Advaxis, Inc. announced updated data from the Company's ongoing Phase 1/2 study evaluating ADXS-503 in combination with KEYTRUDA. ADXS-503 is the first drug construct from the ADXS-HOT off-the-shelf, cancer-type specific, immunotherapy program which leverages Advaxis' proprietary Lm technology platform to target hotspot mutations that commonly occur in specific cancer types as well as other proprietary, tumor-associated antigens. Key Updates and Future Data Read-outs: In Part B of the study, 14 patients have been treated and 13 are evaluable with ADXS-503 as an add on therapy to patients failing pembrolizumab as last therapy with all of them evaluable for safety and efficacy; Combination therapy was well tolerated with no dose-limiting-toxicity (DLT) or added toxicity of the two drugs.

Grade 1 and 2, transient and reversible events included chills, fever, fatigue, in approximately half of the patients; The ORR was 15.4% (2/13) and DCR was 46% (6/13); Clinical benefit was durable, with two partial responses (PR) sustained for 702 and 189 days, respectively, and 3 patients with stable disease (SD), sustained for 448, 175 and 117 days. Another patient with stable disease is still under evaluation; Available data demonstrate that patients who achieve clinical benefit include those with PD-L1 expression =50%, secondary resistance disease to pembrolizumab and those who show proliferation and/or activation of NK and CD8+ T cells within the first weeks of therapy; Additional translational studies, including flow cytometry, ELISPOT, cytokines/chemokine levels, mutational analysis, MSI TMB and cfDNA and their clinical correlates, will be presented at an upcoming medical meeting; In Part C of the study, 3 patients with newly diagnosed NSCLC have been treated with ADXS-503 plus pembrolizumab. Treatment has been well tolerated and disease control rate thus far is 67%, with two patients sustaining stable disease for 332 and 94 days.; Enrollment in Part B and Part C of the ongoing study will continue to further evaluate the clinical benefit and immune effects of adding on ADXS-503 to patients progressing on pembrolizumab.

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 U.S. The two dose levels with monotherapy in Part A, (1 X108 and 5 X108 CFU) have been completed. Part B with ADXS-503 (1 X108 CFU) in combination with KEYTRUDA is currently enrolling its efficacy expansion for up to 18 patients at dose level 1 (1 X108 CFU + KEYTRUDA) with the potential to proceed to dose level 2 (5 X108 CFU + KEYTRUDA) at a later date. Part C of this ADXS-503 trial evaluating ADXS-503 in combination with KEYTRUDA (1 X108 CFU + KEYTRUDA) as a first line treatment for patients with NSCLC with PD-L1 expression = 1% or who are unfit for chemotherapy, is currently enrolling patients.