ADVAXIS PROVIDES UPDATE ON MAA FILING AND ADXS-HOT PROGRAM
PRINCETON, N.J.
Advaxis, Inc. (NASDAQ:ADXS), a late-stage biotechnology company focused on the discovery, development and commercialization of immunotherapy products, today announced a clinical update, as follows:
Plans to withdraw its Conditional Marketing Authorization Application (MAA) in the European Union for axalimogene filolisbac to treat metastatic cervical cancer in patients who progress beyond first-line therapy
Submission of an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) to study its first ADXS-HOT drug candidate for the treatment of non-small cell lung cancer (NSCLC)
Selection of prostate cancer as the second cancer type within its ADXS-HOT program to move towards the clinic, with an IND filing anticipated within the next six months
Advaxis’ regulatory action in Europe is based on European Medicines Agency (EMA) feedback following its initial review indicating the application will likely need additional data to support a conditional approval. The February 2018 submission included data from the Phase 2 GOG-0265 study in 50 patients, which showed a 12-month overall survival rate (primary efficacy endpoint) of 38% (n=19/50) in women with persistent, recurrent or metastatic carcinoma of the cervix, representing a 55% improvement over a model-predicted 12-month overall survival rate of 24.5%. As more than half of the women treated in this study had received multiple prior lines of therapy including with bevacizumab treatment, the 38% 12-month overall survival rate was unprecedented when compared against historical data.
The Company continues to believe that the results from the GOG-0265 study are clinically meaningful and provide proof-of-concept that axalimogene filolisbac demonstrated clinical activity in metastatic cervical cancer. The withdrawal of this application does not impact the ongoing clinical trials of axalimogene filolisbac. As previously communicated, Advaxis is actively seeking a partner to support the late-stage cervical cancer program.
The Company also announced that it has submitted an IND with the FDA to study its first product candidate from the ADXS-HOT program, ADXS-503, for the treatment of NSCLC. Upon allowance of the IND for ADXS-503, the Company plans to initiate an open-label, Phase 1/2 clinical trial. Further details of the study design will be provided after the IND is allowed. Advaxis expects the first patient will be dosed by the end of 2018. Additionally, Advaxis anticipates submitting a second IND from the ADXS-HOT program within the next six months, for its drug candidate referred to as ADXS-504, for the treatment of prostate cancer.
“We are pleased to submit the ADXS-503 IND and look forward to advancing our ADXS-HOT NSCLC drug candidate into the clinic. Our ADXS-HOT program leverages both the benefits of our Lm technology platform, which has shown clinical activity in earlier generation drug candidates, and the use of neoantigen targets. We believe that neoantigen-based treatments have the potential to transform cancer care, and the ADXS-HOT program allows us to develop cancer-type specific therapies across a broad range of tumor types,” said Kenneth A. Berlin, President and Chief Executive Officer of Advaxis. “With our announcement today of plans for a second IND submission for an ADXS-HOT construct in prostate cancer, we feel confident we can reach proof-of-concept for these off-the-shelf therapeutics in a relatively rapid and cost-effective manner.”
Advaxis affirms plans to submit a total of four INDs for drug candidates from its ADXS-HOT program by the end of calendar year 2019, resulting in Phase 1/2 studies evaluating safety, immune responses and preliminary clinical activity of four different constructs addressing four different tumor types. Beyond NSCLC and prostate cancer, the next two ADXS-HOT product candidates will be selected from breast, colorectal, bladder, ovarian and head and neck cancers.
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 cancer-testes and oncofetal tumor-associated antigens that also commonly occur in specific cancer types. Although ADXS-HOT drug candidates have not yet been tested in patients, each product candidate has been designed to potentially treat all patients with a specific cancer type, without the need for pre-treatment biomarker testing, biopsy, DNA sequencing or diagnostic testing.
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