DURHAM, N.C., April 14, 2015 (GLOBE NEWSWIRE) — Argos Therapeutics, Inc. (Nasdaq:ARGS) (“Argos”), a biopharmaceutical company focused on the development and commercialization of fully personalized immunotherapies for the treatment of cancer based on the Arcelis® technology platform, and Lummy (Hong Kong) Co. Ltd., a wholly owned subsidiary of Chongqing Lummy Pharmaceutical Co. Ltd. (Stock code: 300006) (“Lummy HK”), today announced they have entered into a license agreement. Under the terms of the agreement, Lummy HK will license from Argos the rights to manufacture, develop and commercialize AGS-003, Argos’ investigational immunotherapy for the treatment of cancer, in China, Hong Kong, Taiwan and Macau.
In connection with the license agreement, Tianyi Lummy International Holdings Group Ltd., an affiliate of Lummy HK (“Tianyi Lummy”), and the China BioPharma Capital I Fund (“China BioPharma Capital”) have purchased an aggregate of one million shares of Argos’ common stock at a premium of 12.5% for a purchase price of approximately $10 million. Lummy HK has agreed to pay Argos a royalty on net sales of AGS-003 at a rate in the teens and up to an aggregate of $20 million for regulatory and commercial milestones. In addition, Tianyi Lummy and China BioPharma Capital have agreed to purchase an additional $10 million of Argos’ common stock following and subject to the interim data analysis from Argos’ pivotal phase 3 ADAPT trial of AGS-003 by the Independent Data Monitoring Committee expected in late 2015 that will occur at approximately 50% of events in the trial and certain other conditions. China BioPharma Capital recently announced its first closing and is focusing on investments in pharmaceutical life science innovation in Western companies with the objective to obtain licenses for development and commercialization in China.
“We are excited about the potential for Arcelis®-based products to advance the treatment of cancer throughout Greater China and in markets around the world,” said Jeff Abbey, president and CEO of Argos. “Our agreement with Lummy HK is another reflection of the strong clinical data that we have observed with AGS-003 and our ability to attract outstanding partners to support commercialization in the years ahead.”
Argos’ proprietary Arcelis® technology platform uses a patient’s own dendritic cells and tumor sample to create a fully personalized immunotherapy. AGS-003, Argos’ lead product candidate, is currently being tested in the pivotal phase 3 ADAPT clinical trial for the treatment of metastatic renal cell carcinoma (mRCC).
Under the license agreement, Lummy HK also acquires rights to develop Arcelis®-based products for additional oncology indications, potentially including pancreatic, lung, liver, stomach, rectal, gastric, and esophageal cancers. Lummy HK will be responsible, at its expense, for all development costs that are necessary for regulatory approval in all markets covered in the license agreement.
“Our agreement with Argos to develop AGS-003 in China, Hong Kong, Taiwan and Macau is another example of our ongoing commitment to develop and market new therapies that can address serious unmet needs in the treatment of cancer in China and throughout Asia,” said Mr. Qiu Yu, chairman of Lummy HK. “The Arcelis® technology platform also holds great promise for automating the manufacturing and commercialization of a portfolio of fully personalized immunotherapies and we look forward to working with Argos to initiate our own development programs to bring products based on this innovative technology to the patients we serve.”
About the Arcelis® Technology Platform
Arcelis® is a fully personalized immunotherapy technology that captures mutated and variant antigens that are specific to each patient’s disease. It is designed to overcome immunosuppression by producing a durable memory T-cell response without adjuvants that may be associated with toxicity. The technology is potentially applicable to a wide range of different cancers, and is designed to overcome many of the manufacturing and commercialization challenges that have impeded other personalized cancer immunotherapies. The Arcelis® process uses only a small tumor or blood sample and the patient’s own dendritic cells, which are collected and optimized following a single leukapheresis procedure. The proprietary process uses RNA isolated from the patient’s disease sample to program dendritic cells to target disease specific antigens. The activated, antigen-loaded dendritic cells are then formulated into the patient’s plasma and administered via intradermal injection.
About Argos Therapeutics
Argos Therapeutics is a biopharmaceutical company focused on the development and commercialization of fully personalized immunotherapies for the treatment of cancer using its Arcelis® technology platform. Argos’ most advanced product candidate, AGS-003, is being evaluated in the pivotal ADAPT phase 3 clinical trial for the treatment of metastatic renal cell carcinoma (mRCC). The Company is also developing a separate Arcelis®-based product candidate, AGS-004, for the treatment of HIV, currently being evaluated in a phase 2 clinical trial in combination with a latency reversing drug for HIV eradication in adult patients. For more information about Argos Therapeutics, visit www.argostherapeutics.com.
About Lummy HK
Chongqing Lummy Pharmaceutical Co., Ltd. is a Shenzhen GEM listed enterprise engaged in R&D, manufacture and sales of drugs, which was founded in 1999 and is headquartered in Chongqing. It has a rich experience to develop and commercialize therapeutic products and a broad network for pharmaceutical markets. For more information about Lummy HK, visit www.cqlummy.com.
Forward Looking Statements
Any statements in this press release about Argos’ future expectations, plans and prospects, including statements about Argos and other statements containing the words “believes,” “anticipates,” “plans,” “expects,” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including whether Argos’ cash resources will be sufficient to fund our continuing operations for the period anticipated; whether results obtained in clinical trials will be indicative of results obtained in future clinical trials; whether Argos’ product candidates will advance through the clinical trial process on a timely basis and receive approval from the United States Food and Drug Administration or equivalent foreign regulatory agencies; whether, if product candidates obtain approval, they will be successfully distributed and marketed; and other factors discussed in the “Risk Factors” section of Argos’ Quarterly Report on Form 10-Q for the quarter ended September 30, 2014 which is on file with the SEC. In addition, the forward-looking statements included in this press release represent Argos’ views as of April 14, 2015. Argos anticipates that subsequent events and developments will cause Argos’ views to change. However, while Argos may elect to update these forward-looking statements at some point in the future, Argos specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing Argos’ views as of any date subsequent to April 14, 2015.
Media contact: Adam Daley Berry & Company Public Relations 212-253-8881 Investor contact: Nancy Yu Burns McClellan 212-213-0006