Clinical Activity & Immunogenicity of a Neoantigen Immunotherapy in Non-Small Cell Lung Cancer

Andres A. Gutierrez MD PhD

EVP Chief Medical Officer

28 Oct 2021

Cancer Vaccine Landscape (2021)

Beacon | Focussed research division of Hanson Wade

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Considerations relating to therapeutic personalized neoantigen vaccine regimens

Preferred platform?

Use of adjuvants?

Listeria

Preventive vs.

Therapeutic?

Mono vs combo?

Tumor stage?

TMB, MSI, etc. ?

CD8+ and/or CD4+ activation?

Long term memory?

Adapted from Blass & Ott, Nature Review, Clinical Oncology 2021 I 3

Lm TechnologyTM: Harnessing Unique Life Cycle of Lm

Induction of antigen- specific CD8 +T cell responses and antigen spreading

Legend: APC antigen-presenting cell | Lm Listeria monocytogenes | MHC major histocompatibility complex | TAA tumor-associated antigen | tLLO, truncated listeriolysin O.

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Advaxis' Lm Platform

Validated and Versatile I/O Platform, focused pipeline and several near-term milestones

Innovative Platform

Clinical Signals

Pipeline

  • Proprietary bacterial vector/platform can elicit rapid and strong immunological activity
  • Nearly 500 patients treated, manageable safety profile(1)
  • HOT Lung (ADXS-503):
    • 50% (3 of 6) of evaluable patients from the monotherapy arm, showed stable disease (SD) in a heavily pre-treated population
    • Overall response rate = 11% and disease control rate = 44% in first 9 evaluable patients in whom ADXS-503 was added on to pembrolizumab at progression, which compare favorably to current checkpoint rechallenge data(2)
    • Two of the patients with Partial Response (PR) and Stable Disease (SD) have had durable disease control for over 1 year
  • PSA (ADXS-PSA): Phase 2 study in prostate cancer(3) showed prolonged survival in combination with pembrolizumab
  • ADXS-HOT:Trial in lung cancer initiated in February 2019, currently enrolling both pts. who have progressed on pembrolizumab as well as 1L pts.; prostate cancer study to start in 3Q2021 with another >10 constructs designed that can be moved into the clinic
  • ADXS-PSA:Seeking global and regional partners

Notes: (1) Most patients experienced a Grade 1 or Grade 2 treatment-related adverse event (TRAE) associated with axalimogene filolisbac (AXAL) , ADXS-NEO & ADXS-HOT. Some patients have experienced Grade 3

events, including hypotension in 6% of pts treated with AXAL and hypoxia and/or hypotension in 3 pts treated at the highest doses with ADXS-NEO in Phase 1. The most common (>30%) Grade 1 or Grade 2 TRAEs were

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fatigue, chills, anemia, nausea and fever. (2) Best emerging data on checkpoint inhibitor re-challenge after disease progression show a low ORR (3-13%, only PR) and disease control rate of up to 45% in NSCLC (Katayama

Y, 2020; Gobbini E, 2020). (3) Metastatic castration resistant.

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Advaxis Inc. published this content on 31 January 2022 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 31 January 2022 17:41:10 UTC.