Aileron Therapeutics, of Cambridge, Mass., and Roche Holdings AG, of Basel, Switzerland, expanded their collaboration to develop and commercialize stapled peptide drugs. The potential $1.1 billion drug development collaboration, launched in August 2010, encompassed up to five programs of strategic importance to Roche; initially Aileron launched the collaboration around two key programs in oncology. Aileron and Roche will now work on a third program in inflammatory diseases. Aileron also said it achieved a key milestone under the collaboration related to in vivo proof of concept, triggering a milestone payment. Financial terms were not disclosed. (See BioWorld Today, Aug. 31, 2010.)
Aldagen Inc., of Durham, N.C., published a paper in the Journal of Stem Cell Research & Therapy describing the mechanisms by which its cell therapy products promoted formation of new blood vessels in ischemic tissues. The products induced expression of angiogenic genes encoding soluble growth factors, regulatory molecules and extracellular molecules that protect endothelial tubules from hypoxia-induced damage. Aldagen has clinical-stage programs targeting ischemia in the heart, brain and limbs.
Amsterdam Molecular Therapeutics NV, of Amsterdam, the Netherlands, received orphan drug designation from the European Medicines Agency for its hemophilia B gene therapy. A Phase I/II trial is ongoing with the treatment, which consists of an adeno-associated viral vector containing the human factor IX gene.
Genzyme Corp., the Cambridge, Mass.-based subsidiary of Sanofi SA, formed a research collaboration with Cystic Fibrosis Foundation Therapeutics Inc., the nonprofit affiliate of the Cystic Fibrosis Foundation. The collaboration will focus on the discovery of drugs to treat cystic fibrosis patients with the Delta F508 mutation. Terms were not disclosed.
Gilead Sciences Inc., of Foster City, Calif., signed a license agreement with Tibotec Pharmaceuticals, a unit of New Brunswick, N.J.-based Johnson & Johnson, to develop and commercialize a single-tablet HIV regimen combining Prezista (darunavir) with Gilead's Emtriva (emtricitabine); its investigational agent GS 7340, a prodrug of tenofovir; and cobicistat, a pharmacoenhancer. Gilead will be responsible for the formulation, manufacturing, registration and, subject to regulatory approval, distribution and commercialization of the single-tablet regimen worldwide. Tibotec will have the right to co-detail the single-tablet regimen in certain major markets. Additional terms were not disclosed. Gilead first partnered with Tibotec in July 2009 to develop and commercialize a single-tablet regimen combining Truvada (emtricitabine/tenofovir disoproxil fumarate) and Edurant (rilpivirine), which was approved in August as Complera. (See BioWorld Today, July 20, 2009, and Aug. 12, 2011.)
OncoSec Medical Inc. and Serametrix Corp., both of San Diego, inked a collaborative research agreement to analyze subjects in three OncoSec Phase II trials treating melanoma, Merkel cell carcinoma and cutaneous T-cell lymphoma. The companies will seek to identify biomarkers that may refine and enhance the selection of patients potentially responsive to OncoSec's OMS electroimmunotherapy treatments. Financial terms were not disclosed.
Sunshine Biopharma Inc., of Montreal, completed preclinical studies of Adva-27a, a topoisomerase II inhibitor with relevance in breast cancer. The drug was found to be more effective at killing multidrug-resistant breast cancer cells than chemotherapy drug etoposide, with good pharmacokinetics and clearance time. Sunshine said it will now begin investigational new drug application enabling studies.