Invetech and Argos Therapeutics announce agreement to support gloval production of fully personalized immunotherapies
Invetech to supply automated production systems for commercialization of patient-specific immunotherapies based on Argos' proprietary Arcelis® technology platform.
SAN DIEGO, CA and DURHAM, NC – Nov. 5, 2014 – Invetech, a global leader in instrument development, custom automation and contract manufacturing, and Argos Therapeutics Inc. (Nasdaq: ARGS) ("Argos"), a biopharmaceutical company focused on the development and commercialization of fully personalized immunotherapies for the treatment of cancer and infectious diseases, today announced that they have entered into an agreement under which Invetech will develop and supply manufacturing systems to support production needs for fully personalized immunotherapies based on Argos' Arcelis® technology platform. Under the terms of the agreement, Invetech will provide Argos with services, technology and equipment to support the design, development, supply and maintenance of customized manufacturing systems to support production of patient-specific immunotherapies.
Argos and Invetech previously established a collaboration to develop prototype manufacturing systems for the production of fully personalized immunotherapies based on Argos' Arcelis® technology platform. This new collaboration will support automated production for Argos' potential regulatory approvals and subsequent commercialization of its Arcelis®-based patient-specific immunotherapies.
RNA processing station, part of the Arcelis® platform technology.
"As we work to advance our lead product candidate, AGS-003, through late-stage clinical research and on to the final stages of the regulatory approval process, our production needs are positioned to expand with any commercial approvals we receive. The Invetech team has supported our production goals in the past and we believe is uniquely positioned to deliver the range of technology solutions necessary to meet the specialized needs of commercializing products based on our Arcelis® technology platform," said Jeff Abbey, president and CEO of Argos.
"This agreement reflects Invetech's proven ability to design highly automated, reliable, and cost-effective technology solutions to support production of complex cell-based immunotherapies for companies including development-stage and startup organizations. Our depth of experience means that we can engineer manufacturing systems able to rapidly advance clinical research and commercialization strategies," said Richard Grant, senior VP, cell therapy at Invetech.
In this collaboration, the system design and production teams at Invetech will supply Argos with modular, readily scalable and highly automated equipment able to facilitate simultaneous processing of multiple patient-specific therapies in the same clean room. The technology is designed to be rapidly expandable to accommodate anticipated increases in production volume to support future global commercialization pending regulatory approvals. The parties intend that the systems developed will be able to support production of new therapies based on the Arcelis® technology platform targeting additional indications.
Invetech has been creating breakthrough products and custom automation systems for more than 30 years. With experience drawn from more than 5,000 projects globally, Invetech partners with global leaders in industry to deliver product design and development, contract manufacturing and custom automation services. The company has experience in a broad range of market sectors including laboratory diagnostics, point of care diagnostics, life sciences, cell therapy, industrial and consumer products. With active projects in North America, Europe, and Asia Pacific, Invetech is well positioned to service clients ranging from start-ups to established multinationals. For more information, visit www.invetech.us.
About Argos Therapeutics
Argos Therapeutics is a biopharmaceutical company focused on the development and commercialization of fully personalized immunotherapies for the treatment of cancer and infectious diseases 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 second 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, visitwww.argostherapeutics.com.
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 infectious diseases and is designed to overcome many of the manufacturing and commercialization challenges that have impeded other personalized 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 antigens. The activated, antigen-loaded dendritic cells are then formulated into the patient's plasma and administered via intradermal injection.
Forward Looking Statements
Any statements in this press release about the Company's future expectations, plans and prospects, including statements about the Company 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 the Company's 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 the Company's 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 obtains approval, they will be successfully distributed and marketed; and other factors discussed in the "Risk Factors" section of the Company's Quarterly Report on Form 10-Q for the quarter ended June 30, 2014 which is on file with the SEC. In addition, the forward-looking statements included in this press release represent the Company's views as of November 5, 2014. The Company anticipates that subsequent events and developments will cause the Company's views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing the Company's views as of any date subsequent to November 5, 2014.