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▎WuXi AppTec Content Team Editor On January 13, 2022, Gritstone bio announced that it is evaluating a personalized cancer vaccine in combination with immune checkpoint inhibitors as first-line maintenance therapy for newly diagnosed microsatellite stable metastatic colorectal cancer (MSS).
-CRC) patients have completed the first patient enrollment in a Phase 2/3 clinical trial
.
The neoantigen cancer vaccine, called GRANITE, has been granted Fast Track designation by the US FDA for the treatment of MSS-CRC patients
.
The cancer vaccine is designed by taking biopsies from patients, sequencing the tumors, and then using a proprietary artificial intelligence platform to screen for tumor-specific neoantigens
.
This cancer vaccine requires two vaccinations, the first using an adenovirus vector to deliver the neoantigen-expressing gene, and the second using a self-amplifying mRNA (self-amplifying mRNA) vector to deliver the neoantigen-expressing mRNA
.
Self-amplifying mRNA vectors contain mRNA encoding the selected target antigen and RNA polymerase
.
After being injected into the muscle and taken up by the host cell, the mRNA is translated into protein, and RNA polymerase begins to replicate the originally injected mRNA, greatly expanding its number within the cell
.
This results in the production of a large number of target antigens
.
During RNA replication, these RNA structures send strong danger signals to surrounding immune cells, triggering an early immune response (the innate immune response)
.
In an immunostimulatory environment, the presence of a large number of antigens can elicit antigen-specific T cell responses, namely adaptive immune responses, especially CD8-positive cytotoxic T cells.
.
Image source: Gritstone bio's official website The Phase 2/3 trial is designed to evaluate this neoantigen cancer vaccine in combination with the PD-L1 inhibitor atezolizumab and the CTLA-4 inhibitor Yervoy (ipilimumab) as first-line Efficacy of maintenance therapy in patients with newly diagnosed metastatic MSS-CRC who have received induction therapy with fluorouracil, oxaliplatin, and bevacizumab
.
The results of this Phase 2/3 clinical trial may support the submission of a regulatory application
.
In addition, the company reported updated overall survival (OS) data from a Phase 1/2 clinical trial of the cancer vaccine, in combination with Opdivo and Yervoy, in patients with advanced solid tumors
.
Results of the trial showed that MSS-CRC patients who achieved molecular remission, as manifested by a decrease in circulating tumor DNA levels, continued to have an OS advantage compared with those who did not
.
All patients alive at the time of data presentation at the 2021 ESMO Annual Meeting are alive after an additional approximately 22 weeks of follow-up
.
Dr Andrew Allen, co-founder, president and chief executive officer of Gritstone, said: "We are pleased with the magnitude of clinical benefit GRANITE has observed to date in patients with difficult-to-treat advanced CRC, and we are delighted that patients receiving earlier treatment benefit from this Optimism is expressed for greater benefit from immunotherapy, with stronger immune responses and less complex tumor genomes
.
"Reference: [1] Gritstone Announces First Patient Enrolled for Phase 2/3 Trial Evaluating Individualized Neoantigen Vaccine GRANITE for First Line (1L) Maintenance Treatment of Metastatic, Microsatellite-Stable Colorectal Cancer (MSS-CRC).
Retrieved January 13, 2022 , from https://ir.
gritstonebio.
com/news-releases/news-release-details/gritstone-announces-first-patient-enrolled-phase-23-trial Health research progress
.
This article is for the purpose of information exchange only.
The opinions in this article do not represent WuXi AppTec's position, nor do they represent WuXi AppTec's support or opposition to the views in the article
.
This article is not a treatment plan recommendation
.
For guidance on treatment plans, please go to the official website hospital visit
.
-CRC) patients have completed the first patient enrollment in a Phase 2/3 clinical trial
.
The neoantigen cancer vaccine, called GRANITE, has been granted Fast Track designation by the US FDA for the treatment of MSS-CRC patients
.
The cancer vaccine is designed by taking biopsies from patients, sequencing the tumors, and then using a proprietary artificial intelligence platform to screen for tumor-specific neoantigens
.
This cancer vaccine requires two vaccinations, the first using an adenovirus vector to deliver the neoantigen-expressing gene, and the second using a self-amplifying mRNA (self-amplifying mRNA) vector to deliver the neoantigen-expressing mRNA
.
Self-amplifying mRNA vectors contain mRNA encoding the selected target antigen and RNA polymerase
.
After being injected into the muscle and taken up by the host cell, the mRNA is translated into protein, and RNA polymerase begins to replicate the originally injected mRNA, greatly expanding its number within the cell
.
This results in the production of a large number of target antigens
.
During RNA replication, these RNA structures send strong danger signals to surrounding immune cells, triggering an early immune response (the innate immune response)
.
In an immunostimulatory environment, the presence of a large number of antigens can elicit antigen-specific T cell responses, namely adaptive immune responses, especially CD8-positive cytotoxic T cells.
.
Image source: Gritstone bio's official website The Phase 2/3 trial is designed to evaluate this neoantigen cancer vaccine in combination with the PD-L1 inhibitor atezolizumab and the CTLA-4 inhibitor Yervoy (ipilimumab) as first-line Efficacy of maintenance therapy in patients with newly diagnosed metastatic MSS-CRC who have received induction therapy with fluorouracil, oxaliplatin, and bevacizumab
.
The results of this Phase 2/3 clinical trial may support the submission of a regulatory application
.
In addition, the company reported updated overall survival (OS) data from a Phase 1/2 clinical trial of the cancer vaccine, in combination with Opdivo and Yervoy, in patients with advanced solid tumors
.
Results of the trial showed that MSS-CRC patients who achieved molecular remission, as manifested by a decrease in circulating tumor DNA levels, continued to have an OS advantage compared with those who did not
.
All patients alive at the time of data presentation at the 2021 ESMO Annual Meeting are alive after an additional approximately 22 weeks of follow-up
.
Dr Andrew Allen, co-founder, president and chief executive officer of Gritstone, said: "We are pleased with the magnitude of clinical benefit GRANITE has observed to date in patients with difficult-to-treat advanced CRC, and we are delighted that patients receiving earlier treatment benefit from this Optimism is expressed for greater benefit from immunotherapy, with stronger immune responses and less complex tumor genomes
.
"Reference: [1] Gritstone Announces First Patient Enrolled for Phase 2/3 Trial Evaluating Individualized Neoantigen Vaccine GRANITE for First Line (1L) Maintenance Treatment of Metastatic, Microsatellite-Stable Colorectal Cancer (MSS-CRC).
Retrieved January 13, 2022 , from https://ir.
gritstonebio.
com/news-releases/news-release-details/gritstone-announces-first-patient-enrolled-phase-23-trial Health research progress
.
This article is for the purpose of information exchange only.
The opinions in this article do not represent WuXi AppTec's position, nor do they represent WuXi AppTec's support or opposition to the views in the article
.
This article is not a treatment plan recommendation
.
For guidance on treatment plans, please go to the official website hospital visit
.
