Groundbreaking mRNA vaccine could help cure pancreatic cancer

[Kamaji]

Groundbreaking mRNA vaccine could help cure pancreatic cancer

By Nika Shakhnazarova
June 8, 2022

A new vaccine using the same mRNA technology as the Pfizer jab against COVID-19 could be a breakthrough in the fight against pancreatic cancer.

In a promising early study conducted by German company BioNTech — which partnered with Pfizer to develop the lifesaving COVID shot — half of the patients remained cancer-free 18 months after having their tumors removed and receiving the jabs.

The groundbreaking trial — led by Dr. Vinod Balachandran at the Memorial Sloan Kettering Cancer Center in Manhattan — presented its promising results at the American Society of Clinical Oncology conference in Chicago on Sunday.

Doctors said the results showed that the vaccine could train the immune system to kill pancreatic cancer cells by boosting immune cells that target tumors.

The trial was carried out on 16 patients, each of whom was given eight doses of the individualized vaccine made using the mRNA genetic code found in each of their tumors.

The patients received their jabs after undergoing surgery to remove a tumor.

Results showed the jab produced a T cell response in eight out of the 16 patients, who remained cancer-free throughout the duration of the trial.

The remaining patients who did not respond to the vaccine either died or saw their cancer return.

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Source:  https://nypost.com/2022/06/08/breakthrough-vaccine-could-help-cure-pancreatic-cancer/

[Kamaji]

With a base of 16 patients, I'm not sure exactly how robust these results are.

[rustynail]

Or not.

[PeteS in CA]

Oy, "journalists"!

If one goes to the NYP article and selects the link to the clinical study, one finds that the "mRNA vaccine" is actually Atezolizumab, a monoclonal antibody (that's what mab means) treatment, not a vaccine. Atezolizumab is already a treatment for several types of cancers, https://en.wikipedia.org/wiki/Atezolizumab . A traditional problem with pancreatic cancer is that early diagnosis is difficult, as early symptoms are non-specific.

[Kamaji]

Oy, "journalists"!

If one goes to the NYP article and selects the link to the clinical study, one finds that the "mRNA vaccine" is actually Atezolizumab, a monoclonal antibody (that's what mab means) treatment, not a vaccine. Atezolizumab is already a treatment for several types of cancers, https://en.wikipedia.org/wiki/Atezolizumab . A traditional problem with pancreatic cancer is that early diagnosis is difficult, as early symptoms are non-specific.

@PeteS in CA

Thanks for the clarification.  So this is basically a fubar article?

[PeteS in CA]

@PeteS in CA

Thanks for the clarification.  So this is basically a fubar article?

Well, it turns out that the test the NYP was reporting was more complex that the NYP or I understood. Here's the news release from BioNTech, https://investors.biontech.de/news-releases/news-release-details/positive-phase-1-data-mrna-based-individualized-neoantigen

Positive Phase 1 Data from mRNA-based Individualized Neoantigen Specific Immunotherapy in Patients with Resected Pancreatic Cancer presented at ASCO

MAINZ, Germany and CHICAGO, June 5, 2022 (GLOBE NEWSWIRE) – BioNTech SE (Nasdaq: BNTX, “BioNTech”) today announced initial data from an ongoing investigator-initiated first-in-human Phase 1 study evaluating the safety and tolerability of the mRNA-based individualized neoantigen specific immunotherapy (iNeST) autogene cevumeran (also known as BNT122, RO7198457) in combination with anti-PD-L1 immune checkpoint inhibitor atezolizumab and chemotherapy in patients with resected pancreatic ductal adenocarcinoma (PDAC). Feasibility of the process of profiling each patient’s tumor to inform individualized vaccine design and on-demand manufacturing of iNeST in a clinically relevant timeframe was confirmed. The preliminary results showed a favorable safety profile as well as encouraging signs of clinical activity. The data have been presented at the American Society of Clinical Oncology (“ASCO”) Annual Meeting 2022 by Vinod Balachandran, M.D., at Memorial Sloan Kettering Cancer Center. Autogene cevumeran is the lead candidate from BioNTech’s iNeST platform, which is jointly developed together with Genentech, a member of the Roche Group, in multiple solid tumor indications.

The data presented at the ASCO Annual Meeting include a total of 19 patients who underwent surgery and received atezolizumab. 16 out of these 19 patients (84%) received autogene cevumeran at 9.4 weeks (median; 95% CI 9–10) after surgery. The preliminary data readout from these 16 vaccinated patients revealed that autogene cevumeran in combination with atezolizumab was well-tolerated. Only 1 of 16 patients (6%) developed a vaccine-related Grade 3 fever and hypertension, no other Grade 3 or higher adverse events were observed. In addition, the treatment induced de-novo, neoantigen-specific T cell response in half (8/16) of these patients from undetectable levels to large fractions of all blood T cells (median 2.9%). At an early median follow-up of 18 months, patients with de-novo immune response (n=8) had a significantly longer recurrence-free survival (RFS) as compared to those without vaccine-induced immune responses (n=8) (median not reached vs. 13.4 months, HR 0.08, 95% CI 0.01-0.4, P = 0.003). Based on these data, BioNTech and Genentech are planning a randomized study to further evaluate the efficacy and safety of autogene cevumeran in combination with atezolizumab and chemotherapy in patients with resected PDAC.

My emphasis. So what was tested was an mRNA-based "immunotherapy" plus the monoclonal antibody treatment plus chemotherapy. Further down the article:

About iNeST (individualized Neoantigen Specific immunoTherapy)
iNeST immunotherapies are individualized cancer therapies tailored to a specific patient’s tumor. They contain unmodified, pharmacologically optimized mRNA encoding up to 20 patient-specific neoantigens, identified using real-time next generation sequencing and bioinformatic neoantigen discovery. Neoantigens are proteins that are produced by cancer cells that differ from the proteins produced by healthy cells and are recognized by immune cells. The mRNA is encapsuled in BioNTech’s proprietary intravenous RNA-lipoplex delivery formulation which is designed to enhance stability as well as enable targeted delivery to dendritic cells. By analyzing each patient’s tumor, BioNTech is able to identify the cancer mutations that may act as neoantigens. Each individual cancer vaccine encodes for neoantigen candidates with the highest likelihood to help the immune system to recognize the cancer. For this purpose, BioNTech has developed a first of its kind, on-demand manufacturing process, following Good Manufacturing Practice (GMP) conditions.

If I understand that correctly, each patient in the test received an "immunotherapy" custom-designed from each patient's tumor. IOW, this isn't really a vaccine, but another use of mRNA technology. Or maybe it could be considered a vaccine custom-designed for each recipient.

Anyway, immunotherapy, vaccine-for-one, or ham sandwich, that it's in Phase 1 testing means it's just begun the test process.

[Kamaji]

Well, it turns out that the test the NYP was reporting was more complex that the NYP or I understood. Here's the news release from BioNTech, https://investors.biontech.de/news-releases/news-release-details/positive-phase-1-data-mrna-based-individualized-neoantigen

My emphasis. So what was tested was an mRNA-based "immunotherapy" plus the monoclonal antibody treatment plus chemotherapy. Further down the article:

If I understand that correctly, each patient in the test received an "immunotherapy" custom-designed from each patient's tumor. IOW, this isn't really a vaccine, but another use of mRNA technology. Or maybe it could be considered a vaccine custom-designed for each recipient.

Anyway, immunotherapy, vaccine-for-one, or ham sandwich, that it's in Phase 1 testing means it's just begun the test process.

@PeteS in CA

Thanks!  Your erudition is much appreciated.

[Free Vulcan]

@PeteS in CA

Thanks for the clarification.  So this is basically a fubar article?

A whirling circle of flaming cluster fubar it looks like.

[PeteS in CA]

@PeteS in CA

Thanks!  Your erudition is much appreciated.

My career is pretty far from anything medical-pharmaceutical. That BioNTech article leaves me feeling like I'm trying to wade in 7' deep water (and I'm just 6' tall). It sounds like BioNTech is working to field a platform for developing mRNA-technology-based custom-to-each-patient therapies for a broad variety of cancers.