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Preliminary Data from Phase 1 Study Evaluating ADXS-NEO Suggest Rapid Immunogenicity and Clinical Activity
Source: Business Wire
Data to be Presented at AACR Annual Meeting
Advaxis, Inc. (NASDAQ: ADXS), a late-stage biotechnology company focused on the discovery, development and commercialization of immunotherapy products, announces the presentation of ADXS-NEO data in a poster discussion entitled “Safety and Immunogenicity of a Personalized Neoantigen-Listeria Vaccine in Cancer Patients” at the American Association for Cancer Research (AACR) Annual Meeting underway in Atlanta. The discussion will be held on Sunday, March 31, 2019 from 1:00-5:00 p.m. ET and will be led by J. Randolph Hecht, M.D., Professor of Clinical Medicine, David Geffen School of Medicine at UCLA and Director of the UCLA Gastrointestinal Oncology Program.
ADXS-NEO is a live, attenuated Listeria monocytogenes (Lm) immunotherapy, using personalized antigen delivery based on whole-exome sequencing of a patient’s tumor to identify personal neoantigens. The ongoing Phase 1 trial is designed to evaluate the safety, tolerability and preliminary clinical immunological activity of ADXS-NEO alone (Part A) and in combination with anti-PD-1 antibody therapy (Part B) in subjects with certain types of advanced or metastatic solid tumors. Part C of the trial will be an expansion of the combination therapy arm and will be initiated based on emerging data from the first two parts of the trial.
Preliminary findings from the ADXS-NEO Phase 1 study include the following:
Substantial anti-tumor immunity, including T cell responses to neoantigens and antigen spreading, was observed within one week of first dose at both dose levels
Dosing of ADXS-NEO at 1x108 colony forming units (CFU) has been well-tolerated in two patients
ADXS-NEO dosed at 1x109 CFU was beyond the maximum tolerated dose (MTD)
Reversible Grade 3 hypoxia (n=2) and Grade 3 hypotension (n=1) were dose-limiting toxicities (DLTs)
Manufacturing of ADXS-NEO, comprised of 40 personal neoantigens, was successfully completed within seven to eight weeks for each subject
“Advaxis’ ADXS-NEO is a novel, personalized vaccine encoding mutations specific to an individual patient's tumor designed to induce anti-cancer immunity. Four patients have been evaluated across two dose levels thus far in this ongoing clinical trial. While dose level 1 (1x109 CFU) was determined to be above the MTD, dose level -1a (1x108 CFU) has been safe and well tolerated in two patients treated to date, with primarily Grade 1 and Grade 2 chills, fever and tachycardia. Substantial immunological activity was observed across both dose levels, including rapid neoantigen-specific CD8+ T cell generation, which is essential for potential clinical benefit. We look forward to the planned combination therapy arm with checkpoint inhibitors,” said Dr. Hecht.
“The patients being evaluated for safety and tolerability in Part A all have late-stage disease and have been treated with numerous prior therapies. As a result, we did not expect to observe significant clinical activity in this cohort,” said Andres Gutierrez, M.D. Ph.D., Chief Medical Officer of Advaxis. “Nevertheless, we have seen some encouraging clinical signals to date, including one patient at dose level 1 with non-small cell lung cancer who achieved stable disease after only two doses of ADXS-NEO, which is consistent with rapid immune activation.” He concluded, “This is the first presentation of clinical data from our ADXS-NEO program at a major medical conference. We are continuing to enroll subjects and gather additional clinical and immune correlative data, and plan to share updated data from this study throughout this year.”
The full abstract is available at www.advaxis.com and the poster will be available on the Company’s website on Sunday, March 31, 2019 at 1:00 p.m. ET.
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