Advaxis bails on Phase 1/2 study of AXAL + Imfinzi; may tweak design of Phase 3 trial of AXAL monotherapy to accelerate data readout; shares down 6% premarket

|About: Advaxis Inc. (ADXS)|By:, SA News Editor

Advaxis (NASDAQ:ADXS) updates on its clinical clinical programs. Key points:

Phase 3 AIM2CERV study of axalimogene filolisbac (AXAL) in high-risk, locally advanced cervical cancer: the company is mulling a redesign that will allow a shorter timeline for an interim data readout and a more stringent futility boundary. Enrollment is ongoing under the current design.

An investigator-sponsored study assessing AXAL in head and neck cancer should launch in early 2019.

A Phase 1/2 trial assessing ADXS-PSA + Merck's (NYSE:MRK) Keytruda (pembrolizumab) in metastatic castration-resistant prostate cancer remains on track. Updated data on survival and biomarkers should be available next quarter.

Enrollment has been terminated in its Phase 1/2 study evaluating AXAL + AstraZeneca's (NYSE:AZN) Imfinzi (durvalumab) in treatment-resistant cervical cancer and HPV-associated head and neck cancer. It will also not launch the ADVANCE study in cervical cancer.

Preliminary data from its Phase 1 dose-escalation study of ADXS-NEO in solid tumors should be available in H1 2019.

Enrollment in a Phase 1/2 trial of ADXS-HOT 503 + Keytruda in non-small cell lung cancer (NSCLC) should start this quarter with preliminary data expected in H1 2019.

Management will host a conference call today at 11:00 am ET to discuss its clinical programs.

Shares are down 6% premarket on light volume.

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