ADXS Advaxis Inc.

0.34
+0.02  (+8%)
Previous Close 0.31
Open 0.32
52 Week Low 0.2639
52 Week High 1.48
Market Cap $37,020,892
Shares 109,821,692
Float 109,756,255
Enterprise Value $17,230,422
Volume 14,704,769
Av. Daily Volume 3,452,895
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Drug Pipeline

Drug Stage Notes
ADXS-503
Non-small cell lung cancer (NSCLC)
Phase 1/2
Phase 1/2
Phase 1/2 data presented at SITC meeting November 2020. Noted October 26, 2020 overall response rate of 17% (1/6 patients).
ADXS-504
Prostate Cancer
Phase 1
Phase 1
Phase 1 trial to be initiated 4Q 2020.
ADXS-NEO
Non-small cell lung cancer (NSCLC)
Phase 1
Phase 1
Phase 1 safety and immunogenicity data presented at AACR March 2019
ADXS-PSA and Keytruda - KEYNOTE-046
Castrate-resistant prostate cancer
Phase 1/2
Phase 1/2
Phase 1 presentation at ASCO Genitourinary Cancers Symposium February 13, 2020 noted median overall survival (95% CI) of 33.7 months.
Axalimogene filolisbac + durvalumab
Recurrent or refractory HPV-associated cervical cancer and head & neck cancer
Phase 1/2
Phase 1/2
Enrollment to be terminated - noted November 2, 2018.
Axalimogene filolisbac - AIM2CERV Trial
High-risk, locally advanced cervical cancer
Phase 3
Phase 3
Phase 3 trial closed - noted June 27, 2019.
Axalimogene filolisbac
Anal cancer (FAWCETT)
Phase 2
Phase 2
Noted in 10-K December 21, 2017 that it will not initiate the Stage 2 portion of the trial in order to focus its resources on other clinical priorities.
ADXS-HER2
HER2-driven malignancies - cancer
Phase 1b
Phase 1b
Decided not to proceed to the expansion phase of the trial - noted in 10K December 21, 2017.

Latest News

  1. PRINCETON, N.J., Nov. 27, 2020 (GLOBE NEWSWIRE) -- Advaxis, Inc. (NASDAQ:ADXS) (the "Company"), a clinical-stage biotechnology company focused on the development and commercialization of immunotherapy products, today announced the closing of an underwritten public offering of 26,666,666 shares of common stock and warrants to purchase up to 13,333,333 shares of common stock, along with an additional 3,999,999 shares of common stock and 1,999,999 warrants pursuant to the full exercise of the underwriters' option. The shares of common stock and warrants were sold together at a combined public offering price of $0.30 per share for total gross proceeds of approximately $9.2 million, before underwriting commissions and estimated expenses.

    The Company…

    PRINCETON, N.J., Nov. 27, 2020 (GLOBE NEWSWIRE) -- Advaxis, Inc. (NASDAQ:ADXS) (the "Company"), a clinical-stage biotechnology company focused on the development and commercialization of immunotherapy products, today announced the closing of an underwritten public offering of 26,666,666 shares of common stock and warrants to purchase up to 13,333,333 shares of common stock, along with an additional 3,999,999 shares of common stock and 1,999,999 warrants pursuant to the full exercise of the underwriters' option. The shares of common stock and warrants were sold together at a combined public offering price of $0.30 per share for total gross proceeds of approximately $9.2 million, before underwriting commissions and estimated expenses.

    The Company plans to use the net proceeds from the offering to fund its continued research and development initiatives in connection with expanding its product pipeline including, but not limited to, investment in its ADXS-HOT program and for general corporate purposes. The Company may also use a portion of the net proceeds to acquire or invest in other businesses, products and technologies.

    A.G.P./Alliance Global Partners acted as sole book-running manager for the offering.

    This offering was made pursuant to an effective shelf registration statement on Form S-3 (File No. 333-226988) previously filed with the U.S. Securities and Exchange Commission (the "SEC"), which became effective upon filing on August 30, 2018. A prospectus supplement describing the terms of the proposed offering will be filed with the SEC and will be available on the SEC's website located at www.sec.gov. Electronic copies of the prospectus supplement may be obtained, when available, from A.G.P./Alliance Global Partners, 590 Madison Avenue, 28th Floor, New York, NY 10022 or via telephone at 212-624-2060 or email: .

    No securities regulatory authority has either approved or disapproved of the contents of this press release. This press release is for information purposes only and shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

    About Advaxis

    Advaxis, Inc. is a clinical-stage biotechnology company focused on the development and commercialization of proprietary Lm-based antigen delivery products. These immunotherapies are based on a platform technology that utilizes live attenuated Listeria monocytogenes (Lm) bioengineered to secrete antigen/adjuvant fusion proteins. These Lm-based strains are believed to be a significant advancement in immunotherapy as they integrate multiple functions into a single immunotherapy and are designed to access and direct antigen presenting cells to stimulate anti-tumor T cell immunity, activate the immune system with the equivalent of multiple adjuvants, and simultaneously reduce tumor protection in the tumor microenvironment to enable T cells to eliminate tumors.

    Forward Looking Statements

    This press release contains forward-looking statements that are made pursuant to the safe harbor provisions within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements are any statements that express the current beliefs and expectations of management. Any statements contained herein that do not describe historical facts are forward-looking statements that are subject to risks and uncertainties that could cause actual results, performance and achievements to differ materially from those discussed in such forward-looking statements. Such risks include, but are not limited to: the success and timing of the Company's clinical trials, including patient accrual; the Company's ability to develop and commercialize its products; the Company's ability to identify license and collaboration partners and to maintain existing relationships; the Company's available cash and its ability to obtain additional funding; and any outcomes from the Company's review of strategic transactions. These and other risks are discussed in the Company's filings with the SEC, including, without limitation, its Annual Report on Form 10-K, filed on December 20, 2019, as amended, and its periodic reports on Form 10-Q and Form 8-K. The Company cautions readers not to place undue reliance on any forward-looking statements, which speak only as of the date they were made. The Company undertakes no obligation to update or revise forward-looking statements whether as a result of new information, future events or otherwise, except as otherwise required by law.

    Investor Contact

    Tim McCarthy

    LifeSci Advisors, LLC



    (212) 915-2564



    Primary Logo

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  2. PRINCETON, N.J., Nov. 24, 2020 (GLOBE NEWSWIRE) -- Advaxis, Inc. (NASDAQ:ADXS) (the "Company"), a clinical-stage biotechnology company focused on the development and commercialization of immunotherapy products, today announced the pricing of an underwritten public offering of (i) 26,666,666 shares of common stock and warrants to purchase up to 13,333,333 shares of common stock. The shares of common stock and warrants are being sold together at a combined public offering price of $0.30 per share. The warrants will have an exercise price of $0.35 per share, will be immediately exercisable and will expire five years from the date of issuance. The Company has granted the underwriters a 30-day option to purchase up to an additional 3,999,999 shares…

    PRINCETON, N.J., Nov. 24, 2020 (GLOBE NEWSWIRE) -- Advaxis, Inc. (NASDAQ:ADXS) (the "Company"), a clinical-stage biotechnology company focused on the development and commercialization of immunotherapy products, today announced the pricing of an underwritten public offering of (i) 26,666,666 shares of common stock and warrants to purchase up to 13,333,333 shares of common stock. The shares of common stock and warrants are being sold together at a combined public offering price of $0.30 per share. The warrants will have an exercise price of $0.35 per share, will be immediately exercisable and will expire five years from the date of issuance. The Company has granted the underwriters a 30-day option to purchase up to an additional 3,999,999 shares of common stock and/or 1,999,999 warrants to cover over-allotments, if any.

    The Company plans to use the net proceeds from the offering to fund its continued research and development initiatives in connection with expanding its product pipeline including, but not limited to, investment in its ADXS-HOT program and for general corporate purposes. The Company may also use a portion of the net proceeds to acquire or invest in other businesses, products and technologies.

    A.G.P./Alliance Global Partners is acting as sole book-running manager for the offering.

    This offering is being made pursuant to an effective shelf registration statement on Form S-3 (File No. 333-226988) previously filed with the U.S. Securities and Exchange Commission (the "SEC"), and an additional registration statement on Form S-3 filed pursuant to Rule 462(b) under the Securities Act, which became effective upon filing on August 30, 2018. A prospectus supplement describing the terms of the proposed offering will be filed with the SEC and will be available on the SEC's website located at www.sec.gov. Electronic copies of the prospectus supplement may be obtained, when available, from A.G.P./Alliance Global Partners, 590 Madison Avenue, 28th Floor, New York, NY 10022 or via telephone at 212-624-2060 or email: . Before investing in this offering, interested parties should read in their entirety the prospectus supplement and the accompanying prospectus and the other documents that the Company has filed with the SEC that are incorporated by reference in such prospectus supplement and the accompanying prospectus, which provide more information about the Company and such offering. Copies of the Supplement, the Base Shelf Prospectus and the Registration Statement may also be obtained from A.G.P./Alliance Global Partners, 590 Madison Avenue, 28th Floor, New York, NY 10022 or via telephone at 212-624-2060 or email: .

    No securities regulatory authority has either approved or disapproved of the contents of this press release. This press release is for information purposes only and shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

    About Advaxis

    Advaxis, Inc. is a clinical-stage biotechnology company focused on the development and commercialization of proprietary Lm-based antigen delivery products. These immunotherapies are based on a platform technology that utilizes live attenuated Listeria monocytogenes (Lm) bioengineered to secrete antigen/adjuvant fusion proteins. These Lm-based strains are believed to be a significant advancement in immunotherapy as they integrate multiple functions into a single immunotherapy and are designed to access and direct antigen presenting cells to stimulate anti-tumor T cell immunity, activate the immune system with the equivalent of multiple adjuvants, and simultaneously reduce tumor protection in the tumor microenvironment to enable T cells to eliminate tumors.

    Forward Looking Statements

    This press release contains forward-looking statements that are made pursuant to the safe harbor provisions within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements are any statements that express the current beliefs and expectations of management. Any statements contained herein that do not describe historical facts are forward-looking statements that are subject to risks and uncertainties that could cause actual results, performance and achievements to differ materially from those discussed in such forward-looking statements. Such risks include, but are not limited to: the success and timing of the Company's clinical trials, including patient accrual; the Company's ability to develop and commercialize its products; the Company's ability to identify license and collaboration partners and to maintain existing relationships; the Company's available cash and its ability to obtain additional funding; and any outcomes from the Company's review of strategic transactions. These and other risks are discussed in the Company's filings with the SEC, including, without limitation, its Annual Report on Form 10-K, filed on December 20, 2019, as amended, and its periodic reports on Form 10-Q and Form 8-K. The Company cautions readers not to place undue reliance on any forward-looking statements, which speak only as of the date they were made. The Company undertakes no obligation to update or revise forward-looking statements whether as a result of new information, future events or otherwise, except as otherwise required by law.

    Investor Contact

    Tim McCarthy

    LifeSci Advisors, LLC



    (212) 915-2564



    Primary Logo

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  3. PRINCETON, N.J., Nov. 23, 2020 (GLOBE NEWSWIRE) -- Advaxis, Inc. (NASDAQ:ADXS) (the "Company"), a clinical-stage biotechnology company focused on the development and commercialization of immunotherapy products, today announced that it intends to offer and sell shares of its common stock and warrants to purchase shares of its common stock in an underwritten public offering. In connection with the offering, the Company intends to grant the underwriters a 30-day option to purchase up to an additional 15% of the shares of common stock and/or purchase warrants to purchase additional shares of common stock offered in the public offering. The proposed offering is subject to market and other conditions, and there can be no assurance as to whether…

    PRINCETON, N.J., Nov. 23, 2020 (GLOBE NEWSWIRE) -- Advaxis, Inc. (NASDAQ:ADXS) (the "Company"), a clinical-stage biotechnology company focused on the development and commercialization of immunotherapy products, today announced that it intends to offer and sell shares of its common stock and warrants to purchase shares of its common stock in an underwritten public offering. In connection with the offering, the Company intends to grant the underwriters a 30-day option to purchase up to an additional 15% of the shares of common stock and/or purchase warrants to purchase additional shares of common stock offered in the public offering. The proposed offering is subject to market and other conditions, and there can be no assurance as to whether or when the proposed offering may be completed, or as to the size or terms of the proposed offering.

    The Company plans to use the net proceeds from the offering to fund its continued research and development initiatives in connection with expanding its product pipeline including, but not limited to, investment in its ADXS-HOT program and for general corporate purposes. The Company may also use a portion of the net proceeds to acquire or invest in other businesses, products and technologies.

    A.G.P./Alliance Global Partners is acting as sole book-running manager for the offering.

    This offering is being made pursuant to an effective shelf registration statement on Form S-3 (File No. 333-226988) previously filed with the U.S. Securities and Exchange Commission (the "SEC"), and an additional registration statement on Form S-3 filed pursuant to Rule 462(b) under the Securities Act, which became effective upon filing on August 30, 2018. A prospectus supplement describing the terms of the proposed offering will be filed with the SEC and will be available on the SEC's website located at www.sec.gov. Electronic copies of the prospectus supplement may be obtained, when available, from A.G.P./Alliance Global Partners, 590 Madison Avenue, 28th Floor, New York, NY 10022 or via telephone at 212-624-2060 or email: . Before investing in this offering, interested parties should read in their entirety the prospectus supplement and the accompanying prospectus and the other documents that the Company has filed with the SEC that are incorporated by reference in such prospectus supplement and the accompanying prospectus, which provide more information about the Company and such offering. Copies of the Supplement, the Base Shelf Prospectus and the Registration Statement may also be obtained from A.G.P./Alliance Global Partners, 590 Madison Avenue, 28th Floor, New York, NY 10022 or via telephone at 212-624-2060 or email: .

    No securities regulatory authority has either approved or disapproved of the contents of this press release. This press release is for information purposes only and shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

    About Advaxis

    Advaxis, Inc. is a clinical-stage biotechnology company focused on the development and commercialization of proprietary Lm-based antigen delivery products. These immunotherapies are based on a platform technology that utilizes live attenuated Listeria monocytogenes (Lm) bioengineered to secrete antigen/adjuvant fusion proteins. These Lm-based strains are believed to be a significant advancement in immunotherapy as they integrate multiple functions into a single immunotherapy and are designed to access and direct antigen presenting cells to stimulate anti-tumor T cell immunity, activate the immune system with the equivalent of multiple adjuvants, and simultaneously reduce tumor protection in the tumor microenvironment to enable T cells to eliminate tumors.

    Forward Looking Statements

    This press release contains forward-looking statements that are made pursuant to the safe harbor provisions within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements are any statements that express the current beliefs and expectations of management. Any statements contained herein that do not describe historical facts are forward-looking statements that are subject to risks and uncertainties that could cause actual results, performance and achievements to differ materially from those discussed in such forward-looking statements. Such risks include, but are not limited to: the success and timing of the Company's clinical trials, including patient accrual; the Company's ability to develop and commercialize its products; the Company's ability to identify license and collaboration partners and to maintain existing relationships; the Company's available cash and its ability to obtain additional funding; and any outcomes from the Company's review of strategic transactions. These and other risks are discussed in the Company's filings with the SEC, including, without limitation, its Annual Report on Form 10-K, filed on December 20, 2019, as amended, and its periodic reports on Form 10-Q and Form 8-K. The Company cautions readers not to place undue reliance on any forward-looking statements, which speak only as of the date they were made. The Company undertakes no obligation to update or revise forward-looking statements whether as a result of new information, future events or otherwise, except as otherwise required by law.

    Investor Contact

    Tim McCarthy

    LifeSci Advisors, LLC



    (212) 915-2564



    Primary Logo

    View Full Article Hide Full Article
  4. Disease control rate of 67% and overall response rate of 17% in first six evaluable patients with immediate prior progression on KEYTRUDA®

    Biomarker data confirms on-mechanism activation of innate and adaptive immune responses to ADXS-503

    ADXS-503 appeared safe and well tolerated as a monotherapy and in combination with KEYTRUDA®

    PRINCETON, N.J., Nov. 09, 2020 (GLOBE NEWSWIRE) -- Advaxis, Inc. (NASDAQ:ADXS), a clinical-stage biotechnology company focused on the development and commercialization of immunotherapy products today announced the presentation of data from the Company's ongoing Phase 1/2 study evaluating ADXS-503 as a monotherapy and in combination with KEYTRUDA® (pembrolizumab), Merck's anti-PD-1 therapy in non-small cell lung

    Disease control rate of 67% and overall response rate of 17% in first six evaluable patients with immediate prior progression on KEYTRUDA®

    Biomarker data confirms on-mechanism activation of innate and adaptive immune responses to ADXS-503

    ADXS-503 appeared safe and well tolerated as a monotherapy and in combination with KEYTRUDA®

    PRINCETON, N.J., Nov. 09, 2020 (GLOBE NEWSWIRE) -- Advaxis, Inc. (NASDAQ:ADXS), a clinical-stage biotechnology company focused on the development and commercialization of immunotherapy products today announced the presentation of data from the Company's ongoing Phase 1/2 study evaluating ADXS-503 as a monotherapy and in combination with KEYTRUDA® (pembrolizumab), Merck's anti-PD-1 therapy in non-small cell lung cancer (NSCLC) at the 2020 Society for Immunotherapy of Cancer (SITC) Annual Meeting. ADXS-503 is the first drug construct from the Company's ADXS-HOT off-the-shelf, cancer-type specific, immunotherapy program which leverages Advaxis' proprietary Lm technology platform to target hotspot mutations that commonly occur in specific cancer types as well as other proprietary, tumor-associated antigens.

    The data presented across three cohorts; Part A monotherapy, Part B combination with KEYTRUDA® and Part C combination with KEYTRUDA® in the first line setting for patients with NSCLC with PD-L1 expression ≥ 1% or who are unfit for chemotherapy, together, demonstrate that ADXS-503 was safe and well tolerated, and may restore or enhance sensitivity to checkpoint inhibitors as an off-the-shelf, neoantigen immunotherapy.

    "The results observed thus far in Part B of this study, with ADXS-503 added to KEYTRUDA® without intervening treatment or a change in the checkpoint inhibitor at the time of progression on KEYTRUDA®, provide encouraging proof-of-concept that ADXS-503 may re-sensitize or enhance the response to KEYTRUDA®," said Jonathan W. Goldman, M.D., Department of Medicine, Ronald Regan UCLA Medical Center, UCLA Health Santa Monica Medical Center, and Lead Study Investigator. "The results in Part B also demonstrate an improved disease control rate compared to other checkpoint rechallenge studies. We are equally intrigued with the duration and quality of the clinical benefit, as four patients have been safely treated and done well with the combination therapy, two of them for more than 10 months as of today. Importantly, the immune correlative data support the thesis that ADXS-503 is synergizing well with KEYTRUDA® by activating cytotoxic and memory CD8+ T cells. We are eagerly collecting additional data to better define the role of ADXS-503 and KEYTRUDA® in this setting and in Part C of the study in first line therapy of NSCLC patients."

    Key presentation highlights:

    Poster presentation titled, "Phase 1/2 Study of an Off-the-Shelf, Multi-Neoantigen Vector (ADXS-503) Alone and in Combination with Pembrolizumab in Subjects with Metastatic Non-Small Cell Lung Cancer (NSCLC)" presented by Jonathan W. Goldman, M.D., Department of Medicine, Ronald Reagan UCLA Medical Center, UCLA Health Santa Monica Medical Center, and lead study investigator

    • ADXS-503 alone (Part A) and in combination with Pembrolizumab (Part B-DL1 and Part C) appeared safe and tolerable.
      • There were no added toxicities from combining ADXS-503 with Pembrolizumab
    • In Part A, ADXS-503 alone achieved stable disease in 50% (n=6) of heavily pre-treated patients including prior treatment with checkpoint inhibitors in all but one patient



    • In Part B, the overall response rate (17%) and disease control rate (67%) (n=6) suggest that adding on ADXS-503 after immediate prior progression on Pembrolizumab may re-sensitize or enhance response to Pembrolizumab



    • The first two patients treated in the Part B that had achieved SD and PR have now lasted 10 months



    • In Part B, one patient with squamous histology also achieved stable disease, suggesting this regimen may be broadly applicable across NSCLC



    • Biomarker data from 9 patients to date, 6 from Part A and 3 from Part B, show:



      • Activation of cytotoxic- and/or memory-CD8+ T cells in patients treated with monotherapy and in combination therapy
      • 100% efficient priming by ADXS-503 with generation of CD8+ T cells against neoantigens in the vector as well as antigen spreading observed
      • Patients with known KRAS mutations in tumor samples have achieved stable disease in the study, including KRAS G12D in 2 out of 6 patients in Part A and KRAS G12V in 1 out of 3 in Part B DL1. Mutational analysis is ongoing across all patients.

    Ken Berlin, Chief Executive Officer of Advaxis, said, "We are increasingly confident that ADXS-503, as an off-the-shelf neoantigen therapy, may be an important new approach to expand the benefit and durability of treatment with checkpoint inhibitors. These expanded biomarker data serve as in important proof-of-mechanism of ADXS-503 activity, stimulating both innate and adaptive immune responses with measured responses to neoantigens in our vector and antigen spreading observed. These encouraging efficacy and immune response data, in combination with a favorable safety and tolerability profile, suggest that our unique approach to neoantigen immunotherapy may be broadly applicable in lung cancer and potentially in other solid tumors. We look forward to increased momentum in the program as we continue to enroll patients in the Part B efficacy expansion and Part C expansion to the first line setting."

    The Phase 1/2 clinical trial of ADXS-503 is seeking to establish the recommended dose, safety, tolerability and clinical activity of ADXS-503 administered alone and in combination with a KEYTRUDA® in approximately 50 patients with NSCLC, in at least five sites across the U.S. The two dose levels with monotherapy in Part A, (1 X108 and 5 X108 CFU) have been completed. Part B with ADXS-503 (1 X108 CFU) in combination with KEYTRUDA® is currently enrolling its efficacy expansion for up to 15 patients at dose level 1 (1 X108 CFU + KEYTRUDA®) with the potential to proceed to dose level 2 (5 X108 CFU + KEYTRUDA®) at a later date. Part C, which is evaluating ADXS-503 in combination with KEYTRUDA® (1 X108 CFU + KEYTRUDA®) as a first line treatment for patients with NSCLC with PD-L1 expression ≥ 1% or who are unfit for chemotherapy is currently enrolling patients.

    About ADXS-HOT

    ADXS-HOT is a program that leverages the Company's proprietary Lm technology to target hotspot mutations that commonly occur in specific cancer types. ADXS-HOT drug candidates are designed to target acquired shared or "public" mutations in tumor driver genes along with other proprietary cancer-testes and oncofetal tumor-associated antigens that also commonly occur in specific cancer types. ADXS-HOT drug candidates are an off-the-shelf treatment, designed to potentially treat all patients with a specific cancer type, without the need for pretreatment biomarker testing, DNA sequencing or diagnostic testing.

    About Advaxis, Inc.

    Advaxis, Inc. is a clinical-stage biotechnology company focused on the development and commercialization of proprietary Lm-based antigen delivery products. These immunotherapies are based on a platform technology that utilizes live attenuated Listeria monocytogenes (Lm) bioengineered to secrete antigen/adjuvant fusion proteins. These Lm-based strains are believed to be a significant advancement in immunotherapy as they integrate multiple functions into a single immunotherapy and are designed to access and direct antigen presenting cells to stimulate anti-tumor T cell immunity, activate the immune system with the equivalent of multiple adjuvants, and simultaneously reduce tumor protection in the tumor microenvironment to enable T cells to eliminate tumors.

    To learn more about Advaxis, visit www.advaxis.com and connect on Twitter, LinkedIn, Facebook and YouTube.

    KEYTRUDA® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, N.J., USA.

    Investor Contact

    Tim McCarthy

    LifeSci Advisors, LLC



    (212) 915-2564

            

     

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  5. Disease control rate of 67% in first six evaluable patients who had progressed on KEYTRUDA

    Approximate 50% improvement in disease control rate versus the rates reported in other checkpoint rechallenge studies

    Durable, sustained tumor control of over 43 and 33 weeks observed in first two evaluable patients

    PRINCETON, N.J., Oct. 26, 2020 (GLOBE NEWSWIRE) -- Advaxis, Inc. (NASDAQ:ADXS), a clinical-stage biotechnology company focused on the development and commercialization of immunotherapy products today announced updated clinical results from the combination arm of the Company's ongoing Phase 1/2 study evaluating ADXS-503 in combination with KEYTRUDA® (pembrolizumab), Merck's anti-PD-1 therapy in non-small cell lung cancer (NSCLC).

    Disease control rate of 67% in first six evaluable patients who had progressed on KEYTRUDA

    Approximate 50% improvement in disease control rate versus the rates reported in other checkpoint rechallenge studies

    Durable, sustained tumor control of over 43 and 33 weeks observed in first two evaluable patients

    PRINCETON, N.J., Oct. 26, 2020 (GLOBE NEWSWIRE) -- Advaxis, Inc. (NASDAQ:ADXS), a clinical-stage biotechnology company focused on the development and commercialization of immunotherapy products today announced updated clinical results from the combination arm of the Company's ongoing Phase 1/2 study evaluating ADXS-503 in combination with KEYTRUDA® (pembrolizumab), Merck's anti-PD-1 therapy in non-small cell lung cancer (NSCLC). ADXS-503 is the first drug construct from the Company's ADXS-HOT off-the-shelf, cancer-type specific, immunotherapy program which leverages Advaxis' proprietary Lm technology platform to target hotspot mutations that commonly occur in specific cancer types as well as other proprietary, tumor-associated antigens.

    Key data updates for the first 6 evaluable patients who have received ADXS-503 as an add-on therapy immediately following progression with KEYTRUDA®, include:

    • Disease control rate of 67% (4/6 patients) and overall response rate of 17% (1/6 patients) achieved after immediate prior progression on KEYTRUDA® with previous best responses of stable disease
    • Sustained clinical benefit with the first two treated patients remaining on treatment for over 43 and 33 weeks
    • Updated and new patient level data for the four patients with observed disease control, all of whom remain on study, include:

      °  Previously reported partial response (PR) with 60% tumor reduction seen on 8-week scan and sustained at 33-week scan in an elderly patient with non-squamous NSCLC who had received Pembrolizumab for approximately 30 months with a best overall response (BOR) of stable disease

      °  Previously reported stable disease (SD) with a 25% reduction in target lesion sustained at 43-week scan in an elderly patient with non-squamous NSCLC who had received Pembrolizumab for ~32 months with a BOR of stable disease.

      °  Stable disease (SD) confirmed on 13 week-scan in a patient with squamous NSCLC who had received Pembrolizumab for approximately 15 months with a BOR of stable disease

      °  Stable disease (SD) on 6 week-scan in a patient with non-squamous NSCLC who had received Pembrolizumab for approximately 14 months, including combination therapy with chemotherapy in the beginning

    "I am highly encouraged by these data which suggest that treatment with ADXS-503 has the potential to re-sensitize or enhance response to KEYTRUDA®, even in patients with immediate prior progression on treatment," said Dr. Andres Gutierrez, Chief Medical Officer of Advaxis. "Other checkpoint inhibitor rechallenge studies have reported disease control rates of approximately 45 percent, with these studies typically including bridging therapy, a change in checkpoint inhibitor, or an interruption in treatment of varying intervals. The 67% disease control rate demonstrated thus far in this ongoing study represents an impressive 50 percent improvement versus the disease control rate observed in other studies in similar settings. This improvement in the setting of uninterrupted treatment on KEYTRUDA® is promising and suggests that ADXS-503 may be capable of re-stimulating the immune system to drive clinically meaningful benefit. The sustained durability of responses is also noteworthy, and I look forward to the continued evaluation of ADXS-503 in additional patients as we advance through the efficacy expansion phase of the study."

    Ken Berlin, Chief Executive Officer of Advaxis, said, "We are pleased that the growing and maturing data from our ongoing ADXS-503 clinical trial suggest that this drug candidate may represent an important new treatment option for patients who have progressed on checkpoint inhibitors. Notably, all patients with disease control were on treatment with KEYTRUDA® for over one year at the time of progression, with prior best responses that were limited to stable disease throughout their treatment. In addition, one patient with squamous histology also achieved stable disease, suggesting this regimen may be broadly applicable across NSCLC. As to the durability of tumor control, the first 2 evaluable patients remain on treatment with sustained clinical benefit for over 10 months, suggesting treatment with ADXS-503 is capable of providing long-term resensitization or enhancement to checkpoint inhibitors after disease progression."

    Mr. Berlin continued, "Our belief is that ADXS-503, as an off-the-shelf neoantigen therapy that to date has a favorable safety and tolerability profile, may be broadly beneficial to lung cancer patients in diverse treatments settings and specifically, those with limited treatment options. These results, paired with our recent biomarker data that show on-mechanism activation of an immune response to ADXS-503 antigens, leave us increasingly confident that ADXS-503 has the potential to restore or enhance sensitivity to checkpoint inhibitors. We look forward to continued progress in our expanded clinical program, now evaluating patients in Part B, the efficacy expansion arm, and Part C, our expansion to the first line setting, both of which are continuing to enroll patients."

    The Phase 1/2 clinical trial of ADXS-503 is seeking to establish the recommended dose, safety, tolerability and clinical activity of ADXS-503 administered alone and in combination with a KEYTRUDA® in approximately 50 patients with NSCLC, in at least five sites across the U.S. The two dose levels with monotherapy in Part A, (1 X108 and 5 X108 CFU) have been completed. Part B with ADXS-503 (1 X108 CFU) in combination with KEYTRUDA® is currently enrolling its efficacy expansion for up to 15 patients at dose level 1 (1 X108 CFU + KEYTRUDA®) with the potential to proceed to dose level 2 (5 X108 CFU + KEYTRUDA®) at a later date. Part C, which is evaluating ADXS-503 in combination with KEYTRUDA® (1 X108 CFU + KEYTRUDA®) as a first line treatment for patients with NSCLC with PD-L1 expression ≥ 1% or who are unfit for chemotherapy is currently enrolling patients.

    About ADXS-HOT

    ADXS-HOT is a program that leverages the Company's proprietary Lm technology to target hotspot mutations that commonly occur in specific cancer types. ADXS-HOT drug candidates are designed to target acquired shared or "public" mutations in tumor driver genes along with other proprietary cancer-testes and oncofetal tumor-associated antigens that also commonly occur in specific cancer types. ADXS-HOT drug candidates are an off-the-shelf treatment, designed to potentially treat all patients with a specific cancer type, without the need for pretreatment biomarker testing, DNA sequencing or diagnostic testing.

    About Advaxis, Inc.

    Advaxis, Inc. is a clinical-stage biotechnology company focused on the development and commercialization of proprietary Lm-based antigen delivery products. These immunotherapies are based on a platform technology that utilizes live attenuated Listeria monocytogenes (Lm) bioengineered to secrete antigen/adjuvant fusion proteins. These Lm-based strains are believed to be a significant advancement in immunotherapy as they integrate multiple functions into a single immunotherapy and are designed to access and direct antigen presenting cells to stimulate anti-tumor T cell immunity, activate the immune system with the equivalent of multiple adjuvants, and simultaneously reduce tumor protection in the tumor microenvironment to enable T cells to eliminate tumors.

    To learn more about Advaxis, visit www.advaxis.com and connect on Twitter, LinkedIn, Facebook and YouTube.

    KEYTRUDA® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, N.J., USA.

    Investor Contact

    Tim McCarthy

    LifeSci Advisors, LLC



    (212) 915-2564

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