Five Promising Cancer Vaccines to Watch in 2024!

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Five Promising Cancer Vaccines to Watch in 2024!

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Five Promising Cancer Vaccines to Watch in 2024!

Several candidate drugs for cancer vaccines are undergoing clinical trials, showing promising results.

Unlike traditional vaccines aimed at preventing diseases, therapeutic cancer vaccines train the patient’s immune system to patrol the body, identifying and destroying cancer cells.

This article introduces five cancer vaccines currently in the clinical trial phase.

01. V940/mRNA-4157

Developed jointly by Moderna and Merck, V940/mRNA-4157 is in Phase 3 clinical trials. It is a personalized tumor vaccine based on new antigens and mRNA technology. Composed of a single synthetic mRNA, V940/mRNA-4157 can encode up to 34 new antigens unique to the patient’s genetic cancer markers. The vaccine, used in conjunction with the immune checkpoint inhibitor Keytruda (pembrolizumab), is applicable to high-risk melanoma patients (Stage IIB-IV) post-surgery.

Analysis indicates that, during a median follow-up of approximately 3 years, the combination therapy significantly improves Recurrence-Free Survival (RFS) by reducing the risk of recurrence or death by 49% (HR=0.510, 95% CI: 0.288-0.906; one-sided p=0.0095) compared to Keytruda monotherapy. It also enhances Distant Metastasis-Free Survival (DMFS), lowering the risk of distant metastasis or death by 62% (HR=0.384, 95% CI: 0.172-0.858; one-sided p=0.0077).

These findings are based on preliminary analyses presented at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting. The combination therapy demonstrates a 44% reduction in the risk of recurrence or death and a 65% reduction in the risk of distant metastasis or death after approximately two years of planned follow-up.

Adverse events observed during the trial were consistent with previous reports. At a median follow-up of about 3 years, the incidence of treatment-related ≥3 grade adverse events was similar between the combination therapy group (25%) and the Keytruda monotherapy group (20%). The most common adverse events with any grade of mRNA-4157 were fatigue (60.6%), injection site pain (56.7%), and chills (49%).

02. Autogene Cevumeran

Developed jointly by BioNTech and Genentech, autogene cevumeran is in Phase 2 clinical trials. The vaccine, used in combination with the immune checkpoint inhibitor atezolizumab, is tailored for different patients. It expresses 20 new antigens of PDAC patients through mRNA, administered intravenously using LNP. In PDAC patients post-surgery, the mRNA vaccine has the potential to delay recurrence when used in conjunction with chemotherapy and immune checkpoint therapy. The vaccine is suitable for pancreatic ductal adenocarcinoma (PDAC) patients.

Autogene cevumeran, based on BioNTech’s iNeST cancer vaccine technology platform, encodes dozens of new antigens, aiming to stimulate a more comprehensive immune response against tumor cells, preventing them from evading the immune system.

In a study with 34 pancreatic cancer (PDAC) patients, 28 of whom underwent surgery, 19 post-surgery patients received atezolizumab treatment, with 16 subsequently receiving autogene cevumeran treatment. Of these 16 patients, 50% developed T-cell responses, considered responders to the cancer vaccine treatment. Phenotypic and functional analysis of expanded T-cells after vaccine treatment revealed the most significant expansion in CD8-positive T-cells expressing lytic markers (perforin-1 and granzyme B) and interferon-gamma (IFNγ), resembling effector T-cells.

03. TG4050

At the 2023 ASCO Annual Meeting, Transgene and NEC released new data on the Phase 1 clinical trial of the personalized new antigen cancer vaccine TG4050 for treating HPV-negative head and neck cancer patients. Analysis shows that all patients treated with TG4050 in the trial developed specific immune responses, as proven by additional immunological tests, and have remained disease-free to date.

TG4050 is a personalized immunotherapy for solid tumors based on the virus vector personalized immunotherapy platform technology developed by NEC with long-standing expertise in artificial intelligence (AI). Notably, the data released indicates favorable outcomes even in patients confirmed as PD-L1 negative or low expression.

As of May 2023, the Phase 1 trial for head and neck cancer included 32 randomized patients. All 16 patients treated with TG4050 maintained remission, with a median follow-up of 10.4 months. In the control group, two patients with similar characteristics experienced relapse, and two others showed signs of biochemical recurrence. So far, the vaccine has demonstrated good tolerability with no occurrence of related severe adverse events. Transgene and NEC plan to achieve an 18-month median follow-up in mid-2024 and further prepare for the launch of a Phase II auxiliary trial for head and neck cancer in the second half of 2023.

04. Tedopi

On September 11, 2023, OSE Immunotherapeutics announced a peer-reviewed article in the Annals of Oncology regarding the T-cell epitope cancer vaccine Tedopi® (OSE-2101) in a randomized Phase 3 clinical trial (ATALANTE-1) for HLA-A2 positive advanced or metastatic non-small cell lung cancer (NSCLC) patients who developed secondary resistance to immune checkpoint inhibitors (ICI) after sequential treatment.

OSE-2101, a novel T-cell epitope-based cancer vaccine targeting five tumor-related antigens, represents an activated and differentiated off-the-shelf immunotherapy capable of expanding tumor-specific T lymphocytes in HLA-A2 positive cancer patients. The Phase 3 study indicates that compared to chemotherapy, the new cancer vaccine OSE-2101, when used as a monotherapy, enhances overall survival, safety, and quality of life in HLA-A2 positive advanced or metastatic NSCLC patients progressing for at least 12 weeks after sequential treatment with chemotherapy and immune checkpoint inhibitors (ICI).

ATALANTE-1 (NCT02654587) is a two-step open-label study evaluating the efficacy and safety of OSE2101 compared to standard treatment (SoC) chemotherapy (CT). HLA-A2 positive advanced NSCLC patients with no feasible operable changes were randomized (2:1) to receive treatment with OSE2101 or SoC (docetaxel or pemetrexed). The primary endpoint is overall survival (OS).

The trial enrolled 219 patients who were randomized (139 OSE2101, 80 SoC), with 118 having developed secondary resistance to sequential ICB. Overall, the median OS for OSE2101 was superior to SoC [hazard ratio (HR) [95% confidence interval (CI)] 0.86 [0.62-1.19], P=0.36]. In the secondary resistance subgroup, OSE2101 significantly improved median OS compared to SoC [11.1 months vs. 7.5 months; HR (95% CI) 0.59 (0.38-0.91), P=0.017], markedly improving post-progression survival (HR 0.46, P

=0.004). Disease control rates and progression-free survival rates at 6 months were similar between the two groups. The incidence of grade 3 adverse reactions was 11.4% in the OSE2101 group and 35.1% in the SoC group (P=0.002).

The results demonstrate that in HLA-A2 positive advanced NSCLC patients, OSE2101, compared to CT, extends survival with better safety.

05. VB10.16

Developed by Nykode Therapeutics, VB10.16 is currently in Phase 2 clinical trials. VB10.16 is an excellent therapeutic cancer candidate vaccine for treating cervical cancer caused by the HPV16 virus. Designed based on Nykode’s Vaccibody technology platform, the technical principle is to deliver targeted antigens to cancer cells. In the Phase 2 clinical study (NCT0405349), VB10.16, in combination with atezolizumab, has been used to treat late-stage cervical cancer patients, with a median overall survival exceeding 25 months. The Phase 1/2a study in CIN2/3 demonstrated promising clinical data.

Recently, Nykode reported the results of the Phase 2 trial: the combined treatment of VB10.16 and atezolizumab in late-stage cervical cancer patients showed good safety and effectiveness. Data revealed an overall response rate (ORR) of 29% in patients with high PD-L1 expression. The median progression-free survival (mPFS) was over 6 months, and the median overall survival (OS) has not been reached, but analysis has exceeded 25 months. In the recent VB-C-04 clinical trial, subgroup analysis showed that, in patients with high PD-L1 expression and prior resistance to at least one systemic therapy, the objective response rate (ORR) reached 40%, and the disease control rate (DCR) was as high as 80%, with a median progression-free survival (PFS) of 17 months. The median OS has not been reached, but data cutoff indicates over 25 months. The results suggest remarkable efficacy for this combination therapy.

Conclusion

Advancements in personalized medicine have made sequencing patient genomes, extracting unique cancer markers, and preparing vaccines encoding these new antigens easier and more economically feasible.

As scientific technologies continue to evolve, cancer vaccines hold the promise of developing more personalized and effective treatment methods in the future, bringing greater hope to cancer patients.

Five Promising Cancer Vaccines to Watch in 2024!

(source:internet, reference only)

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