On September 10, 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 third quarter ended July 31, 2020 (Press release, Advaxis, SEP 10, 2020, View Source [SID1234564925]).
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Key recent corporate and clinical pipeline updates:
Presented updated clinical data from the ongoing Phase 1/2 trial of ADXS-503 in non-small cell lung cancer (NSCLC) demonstrating durable clinical benefit in two out of 3 evaluable patients with immediate prior progression on KEYTRUDA including one durable response now out to 34 weeks with 25% reduction in target lesion and another sustained response now out to 33 weeks with a 60% reduction in site lesions. Both patients remain on treatment in Part B, the combination arm with KEYTRUDA
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
Initiated ADXS-503 Part B combination arm efficacy expansion which will enroll up to 15 patients to evaluate the potential of ADXS-503 in combination with KEYTRUDA to restore and/or enhance responsiveness to checkpoint inhibitors in PD-1/L-1 refractory NSCLC patients
Initiated ADXS-503 Part C combination arm to evaluate ADXS-503 in combination with KEYTRUDA as a first line treatment in patients with NSCLC with PD-L1 expression ≥ 1% or who are unfit for chemotherapy
ADXS-503 monotherapy and in combination with KEYTRUDA appeared safe and well tolerated with no dose limiting toxicities or added toxicity in the combination setting
Announced common stock purchase agreement for up to $20 million with Lincoln Park Capital
Management Commentary
"We are highly encouraged by the clinical and on-mechanism biomarker data from our ongoing Phase 1/2 study of ADXS-503 in NSCLC and have continued to execute on our expansion of the evaluation of the potential of ADXS-503 to synergistically enhance and/or restore sensitivity to checkpoint inhibitors," said Kenneth A. Berlin, President and Chief Executive Officer of Advaxis. "This quarter, we have begun enrollment in the expansion of Part B to further evaluate the promising signals of sustained clinical benefit observed in the first dose cohort of Part B in NSCLC patients with immediate prior progression on KEYTRUDA. This could yet be another strategy to rechallenge the tumor with a checkpoint inhibitor without having to stop the drug at progression. In addition, we have started enrollment in Part C which will evaluate ADXS-503 in combination with KEYTRUDA, moving our HOT program to a first line treatment for patients with metastatic NSCLC that would receive KEYTRUDA alone as per label indication (i.e., PD-L1 expression ≥ 1%) and patients who are unfit to receive the standard of care regimen of KEYTRUDA in combination with platinum based-chemotherapy. We believe these two clinical evaluations in Part B and Part C of this study will elucidate the potential of ADXS-503 to improve responses to checkpoint inhibitors in diverse clinical settings and for patients who have limited treatment options. We anticipate having additional data on this program by the end of the year."
Mr. Berlin continued, "We are particularly encouraged by the safety and tolerability profile of ADXS-503 as a monotherapy and in combination KEYTRUDA, and with no dose limiting toxicities observed, we believe this can be an important addition to standard of care for those patients whose illness makes them ineligible for other forms of chemotherapy. Our recently announced common stock purchase agreement allows us to continue the prioritization of our HOT program with the ongoing expansions in NSCLC as well as the initiation of a Phase 1 study of ADXS-504 in prostate cancer patients with biochemical recurrence before year end."
Third Quarter Ended July 31, 2020 Financial Results
Research and development expenses for the third quarter of fiscal year 2020 were $3.5 million, compared with $7.1 million for the third quarter of fiscal year 2019. The decrease is largely attributable to the winding down of the 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 July 31, 2020 were approximately $2.4 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 business development costs.
As of July 31, 2020, the Company had approximately $23.8 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 July 2021.