US biotechnology company Anixa Biosciences has made progress in developing a breast cancer vaccine after completing enrollment in phase one of its clinical trial.
The vaccine is being developed in partnership with the Cleveland Clinic, and the phase one trial is fully funded by a grant from the US Department of Defence (DoD).
During the trial, at least 35 women received the vaccine, including 26 in the triple-negative breast cancer (TNBC) group, four in the prevention group, and five in the pembrolizumab group.
The group's are divided as follows:
- TNBC Group: Women who have completed treatment for triple-negative breast cancer, are currently cancer-free, and are at risk of recurrence.
- Prevention Group: Women who are cancer-free but carry genetic mutations that place them at high risk of developing breast cancer and have elected to undergo preventative mastectomy to lower their risk.
- Pembrolizumab (Keytruda) Group: Women who are receiving pembrolizumab in a post-operative setting. These women are receiving the vaccine concurrently with pembrolizumab.
Audrey Noble reports that the vaccine comes in three shots, administered two weeks apart, and targets alpha-lactalbumin, a milk protein that is produced during lactation. While this protein is not usually found after lactation in normal breast tissue, scientists found that the protein is expressed in about 70% of TNBC cases.
According to Anixa, the vaccine is designed to stimulate the immune system to target breast cancer before it can recur or develop.
Speaking to Vogue, Anixa CEO Amit Kumar said: “The vaccine is designed to mobilise the patient’s immune system to find, recognise, and destroy breast cancer cells for primary prevention.
"If a patient is vaccinated and (their) immune system is trained to destroy the cancer cells when the cancer appears, the vaccinated immune system will destroy the cells before they can grow into a cell tumour.”
In a company press release, Kumar indicated that the vaccine shows promise with more than 70% of patients demonstrating protocol-defined immune responses.
“These encouraging findings are guiding our planning for phase two trials, which will include discussions with the FDA, protocol development, manufacturing, and clinical site selection,” Kumar said.
Francisca Mutap 24 Apr 2025
Following final patient visits in August 2025, the company will submit its final report to the US Department of Defence. After which, it will prepare the submission of a clinical study report (CSR) to the US Food and Drug Administration (FDA).
