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
). 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.