June 29, 2022

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A major breakthrough: Cancer may be terminated by new vaccines

A major breakthrough: Cancer may be terminated by new vaccines

 

A major breakthrough: Cancer may be terminated by new vaccines.   The cancer-free era is getting closer and closer to us!


The risk of death is reduced by 45% and overall survival is extended by 14.5 months. Provenge lives up to expectations!

As we all know, to this day, vaccines are still the best weapon for humans to prevent diseases before they occur. Looking back at history, it is precisely because of vaccines that humans have been able to end the raging smallpox, polio and other high-incidence diseases.

Many people are wondering, can cancer be ended by a vaccine? In fact, humans have never given up on cancer vaccine research. With a few steps in medicine, personalized vaccines have become one of the goals of precision medicine. Biomedical companies around the world are scrambling to study, hoping to activate the body’s own immune cells to achieve the goal of killing cancer cells!

For decades, cancer vaccines have become a form of immunotherapy, which can prevent the development of cancer or kill existing tumors by stimulating or restoring the body’s own immune system. In addition to the HPV vaccine, which is a well-known preventive cancer vaccine, the world’s first and only cancer treatment vaccine approved by the US Food and Drug Administration is Provenge (sipuleucel-T).

This vaccine is the first to use patients. The assumption that one’s own immune system attacks cancer cells.

 

The risk of death is reduced by 45% and overall survival is extended by 14.5 months. Provenge lives up to expectations!

On February 15, 2020, the first real-world research data was announced at the 2020 American Society of Clinical Oncology Symposium on Urogenital Cancer (ASCO-GU 2020) in San Francisco. The shining star in this research is a vaccine called Provenge.

Provenge is the first vaccine approved for treatment in the United States, ushering in a new era of cancer immunotherapy. This is an autologous cell immunotherapy, which was approved by the US FDA on April 29, 2010 for the treatment of asymptomatic or mildly symptomatic mCRPC. This approval marks the success of 20 years of unremitting efforts. In the United States, Provenge is the only FDA-approved prostate cancer immunotherapy made from patients’ own immune cells. So far, more than 30,000 male patients have been prescribed Provenge treatment, which has been clinically proven to prolong the lives of men with advanced disease.

 


The most amazing data of this research

Adding Provenge to Zytiga® (abiraterone acetate) or Xtandi® (enzalutamide) at any time in the patient’s mCRPC treatment regimen can reduce the risk of death by 45% and prolong overall survival (OS) by 14.5 months .

The 2-year disease-free survival rate is 73%, and the TLPLDC vaccine has a strong curative effect in the treatment of melanoma

Next, we will introduce the innovative personalized cancer vaccine TLPLDC. At the 2020 ASCO-SITC Clinical Immuno-oncology Conference, the results of the subgroup analysis of the phase IIb clinical trial of the TLPLDC vaccine for the treatment of melanoma were announced.

This trial included a total of 144 patients with stage III (advanced) and stage IV (metastatic) melanoma who had been resected. The main analysis data has been published before that: In the analysis of the population following the clinical study protocol (PT), Compared with the comfort crew, the 24-month disease-free survival rate in the TLPLDC treatment group was significantly improved (62.9% vs 34.8%), indicating that the relative risk of disease recurrence was reduced by nearly 50%. In the intent-to-treat (ITT) population analysis, the TLPLDC treatment group and the placebo group had no significant improvement in 24-month disease-free survival (38.5% vs 27%), but in this analysis, the 24-month overall survival rate The improvement trend of (OS) is stronger (86.4% vs 75.1%).

 

[Subgroup results]

Data from the PT analysis showed that in patients with stage IV melanoma, compared with the placebo group, the 24-month disease-free survival rate of the TLPLDC vaccine group was significantly improved (73.0% vs 0), indicating that such patients The relative risk of disease recurrence is statistically significantly reduced and has clinical significance. The ITT analysis also showed improvement (43.0% vs 0). Stage IV patients are more likely to receive checkpoint inhibitor therapy (50% vs 26%).

The dawn of a new type of dendritic cell vaccine has appeared, with an overall survival time of 76% at 15 months!

On April 8, 2020, the Phase II clinical trial data of the new dendritic cell therapy AV-GBM-1 was announced. The study showed that this new vaccine is extremely effective in prolonging the mid-term overall survival of newly diagnosed glioblastoma patients. Great potential.

The 15-month overall survival rate of the 50 evaluable patients who received AV-GBM-1 treatment was 76%, while the 12-month and 15-month overall survival rates of the 287 patients in the control group who received standard treatment, respectively They are 61% and 48%. This shows that the 15-month overall survival rate of patients receiving AV-GBM-1 treatment has increased by 28%, and the effect is particularly significant.

AV-GBM-1 is a patient’s own specific dendritic cell vaccine, which aims to use the patient’s own immune system to find and eliminate cancer cells. This dendritic cell vaccine can carry specific antigens extracted from tumor tissues after surgery. After the injection, the antigen information is transmitted to the T cells to stimulate the tumor-killing activity. Although the autologous vaccine for patients is logically complicated, it is a feasible method that can be administered simultaneously with temozolomide and radiotherapy; it can also be injected with AV-GBM-1 vaccine after recovery from chemotherapy and radiotherapy. If patients can successfully perform single-disciplinary white blood cell collection, they are eligible to participate in the study under the age of 70.

This therapy is theoretically applicable to all solid tumors, so in addition to glioblastoma, Aivita Biomedical is also conducting clinical trials of two other AV-GBM-1 in other tumor types. An open, single-arm Phase Ib trial is evaluating the safety and effectiveness of AV-GBM-1 combined with PD-1 inhibitors in patients with metastatic melanoma. Recruitment for this trial has not yet begun (NCT03743298).

Another trial that is recruiting patients with ovarian cancer is a double-blind phase II study that targets 99 patients (NCT02033616). The test uses a 2:1 ratio to compare patients with AV-GBM-1 or autologous monocytes. 53851620471706389

 

 


Researches of dendritic cell vaccines in major cancers

In fact, dendritic cell vaccines have already made many major breakthroughs in animal experiments and early clinical trials. Among them, the development of dendritic cell vaccines for brain tumor, kidney cancer, and melanoma has entered the phase III clinical trial stage and is expected to be marketed. Cancer-free Homeland (400-626-9916) specifically listed some blockbuster studies for everyone by consulting a large amount of literature. If you want to know more detailed clinical trials, you can call for consultation.

1.Brain tumor-DCVax-L vaccine

The biotechnology company Northwest Biotherapeutics recently announced the interim trial data of its lead therapy DCVax®-L for the treatment of newly diagnosed glioblastoma multiforme (GBM) in a Phase III clinical study. A total of 331 patients were enrolled in the study. All patients had undergone surgical resection and received 6 weeks of standard care treatment SOC radiotherapy and chemotherapy before being enrolled in the study. As of the publication of the paper, 67 patients (30%) survived for more than 30 months and 44 patients (24.2%) survived for more than 36 months of the patients enrolled in the group for more than 3 years. The median survival time of these patients is estimated to be 46.5-88.2 months. At the time of analysis, 108 (32.6%) of the 331 patients who participated in the trial were still alive.

2. Ovarian cancer—DCVAC/OvCA vaccine

The DCVAC dendritic vaccine is a live cell immunotherapy that uses its own dendritic cells to be produced and customized for each patient in an attempt to induce an immune response against tumor antigens.

At the 50th Annual Meeting of the Society of Gynecological Oncology (SGO) in 2019, the final results of a phase II clinical trial SOV02 were announced: patients with relapsed, platinum-sensitive, epithelial ovarian cancer using dendritic cell-based immunotherapy DCVAC/OvCA added The standard carboplatin and gemcitabine regimen can extend the overall survival (OS) of patients with advanced recurrence of ovarian cancer by more than one year. Moreover, DCVAC/OvCa reduced the risk of death from second-line treatment for ovarian cancer by 62%. The overall survival (OS) increased significantly by 13.4 months. The median progression-free survival rate (mPFS) increased by 1.8 months. The global phase III study will be launched soon.

3. Lymphoma-dendritic vaccine

A new small new study shows that a new type of cancer “vaccine” injected directly into a single tumor can activate the immune system to attack cancer cells throughout the body. The research was led by Dr. Joshua Brody, director of the Lymphoma Immunotherapy Program at Icahn School of Medicine, Mount Sinai, New York. He said, “After the vaccine is injected into a tumor (in situ vaccination), we see the tumor throughout the body disappear”. The results of this blockbuster study showed that under the treatment of anti-cancer vaccines, 8 of 11 patients achieved remission, of which 2 patients were in complete remission. For one patient who achieved complete remission, the progression-free survival period was nearly 4 years!

4. Lung cancer—CCL21-dendritic vaccine

Scientists at the University of California, Los Angeles discovered a dendritic cell vaccine and conducted the first study to test the vaccine in humans. In a phase I clinical trial, the CCL21-dendritic vaccine was directly administered to the tumors of 16 patients with non-small cell lung cancer, with an interval of about 7 days between the two doses. Scientists at the University of California, Los Angeles compared a set of tumor samples from each patient on the day of vaccination.

The results showed that on the 56th day, 25% of patients were in stable condition (the size of the tumor did not increase or decrease). In 54% of patients, CD8 cells infiltrated the tumor, and the expression of PD-L1 in patients also increased significantly after vaccination. Side effects are manageable and are mainly limited to flu-like symptoms, nausea and fatigue.

5. Breast Cancer-Her2 Pulsed Dendritic Cell Vaccine

A HER-2 pulsed DC1 vaccine trial being conducted at the H. Lee Moffitt Cancer Center and Institute will test the safety and immunogenicity in high-risk HER-2 high- and moderate-expressing breast cancers to prevent breast cancer Recurrence of cancer.

Researchers believe that the dendritic cell vaccine combined with chemotherapy can increase the complete response, give breast cancer-specific immune cells a greater chance of functioning, and prevent breast cancer recurrence. After the initial vaccine induction, the enrolled patients were subjected to immunological analysis, and then three doses of booster vaccine were administered every 3 months, and the immunological analysis was performed separately.

 

(source:internet, reference only)


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