IGDRASOL will present updates on Cynviloq™, its late clinical stage paclitaxel nanoparticle formulation. Highlights include the therapeutic evaluation of Cynviloq™ in poorly perfused tumors as well as the potential development of Cynviloq™-based personalized paclitaxel cancer therapy.
San Diego, CA and Fountain Valley, CA – March 31st, 2013 Sorrento Therapeutics, Inc. (“STI”; SRNE) and IGDRASOL announced today that IGDRASOL will be presenting updates of its development of CynviloqTM (IG-001) at the annual meeting of the American Association for Cancer Research (AACR) in Washington, DC (April 6th to 10th). 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 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 U.S. and/or non-U.S. 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) bioequivalence regulatory pathway versus albumin-bound paclitaxel (nab-paclitaxel; Abraxane®) in its currently approved MBC and NSCLC indications. Abraxane® sales exceeded $400 million in MBC in fiscal 2012.
The time, title, authors and location of the presentations are as follows:
1) Mon, Apr 8, 1:00 – 5:00 PM (2141/10) – “IG-001 utilization of albumin mediated transport and its potential application in difficult to perfuse tumors.” Kouros Motamed, Larn Hwang, Chao Hsiao, Vuong Trieu. IGDRASOL, Fountain Valley, CA. Poster Session, PO.ET01.03. Novel Targeted Therapies 1.
2)Tue, Apr 9, 1:00 – 5:00 PM (3481/27) – “Development of personalized paclitaxel therapy (IG-001) for ovarian cancer.” Larn Hwang, Chao Hsiao, Kouros Motamed, Vuong Trieu. IGDRASOL, Fountain Valley, CA. Poster Session, PO.CL13.08. Biomarkers 5: Breast and Gynecologic Cancers.
3) Tue, Apr 9, 1:00 – 5:00 PM (4526/24) – “IG-001 – Evaluation as next generation nanoparticle paclitaxel against poorly perfused tumors.” Vuong Trieu, Larn Hwang, Kouros Motamed, Chao Hsiao. IGDRASOL, Fountain Valley, CA. Poster Session, PO.CH06.01. Drug Delivery Technology.
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®.
The mission of the American Association for Cancer Research is to prevent and cure cancer. Founded in 1907, the AACR is the world’s oldest and largest professional organization dedicated to advancing cancer research. The membership includes 33,000 laboratory, translational and clinical researchers; health care professionals; and cancer survivors and advocates in the United States and more than 90 other countries. The AACR marshals the full spectrum of expertise from the cancer community to accelerate progress in the prevention, diagnosis and treatment of cancer through high-quality scientific and educational programs.
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.
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.
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.
Mr. Jaisim Shah
Chief Business Officer
Sorrento Therapeutics, Inc.
T: + 1 (650) 996-2367