Replies to post #28505 on Ayala Pharmaceuticals Inc (ADXS)

[James salmon]

From PR after investor day;

ADXS-PSA: Prostate Cancer Program

Mark Stein, MD, of Rutgers Cancer Institute of New Jersey, discussed encouraging preliminary immunological data generated from Advaxis’ prostate cancer program with ADXS-PSA in combination with Keytruda® (pembrolizumab). Dr. Stein reported that ADXS-PSA when used as monotherapy was shown to stabilize disease progression in ~30% (4/13) of patients in the dose escalation phase of the study. He also reported that ADXS-PSA was shown to be able to both activate and expand pre-existing T cell clones and was also responsible for generation of new clones of T cells in nearly all patients. He remarked that for patients who have stabilization of disease, high levels of the new T cell clones persist. However, in patients where the expanded T cell clones diminish, it leads to disease progression.

Early data on the first few patients treated with ADXS-PSA in combination with Keytruda suggested that the combination may lead to the emergence of a larger number of expanded and new T cell clones, especially over the first few treatments, thereby increasing the frequency of expanded T cells that can persist. This T cell clone expansion and persistence effect correlates with stabilization of disease. These findings and additional correlative immunologic data from this ongoing trial have been submitted for presentation at the CRI-CIMT-EATI-AACR International Cancer Immunotherapy Conference in Frankfurt, Germany, in September. Dr. Stein also detailed plans to initiate an investigator sponsored trial of ADXS-PSA in patients with earlier stage prostate cancer.