Advaxis Inc. (NASDAQ:ADXS) has reported its Q2 financial results for the quarter that ended April 30 and provided its clinical pipeline updates.
Promising Phase 1/2 ADXS 503 results
The company recently presented an update of its clinical and initial biomarker data for the current Phase 1/2 study of ADXS-503 in treating non-small cell lung cancer. The data demonstrated clinical benefit in two patients that had progression previously on KEYTRUDA. This included one durable response after 25 weeks and a sustained response after at least 16 weeks, but both patients are still in the Part B treatment, the KEYTRUDA combination arm.
Results indicate that one patient shows partial response after 16 weeks in site lesions with a 60% reduction while there was a 25% reduction in target lesion after 25 weeks in the durable response. Advaxis has already completed Part A monotherapy, and three of the six patients under evaluation have attained stable disease responses. ADXS-503 as a monotherapy and a KEYTRUDA combination has demonstrated positive safety and tolerability responses without dose-limiting toxicities.
In the quarter, the company also provided an update on survival data from Phase 1/2 ADXS-PSA study in with KEYTRUDA combination. The company presented data at the ASCO Genitourinary Cancer Conference. Also, the company signed a research agreement with Personalis for deploying the ImmunoID NeXT Platform in its ADXS-503 program.
Advaxis has enough cash to run up to August 2021
Advaxis CEO Kenneth Berlin indicated that in the second quarter, the company updated clinical data supporting the prioritization of the off-shelf neoantigen HOT Program. He added that the results from the current ADX-503 study in NSCLC are promising and could enhance or restore checkpoint inhibitors’ sensitivity. Berlin said they were pleased with the sustained clinical benefit in the patients.
The company’s R&D expenses in Q2 were $3.9 million compared to $6.0 in Q2 2019. The drop was due to the winding down of the Phase 1 ADXS-NEO and AIM2CERV studies. The company ended the quarter with $25.2 million in cash and investment, which is adequate to fund obligations until August 2021.