Stage 3 Cancer: Definition, Diagnosis, Treatment, Prognosis
New Data From Phase 1 Study Of A Triple-Negative Breast Cancer Vaccine Reported
Anixa Biosciences, a publicly traded (Nasdaq: ANIX) biotechnology company based in San Jose, California, recently announced in San Jose, California, recently announced the newest data from a Phase 1 clinical trial testing their unnamed drug to prevent triple-negative breast cancer (TNBC). According to their website, Anixa focuses on both cancer treatment and prevention, including vaccines that immunize against "retired proteins," which, while expressed at certain times, no longer remain in healthy individuals.
The press release notes that the United States Department of Defense (DOD) funded the Phase 1 study conducted in collaboration with Cleveland Clinic. Data presented at the 2023 San Antonio Breast Cancer Symposium (PO2-17-12) showed some exciting and promising results from the trial, which included 16 TNBC survivors who were cured with prior treatment. Every two weeks, patients received a vaccination for a total of three treatments.
In addition to testing the vaccine's safety, the Phase 1 study also evaluated immunogenicity and immune cells' ability to elicit an immune response. The researchers assessed the effects of the vaccine regimen by monitoring immune readouts, including the expression of two key cytokines, interferon-gamma (IFNγ) and interleukin-17 (IL-17). These cytokines indicate a beneficial cellular immune response (immunity resulting in the destruction of a cancer cell). In addition, the researchers measured antibody production as an indication of humoral immune response (immunity directed against a specific antigen).
The vaccine targets α-Lactalbumin (aLA), a protein expressed in breast tissue during lactation, but otherwise remains undetectable in healthy women. However, about 70% of TNBC tissues express aLA. Thus, Anixa developed the vaccine against aLA, a "retired protein."
The data revealed that 75% of the participants exhibited antigen-specific cytokine responses. Compared to baseline, IFNγ became significantly elevated by Day 56. Similarly, the researchers observed IL-17 elevated by Day 14 compared to baseline. The researchers noted no severe side effects like myalgias or flu-like symptoms. The only side effect reported was irritation after the injection site.
Dr. Amil Kumar, the Chairman and CEO of Anixia Biosciences, explained that the data presented currently "exceeded our expectations, and we are pleased with our progress. This vaccine is designed to direct the immune system to destroy TNBC cancer cells through a mechanism that has never previously been utilized for cancer vaccine development." In addition, the statement continued to explain the intention to move into Phase 2 and 3 trials to test the ability of the vaccine to prevent recurrence of TNBC in survivors.
Sources: Anixa Press Release, Semin Immunol, SABCS 2024 Abstracts, Immunobiology (Chapter 8), Immunobiology (Chapter 9), Cancers
Drug Combo Improved Survival For Women With Triple-Negative Breast Cancer
Researchers may have identified a new effective treatment regimen for patients with metastatic triple-negative breast cancer (TNBC).
A new clinical trial found that atezolizumab, a monoclonal antibody medication, combined with carboplatin, a chemotherapy drug, may significantly improve survival in people with TNBC.
Atezolizumab is an anti-programmed death-ligand 1 (PD-L1) monoclonal antibody medication that stimulates the immune system to attack cancer cells.
While past clinical trials have shown that atezolizumab combined with certain chemotherapy drugs did not improve survival outcomes in people with metastatic TNBC, that was not the case in the most recent study.
Experts say there's a need to identify new treatment options since some people with TNBC don't respond well to available treatments.
"The combination of atezolizumab with carboplatin shows a significant improvement in both progression-free survival and overall survival in metastatic TNBC patients, regardless of PD-L1 status. This suggests a potential shift in the therapeutic approach for this patient group," said Dr. Wael Harb, a board-certified hematologist and medical oncologist at MemorialCare Cancer Institute at Orange Coast and Saddleback Medical Centers in Orange County, CA.
The findings were published in JAMA Oncology Thursday.
The researchers recruited 106 people with metastatic TNBC.
The participants were randomized to receive either intravenous carboplatin alone or intravenous carboplatin with atezolizumab (1200) mg every three weeks.
The trial was conducted at six medical centers between August 2017 and June 2021.
The team found that the combination of carboplatin and atezolizumab improved progress-free survival, or the amount of time before the cancer progresses, from a median of 2.2 to 4.1 months.
The combination treatment increased overall survival from a median of 8.6 months to 12.6 months.
"The combination of immunotherapy (atezolizumab) and carboplatin improved the amount of time before disease progressed as well as patient's overall survival when compared to carboplatin alone," said Dr. Brittney Zimmerman, a breast medical oncologist at Northwell Health Cancer Institute in Huntington and Riverhead, NY.
Those with high tumor-infiltrating lymphocytes, a high mutation burden, obesity, and uncontrolled blood glucose levels experienced the greatest benefits.
"The study's findings could modify the current treatment paradigm, offering a new effective combination for a broader range of patients, irrespective of PD-L1 status," says Harb.
Typically, patients with TNBC are treated with chemotherapy and in some cases, immunotherapy as well.
Some patients, however, don't respond to immunotherapy.
This may be due to various factors, including low mutation burden or lack of PD-L1 expression, according to Harb.
"However, in this trial, the improvement in outcomes was not related to PD-L1 status. Patients with a high number of mutations within their tumor had improved outcomes in this study," says Zimmerman.
Recent data has suggested that immunotherapy when combined with chemotherapy, can improve outcomes, says Zimmerman.
But in recent trials, combining atezolizumab with other chemotherapy drugs didn't boost survival. However, a different type of chemotherapy drug may help explain why survival was extended in this trial.
Atezolizumab improves the immune system's ability to fight cancer cells, explains Harb, while carboplatin, a chemotherapy drug, damages the DNA of cancer cells.
"However, carboplatin works by a different mechanism, which might enhance the activity of immunotherapy such as atezolizumab," Harb said. "Their combined use likely offers a synergistic effect, boosting the overall efficacy of the treatment."
Future studies will need to explore the benefits of combining atezolizumab with carboplatin and identify which patients will experience the greatest benefits.
"Immunotherapy is an exciting class of medications in the field of medical oncology," says Zimmerman.
Researchers may have identified a new effective treatment regimen for patients with metastatic triple-negative breast cancer (TNBC). A clinical trial found that atezolizumab, a monoclonal antibody medication, combined with carboplatin, a chemotherapy drug, may significantly improve survival.
Vaccine Targeting Triple-Negative Breast Cancer Shows Good Response In First Clinical Trial Of Patients
A breast cancer tumor, credit NASA/Goddard Space Flight Center.T A drug that targets the deadliest form of breast cancer has recently been found to elicit no side effects, and triggered an immune response in 75% of patients.
Conducted at the Cleveland Clinic with funding from the Pentagon, the vaccine was administered to 16 women in three separate doses. The form of the vaccine that went through trials is meant to stop the return of this aggressive form of cancer in those who have already been treated.
Further research will tool it to attack tumors in women who have yet to undergo treatment.
mRNA vaccines for cancer tumors are really where this technology comes into its own. Using a piece of the tumor to train immune cells like bloodhounds to search them out is far more effective than using it to train a single component of a constantly mutating virus, as was done to try and combat COVID-19.
It could be available in five years, estimates ABC's medical correspondent Dr. Jennifer Ashton, who didn't participate in the research.
According to Anixa Biosciences, the firm behind this vaccine, the drug will target a lactation protein, known as α-lactalbumin, that is present in the majority of triple-negative breast cancer patients.
"The data from our Phase 1 trial to date has exceeded our expectations, and we are pleased with our progress. This vaccine is designed to direct the immune system to destroy TNBC cancer cells through a mechanism that has never previously been utilized for cancer vaccine development," stated Dr. Amit Kumar, Chairman and CEO of Anixa Biosciences.
OTHER CANCER DEVELOPMENT: Scientists Develop Personalized Anti-Cancer Vaccine That Works in Mice
This year, GNN reported on another cancer vaccine with immense promise; this one for melanoma, which is predicted to be the second-most common type of cancer in the US by 2040.
In a phase 2b trial, 107 participants were treated with both the vaccine and immunotherapy drug pembrolizumab. Their melanoma returned in only 24 patients (22.4%) within two years, compared with 20 out of 50 (40%) who received only pembrolizumab.
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