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 www.sorrentotherapeutics.com.
About IGDRASOL
IGDRASOL’s lead therapeutic platform is Cynviloq, a branded micellar paclitaxel formulation which is free of cremophor and human serum albumin (HSA), the excipients for Taxol® (cremophor-based paclitaxel) and albumin-bound paclitaxel (Abraxane®), respectively. Cynviloq combines the simplicity of manufacturing and preparation of Taxol® and potentially the albumin-mediated transport of paclitaxel. IGDRASOL intends to conduct registration trials for multiple cancer indications.
The executives of IGDRASOL are a group of pharmaceutical veterans who believe that personalized paclitaxel nanoparticle therapy will present a paradigm shift in the delivery of chemotherapeutic agents. To learn more about IGDRASOL’s mission, please visit its website (http://www.igdrasol.com).
Forward-Looking Statements
This press release contains forward-looking statements subject to risks and uncertainties that could cause actual results to differ materially from those projected. Words such as “plans,” “believes,” “expects,” “anticipates,” and “will,” and similar expressions, are intended to identify forward-looking statements. Forward-looking statements include statements about the potential combination of STI and IGDRASOL and the synergies and prospects for a combined enterprise going forward; and the clinical development and commercial potential of Cynviloq. All such forward-looking statements are based on STI’s current beliefs and expectations, and should not be regarded as a representation by STI that any of its plans will be achieved. Actual results may differ materially from those set forth in this press release due to the risks and uncertainties inherent in STI’s and IGDRASOL’s businesses, including: whether STI will have sufficient cash and other resources to exercise the option and ultimately acquire IGDRASOL; the potential that STI and the combined company may require substantial additional funding in order to obtain regulatory approval for and commercialize any oncology products; the risk that delays in the regulatory approval or commercial launch of Cynviloq will enable competitors to further entrench existing products, or develop and bring new competing products to market before the approval, if any, of Cynviloq; the scope and validity of patent protection for Cynviloq as well as STI’s and IGDRASOL’s platform technologies, and the risk that the development or commercialization of product candidates may infringe the intellectual property rights of others; and additional risks set forth in Sorrento Therapeutics’ filings with the Securities and Exchange Commission. These forward-looking statements represent Sorrento Therapeutics’ judgment as of the date of this release. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement and STI undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof. This caution is made under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995.
Genexol-PM® is a registered trademark of Samyang Corporation; Abraxane® is a registered trademark of Celgene, Inc; Taxol® is a registered trademark of Bristol-Myers Squibb, Inc.
SOURCE Sorrento Therapeutics, Inc.
