On November 02, 2015 Advaxis, Inc. (NASDAQ:ADXS), a clinical-stage biotechnology company developing cancer immunotherapies, reported additional information about the clinical hold issued by the U.S. Food and Drug Administration (FDA) on the Company’s Investigational New Drug (IND) application for axalimogene filolisbac (Press release, Advaxis, NOV 2, 2015, View Source [SID:1234507885]). Since announcing the verbal notification of the clinical hold of axalimogene filolisbac, Advaxis has received written notification from the FDA of the clinical hold. Schedule your 30 min Free 1stOncology Demo! Since early October, Advaxis has been in an ongoing dialogue with the FDA. Over the course of these discussions, the FDA has identified certain risk mitigation measures for implementation once the hold is lifted. The Agency requested proposals from the Company regarding such measures. The Company promptly provided its recommendations, including appropriate patient inclusion / exclusion criteria, as well as certain patient surveillance and monitoring measures.
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Further, the FDA has concurred with the Investigator’s assessment that the patient’s cause of death, in the safety report triggering the clinical hold, was due to cervical cancer progression. While no additional safety concerns have been identified by the Agency, it also verbally notified the Company that the clinical hold included the INDs for ADXS-PSA and ADXS-HER2 so that their evaluation, and any mitigation measures, could be simultaneously applied to all product candidates.
Advaxis is continuing to work with the FDA to facilitate review and resolution of this matter. The Company expects that the clinical hold will be resolved without significant interruption to its clinical development programs.
About Axalimogene Filolisbac
Axalimogene filolisbac (ADXS-HPV) is Advaxis’s lead Lm Technology immunotherapy candidate for the treatment of HPV-associated cancers and is in clinical trials for three potential indications: invasive cervical cancer, head and neck cancer, and anal cancer. In a completed randomized Phase 2 study in recurrent/refractory cervical cancer, axalimogene filolisbac showed apparent prolonged survival, objective tumor responses, and a manageable safety profile alone or in combination with chemotherapy, supporting further development of the company’s Lm Technology.
About ADXS-PSA
ADXS-PSA is an Lm Technology immunotherapy under investigation for targeting the prostate-specific antigen (PSA) associated with prostate cancer. ADXS-PSA is in clinical development both as a monotherapy and in combination with immune checkpoint inhibitors for the treatment of metastatic castration-resistant prostate cancer (mCRPC).
About ADXS-HER2
ADXS-HER2 is an Lm Technology immunotherapy product candidate being developed by Advaxis to target HER2 expressing cancers. ADXS-HER2 has received orphan drug designation by the U.S. Food and Drug Administration (FDA) for the treatment of osteosarcoma. Advaxis is developing ADXS-HER2 for both human and animal health, and has seen encouraging data in canine osteosarcoma, which is considered a model for human osteosarcoma. Advaxis has licensed ADXS-HER2 and three other immunotherapy constructs to Aratana Therapeutics, Inc. for the development of pet therapeutics.