SAN DIEGO and FOUNTAIN VALLEY, Calif., April 8, 2013 /PRNewswire/ -- Sorrento Therapeutics, Inc. ("STI"; SRNE) and IGDRASOL announced today that IGDRASOL will be presenting updates of its analysis of proprietary late clinical stage NBN-Pac formulations, namely IG-001 (Cynviloq) and IG-004 (a D-a-tocopheryl polyethylene glycol succinate (TPGS)-based paclitaxel formulation) at the annual Nanomedicine 2013 meeting in Barcelona, Spain (April 11th - 12th). IGDRASOL is a privately-held company for which STI was granted an irrevocable option right to acquire. The two companies' combined pipeline features an oncology franchise of potential products with Phase 2/3 data for multiple solid tumor indications as well as two synergistic drug discovery and development platforms, namely the G-MAB human antibody library and MABiT, a proprietary technology to generate antibody formulated drug conjugates (AfDC).
Cynviloq (or IG-001) is a next-generation, branded, micellar diblock copolymeric paclitaxel formulation currently approved and marketed in several countries as Genexol-PM. Cynviloq has completed Phase 1 or 2 trials in MBC, NSCLC, pancreatic cancer, ovarian cancer and bladder cancer in the US and/or non-US. IGDRASOL is preparing for an "End of Phase 2" meeting with the U.S. Food & Drug Administration (FDA) targeted for the first half of 2013 regarding Cynviloq. As an injectable nanoparticle formulation of paclitaxel, Cynviloq is potentially eligible for approval via FDA's 505(b)(2) regulatory pathway versus albumin-bound paclitaxel (nab-paclitaxel; Abraxane) in its currently approved metastatic breast cancer (MBC) and non-small cell lung cancer (NSCLC) indications.
IG-004 (formerly known as TOCOSOL paclitaxel) is a TPGS-based emulsion of paclitaxel, which was recently acquired from OncoGenex Pharmaceuticals, Inc. (OGXI). IG-004 has completed Phase 2 trials in NSCLC, pancreatic cancer, ovarian cancer, colorectal cancer or bladder cancer as well as completed Phase 3 studies in MBC in the US and/or non-US. IGDRASOL recently acquired the IG-004 portfolio asset from OncoGenex. IGDRASOL plans to reexamine the clinical data of IG-004 to map out the best path forward given the benefit of hindsight.
"We intend to leverage our comprehensive domain knowledge of paclitaxel nanoparticle formulations to build a franchise of next generation paclitaxel nanomedicines. I am convinced that our team who played a key role in the development and success of Abraxane will be able to do it here again," said Vuong Trieu Ph.D., Chief Executive Officer of IGDRASOL.
Also, the acquisition of TOCOSOL paclitaxel allows IGDRASOL to compare and contrast stable paclitaxel nanoparticles (TOCOSOL paclitaxel) versus plasma-unstable paclitaxel nanoparticles (Abraxane and Genexol-PM). Data mining of these large databases have generated exciting insights into the field of nanomedicine.
Some of the findings are being presented at Nanomedicine 2013, April 11th -12th, Barcelona, Spain. The presentation is entitled: "Non-biologic Nanoparticle Paclitaxel for the Treatment of Cancer" authored by:Vuong Trieu, Catherine Cheng, Larn Hwang, Chao Hsiao, and Kouros Motamed.
About Cynviloq
Cynviloq (or IG-001; a paclitaxel-loaded micellar diblock copolymer) is a next-generation branded paclitaxel formulation currently approved and on the market in several countries as Genexol-PM.
About Sorrento Therapeutics, Inc.
Sorrento Therapeutics, Inc. ("STI"; SRNE) is a publicly-traded, development-stage biopharmaceutical company focused on the discovery, development and commercialization of novel and proprietary biotherapeutics for the treatment of a variety of disease conditions, including cancer, inflammation, metabolic and infectious diseases. STI's objective is to identify drug development candidates derived from its proprietary human antibody libraries and, either independently or through partnerships, advance selected targets into preclinical or clinical development. In 2012, STI identified and further developed a number of potential drug product candidates across various therapeutic areas, and STI intends to select several lead product candidates to progress into preclinical development activities in 2013. More information is available at http://www.sorrentotherapeutics.com.
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Sorrento Therapeutics, Inc. and IGDRASOL Announce Presentation on Non-Biologic Nanoparticle paclitaxel (NBN-Pac ...