San Diego, CA – February 11, 2014 – Sorrento Therapeutics, Inc. (NASDAQ: SRNE; Sorrento), a late-stage clinical oncology company developing new treatments for cancer and associated pain, today announced that it will present results of preclinical and Phase II clinical studies of Cynviloq™ in patients with metastatic pancreatic cancer at the Beaujon International Conference: Cutting Edge in Liver and Pancreatic Tumors in Paris, France on February 13, 2014. Highlights of the findings include data on Cynviloq Phase II monotherapy and Phase I combination therapy with Gemcitabine that support similar efficacy of Cynviloq when compared to historical data for nab-paclitaxel (Abraxane®).
The findings will be presented by Paul Bhar, vice president of Biometrics at Sorrento, during the poster session titled, “Pancreatic Tumors – Novel Treatment Options,” to be held at Pullman Montparnasse Hotel. The presentations are “Evaluation of a Non-Biologic Nanoparticle Form of Paclitaxel in Metastatic Pancreatic Cancer,” authored by Kouros Motamed, Larn Hwang, Paul Bhar, David Nam and Vuong Trieu, and “Preclinical Evaluation of NBN-Paclitaxel against Pancreatic Xenograft Models,” authored by Vuong Trieu, Paul Bhar, Jeff Hsu, Monica Choi and Larn Hwang.
Mr. Bahr led the biostatistical team at Abraxis BioScience, Inc., and was instrumental in the approval of Abraxane® in multiple indications. He is now leading the biostatistical team at Sorrento and will play an important role in the preparation of the NDA filing for Cynviloq.
Cynviloq (Genexol-PM® or IG-001; a paclitaxel-loaded micellar diblock copolymer) is a next-generation branded paclitaxel formulation for the potential treatment of metastatic breast cancer, non-small cell lung cancer, pancreatic cancer, and other solid tumors. In July 2013, the FDA Division of Oncology Products 1 agreed that the data available are sufficient to support a 505(b)(2) pathway, using Abraxane and Taxol® as the Reference Listed Drugs, to obtain approval. Sorrento anticipates initiating the single Bioequivalence trial required for registration, in the first quarter of 2014.
Sorrento has exclusive distribution rights to Cynviloq in North America, the 27 countries of the European Union and Australia, from Samyang Biopharmaceuticals, a South Korean corporation.
About Sorrento Therapeutics, Inc.
Sorrento is an oncology company developing new treatments for cancer and associated pain. Sorrento’s most advanced asset Cynviloq, the next-generation paclitaxel, will commence its registrational trial and be developed under the abbreviated 505(b)(2) regulatory pathway. Sorrento is also developing RTX, a non-opiate TRPV1 agonist currently in a Phase 1/2 study at the National Institutes of Health to treat terminal cancer patients suffering from intractable pain. The Company has made significant advances in developing human monoclonal antibodies, complemented by a comprehensive and fully integrated Antibody Drug Conjugate (ADC) platform that includes proprietary conjugation chemistries, linkers, and toxic payloads. Sorrento’s strategy is to enable a multi-pronged approach to combating cancer with small molecules, therapeutic antibodies, and ADCs.
More information is available at www.sorrentotherapeutics.com.
This press release contains forward-looking statements under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995 and subject to risks and uncertainties that could cause actual results to differ materially from those projected. Forward-looking statements include statements about the potential for products to be successfully developed using proprietary technologies; the synergies and prospects for a combined enterprise going forward, including the retention of key personnel; and the clinical development and commercial potential of conjugated antibodies that may be developed based on recently acquired technologies; the potential for claims from third parties regarding the use of the ADCs and related technology that may be developed; the costs and expenses associated with additional clinical development programs from successful product development efforts, if any; and other matters that are described in Sorrento’s Annual Report on Form 10-K for the year ended December 31, 2012, and subsequent Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission, including the risk factors set forth in those filings. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release and we undertake no obligation to update any forward-looking statement in this press release except as required by law.
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. Amar Singh
EVP and Chief Business Officer
T: + 1 (858) 210-3719
Mr. Ian Stone
T: + 1 (619) 849-5388