Advaxis Presents Translational Biomarker Data from Ongoing ADXS-503 Phase 1/2 Lung Cancer Trial at the American Associated for Cancer Research (AACR) 2021 Annual Meeting
Assay enables determination of PD-1 expression independent of PD-1 receptor status, accounting for both free and drug-bound PD-1
Results confirm on-mechanism activation of innate and adaptive immune responses in patients with demonstrated clinical benefit from ADXS-503 treatment in combination with pembrolizumab
“These presented data suggest this novel immunophenotyping assay has the potential to more accurately measure pharmacodynamic biomarkers in immunotherapy,” said
Key presentation highlights:
Poster presentation titled, “Evaluation of total PD-1 expression using multi-color flow cytometry in metastatic non-small cell lung cancer patients treated with multi-neoantigen vector (ADXS-503) alone and in combination of pembrolizumab to assess T-cell & T-cell memory subsets” presented by Dr.
- A novel multi-color flow cytometry analysis was developed to accurately identify PD-1 expression on peripheral blood mononuclear cells (PBMCs) of NSCLC patients receiving PD-1/PD-L1 blockade therapy with pembrolizumab and ADXS-503
- No interference in PD-1 detection due to pembrolizumab blockage was observed, enabling the determination of PD-1 expression independent of PD-1 receptor status, with both free and drug-bound PD-1 detected
- Preliminary flow cytometry data demonstrated on-mechanism activation of innate and adaptive immune responses to ADXS-503. Three patients from the ongoing Phase 1/2 with demonstrated clinical benefit of stable disease showed:
- Proliferation and activation of NK cells
- Increased PD-1 expression on circulating CD4+, CD8+ and NK cells
- Increased counts of CD8+ T cells including proliferative, cytotoxic and memory CD8+ T cells
- Proliferation and activation of NK cells
The Phase 1/2 clinical trial of ADXS-503 is seeking to establish the recommended dose, safety, tolerability and clinical activity of ADXS-503 administered alone and in combination with a KEYTRUDA® in approximately 50 patients with NSCLC, in at least five sites across the
ADXS-HOT is a program that leverages the Company’s proprietary Lm technology to target hotspot mutations that commonly occur in specific cancer types. ADXS-HOT drug candidates are designed to target acquired shared or “public” mutations in tumor driver genes along with other proprietary cancer-testes and oncofetal tumor-associated antigens that also commonly occur in specific cancer types. ADXS-HOT drug candidates are an off-the-shelf treatment, designed to potentially treat all patients with a specific cancer type, without the need for pretreatment biomarker testing, DNA sequencing or diagnostic testing.
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KEYTRUDA® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of
Source: Advaxis, Inc.