San Diego, CA and Irvine, CA – June 21, 2013. Sorrento Therapeutics, Inc. (OTCQB: SRNE; Sorrento) and IGDRASOL announced today that the companies will present updates of their analyses of proprietary late clinical stage paclitaxel formulations, IG-001 (Cynviloq™) and IG-004 (TOCOSOL® paclitaxel) at the joint meeting of the European Foundation for Clinical Nanomedicine (CLINAM) and the European Technology Platform on Nanomedicine (ETPN) in Basel, Switzerland on June 23- 26. Sorrento has the right to acquire IGDRASOL pursuant to a previously-announced option agreement, entered into in March 2013.
IGDRASOL’S data mining of the clinical data for both IG-001 and IG-004 has generated exciting insights into the field of nanomedicine, which will be presented at the joint meeting. These findings are highly relevant to the theme of this year’s conference, namely “Nanomedicine & Targeted Medicine – the paradigm of precise, highly effective and innocuous medicine for the benefit of patients and mankind”.
IG-001 (Cynviloq™) is a next-generation, branded, micellar diblock copolymeric paclitaxel formulation currently approved and marketed in several countries as Genexol-PM®. It has completed Phase 1 or 2 trials in metastatic breast cancer (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.
IG-004 (TOCOSOL® paclitaxel) is a tocopheryl polyethylene glycol succinate (TPGS)-based emulsion of paclitaxel. IG-004 has completed Phase 2 or 3 trials in MBC, NSCLC, ovarian cancer, colorectal cancer and bladder cancer in the U.S. and/or ex-U.S. The IG-004 portfolio of assets was recently acquired from OncoGenex.
The presentation, titled “IG-001―A Non-Biologic Nanoparticle Paclitaxel for the Treatment of Ovarian Cancer – First Results of a Phase 2 Ovarian Trial”, will be presented by Dr. Larn Hwang on Wednesday, June 26, 2:30 p.m., in Track 3, Hall Singapore, and was authored by Larn Hwang, Chao Hsiao, Kouros Motamed, and Vuong Trieu. Dr. Hwang will present the clinical outcome of Cynviloq™ in a Phase 2 multicenter non-inferior study (GPMOC202) where Cynviloq™ in combination with Carboplatin was evaluated against generic Taxol® plus Carboplatin (comparator group). Cynviloq™ in combination with Carboplatin administered to patients with ovarian cancer produced an objective response rate of 88%. Time to progression and progression free survival were 444 days and 437 days, respectively. The results showed Cynviloq™ (IG-001) in combination with Carboplatin was an effective first line treatment for patients with ovarian cancer, and non-inferior to traditional solvent based paclitaxel.
Two poster presentations entitled: “IG-004―A Non-Biologic Nanoemulsion Paclitaxel for the Treatment of Solid Tumors- Comparison to Abraxane”, and “CynviloqTM/IG-001―A Non-Biologic Nanoparticle Paclitaxel for the Treatment of Solid Tumors” will be presented by Dr. Kouros Motamed. The posters were authored by Vuong Trieu, Chao Hsiao, Larn Hwang, Kouros Motamed, Chulho Park and Catherine Cheng.
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 STI 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