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Advaxis (ADXS) announced updated clinical results from the combination arm of the Company's ongoing Phase 1/2 study evaluating ADXS-503 in combination with KEYTRUDA, Merck's (MRK) anti-PD-1 therapy in non-small cell lung cancer. 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% and overall response rate of 17% 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 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 of stable disease; Previously reported stable disease 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 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 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 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, have been completed. Part B with ADXS-503 in combination with KEYTRUDA is currently enrolling its efficacy expansion for up to 15 patients at dose level 1 with the potential to proceed to dose level 2 at a later date. Part C, which is evaluating ADXS-503 in combination with KEYTRUDA as a first line treatment for patients with NSCLC with PD-L1 expression greater than or equal to 1% or who are unfit for chemotherapy is currently enrolling patients.

Advaxis announced that its Board of Directors has approved the adoption of a limited duration stockholder rights plan and declared a dividend distribution of one right for each outstanding share of common stock. The record date for such dividend distribution is October 12, 2020. The rights plan expires, without any further action being required to be taken by the Company's Board of Directors, on September 28, 2021. The adoption of the rights plan is intended to protect Advaxis and its stockholders from the actions of third parties that Advaxis' Board of Directors determines are not in the best interests of Advaxis and its stockholders, and to enable all stockholders to realize the full potential value of their investment in Advaxis. The rights plan was not adopted in response to any specific takeover proposal or any currently threatened or pending effort to acquire control of Advaxis of which the Board of Directors is aware. The rights plan was adopted to provide the Board of Directors with time to make informed decisions that are in the best long-term interests of Advaxis and its stockholders and does not prevent Advaxis' Board of Directors from considering any offer to acquire Advaxis that it considers to be in the best interest of Advaxis' stockholders. The rights plan is similar to stockholder rights plans adopted by other publicly-traded companies. Under the rights plan, the rights generally would become exercisable only if a person or group acquires beneficial ownership of 10% or more of Advaxis' common stock in a transaction not approved by Advaxis' Board of Directors. In that situation, each holder of a right will have the right to purchase, upon payment of the exercise price and in accordance with the terms of the rights plan, a number of shares of Advaxis' common stock having a market value of twice such price. In addition, if Advaxis is acquired in a merger or other business combination after an acquiring person acquires 10% or more of Advaxis' common stock, each holder of the right would thereafter have the right to purchase, upon payment of the exercise price and in accordance with the terms of the rights plan, a number of shares of common stock of the acquiring person having a market value of twice such price. The acquiring person or group would not be entitled to exercise these rights. In the rights plan, the definition of "beneficial ownership" includes derivative securities. Stockholders who beneficially owned 10% or more of Advaxis' outstanding common stock prior to the first public announcement by Advaxis of the adoption of the rights plan will not trigger any penalties under the rights plan so long as they do not acquire beneficial ownership of any additional shares of common stock at a time when they still beneficially own 10% or more of such common stock, subject to certain exceptions as described in the rights plan.

Advaxis announced the U.S. Food and Drug Administration has cleared a new Investigational New Drug application for the initiation of an Investigator Sponsored Phase 1 clinical study of ADXS-504, the Company's off-the-shelf neoantigen ADXS-HOT candidate for prostate cancer. This new IND is in addition to the Advaxis sponsored IND, previously announced in January 2020. Advaxis intends to first advance the clinical evaluation of ADXS-504 through an Investigator Sponsored Phase 1 study in prostate cancer patients with biochemical recurrence which remains on-track for initiation in the fourth quarter this year.