On June 11, 2020 Advaxis, Inc. (Nasdaq: ADXS), a clinical-stage biotechnology company focused on the development and commercialization of immunotherapy products reported an update on its clinical pipeline and financial results for the second quarter ended April 30, 2020 (Press release, Advaxis, JUN 11, 2020, View Source [SID1234561009]).
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Key recent corporate and clinical pipeline updates:
Presented updated clinical and preliminary biomarker data from the ongoing Phase 1/2 trial of ADXS-503 in non-small cell lung cancer (NSCLC) demonstrating clinical benefit in two patients with immediate prior progression on KEYTRUDA including one durable response out to 25 weeks and another sustained response out to out least 16 weeks with both patients remaining on treatment in Part B, the combination arm with KEYTRUDA
One sustained partial response with 60% reduction in site lesions at 16 weeks and one durable response of stable disease with 25% reduction in target lesion at 25 weeks confirmed by radiographic scans
Clinical benefit achieved after immediate prior progression on KEYTRUDA with previous best responses of stable disease suggest ADXS-503 may re-sensitize or enhance response to KEYTRUDA
Part A monotherapy has been completed with three of six evaluable patients achieving responses of stable disease
As monotherapy, as well as in combination with KEYTRUDA, ADXS-503 appeared safe and well tolerated with no dose-limiting toxicities
Preliminary biomarker data from seven patients in Part A monotherapy demonstrated activation of cytotoxic and memory CD8+ and CD4+ T cells in 100% of patients and antigen spreading in five of seven evaluable patients, including the first patient in combination therapy
Presented updated survival data from the Phase 1/2 trial with ADXS-PSA in combination with KEYTRUDA at the ASCO (Free ASCO Whitepaper) Genitourinary Cancers Symposium. Data highlights include reported median overall survival (95% CI) of 16.4 months (4.0-NR) (n=11) for advanced prostate cancer patients with prior docetaxel therapy and visceral metastases treated with ADXS-PSA in combination with KEYTRUDA compared to an estimated 11 months with current standard of care. In addition, median overall survival (95% CI) was 33.7 months (15.4-33.7) in all patients treated with ADXS-PSA in combination with KEYTRUDA (n=37)
Announced a research agreement with Personalis to deploy ImmunoID NeXT Platform in the ADXS-503 clinical program. Personalis will conduct comprehensive tumor genomic profiling to enable the identification of predictive composite biomarkers and/or signatures of response, as well as the broad evaluation of potential mechanisms of therapy resistance
Management Commentary
"We have continued our momentum throughout the second quarter with updated clinical data which support the prioritization of our off-the-shelf neoantigen HOT program," said Kenneth A. Berlin, President and Chief Executive Officer of Advaxis. "These updated data from our ongoing Phase 1/2 study of ADXS-503 in NSCLC increase our confidence that ADXS-503 may synergistically enhance and/or restore sensitivity to checkpoint inhibitors and we are particularly encouraged by the sustained clinical benefit observed, now out to 16 and 25 weeks, in two patients who had immediate prior progression on KEYTRUDA. Our results are further supported by preliminary biomarker data which provide insight into the on-mechanism immune stimulation which we believe are driving these responses."
Mr. Berlin continued, "Based on these results, we are expanding Part B, dose level 1, to enroll up to an additional 15 patients who have progressed on KEYTRUDA to further characterize the clinical activity of ADXS-503 in combination with KEYTRUDA as previously observed in the first two evaluable patients in this part of our study. In addition, we have opened enrollment in Part C to evaluate ADXS-503 in combination with KEYTRUDA as a first line treatment for patients with metastatic NSCLC that either have a high PD-L1 expression score and can receive KEYTRUDA alone or for patients who are ineligible to receive the standard of care regimen of KEYTRUDA in combination with platinum based-chemotherapy." He added, "The safety, tolerability and clinical activity observed so far supports the initiation of Part C for advanced patients in a first-line setting as well as the expansion of Part B in later treatment settings. Based on the clinical and immune correlative results to date, we are hopeful for enhanced responses to KEYTRUDA in patients in both of these settings who have limited treatment options and poor prognoses. We look forward to continued execution and the expansion of our HOT program to new indications including our planned Phase 1 study of ADXS-504 in prostate cancer patients with biochemical recurrence which we expect to enter the clinic by the end of this year."
Second Quarter Ended April 30, 2020 Financial Results
Research and development expenses for the second quarter of fiscal year 2020 were $3.9 million, compared with $6.0 million for the second quarter of fiscal year 2019. The decrease is largely attributable to the winding down of our Phase 3 AIM2CERV and Phase 1 ADXS-NEO studies as announced in June 2019 and October 2019, respectively.
General and administrative expenses for the three months ended April 30, 2020 were approximately $2.6 million compared to $3.1 million in the same three-month period in 2019. The decrease in expenses is mainly attributable to lower legal fees, and reduced employee and business development costs.
As of April 30, 2020, the Company had approximately $28.2 million in cash and cash equivalents. The Company believes this is sufficient capital to fund its obligations, as they become due, in the ordinary course of business until at least August 2021.