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US biotech company to launch trial for preventative breast cancer vaccine

The trial is estimated to be completed by the end of 2023

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Breast cancer is the most common cancer in women

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.

More than 264,000 women in the US are diagnosed with breast cancer each year.

Based on current incidence rates, 12.9 per cent of women born in the US today will develop breast cancer at some time during their lives, according to the National Cancer Institute.

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.

Diagnosis

New test could cut need for invasive womb cancer checks

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A urine and vaginal fluid test could help rule out womb cancer in women with postmenopausal bleeding, potentially reducing invasive checks.

In a study of 1,864 women with postmenopausal bleeding, the test identified 80 of 99 womb cancers and correctly gave a negative result for 93 per cent of women without the disease.

Researchers said the test was not accurate enough to rule out cancer on its own, but could help fast-track women at the highest risk for urgent investigation while reducing immediate invasive testing for those at lower risk.

Professor Emma Davidson, of the University of Manchester and Manchester University NHS Foundation Trust, said: “Bleeding after the menopause is understandably alarming for women because it can be a sign of cancer, but the vast majority of those investigated will not have the disease.

“At the moment, many women face invasive, uncomfortable tests that can be stressful as well as costly for health services before cancer can be ruled out.

“Our study shows that a simple test using urine and vaginal samples could help identify the women most likely to have cancer while safely reassuring many others much earlier in the diagnostic pathway.

“If further studies confirm these findings in routine practice, this approach has the potential to transform care for thousands of women every year.”

Developed at the University of Manchester and Manchester University NHS Foundation Trust, the test examines cells collected from urine and vaginal fluid samples.

Postmenopausal bleeding currently triggers an urgent cancer referral, although only about 5 to 10 per cent of women who report it have an underlying cancer.

Current investigations include an internal ultrasound scan, a biopsy of the womb lining and hysteroscopy, in which a camera is passed into the womb.

Women taking part in the study attended seven hospitals in north-west England and provided urine and vaginal fluid samples before undergoing their routine tests.

Five per cent of participants, 99 of 1,864 women, were diagnosed with womb cancer through biopsy or surgery.

Cytologists assessed the samples without knowing the women’s diagnoses.

Researchers said the test could be used to triage women suspected of having womb cancer, with lower-risk patients monitored through repeat sampling or given a full assessment if symptoms continued.

They cautioned that the samples were assessed by highly trained specialist cytologists, so it is not yet known whether the same accuracy could be achieved in other settings.

The test has also not been studied in women without symptoms.

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Insight

Trust apologises for ‘human error’ after maternity data loss

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Nottingham University Hospitals NHS Trust has apologised after a human error caused 11 years of maternity data to be overwritten.

The incident happened during routine technical work on 18 August, when computer instructions intended to create a copy of a radiotherapy database were mistakenly applied to the maternity database.

Most of the affected information has since been recovered, including notes, observations, test results and other information recorded as part of patient care.

However, the trust has been unable to fully restore the historical record showing who viewed maternity records between September 2011 and November 2022.

Current data was not affected and the incident has had no impact on current maternity services or care provided to women and babies, according to the trust.

It also said no information was accessed or used inappropriately as a result of the incident.

Andy Callow, chief digital and information officer at Nottingham University Hospitals, said: “I am sorry for the concern and distress this incident may cause to women and families affected.

“On 18 August 2026, a human error during a routine technical process resulted in a maternity records database being unintentionally overwritten.

“We took immediate action to investigate the incident and recover the affected information.

“The information needed to support patient care has been restored and there has been no impact on current maternity services or the care provided to women and babies today.

“However, to date, we have been unable to fully restore the historical record showing who viewed maternity records between September 2011 and November 2022.

“We have informed the Information Commissioner’s Office, completed a full investigation and strengthened our processes and controls to help prevent a similar incident from happening again.”

The error occurred when pre-written computer instructions previously used for another hospital system were used during the technical work.

A setting that should have been changed was not altered, resulting in work being carried out on the maternity database instead of the radiotherapy database.

The issue was escalated within minutes of being identified and experts were brought in to recover as much information as possible.

The trust has referred the incident to the Information Commissioner’s Office and notified Nottinghamshire Police, which is conducting a separate criminal investigation into maternity care at the trust.

The force is assessing whether the loss of information about who accessed maternity records could affect that investigation.

The incident follows a maternity review led by midwife Donna Ockenden, which concluded in June after examining the cases of 2,500 families over a 20-year period.

The review found more than 500 mothers and babies suffered potentially avoidable harm, with 162 dying following substandard care. Some babies who survived were left seriously disabled.

Nottinghamshire Police announced its separate criminal investigation, Operation Perth, in September 2023.

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Hormonal health

Mira launches at-home cortisol tracking kit

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Mira has launched an at-home cortisol tracking kit that allows women to monitor stress-related patterns over time using urine samples.

The Cortisol Pattern Kit measures urinary free cortisol directly from a urine sample and displays results through the company’s existing monitor and app.

The system is intended for repeated testing rather than a single measurement, allowing users to compare results with a personal baseline built from their own data.

Mira said consistent daily testing can establish a baseline in about a week. It recommends testing in the morning and evening to see how cortisol patterns change throughout the day.

Cortisol is involved in the body’s stress response but is not a direct or complete measure of stress. The company said the kit is intended for general wellness use and is not designed to diagnose stress, an endocrine condition or any other medical condition.

The Cortisol Pattern Wands use the same lateral-flow testing format as Mira’s existing hormone tests. Users dip a wand into a urine sample, insert it into the Mira Monitor and view the result in the app within minutes.

The company said cortisol data can be viewed alongside cycle, hormone and daily routine information.

Sylvia Kang, founder and chief executive of Mira, said: “The Cortisol Pattern™ Kit gives women a new way to understand their stress patterns over time, in the context of their own biology.”

She added: “We built Mira to give women answers they had spent far too long searching for, beginning with the TTC journey and expanding into hormone and cycle tracking across life stages, including perimenopause. Now, we’re taking Mira beyond reproductive health and into everyday wellness, bringing personalised stress-pattern tracking directly into women’s homes.”

Mira said more than 350,000 women already use its platform to track their cycle and hormones.

Waitlist sign-ups for the Cortisol Pattern Kit and Cortisol Pattern Wands opened on 22 September, with wand refills available to pre-order in 20- and 30-count options.

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