Personalis to Provide Immunogenic Profiling in Support of Advaxis’ NSCLC Clinical Trial

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[Science Photo Library - SCIEPRO / Getty Image.]

Clinical-stage biotech Advaxis, which is focused on the development and commercialization of immunotherapy products announced a collaboration with cancer genomics company Personalis to use 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).

ImmunoID NeXT consolidates multiple biomarker assays into one by conducting a deep analysis of roughly 20,000 genes in both DNA and RNA, providing a multidimensional view of the tumor and the immune microenvironment from a single sample.

“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,” said Dr. Andres A. Gutierrez, chief medical officer of Advaxis, in a press release.

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.

Gutierrez added that Advaxis anticipates its ongoing collaborations with Personalis could help the company identify predictive biomarkers and the characterization of immunological impact of treatments across a range of its off-the-shelf neoantigen constructs.

The new agreement builds upon the prior two-year collaboration between Advaxis and Personalis for the genomic analysis of clinical tumor samples to manufacture the ADXS-NEO drug construct, a personalized, neoantigen-directed immunotherapy to treat a variety of late stage cancers. In published reports Advaxis has shown that the ADXS-NEO drug constructs were able 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.

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