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Advaxis, Inc. (Nasdaq: ADXS), a clinical-stage biotechnology company focused on the development and commercialization of immunotherapy products, and Personalis Inc. (Nasdaq: PSNL), a leader in advanced genomics for cancer, today announced a collaboration to leverage Personalis’ ImmunoID NeXT™ Platform in Advaxis’ ongoing Phase 1/2 ADXS-503 (HOT Lung) program evaluating ADXS-503 alone and in combination with pembrolizumab in patients with non-small cell lung cancer (NSCLC). The ADXS-503 construct targets 11 public or shared hotspot neoantigens in KRAS, EGFR and TP53 as well as 11 proprietary tumor-associated antigen targets. Under the terms of the expanded agreement, Personalis will conduct comprehensive tumor immunogenomic profiling to enable the identification of predictive composite biomarkers and/or signatures of response, as well as the broad evaluation of potential mechanisms of therapy resistance.
Via the deep analysis of approximately 20,000 genes in both DNA and RNA, ImmunoID NeXT consolidates multiple biomarker assays into one, providing a multidimensional view of the tumor and the immune microenvironment from a single sample. The platform is an end-to-end solution for immuno- and precision oncology biomarker discovery and CDx development.
“We are thrilled to expand our relationship with Personalis and believe the resulting analyses may lead to the establishment of predictive biomarkers and the characterization of immunological impact of treatment, which will be relevant to the successful development of ADXS-503 and our other off-the-shelf neoantigen constructs,” said Dr. Andres A. Gutierrez, Chief Medical Officer of Advaxis. “With the emerging clinical signals we are seeing in our ongoing ADXS-503 clinical study and the extensive capabilities of ImmunoID NeXT to interrogate a patient’s tumor and immune response at both the DNA- and RNA-level from a single FFPE tissue sample, the analysis will help guide our development plans in order to target the right patient population and to potentially increase the clinical benefit of our off-the-shelf, ADXS-HOT drug constructs.”
This new agreement builds upon the prior two-year collaboration between Advaxis and Personalis for the genomic analysis of clinical tumor samples to manufacture Advaxis’ ADXS-NEO drug construct, its personalized, neoantigen-directed immunotherapy to treat a variety of late stage cancers. As previously published, the ADXS-NEO drug constructs were able to efficiently generate de novo CD8+ T cells versus KRAS and EGFR hotspot mutations in late stage-cancer patients, thus providing proof-of-mechanism for our ADXS-HOT program.
About Advaxis, Inc.
Advaxis, Inc. is a clinical-stage biotechnology company focused on the discovery, development and commercialization of proprietary Lm-based antigen delivery products. These immunotherapies are based on a platform technology that utilizes live attenuated Listeria monocytogenes (Lm) bioengineered to secrete antigen/adjuvant fusion proteins. These Lm-based strains are believed to be a significant advancement in immunotherapy as they integrate multiple functions into a single immunotherapy and are designed to access and direct antigen presenting cells to stimulate anti-tumor T cell immunity, activate the immune system with the equivalent of multiple adjuvants, and simultaneously reduce tumor protection in the tumor microenvironment to enable T cells to eliminate tumors. To learn more about Advaxis, visit www.advaxis.com and connect on Twitter, LinkedIn, Facebook and YouTube.
About Personalis, Inc.
Personalis, Inc. is a growing cancer genomics company transforming the development of next-generation therapies by providing more comprehensive molecular data about each patient’s cancer and immune response. The company’s NeXT™ Platform is designed to adapt to the complex and evolving understanding of cancer, providing its biopharmaceutical customers with information on all of the approximately 20,000 human genes, together with the immune system, from a single tissue sample. Personalis also provides genomic information to the VA Million Veterans Program as part of their goal to sequence over a million veteran genomes. The Personalis Clinical Laboratory is GxP aligned as well as CLIA’88-certified and CAP-accredited. For more information, please visit www.personalis.com and follow Personalis on Twitter (@PersonalisInc).
This press release contains or may imply "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. For example, forward-looking statements include statements regarding the use of Personalis’ ImmunoID NeXT platform in Advaxis’ clinical studies and in other contexts. These forward-looking statements are subject to risks and uncertainties, including those discussed in Personalis’ filings with the Securities and Exchange Commission (SEC), including in the “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of the Company’s most recently filed periodic reports on Form 10-Q and subsequent filings and in the documents incorporated by reference therein. Except as otherwise required by law, Personalis disclaims any intention or obligation to update or revise any forward-looking statements, which speak only as of the date hereof, whether as a result of new information, future events or circumstances or otherwise.
Contact for Advaxis:
Tim McCarthy, LifeSci Advisors, LLC
Contacts for Personalis, Inc.
Investor Relations Contact for Personalis: