ADXS-503, an investigational treatment for non-small cell lung cancer that targets mutations in tumor driver genes, will soon move into a first clinical trial in patients, its developer, Advaxis, announced.
The Phase 1/2 trial is expected to begin enrolling about 50 advanced non-small cell lung cancer (NSCLC) patients across 20 U.S. sites by year’s end, the company in a press release noting U.S. Food and Drug Administration (FDA) approval of its investigational new drug (IND) application.
Eligible patients will have NSCLC that has spread to distant organs, and may be using different lines therapies.
The trial will assess ADXS-503’s safety, tolerability, and effectiveness an an immunotherapy, either alone or in combination with an immune checkpoint inhibitor.
“This is an exciting time for Advaxis as we prepare to initiate the first clinical trial with a drug candidate from our ADXS-HOT program,” said Kenneth A. Berlin, president and CEO of Advaxis.
Treatment candidates, including ADXS-503, developed under ADXS-HOT program are designed to activate the immune system against hotspot mutations — common genetic mutations and proteins that are often present in specific cancers.
Because they can include over 30 different targets, ADXS-HOT candidates are suitable for all patients with a given tumor type, the company said in a presentation.
In mice studies, ADXS-503 stimulated anti-cancer immune responses and promoted the infiltration of reactive T-cells to the tumor site. This led to a significant delay in tumor growth and better long-term survival.
“I am pleased we can move forward to advance our first trial with ADXS-503, the first drug candidate in our ADXS-HOT program,” said Andres Gutierrez, chief medical officer and executive vice president of Advaxis. “This is an important clinical milestone as we seek to demonstrate proof-of-concept for ADXS-HOT immunotherapy in NSCLC, where there remains significant unmet need despite the introduction of checkpoint inhibitors and targeted therapies.”
To date, more than 10 drug candidates have been identified for different tumor types in the ADXS-HOT program. Although none have yet been tested in patients, they are expected to be used without previous biomarker testing, tissue sampling, or genetic analysis.
Advaxis is planning to submit three additional INDs requesting the start of clinical testing of other treatment candidates through late 2019. The first two will target prostate and bladder cancers, and the third is yet to be selected from breast, colorectal, ovarian, and head-and-neck cancers.
“Our next two ADXS-HOT drug candidates will focus on prostate and bladder cancers. These two tumor types, along with NSCLC, were prioritized based on our evaluation of a number of factors relating to each, including the unmet medical need, time and investment required to demonstrate meaningful clinical activity and immunological sensitivity,” Berlin said.