ADVAXIS, INC. (NASDAQ:ADXS) Files An 8-K Regulation FD DisclosureItem 7.01 Regulation FD Disclosure.
A copy of the press release of the Company, dated February 13, 2018, relating to the announcement discussed in Item 8.01 below is attached hereto as Exhibit 99.1.
The information provided to this Item 7.01, including Exhibit 99.1, is “furnished” and shall not be deemed to be “filed” for purposes of Section 18 of the Exchange Act, or otherwise subject to the liabilities of that Section or of Sections 11 and 12(a)(2) of the Securities Act, and shall not be incorporated by reference into any filing with the SEC made by the Company, whether made before or after the date hereof, regardless of any general incorporation language in such filing.
Item 8.01 Other Events.
On February 13, 2018, the Company issued a press release announcing the submission of a conditional Marketing Authorization Application (“MAA”) to the European Medicines Agency (the “EMA”) for the Company’s lead Lm Technology product candidate, axalimogene filolisbac, for the treatment of adult women who progress beyond first-line therapy of persistent, recurrent or metastatic carcinoma of the cervix (“PRmCC”).
The MAA submission was built around data from the GOG-0265 study which examined overall survival rates in 50 women and showed a 12-month overall survival rate (primary efficacy endpoint) of 38% (n=19/50) in women with PRmCC, representing a 55% improvement over an expected, model-predicted, 12-month survival rate of 24.5%. In the GOG-0256 study, axalimogene filolisbac was generally well-tolerated with mostly Grade 1 and 2 flu-like adverse events associated with cytokine release which were managed with standard medical care. This safety profile is consistent with the ongoing clinical experience of axalimogene filolisbac across all clinical trials. The EMA will evaluate the totality of the data, including results from GOG-0265 as well as supportive data from other clinical trials evaluating axalimogene filolisbac. In parallel with the MAA review process, the Company will continue assessing partnership opportunities for the potential commercialization of axalimogene filolisbac in Europe.
The Company has also decided to align and simplify its strategy by using axalimogene filolisbac exclusively in all ongoing and planned HPV-related cancer clinical trials, including the upcoming ADVANCE trial, previously planned with ADXS-DUAL. The Company believes that harmonizing to a single product candidate for all HPV-related programs will streamline developmental, regulatory and commercialization strategies.
Forward-Looking Statements
This report contains forward-looking statements, including, but not limited to, statements regarding the Company’s ability and strategies to develop and commercialize cancer immunotherapies, timing of planned clinical trials and regulatory milestones, potential partnership opportunities and the safety and efficacy of the Company’s proprietary immunotherapies. These forward-looking statements are subject to a number of risks including the risk factors set forth from time to time in the Company’s SEC filings including, but not limited to, its report on Form 10-K for the fiscal year ended October 31, 2017, which is available atwww.sec.gov. Any forward-looking statements set forth in this report speak only as of the date of this report. We do not intend to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof other than as required by law. You are cautioned not to place undue reliance on any forward-looking statements. Information contained on the Company’s website does not constitute part of this report.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits.
The following exhibit is furnished as part of this report:
Advaxis, Inc. ExhibitEX-99.1 2 ex99-1.htm Advaxis Submits Conditional Marketing Authorization Application for Axalimogene Filolisbac for the Second-Line Treatment of Metastatic Cervical Cancer in European Union ● Advaxis reaches important regulatory milestone for axalimogene filolisbac with submission of Conditional MAA to treat metastatic cervical cancer in patients who progress beyond first-line therapy ● The MAA submission is centered around the encouraging results from the GOG-0265 study ● Each year,…To view the full exhibit click here
About ADVAXIS, INC. (NASDAQ:ADXS)
Advaxis, Inc. is a clinical-stage biotechnology company. The Company’s immunotherapies are based on a platform technology that utilizes live attenuated Listeria monocytogenes (Lm or Listeria) bioengineered to secrete antigen/adjuvant fusion proteins. It is focused on the discovery, development and commercialization of Lm-LLO cancer immunotherapies. The Company’s immunotherapy candidates include Axalimogene filolisbac, ADXS-PSA and ADXS-HER2. Axalimogene filolisbac (ADXS-HPV) is a lead Lm-LLO immunotherapy product candidate for the treatment of human papilloma virus (HPV) associated cancers. ADXS-PSA is an Lm-LLO immunotherapy product candidate designed to target the Prostate Specific Antigen (PSA) associated with prostate cancer. ADXS-HER2 is an Lm-LLO immunotherapy product candidate designed for the treatment of Human Epidermal Growth Factor Receptor 2 (HER2) expressing cancers, including human and canine osteosarcoma, breast, gastric and other cancers.