Advaxis announces increasing focus on neoantigen-directed immunotherapies and closing of its phase III AIM2CERV Study of Axal

Advaxis, Inc. announced that it is increasing its focus on neoantigen-directed immunotherapies and closing the AIM2CERV Phase III clinical trial with axalimogene filolisbac (AXAL) in high-risk locally advanced cervical cancer.

Advaxis intends to continue to support the clinical development of AXAL, its single-antigen construct, in other HPV-related cancers while redirecting resources towards advancing its neoantigen-directed programs. Specifically, the company plans to continue developing ADXS-NEO, currently in a Phase 1 clinical trial, in patients with several types of advanced or metastatic solid tumors including melanoma, lung, colorectal, head and neck and bladder cancers, and ADXS-HOT, currently in a Phase 1/II clinical trial, for non-small cell lung cancer.

The company anticipates advancing additional drug constructs from its ADXS-HOT program into the clinic over the next 18 months. The estimated remaining cost to complete the AIM2CERV trial ranges from $80 million to $90 million, and initial efficacy data is not anticipated for at least three years. Therefore, results from the clinical trial were not the basis for the decision to close the study, nor was safety as the trial recently underwent its third Independent Data Monitoring Committee (IDMC) review with no safety issues noted. The company plans to unblind the AIM2CERV clinical data generated to date and anticipates submitting these data for publication. In addition, Advaxis will continue to pursue monetization opportunities for AXAL.