A Phase I/II trial of an unusual two-part therapeutic for brain cancer is under way, according to Tocagen Inc. The San Diego-based company has already dosed its first patient cohort, at the first dose, and received a green light from an independent data monitoring committee to progress to the second dose.
Clovis Oncology Inc. picked up another clinical-stage compound to add to its pipeline of cancer products. The Boulder, Colo.-based company will pay an undisclosed upfront fee to Pfizer Inc., plus potential milestones of $255 million, in exchange for the right to develop and commercialize the drug. In turn, Pfizer Venture Investments will make an equity investment in Clovis.
Seaside Therapeutics Inc. will begin a landmark Phase III trial to evaluate the efficacy of a drug candidate against the core symptoms of Fragile X syndrome.
AltheRx is not like "all of the other Rx's," CEO Shawn Patrick O'Brien told BioWorld Today. The Chadds Ford, Pa.-based company derives its name from Althea, a Greek mythological figure associated with healing. AltheRx's mission is to develop therapies for genitourinary diseases by means of acquiring products that have been discontinued by major pharmaceutical companies.
Elan Corp. has committed as much as $50 million in a new approach to neurodegenerative disease being pioneered by Cambridge, Mass.-based Proteostasis Therapeutics Inc. The alliance will make use of Proteostasis assets and expertise in protein folding to identify and advance molecular entities that prevent misfolding of protein.
Glenmark Pharmaceuticals SA, a subsidiary of Glenmark Pharmaceuticals Ltd. India, based in Mumbai, licensed its monoclonal antibody GBR 500 to Paris-based Sanofi-Aventis SA for an up-front payment of $50 million, plus potential future milestone payments and double-digit royalties, for a total deal value up to $613 million. Glenmark said the deal is the largest of its kind from an emerging market, and is the first example of a novel biologic entity being licensed out of an emerging market.
Interim review of a Phase III trial by the National Institute of Allergy and Infectious Diseases (NIAID) showed a striking benefit of the use of antiretroviral therapy for the partners of HIV-infected individuals. An independent data and safety monitoring board (DSMB) released the results ahead of the trial's scheduled 2015 end date because the results were so clear.
CNS company Naurex Inc., of Evanston Ill., completed an $18 million Series A financing for Phase II trials of its lead depression compound, GLYX-13. At the same time, Prexa Pharmaceuticals, of Boston, landed a $7 million Series B to advance triple reuptake inhibitor PRX-12251 into Phase Ib.
Kite Pharma Inc. is a new company created to pursue what its leadership described as "the next therapeutic modality" in treating cancer: recruiting the body's own immune system to fight malignancies. Its pipeline of immunotherapeutic candidates combines tumor-specific antigens and targeted immune-activating components.