Therapy Areas: Oncology
Advaxis Enrolls First Patient in its Phase 1/2 Trial for ADXS-HOT in the Treatment of Non-Small Cell Lung Cancer
19 February 2019 - - US-based biotechnology company Advaxis, Inc. (NASDAQ: ADXS) has initiated its Phase 1/2 clinical trial to evaluate ADXS-503, part of the company's ADXS-HOT programme, in the treatment of non-small cell lung cancer (NSCLC) and has enrolled the first patient in the trial, the company said.

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 programme.

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 US.

Advaxis anticipates initial data from the first cohort of ADXS-503 in the first half of 2019.

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.

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 programmes in various stages of clinical and preclinical development: HPV-associated cancers, neoantigen therapy, hotspot/cancer antigens and prostate cancer.
Login
Username:

Password: