity acted as joint lead managers.
Takeda Pharmaceutical Co. Ltd., of Osaka, Japan, and Cour Pharmaceutical Development Co. Inc., of Chicago, are partnering to develop immune-modulating therapies for the potential treatment of celiac disease. The partnership will focus on using nanotechnologies based on Cour's Tolerizing Immune Modifying Nanoparticle (TIMP) platform, which can be extended to certain autoimmune and allergic conditions by inhibiting the abnormal immune responses that cause disease, without affecting the beneficial parts of the immune system. The collaboration will explore the potential of TIMP therapy to allow celiac patients to tolerate gluten in their diets. Cour will receive up-front and success-based milestone payments from Takeda leading to an exclusive option to acquire a global license to the TIMP-GLIA program after the completion of the phase IIa trial. Cour will also receive royalties on sales of any successful commercialized products resulting from the partnership. Takeda will have the option to collaborate on up to three additional TIMP compounds each with development, regulatory and sales milestones and royalties on sales. Further terms were not disclosed.
Viralytics Ltd., of Sydney, said it completed a placement of 46.1 million shares at $0.615 each to generate $28.36 million. As a result of the placement Orbimed Advisors has become a substantial shareholder. Existing shareholders who participated in the financing included the Biotechnology Value Fund L.P. and other affiliates of BVF Partners L.P.