On January 25, 2019 Advaxis, Inc. (NASDAQ:ADXS), a late-stage biotechnology company focused on the discovery, development and commercialization of immunotherapy products, reported that two presentations highlighting the potential of Advaxis vectors to generate T cell responses to a large percentage of neoantigens and to promote antigen spreading and potentially slow progression of prostate cancer, were presented at the 2019 Keystone Symposia on Cancer Vaccines, held January 19-24 in Vancouver (Press release, Advaxis, JAN 25, 2019, View Source [SID1234532900]).
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The first presentation, "Neoantigen prioritization for use in a Listeria monocytogenes cancer vaccine" delivered by Brandon Coder, Ph.D., Associate Director Research & Development at Advaxis, shows the impact of CD8+ T cell responses generated to a large proportion of neoantigens, including those that were not immunogenic as peptide vaccines as well as large frameshift mutations (FSMs) that generated tumor-infiltrating lymphocytes that controlled tumor growth in preclinical CT-26 and MC-38 mouse models. The data presented support the potential of Advaxis vectors to be among the most efficient and effective at generating CD8+ T cell responses to neoantigens, including some that are not immunogenic by alternative methods of vaccination.
The second presentation, "Magnitude of anti-PSA T cell response is associated with antigen spreading and slowing in PSA and PAP velocity in ADXS-PSA treated mCRPC patients," was delivered by Robert G. Petit, Ph.D., Chief Scientific Officer and Executive Vice President of Advaxis. These data are from 13 patients treated in the ADXS-PSA monotherapy arm of Advaxis’ Phase 1/2 clinical trial of men with metastatic, castration-resistant prostate cancer (mCRPC). The presentation focused on the 56% of ADXS-PSA monotherapy patients (5/9) who exhibited a greater than three-fold increase above baseline in the magnitude of their PSA-specific T cell responses. All nine ADXS-PSA patients who received three or more treatments showed T cell responses against one or more prostate cancer antigens not included in ADXS-PSA, providing evidence of antigen spreading. Additionally, a greater magnitude of the PSA-specific T cell responses in ADXS-PSA-treated mCRPC patients was associated with more antigen spreading than those with a less than three-fold increase. Similarly, those patients with a greater than three-fold increase in PSA-specific T cells also exhibited a significant slowing in PSA and PAP velocities, which could support the potential for delaying progression and improving survival in larger studies. As previously reported, ADXS-PSA monotherapy showed a manageable safety profile with Grades 1–2 chills/rigors and fever in all patients and Grade 3 and Serious Adverse Events in five and two patients, respectively.
"These presentations highlight some of the potential benefits of the drug constructs from our proprietary Lm platform, namely the efficient generation of CD8+ T cell responses against neoantigens as well as the potential improvement of clinical endpoints due to the magnitude of these T cell responses and antigen spreading. The data directly support our ongoing investigations of the ADXS-NEO and ADXS-PSA constructs as well as future studies of the various drug constructs from our ADXS-HOT program," said Dr. Petit.