Advaxis announces publication of ADXS-PSA data in The

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ADXS-PSA in combination with KEYTRUDA® in metastatic castration-resistant prostate cancer (mCRPC) is associated with prolonged overall survival in this population, especially in patients with visceral metastases

Median overall survival of 16.4 months for patients with visceral metastases treated with ADXS-PSA in combination with KEYTRUDA® vs ~9 months from historical data with KEYTRUDA® only

Median overall survival of 33.7 months in all patients with mCRPC treated with ADXS-PSA in combination with KEYTRUDA®as previously stated

MONMOUTH JUNCTION, NJ, April 08, 2022 (GLOBE NEWSWIRE) — Advaxis, Inc. (OTCQX: ADXS), a clinical-stage biotechnology company focused on the development and commercialization of immunotherapy products, today announced the release of results from their KEYNOTE- 46 Phase 1/2 open-label, dual-arm trial of ADXS-PSA with KEYTRUDA® (pembrolizumab) in patients with metastatic castration-resistant prostate cancer (mCRPC). The article, titled “ADXS31142 Immunotherapy ± Pembrolizumab Treatment for Metastatic Castration-Resistant Prostate Cancer: Open-Label Phase I/II KEYNOTE-046 Study”, was published online in The oncologistt. The article is available online here.

The KEYNOTE-46 trial was conducted in collaboration with Merck (known as MSD outside the United States and Canada) and evaluated ADXS-PSA, one of Advaxis’ products Listeria monocytogenes (lm) based on immunotherapies, alone and in combination with KEYTRUDA®Merck’s anti-PD-1 therapy.

“Published clinical and immunogenicity data demonstrate that ADXS-PSA in combination with KEYTRUDA® has the potential to provide significant increases in median overall survival in patients with advanced, metastatic, and castration-resistant prostate cancer,” said Kenneth A. Berlin, President and CEO of Advaxis. . “Furthermore, these demonstrated survival improvements in an advanced patient population encourage us to continue researching and developing the next generation of Lm-immunotherapies such as our ready-to-use multineoantigen drug construct, ADXS-504, currently being studied in biochemically recurrent prostate cancer. ADXS-504 is a novel treatment alternative for these early-stage prostate cancer patients, which has the potential to delay initiation of androgen blockade therapy, improve quality of life and to increase life expectancy.

As of January 28, 2020, the data cutoff date, 50 patients with mCRPC have been enrolled with evaluable responses in Advaxis’ Ph 1/2 trial of ADXS-PSA alone and ADXS-PSA in combination with KEYTRUDA®. The median overall survival (OS) in 13 patients treated with ADXS-PSA alone was 7.8 months (95% CI: 4.4-18.5) with a progression-free survival (PFS) of 2.2 months (95% CI: 0.8-7.4). The median OS on ADXS-PSA combined with KEYTRUDA® was 33.7 months (95% CI: 15.4-NR), while the median PFS was 5.4 months (95% CI: 2.3 to 7.9; n = 37). 56.8% (21/37) of patients on combination therapy and 30.8% (4/13) on monotherapy had stable disease. A robust response was also seen with combination therapy in docetaxel-experienced patients with visceral metastases. In addition, patients in the combination arm who had previously received docetaxel treatment (n=20; 17 of them had also received 1 or 2 treatments with new generation hormone (NGHA)) had an OS of 16.0 months (95% CI: 6.4-34.6), while patients with prior visceral metastases (n=11; 10 of them had previously received docetaxel and 9 had received 1-2 prior treatments at NGHA) ​​had an OS of 16.4 months (95% CI: 4.0-NE). Of note, 36 of the 37 patients in the combined group were tested for microsatellite instability and all were found to be microsatellite stable (MSS).

The combination of ADXS-PSA and KEYTRUDA® increased T cell expansion compared to ADXS-PSA alone, suggesting broader immune stimulation. Additionally, contraction of T cell clones was observed in the combined group, suggesting that T cell clones with lower avidity for PSA (and other prostate-related antigens) were reduced in favor of high-avidity T cells under PD-1 blockade. The combined arm also showed antigen spread with documented antigen-specific T cell responses against other relevant prostate cancer antigens.

Naomi B Haas, MD, director of the prostate and kidney cancer program and professor of medicine at the University of Pennsylvania Hospital, and lead author of this publication, said, “Overall , these data are encouraging given the prolonged survival observed in patients on combination therapy. regardless of previous treatment with docetaxel, NGHAs or the presence of visceral metastases. Interestingly, increases in median overall survival to 16.4 months in patients with measurable disease/visceral metastases compared to historical data of ≤ 9.5 months with pembrolizumab alone in this population. She added, “In addition, a patient who completed the 2-year treatment study with ADXS-PSA in combination with KEYTRUDA® switched to a compassionate use protocol and remained with stable disease for another 22 months while on combination therapy. These results, obtained with a generally safe and well-tolerated treatment regimen, may warrant further evaluation of ADXS-PSA in combination with KEYTRUDA® or new generation lm-immunotherapies in prostate cancer.

Combination therapy was safe and well tolerated in this heavily pretreated population. All patients had more than one treatment-related adverse event, primarily grade 1-2 transient chills/chills, fever, hypotension, nausea, and fatigue, with no additive toxicity on combination treatment .

About KEYNOTE-046
KEYNOTE-046 (NCT02325557) was a Phase 1/2 open-label, multicenter, dose-finding, safety and tolerability trial of 50 heavily pretreated patients conducted in two parts (Part A and Part B), with an expansion cohort phase 2. While the objective of the study was to evaluate ADXS-PSA as monotherapy (Part A; n=14 [13 treated]) and in combination with KEYTRUDA® (Part B; n=37) in heavily pretreated patients with progressive and refractory mCRPC, the study was not designed to compare the two treatment regimens. Primary endpoints included safety, tolerability, and dosage. Secondary endpoints were anti-tumor activity, progression-free survival and overall survival, and exploratory endpoints included associations between biomarkers of immunological response (serum PSA) and clinical outcomes.

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

To learn more about Advaxis, visit www.advaxis.com.

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 all statements that express management’s current beliefs and expectations, including, but not limited to, statements related to the expected clinical development of the Company’s drug candidates. 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 January 22, 2022, and its subsequent periodic reports on Form 10-Q and Form 8-K. All 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. . The Company cautions readers not to place undue reliance on forward-looking statements, which speak only as of the date on which they are made. The Company undertakes no obligation to update or revise any forward-looking statements, except as required by law, whether as a result of new information, future events or otherwise.

Contact:
Tim McCarthy, LifeSci Advisors, LLC
212.915.2564
[email protected]

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