Advaxis Shares Surge After Positive Clinical Trial Updates

Advaxis, Inc. ADXS has announced a reverse stock split and clinical trial updates at the American Association of Cancer Research annual meeting in recent days.

Investors have viewed the developments positively, and the shares were trading solidly higher Monday.

Prostate Cancer Therapy Prolongs Survival

Small-cap immunotherapy biotech Advaxis announced updated data Monday from the Phase 1/2 KEYNOTE-046 trial that evaluated its ADXS-PSA, one of its listeria monocytogene-based immunotherapies, in combination with Merck & Co., Inc. MRK's anti-PD-1 therapy Keytruda, for metastatic, castration-resistant prostate cancer. The trial showed prolonged survival rates. 

Median overall survival was 21.1 months at the data cutoff date of Feb. 1 in the dataset of 37 patients in the combination arm.

"These results compare favorably to standard-of-care therapy and to study results from similar unselected patient populations with bone-predominant disease, which indicates that this combination warrants further investigation," the company said.

The KEYNOTE-046 is an open-label, multicenter, dose-determining, safety and tolerability Phase 1/2 trial of 50 heavily pretreated patients conducted in two parts: Part A and Part B, with a Phase 2 expansion cohort.

The correlative analysis, according to Advaxis, showed T-cell responses against ADXS-PSA in 75 percent of subjects and antigen spreading in 85 percent of subjects. Additionally, the company said broader immune stimulation was observed in the combination arm than in the monotherapy arm.

Promising Early Stage Vaccine Data

Preliminary data from a Phase 1 study evaluating the listeria monocytogene-based immunotherapy vaccine — ADXS-NEO — for safety, tolerability and preliminary clinical immunological activity in combination with anti-PD-1 antibody therapy in subjects with certain types of advanced or metastatic solid tumors showed rapid immunogenicity and clinical activity.

The early stage study showed substantial anti-tumor immunity, including T cell responses to neo-antigens and antigen spreading within one week of the first dose at both doses tested. The dosing of ADXS-NEO at 1* x108 colony forming units has been well-tolerated in two patients, the company said.

The company said it will initiate Part C of the trial as an expansion of the combination therapy arm based on emerging data the first two parts of the trial.

Incidentally, Advaxis announced Thursday board approval for a 1-for-15 reverse stock split that became effective Friday.
Advaxis shares were trading 20.14-percent higher at $7.10 at the time of publication Monday. 

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