Advaxis (ADXS) Reports Updated Positive Clinical Data in Ongoing Phase 1/2 ADXS-503 Trial in NSCLC

Advaxis, Inc. (NASDAQ: ADXS), a clinical-stage biotechnology company focused on the development and commercialization of immunotherapy products today announced updated results from the combination arms of the Company’s ongoing Phase 1/2 study investigating ADXS-503 in patients with non-small cell lung cancer (NSCLC) at the Immuno-oncology 360° Conference in New York, New York. The trial is evaluating ADXS-503, part of the Company’s ADXS-HOT 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, alone and in combination with KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1 therapy.

Key findings presented by Dr. Andres Gutierrez, Chief Medical Officer of Advaxis, include:

• Demonstrated substantial tumor shrinkage in the first two evaluable patients in the combination arm, Part B; with one patient who achieved a partial response (PR) and the other patient who achieved stable disease (SD) with 25% reduction in a target lesion
• These new data build upon previous results presented at the IASLC 2020 Targeted Therapies of Lung Cancer Meeting from seven evaluable patients demonstrating:— 50% (3 of 6) of evaluable patients from the monotherapy arm, from Part A, showed stable disease (SD)— ADXS-503 monotherapy and in combination with pembrolizumab appeared safe and tolerable in this heavily pretreated population of patients with no dose limiting toxicities observed

“The first two patients treated in the combination arm of ADXS-503 and pembrolizumab were older patients with up to four prior lines of therapy,” said Dr. Jonathan W. Goldman, Director of Clinical Trials in Thoracic Oncology at UCLA. “These data are very encouraging as they preliminarily demonstrate the ability of ADXS-503 to enhance or restore sensitivity to checkpoint inhibitors as we had hypothesized during the design of the study based on preclinical data.” He added, “We will follow the durability of the responses to therapy and look forward to moving into Part C in ADXS-503 later this year, which will enroll patients for first line therapy in combination with pembrolizumab.”

Dr. Andres A. Gutierrez, Chief Medical Officer and EVP at Advaxis, said, “These initial signals of anti-tumor activity in non-small cell lung cancer correlate with the clinical benefit observed with ADXS-PSA and pembrolizumab in our KEYNOTE-046 study in advanced prostate cancer, highlighting the potential synergistic effects of Lm immunotherapies and checkpoint inhibitors.”

The Phase 1/2 clinical trial of ADXS-503 will seek to establish the recommended dose, safety, tolerability and clinical activity of ADXS-503 administered alone and in combination with a checkpoint inhibitor 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 and Part B in combination with a checkpoint inhibitor is currently open to enrollment.

About ADXS-HOTADXS-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.

About KEYNOTE-046KEYNOTE-046 (NCT02325557) is a Phase 1/2 open-label, multicenter, dose-determination and expansion trial that evaluates the safety, tolerability and preliminary clinical activity of ADXS-PSA as monotherapy (Part A; n=14 [13 treated]), and in combination with KEYTRUDA® (Part B; n= 37) in heavily pretreated patients with progressive and refractory metastatic castration-resistant prostate cancer (mCRPC).

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