Advaxis : Gutierrez AA. Clinical activity and immunogenicity of a neoantigen immunotherapy in non-small cell lung cancer. Neoantigen Based Therapies Summit. Weaponizing Vaccines and Cell Based Immunotherapies. October 28, 2021. Virtual Meeting
January 31, 2022 at 11:12 pm IST
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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
I 2
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
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.
Ayala Pharmaceuticals, Inc. is a clinical-stage oncology company primarily focused on developing and commercializing small molecule therapeutics for patients suffering from rare and aggressive cancers, primarily in genetically defined patient populations. The Company's lead candidate is aspacytarabine (BST-236), a novel anti-metabolite for first line treatment in unfit acute myeloid leukemia (AML). Aspacytarabine (BST-236) is composed of cytarabine covalently bound to asparagine, acting as a pro-drug of cytarabine. It is also focused on the development and commercialization of proprietary Listeria monocytogenes (Lm)-based antigen delivery products. These efforts are primarily focused on the development of ADXS-504, a Lm-based therapy for early-stage prostate cancer.
Advaxis : Gutierrez AA. Clinical activity and immunogenicity of a neoantigen immunotherapy in non-small cell lung cancer. Neoantigen Based Therapies Summit. Weaponizing Vaccines and Cell Based Immunotherapies. October 28, 2021. Virtual Meeting