Research & Development
Advaxis Submits IND Application to US FDA for ADXS-HOT Drug Candidate for Prostate Cancer
6 December 2019 - - US-based biotechnology company Advaxis, Inc. (NASDAQ: ADXS) has submitted an Investigational New Drug application with the US Food and Drug Administration for the initiation of a Phase 1 clinical study of ADXS-504, the company's ADXS-HOT drug candidate for prostate cancer, the company said.

ADXS-504 is part of the company's ADXS-HOT off-the-shelf immunotherapy platform which targets hotspot neoantigens, allowing for the development of multiple cancer-type specific clinical candidates.

Advaxis has designed over ten 'HOT' drug candidates that are in various stages of development, with the company's Phase 1/2 clinical trial for ADXS-503 in NSCLC currently enrolling patients at five centers.

Advaxis anticipates reporting the immune data from the first dose level of ADXS-503, Part A, in monotherapy, and expects to dose the first patient in Part B, which is studying ADXS-503 in combination with the checkpoint inhibitor pembrolizumab, in early 2020.

ADXS-HOT is a programme 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 cancer-testes and oncofectal tumor-associated antigens that also commonly occur in specific cancer types.

ADXS-HOT drug candidates are an off-the-shelf treatment approach designed to potentially treat all patients with a specific cancer type, without the need for pretreatment biomarker testing, biopsy, DNA sequencing or diagnostic testing.
Advaxis, Inc. is a clinical-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 utilises live attenuated Listeria monocytogenes 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 T cells to eliminate tumors.
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