Advaxis (ADXS), in collaboration with Merck & Co. (MRK), is conducting a Phase 1 Part 2 trial to evaluate the safety and efficacy of ADXS-PSA[1. prostate-specific antigen] as a monotherapy and in combination with Merck’s Keytruda in patients with previously treated metastatic, castration-resistant prostate cancer.
In the trial, 13 patients were evaluated on monotherapy and 37 patients were evaluated on combination therapy. The safety profile was found to be consistent with prior clinical studies that used Lm Technology. Treatment-related adverse events were mostly mild or moderate, and no new toxicities were observed. At the data cutoff, patients who received the combination therapy experienced the longest overall survival. About 57% of patients on the combination therapy and 38.5% of patients on the monotherapy didn’t experience progression of the disease.
Update on MAA filing and ADXS-Hot program
On July 10, Advaxis announced a clinical update. The company plans to withdraw its conditional MAA (Marketing Authorization Application) for axalimogene filolisbac in the European Union for the treatment of patients with metastatic cervical cancer who progress beyond first-line therapy.
This action is based on feedback from the European Medicines Agency after its initial review that indicated the application will need additional data to support a conditional approval.
Advaxis also announced the submission of an IND (Investigational New Drug) application with the FDA to study ADXS-HOT for treating non-small cell lung cancer. It also selected prostate cancer as the second cancer type for the ADXS-HOT program and expects to file an IND application in the next six months.
So far in 2018, Advaxis stock has fallen from a high of $3.30 on January 25 to a low of $1.15 on July 12. Since hitting the low, the stock has rebounded, boosted by the FDA’s lifting of its clinical hold. It closed at $1.41 on July 17.