Argos Therapeutics
Dec 14, 2016

Argos Therapeutics Enters into Strategic Research Agreement with Personalis, Inc.

-Personalis to support ongoing research efforts to demonstrate that Argos' lead product candidate, rocapuldencel-T, specifically targets patients' tumor-specific neoantigens without the need to identify them first-

DURHAM, N.C., Dec. 14, 2016 (GLOBE NEWSWIRE) -- Argos Therapeutics Inc. (Nasdaq:ARGS) ("Argos"), an immuno-oncology company focused on the development and commercialization of individualized immunotherapies based on the Arcelis® precision immunotherapy technology platform, announced today that it has entered into a strategic research agreement with Personalis, Inc., a precision medicine company, focused on genomics solutions for immuno-oncology, cancer, and genetic disease. 

Personalis will serve as the primary genomic analysis service provider to support ongoing research efforts to demonstrate that Argos' lead product candidate, rocapuldencel-T, specifically targets patient-specific neoantigens without the need to identify them first.  Argos will utilize the Personalis ACE ImmunoID™ next-generation sequencing (NGS) platform to evaluate tumor samples collected during clinical development of Argos' tumor-specific dendritic cell technology to treat renal cell carcinoma. The analytically validated ACE ImmunoID platform offers the unmatched accuracy through whole exome and transcriptome sequencing for tumor/normal evaluation coupled with leading edge bioinformatics and sample tracking to ensure timely delivery of results including neoantigen identification and tumor mutational burden.

"We are pleased to work with Argos and to offer the Personalis ACE ImmunoID platform to support the mechanism of action of its precision immunotherapy clinical trials and research," said John West, CEO of Personalis. "As precision medicine continues to gain momentum, we recognize the importance of work done by companies such as Argos to bring truly personalized medicine into reality and we are delighted to be their partners in transforming cancer treatment."

"The Personalis technology is a key component to our efforts to further understand the mechanism of action of our lead product, rocapuldencel-T for the treatment of advanced renal cell cancer. We hope to demonstrate that rocapuldencel-T specifically targets neoantigens found only in the patients' tumors to explain why we observe tumor regression without autoimmunity to the unaffected contralateral kidney," said Dr. Charles Nicolette, chief scientific officer and vice president of research and development for Argos.

About Personalis, Inc.
Personalis, Inc. (www.personalis.com) is a leading precision medicine company focused on advanced NGS-based clinical diagnostic, clinical trial and research services for cancer and inherited genetic disease.  Personalis also provides DNA sequencing and data analysis of human genomes.

The Personalis ACE Exome and Transcriptome technology is designed to obtain the most comprehensive and accurate tumor molecular profile for immuno-oncology applications. The company's clinical laboratory is GCP compliant, CLIA licensed and CAP accredited.

About the Arcelis® Technology Platform
Arcelis® is a precision immunotherapy technology that captures both mutated (neoantigens) and variant antigens that are specific to each patient's individual disease. It is designed to overcome immunosuppression by producing a specifically targeted, durable memory T-cell response without adjuvants that may be associated with toxicity. The technology is potentially applicable to the treatment of 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 disease sample or biopsy as the source of disease-specific antigens and the patient's own dendritic cells, which are optimized from cells collected by a leukapheresis procedure. The proprietary process uses RNA isolated from the patient's disease sample to program dendritic cells to target disease-specific antigens. These activated, antigen-loaded dendritic cells are then formulated with the patient's plasma and administered via intradermal injection as an individualized immunotherapy.

About Argos Therapeutics
Argos Therapeutics is an immuno-oncology company focused on the development and commercialization of individualized immunotherapies for the treatment of cancer and infectious diseases using its Arcelis® technology platform. Argos' most advanced product candidate, rocapuldencel-T, is being evaluated in the pivotal ADAPT Phase 3 clinical trial for the treatment of mRCC. In addition, rocapuldencel-T is being studied in Phase 2 investigator-initiated clinical trials as neoadjuvant therapy for RCC and for the treatment of NSCLC. Argos is also developing a separate Arcelis®-based product candidate, AGS-004, for the treatment of human immunodeficiency virus (HIV), which is currently being evaluated in an investigator-initiated clinical trial aimed at HIV eradication in adult patients.

Forward Looking Statements
Any statements in this press release about Argos' future expectations, plans and prospects, including statements about the expected and potential future closings of the private placement, Argos' financial prospects, anticipated use of proceeds, future operations and sufficiency of funds for future operations, clinical development of Argos' product candidates, expectations regarding future clinical trials and future expectations and plans and prospects for Argos and other statements containing the words "believes," "anticipates," "estimates," "expects," "intends," "plans," "predicts," "projects," "targets," "may," "potential," "will," "would," "could," "should," "continue," 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 such forward-looking statements as a result of various important factors, including whether Argos' cash resources will be sufficient to fund its continuing operations for the periods 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; whether the results of such trials will warrant submission for approval from the United States Food and Drug Administration or equivalent foreign regulatory agencies; whether Argos' product candidates will receive approval from regulatory agencies on a timely basis or at all; whether, if product candidates obtain approval, they will be successfully distributed and marketed; and other factors discussed in the "Risk Factors" section of Argos' Form 10-Q for the quarter ended June 30, 2016, which is on file with the SEC, and in other filings Argos makes with the SEC from time to time. In addition, the forward-looking statements included in this press release represent Argos' views as of the date hereof. 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 the date hereof.

Media contact:

Adam Daley 
Berry & Company Public Relations
212-253-8881
adaley@berrypr.com

Investor contact:

John Menditto
Argos Therapeutics, Inc.
919-908-0687
jmenditto@argostherapeutics.com