San Diego, CA and Irvine, CA –July 1, 2013. Sorrento Therapeutics, Inc. (OTCQB: SRNE; Sorrento) and IGDRASOL announced today that the companies will present Phase III interim data analysis of Cynviloq in metastatic breast cancer (MBC) patients showing significantly improved overall response rate (ORR) compared to generic paclitaxel as well as updates of their nanomedicine platform, which is being developed for multiple cancer indications in late-stage clinical trials, at the 4th International Nanomedicine Conference in Sydney Australia (July 1st – 3rd, 2013). Sorrento has the right to acquire IGDRASOL pursuant to a previously-announced option agreement, entered into in March 2013.
Cynviloq™ (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, non-small cell lung cancer (NSCLC), pancreatic cancer, ovarian cancer and bladder cancer in the U.S. and/or ex-U.S. IGDRASOL is preparing for an “End of Phase 2” meeting scheduled with the U.S. Food & Drug Administration (FDA) in July 2013, regarding the clinical development of Cynviloq™. As an injectable nanoparticle formulation of paclitaxel, Cynviloq™ may be eligible for approval through the FDA’s 505(b)(2) bioequivalence regulatory pathway versus albumin-bound paclitaxel (nab-paclitaxel; Abraxane®) in its currently approved MBC and NSCLC indications.
Interim data analysis from an ongoing Phase III clinical study of Cynviloq™ in MBC patients conducted in South Korea indicates improved ORR vs. Taxol (40% vs. 26%, respectively, p = 0.03). “This clear ORR improvement of Cynviloq™over generic paclitaxel closely mimics that of Abraxane’s registration trial results, and is a further validation of the similarity in efficacy between these two different formulations”, said Vuong Trieu Ph.D., CEO of IGDRASOL. The oral presentations are entitled:
• “A Non-biologic Nanoparticle Paclitaxel for the Treatment of Pancreatic Cancer”, authored by Vuong Trieu, Catherine Cheng, Larn Hwang, Chao Hsiao, and Kouros Motamed. • “IG-001 for Metastatic Breast Cancer―Interim Analysis of a Phase 3 Trial”, authored by Vuong Trieu, Larn Hwang, Chao Hsiao, Kouros Motamed, and Chulho Park. • “CynviloqTM/IG-001―A Non-Biologic Nanoparticle Paclitaxel for the Treatment of Solid Tumors”, authored by Kouros Motamed, Catherine Cheng, Larn Hwang, Chao Hsiao, and Vuong Trieu.
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
Sorrento Therapeutics, Inc. is a publicly-traded, development-stage biopharmaceutical company engaged in the acquisition, discovery, development and commercialization of proprietary drug therapeutics for addressing significant unmet medical needs in the Unites States, Europe and additional international markets. Sorrento Therapeutics’ primary therapeutic focus is oncology but it is also developing therapeutics products for other indications, including inflammation, metabolic, and infectious diseases. Sorrento Therapeutics’ proprietary G-MAB® fully-human antibody library platform was designed to facilitate the rapid identification and isolation of highly specific antibody therapeutic product candidates that bind to disease targets appropriate for antibody therapy.
More information is available at www.sorrentotherapeutics.com.
IGDRASOL’s lead therapeutic platform is Cynviloq™, a branded micellar paclitaxel formulation which is free of cremophor and human serum albumin, 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).
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 “assumes,” “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 Sorrento and IGDRASOL and the synergies and prospects for a combined enterprise going forward; and the clinical development and commercial potential of nanomedicines such as Cynviloq™ and TOCOSOL® paclitaxel. All such forward-looking statements are based on IGDRASOL and Sorrento’s current beliefs and expectations, and should not be regarded as a representation by IGDRASOL or Sorrento 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 IGDRASOL’s and Sorrento’s businesses, including: whether Sorrento will have sufficient cash and other resources to exercise the option and ultimately acquire IGDRASOL; the potential that Sorrento 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 IGDRASOL’s and Sorrento’s and 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’s filings with the Securities and Exchange Commission. These forward-looking statements represent Sorrento’s 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 Sorrento 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.
Mr. Jaisim Shah
Chief Business Officer
Sorrento Therapeutics, Inc.
T: + 1 (650) 996-2367