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{\*\bkmkstart filing_1}{\*\bkmkend filing_1}{\*\bkmkstart doc_1_1}{\*\bkmkend doc_1_1}\par\pard\plain\cf1\f51\fs20\ql \~\par\pard\plain\brdrb\brdrs\cf1\f51\fs2\ql \~\par\pard\plain\cf1\f51\fs20\ql \~\par\pard\plain\cf1\f51\fs36\b\qc UNITED STATES\par\pard\plain\cf1\f51\fs36\b\qc SECURITIES AND EXCHANGE COMMISSION\par\pard\plain\cf1\f51\fs24\b\qc Washington, D.C. 20549\par\pard\plain\cf1\f51\fs20\qj \~\par\pard\plain\cf1\f51\fs36\b\qc FORM 8-K\par\pard\plain\cf1\f51\fs20\qj \~\par\pard\plain\cf1\f51\fs20\b\qc CURRENT REPORT\par\pard\plain\cf1\f51\fs20\b\qc Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934\par\pard\plain\cf1\f51\fs20\qj \~\par\pard\plain\cf1\f51\fs20\qc Date of Report (Date of earliest event reported): \plain\cf1\f51\fs20\ul\qc February 13, 2020\par\pard\plain\cf1\f51\fs20\qc \~
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\pard\plain\intbl\cf1\f51\fs36\b\qc ADVAXIS, INC.\cell{
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\pard\plain\intbl\cf1\f51\fs20\qc Delaware\cell\pard\plain\intbl\cf1\f51\fs20\ql \~\cell\pard\plain\intbl\cf1\f51\fs20\qc 001-36138\cell\pard\plain\intbl\cf1\f51\fs20\ql \~\cell\pard\plain\intbl\cf1\f51\fs20\qc 02-0563870\cell{
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\pard\plain\intbl\cf1\f51\fs20\qc 305 College Road East\par\pard\plain\intbl\cf1\f51\fs20\qc Princeton, New Jersey\cell\pard\plain\intbl\cf1\f51\fs20\ql \~\cell\pard\plain\intbl\cf1\f51\fs20\qc 08540\cell{
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\pard\plain\intbl\cf1\f51\fs20\qc (Address of principal executive offices)\cell\pard\plain\intbl\cf1\f51\fs20\ql \~\cell\pard\plain\intbl\cf1\f51\fs20\qc (Zip Code)\cell{
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\pard\plain\intbl\cf1\f51\fs20\qc Title of each class\cell\pard\plain\intbl\cf1\f51\fs20\ql \~\cell\pard\plain\intbl\cf1\f51\fs20\qc Trading Symbol(s)\cell\pard\plain\intbl\cf1\f51\fs20\ql \~\cell\pard\plain\intbl\cf1\f51\fs20\qc Name of each exchange on which registered\cell{
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\pard\plain\intbl\cf1\f51\fs20\ql Common stock, par value $0.001 per share\cell\pard\plain\intbl\cf1\f51\fs20\ql \~\cell\pard\plain\intbl\cf1\f51\fs20\qc ADXS\cell\pard\plain\intbl\cf1\f51\fs20\ql \~\cell\pard\plain\intbl\cf1\f51\fs20\qc Nasdaq Global Select Market\cell{
{\trowd\cellx3780\cellx3996\cellx6155\cellx6370\cellx10800\trrh248\row}}}\pard\plain\cf1\f51\fs20\qj \~\par\pard\plain\cf1\f51\fs20\qj Indicate by check mark whether the registrant is an emerging growth company as defined in as defined in Rule 405 of the\plain\cf1\f51\fs20\qj  Securities Act of 1933 (\u167?230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (\u167?240.12b-2\plain\cf1\f51\fs20\qj  of this chapter).\par\pard\plain\cf1\f51\fs20\qj \~\par\pard\plain\cf1\f51\fs20\qj Emerging growth company [\~\~]\par\pard\plain\fi550\cf1\f51\fs20\qj \~\par\pard\plain\cf1\f51\fs20\qj If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for\plain\cf1\f51\fs20\qj  complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. [\~\~]\par\pard\plain\fi550\cf1\f51\fs20\qj \~\par\pard\plain\brdrb\brdrs\cf1\f51\fs2\ql \~\par\pard\plain\fi550\cf1\f51\fs20\qj \~
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\pard\plain\intbl\fi550\cf1\f51\fs20\b\ql Item\plain\intbl\fi550\cf1\f51\fs20\b\ql  8.01\cell\pard\plain\intbl\cf1\f51\fs20\b\ql Other Events\cell{
{\trowd\cellx440\cellx10800\trrh495\row}}}\pard\plain\fi550\cf1\f51\fs20\qj \~\par\pard\plain\fi550\cf1\f51\fs20\qj On February 13, 2020, Advaxis, Inc. (the \u8220?Company\u8221?) issued a press release announcing updated survival\plain\fi550\cf1\f51\fs20\qj  data in the Phase 1/2 ADXS-PSA Trial at the ASCO Genitourinary Cancers Symposium. The Company\u8217?s press release is\plain\fi550\cf1\f51\fs20\qj  attached as Exhibit 99.1 to this current report on Form 8-K and is incorporated herein by reference.\par\pard\plain\cf1\f51\fs20\ql \~{\*\bkmkstart part_1_2_2}{\*\bkmkend part_1_2_2}{\*\bkmkstart item_1_47_1}{\*\bkmkend item_1_47_1}
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{\trowd\cellx440\cellx10800\trrh495\row}}}\pard\plain\cf1\f51\fs20\qc \~\par\pard\plain\cf1\f51\fs20\qj (d)\par\pard\plain\cf1\f51\fs20\qc \~\par\pard\plain\fi550\cf1\f51\fs20\qj The following exhibits are filed as part of this report:\par\pard\plain\cf1\f51\fs20\qc \~
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\pard\plain\intbl\cf1\f51\fs20\ql Exhibit\plain\intbl\cf1\f51\fs20\ql  No.\cell\pard\plain\intbl\cf1\f51\fs20\ql \~\cell\pard\plain\intbl\cf1\f51\fs20\qc Exhibit Name\cell{
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\pard\plain\intbl\cf1\f51\fs20\ql 99.1\cell\pard\plain\intbl\cf1\f51\fs20\ql \~\cell\pard\plain\intbl\ul{\field{\*\fldinst HYPERLINK \\l "doc_1_2" }{\*\fldrslt\cf3\f51\fs20\ql Press Release of Advaxis, Inc., dated February 13, 2020}}\cell{
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\pard\plain\intbl\cf1\f51\fs20\ql February 13, 2020\cell\pard\plain\intbl\cf1\f51\fs20\b\ql ADVAXIS, INC\plain\intbl\cf1\f51\fs20\ql .\cell{
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\pard\plain\intbl\cf1\f51\fs20\ql \~\cell\pard\plain\intbl\cf1\f51\fs20\ql By:\cell\pard\plain\intbl\cf1\f51\fs20\i\ql /s/ Molly Henderson\cell{
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\pard\plain\intbl\cf1\f51\fs20\ql \~\cell\pard\plain\intbl\cf1\f51\fs20\ql Name:\cell\pard\plain\intbl\cf1\f51\fs20\ql Molly Henderson\cell{
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\pard\plain\intbl\cf1\f51\fs20\ql \~\cell\pard\plain\intbl\cf1\f51\fs20\ql Title:\cell\pard\plain\intbl\cf1\f51\fs20\ql Executive Vice President and Chief Financial Officer\cell{
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\page{\*\bkmkstart doc_1_2}{\*\bkmkend doc_1_2}\pard\plain\cf1\f51\fs20\qc \~\par\pard\plain\cf1\f51\fs20\b\qr Exhibit 99.1\par\pard\plain\cf1\f51\fs20\qc \~\par\pard\plain\cf1\f51\fs20\b\qc Advaxis Announces Updated Survival Data in Phase 1/2 ADXS-PSA Trial at the ASCO Genitourinary Cancers\plain\cf1\f51\fs20\b\qc  Symposium\par\pard\plain\cf1\f51\fs20\i\qc \~\par\pard\plain\cf1\f51\fs20\i\qc Median overall survival of 16.4 months for advanced prostate cancer patients with visceral metastases treated with ADXS-PSA\plain\cf1\f51\fs20\i\qc  in combination with KEYTRUDA\u174? compared to an estimated 11 months with Standard of Care\par\pard\plain\cf1\f51\fs20\i\qc \~\par\pard\plain\cf1\f51\fs20\i\qc Median overall survival of 33.7 months in all patients treated with ADXS-PSA in combination with KEYTRUDA\u174?\par\pard\plain\cf1\f51\fs20\qc \~\par\pard\plain\cf1\f51\fs20\b\qj PRINCETON, N.J.- February 13, 2020\plain\cf1\f51\fs20\qj  - Advaxis, Inc. (Nasdaq: ADXS), a clinical-stage biotechnology company focused on\plain\cf1\f51\fs20\qj  the development and commercialization of immunotherapy products today announced updated results from the combination arm\plain\cf1\f51\fs20\qj  of KEYNOTE-46 (Part B), the Company\u8217?s ongoing Phase 1/2 study investigating ADXS-PSA with KEYTRUDA\u174?\plain\cf1\f51\fs20\qj  (pembrolizumab) in patients with metastatic, castrate-resistant prostate cancer (mCRPC) at the ASCO Genitourinary Cancers\plain\cf1\f51\fs20\qj  Symposium in San Francisco, California. The KEYNOTE-46 trial was conducted in conjunction with Merck (known as MSD\plain\cf1\f51\fs20\qj  outside the U.S. and Canada) and evaluated ADXS-PSA, one of Advaxis\u8217?\plain\cf1\f51\fs20\i\qj   Listeria monocytogenes\plain\cf1\f51\fs20\qj   (\plain\cf1\f51\fs20\i\qj  Lm\plain\cf1\f51\fs20\qj  )-based\plain\cf1\f51\fs20\qj  immunotherapies, alone and in combination with KEYTRUDA\u174?, Merck\u8217?s anti-PD-1 therapy.\par\pard\plain\cf1\f51\fs20\ql \~\par\pard\plain\cf1\f51\fs20\qj \u8220?The presented survival data in patients with visceral metastases strengthens our confidence that ADXS-PSA in\plain\cf1\f51\fs20\qj  combination with KEYTRUDA\u174? has the potential to provide meaningful increases in median overall survival in patients\plain\cf1\f51\fs20\qj  with advanced, metastatic, castration-resistant prostate cancer,\u8221? said Kenneth A. Berlin, President and Chief Executive\plain\cf1\f51\fs20\qj  Officer of Advaxis. \u8220?Importantly, these demonstrated impacts on survival have not been previously observed with\plain\cf1\f51\fs20\qj  immunotherapy in this advanced patient population leading us to actively assess next steps for the program with the hope of\plain\cf1\f51\fs20\qj  providing a much-needed new treatment for these patients with limited options.\u8221?\par\pard\plain\cf1\f51\fs20\ql \~\par\pard\plain\cf1\f51\fs20\qj Key findings presented by Mark N. Stein M.D., FACS, Associate Professor of Medical Oncology at Columbia University\plain\cf1\f51\fs20\qj  Medical Center and lead study investigator, titled, \u8220?KEYNOTE-046 (Part B): Effects of ADXS-PSA in combination with\plain\cf1\f51\fs20\qj  pembrolizumab on survival in metastatic, castration-resistant prostate cancer patients with or without prior exposure to\plain\cf1\f51\fs20\qj  docetaxel\u8221? include:\par\pard\plain\cf1\f51\fs20\ql \~
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\pard\plain\intbl\cf1\f51\fs20\ql \~\cell\pard\plain\intbl\cf1\f51\fs20\ql \u9679?\cell\pard\plain\intbl\cf1\f51\fs20\qj Median overall survival (95% CI) of 33.7 months (15.4-NR) for patients treated with ADXS-PSA in combination with\plain\intbl\cf1\f51\fs20\qj  KEYTRUDA\u174? (n=37)\cell{
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{\trowd\cellx70\cellx734\cellx10800\trrh248
\pard\plain\intbl\cf1\f51\fs20\ql \~\cell\pard\plain\intbl\cf1\f51\fs20\ql \u9679?\cell\pard\plain\intbl\cf1\f51\fs20\qj Median overall survival (95% CI) of 16.0 months (6.4-34.6) for patients with prior docetaxel (n=20)\cell{
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\pard\plain\intbl\cf1\f51\fs20\ql \~\cell\pard\plain\intbl\cf1\f51\fs20\ql \u9679?\cell\pard\plain\intbl\cf1\f51\fs20\qj Median overall survival (95% CI) of 16.4 months (4.0-NR) for patients with prior visceral metastasis (n=11; 10 of who\plain\intbl\cf1\f51\fs20\qj  had prior docetaxel)\cell{
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\pard\plain\intbl\cf1\f51\fs20\ql \~\cell\pard\plain\intbl\cf1\f51\fs20\ql \u9679?\cell\pard\plain\intbl\cf1\f51\fs20\qj 72.4% (21/29) of evaluable patients showed stable disease\cell{
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\pard\plain\intbl\cf1\f51\fs20\ql \~\cell\pard\plain\intbl\cf1\f51\fs20\ql \u9679?\cell\pard\plain\intbl\cf1\f51\fs20\qj 38% of patients had PSA declines and 27% had >= 30% PSA decline from baseline\cell{
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\pard\plain\intbl\cf1\f51\fs20\ql \~\cell\pard\plain\intbl\cf1\f51\fs20\ql \u9679?\cell\pard\plain\intbl\cf1\f51\fs20\qj The combination of ADXS-PSA and pembrolizumab appeared safe and tolerable in this heavily pretreated, unselected\plain\intbl\cf1\f51\fs20\qj  population of patients with MSI-High-negative mCRPC\cell{
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\pard\plain\intbl\cf1\f51\fs20\ql \~\cell\pard\plain\intbl\cf1\f51\fs20\ql \u9679?\cell\pard\plain\intbl\cf1\f51\fs20\qj Treatment-related adverse events were mostly Grade 1-2, with no additive toxicity observed with combination therapy\cell{
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{\trowd\cellx10800\trrh248\row}}}\pard\plain\cf1\f51\fs20\ql \~\par\pard\plain\cf1\f51\fs20\qj Mark N. Stein M.D., FACS said, \u8220?These data are encouraging given the advanced nature of the patient population which\plain\cf1\f51\fs20\qj  includes those who have failed next generation hormonal agents and/or docetaxel, and now those with visceral metastasis.\u8221?\plain\cf1\f51\fs20\qj  He added, \u8220?I am particularly enthusiastic to see increases in median overall survival to 16.4 months as compared to\plain\cf1\f51\fs20\qj  standard of care, which tends to be closer to 11 months in patients with measurable disease/visceral metastasis. This\plain\cf1\f51\fs20\qj  improvement, delivered with a generally safe and well-tolerated treatment regimen, warrants additional evaluation in larger\plain\cf1\f51\fs20\qj  studies and I look forward seeing the potential of a continued evaluation of ADXS-PSA in combination with\plain\cf1\f51\fs20\qj  KEYTRUDA\plain\cf1\f51\fs18\qj\super  \u174?\plain\cf1\f51\fs20\qj  .\u8221?\par\pard\plain\cf1\f51\fs20\ql \~\par\pard\plain\cf1\f51\fs20\qj KEYNOTE-046 was an open-label, multicenter, dose-determining safety and tolerability Phase 1/2 trial of 50 heavily pretreated\plain\cf1\f51\fs20\qj  patients conducted in two parts (Part A and Part B), with a Phase 2 expansion cohort. The objective of the study was to evaluate\plain\cf1\f51\fs20\qj  ADXS-PSA alone (Part A) and in combination with KEYTRUDA\plain\cf1\f51\fs18\b\qj\super  \u174?\plain\cf1\f51\fs20\qj   (Part B) for primary endpoints that include safety,\plain\cf1\f51\fs20\qj  tolerability and dosing. Secondary endpoints included anti-tumor activity, progression-free survival and overall survival, and\plain\cf1\f51\fs20\qj  exploratory endpoints that include associations between biomarkers of immunologic response (serum PSA) with clinical\plain\cf1\f51\fs20\qj  outcomes. Enrollment in the study has been completed and the database lock occurred on January 28, 2020. The majority of\plain\cf1\f51\fs20\qj  treatment-related adverse events consisted of transient and reversible Grade 1-2 chills/rigors, fever, hypotension, nausea and\plain\cf1\f51\fs20\qj  fatigue. The combination of ADXS-PSA and KEYTRUDA\plain\cf1\f51\fs18\qj\super  \u174?\plain\cf1\f51\fs20\qj   has appeared to be well-tolerated, to date, with no additive\plain\cf1\f51\fs20\qj  toxicity observed.\par\pard\plain\cf1\f51\fs20\ql \~\par\pard\plain\cf1\f51\fs20\b\ql About KEYNOTE-046\par\pard\plain\cf1\f51\fs20\ql \~\par\pard\plain\cf1\f51\fs20\qj KEYNOTE-046 (NCT02325557) was a Phase 1/2 open-label, multicenter, dose-determination and expansion trial that evaluates\plain\cf1\f51\fs20\qj  the safety, tolerability and preliminary clinical activity of ADXS-PSA as monotherapy (Part A; n=14 [13 treated]), and in\plain\cf1\f51\fs20\qj  combination with KEYTRUDA\plain\cf1\f51\fs18\qj\super  \u174?\plain\cf1\f51\fs20\qj   (Part B; n= 37) in heavily pretreated patients with progressive and refractory mCRPC.\par\pard\plain\cf1\f51\fs20\ql \~\par\pard\plain\cf1\f51\fs20\b\ql About Advaxis, Inc.\par\pard\plain\cf1\f51\fs20\ql \~\par\pard\plain\cf1\f51\fs20\qj Advaxis, Inc. is a clinical-stage biotechnology company focused on the development and commercialization of proprietary\plain\cf1\f51\fs20\i\qj  Lm\plain\cf1\f51\fs20\qj  -based antigen delivery products. These immunotherapies are based on a platform technology that utilizes live attenuated\plain\cf1\f51\fs20\qj  Listeria monocytogenes (\plain\cf1\f51\fs20\i\qj  Lm\plain\cf1\f51\fs20\qj  ) bioengineered to secrete antigen/adjuvant fusion proteins. These\plain\cf1\f51\fs20\i\qj   Lm\plain\cf1\f51\fs20\qj  -based strains are believed to\plain\cf1\f51\fs20\qj  be a significant advancement in immunotherapy as they integrate multiple functions into a single immunotherapy and are\plain\cf1\f51\fs20\qj  designed to access and direct antigen presenting cells to stimulate anti-tumor T cell immunity, activate the immune system with\plain\cf1\f51\fs20\qj  the equivalent of multiple adjuvants, and simultaneously reduce tumor protection in the tumor microenvironment to enable T cells\plain\cf1\f51\fs20\qj  to eliminate tumors.\par\pard\plain\cf1\f51\fs20\ql \~\par\pard\plain\cf1\f51\fs20\qj To learn more about Advaxis, visit \plain\cf1\f51\fs20\ul\qj www.advaxis.com\plain\cf1\f51\fs20\qj  and connect on Twitter, LinkedIn, Facebook and YouTube.\par\pard\plain\cf1\f51\fs20\b\ql \~\par\pard\plain\cf1\f51\fs20\b\ql Forward-Looking Statements\par\pard\plain\cf1\f51\fs20\ql \~\par\pard\plain\cf1\f51\fs20\qj This press release contains forward-looking statements that are made pursuant to the safe harbor provisions within the meaning\plain\cf1\f51\fs20\qj  of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended.\plain\cf1\f51\fs20\qj  Forward-looking statements are any statements that express the current beliefs and expectations of management, including but\plain\cf1\f51\fs20\qj  not limited to statements related to the expected clinical development of the Company\u8217?s drug product candidates. These\plain\cf1\f51\fs20\qj  and other risks are discussed in the Company\u8217?s filings with the SEC, including, without limitation, its Annual Report on\plain\cf1\f51\fs20\qj  Form 10-K, filed on December 20, 2019, and its periodic reports on Form 10-Q and Form 8-K. Any statements contained\plain\cf1\f51\fs20\qj  herein that do not describe historical facts are forward-looking statements that are subject to risks and uncertainties that could\plain\cf1\f51\fs20\qj  cause actual results, performance and achievements to differ materially from those discussed in such forward-looking statements.\plain\cf1\f51\fs20\qj  The Company cautions readers not to place undue reliance on any forward-looking statements, which speak only as of the date\plain\cf1\f51\fs20\qj  they were made. The Company undertakes no obligation to update or revise forward-looking statements, except as otherwise\plain\cf1\f51\fs20\qj  required by law, whether as a result of new information, future events or otherwise.\par\pard\plain\cf1\f51\fs20\ql \~\par\pard\plain\cf1\f51\fs20\b\ql Contact:\par\pard\plain\cf1\f51\fs20\ql Tim McCarthy, LifeSci Advisors, LLC\par\pard\plain\cf1\f51\fs20\ql 212.915.2564\par\pard\plain\cf1\f51\fs20\ul\ql tim@lifesciadvisors.com\par\pard\plain\cf1\f51\fs20\ql \~
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