US biotech company to launch trial for preventative breast cancer vaccine

A US biotechnology company has announced a trial for its preventative breast cancer vaccine.

Anixa Biosciences, Inc, a California-based firm focused on the treatment and prevention of cancer and infectious diseases, has revealed the initiation of the Phase 1b trial, following its ongoing Phase 1a trial.

The study, funded by a grant from the US Department of Defense, will be conducted at Cleveland Clinic and will evaluate safety and immune response.

The company has begun recruitment of healthy, cancer-free participants at high risk for developing breast cancer who have decided to undergo voluntary bilateral mastectomy to lower their risk.

Typically, those women carry mutations in the BRCA1 or related genes and are therefore at risk of developing triple-negative breast cancer or have high familial risk for any form of breast cancer.

During the course of the study, participants will receive three vaccinations, each two weeks apart, and will be closely monitored for side effects and immune response.

Anixa’s current Phase 1a study includes patients who have completed treatment for early-stage, triple-negative breast cancer within the past three years and are currently tumour-free but at high risk for recurrence.

“We are excited to commence the second stage of the Phase 1 trials for our breast cancer vaccine,” said Dr Amit Kumar, chairman and CEO of Anixa.

“While the Phase 1a trial is ongoing, the results to date have given us the confidence to move into this next study earlier than planned.

“This vaccine has the potential to prevent the development of triple negative breast cancer, the most lethal form of breast cancer, and we look forward to advancing this promising technology through further clinical development,” Kumar added.

The vaccine created by Anixa “takes advantage” of endogenously produced proteins that have a function at certain times in life, but then become “retired” and disappear from the body.

One such protein is a breast-specific lactation protein, α-lactalbumin, which is no longer found post-lactation in normal, ageing tissues, but is present in the majority of triple-negative breast cancers.

Activating the immune system against this “retired” protein provides preemptive immune protection against emerging breast tumours that express α-lactalbumin.

The vaccine also contains an adjuvant that activates an innate immune response, which allows the immune system to mount a response against emerging tumours to prevent them from growing.

The study is estimated to be completed by the end of 2023.