Advaxis, Inc. (NASDAQ: 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. (NYSE: 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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