Advaxis Announces Enrollment of the First Patient in its Phase 1/2 Trial for ADXS-HOT in the Treatment of Non-Small Cell Lung Cancer
Business Wire Business Wire•February 14, 2019
PRINCETON, N.J.--(BUSINESS WIRE)--
Advaxis, Inc. (ADXS), a late-stage biotechnology company focused on the discovery, development and commercialization of immunotherapy products, announced it has initiated its Phase 1/2 clinical trial to evaluate ADXS-503, part of the Company’s ADXS-HOT program, in the treatment of non-small cell lung cancer (NSCLC) and has enrolled the first patient in the trial. ADXS-HOT is a 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. To date, more than 10 drug candidates have been designed for different tumor types under the ADXS-HOT program.
“Coming on the heels of the presentation of data from our immunotherapy platform at the I/O 360 conference last week, we are excited to announce the enrollment of the first ADXS-HOT patient in our Phase 1/2 trial evaluating ADXS-503 for the treatment of NSCLC. The data presented at I/O 360 suggest that our neoantigen-directed constructs from both our ADXS-NEO and ADXS-HOT programs have the potential to demonstrate best-in-class CD+8 T cell response for neoantigen therapies,” said Kenneth A. Berlin, President and Chief Executive Officer of Advaxis. He continued, “We believe our ADXS-HOT drug constructs have significant advantages compared to certain other neoantigen-focused therapies in development as our ADXS-HOT drug constructs are off-the-shelf and immediately available to administer to the patient and have a favorable cost to manufacture.” He concluded, “The ADXS-HOT program supports our goal of leveraging the significant experience we have gained from our proprietary platform in order to advance programs in the fight against cancer for patients in need of new therapeutic options and we look forward to studying these constructs in the clinic.”
The Phase 1/2 clinical trial for ADXS-503 will seek to establish the recommended dose, safety, tolerability and clinical activity of ADXS-503 administered alone (initially) and in combination with a checkpoint inhibitor in approximately 50 patients with NSCLC in different lines of therapy, at up to 20 centers across the U.S. Advaxis anticipates initial data from the first cohort of ADXS-503 in the first half of 2019.
About ADXS-HOT
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.
About Advaxis, Inc.
Advaxis, Inc. is a late-stage biotechnology company focused on the discovery, development and commercialization of proprietary Lm-based antigen delivery products. These immunotherapies are based on a platform technology that utilizes live attenuated Listeria monocytogenes (Lm) bioengineered to secrete antigen/adjuvant fusion proteins. These Lm-based strains are believed to be a significant advancement in immunotherapy as they integrate multiple functions into a single immunotherapy and are designed to access and direct antigen presenting cells to stimulate anti-tumor T cell immunity, activate the immune system with the equivalent of multiple adjuvants, and simultaneously reduce tumor protection in the tumor microenvironment to enable the T cells to eliminate tumors. Advaxis has four programs in various stages of clinical and preclinical development: HPV-associated cancers, neoantigen therapy, hotspot/cancer antigens and prostate cancer.
To learn more about Advaxis, visit www.advaxis.com and connect on Twitter, LinkedIn, Facebook and YouTube.
