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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.

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Labcorp launches screening test to identify preeclampsia risk sooner

The new screening tool is capable of assessing the risk of preeclampsia sooner, the test maker says

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Labcorp has launched a screening test that can assess the risk of preeclampsia before 34 weeks of pregnancy.

Preeclampsia is a high blood pressure disorder that can develop during pregnancy or postpartum and is a leading cause of maternal morbidity and mortality worldwide.

Roughly one in 25 pregnancies in the US is affected by preeclampsia, which poses an even greater risk for non-Hispanic black women, who experience the condition at a 60 per cent higher rate compared to white women.

In January, Labcorp announced the launch and availability of an FDA-cleared blood test for risk assessment and clinical management of severe preeclampsia during the second and third trimesters.

The first trimester test uses four early pregnancy biomarkers to provide a risk assessment with up to 90 per cent sensitivity, nearly twice the sensitivity of assessing typical maternal history or biophysical factors alone.

According to Labcorp, the test results provide risk identification earlier than traditional symptoms, such as hypertension or protein in the urine, which tend to develop around 20 weeks gestation.

Eleni Tsigas, chief executive officer of the Preeclampsia Foundation, said: “Our organisation celebrates this innovative new test offering.

“Research shows that patients and providers want access to more tools that better predict progression to preeclampsia, especially for those patients with low- to average-risk or those with first-time pregnancies for whom there is some uncertainty.”

Dr Brian Caveney, chief medical and scientific officer at Labcorp, added: “Labcorp is committed to advancing maternal and foetal health through innovative diagnostic and screening solutions.

“This new first trimester blood test is another significant milestone in our mission to improve health and improve lives. By giving healthcare providers another tool to assess preeclampsia risk in their pregnant patients with objective biomarkers, we’re helping to advance prenatal care and improve outcomes for mothers and their babies.”

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People with HIV can be sperm and egg donors

A change in law will allow people with non-transmissible HIV in the UK to donate gametes to partners

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Same-sex couples with non-transmissible HIV will now be able to donate eggs or sperm and become parents.

People with HIV will able to donate their sperm or eggs to their partners, as the law in the UK is updated.

The Human Fertilisation and Embryology Act will be amended via a statutory instrument to allow people with non-transmissible HIV – with a viral load low enough not to pass on – to donate eggs or sperm, known as gametes, as part of fertility treatment to their partners.

Under current rules on IVF, only a male partner with HIV can give their sperm to their female partner and not to anyone else.

The law change will also eliminate extra screening costs for female same-sex couples undertaking reciprocal IVF treatment.

The government says this is part of wider work to improve access to IVF for everyone and ensure same-sex couples have the same rights as a man and woman when trying to conceive.

“These changes will allow more people to fulfil their dream of becoming parents,” said UK health minister, Maria Caulfield.

“We have changed the law to ensure equality for people living with HIV when accessing IVF, allowing them to donate their eggs and sperm.

“In addition, the change will allow female same-sex couples to access IVF with no extra screening costs, the same as heterosexual couples.”

She added: “These changes will help create a fairer system by removing barriers to accessing fertility care as we have set out in the Women’s Health Strategy.”

The changes to the law will allow people with HIV to donate their gametes to family, friends and known recipients.

The regulations include an updated definition of partner donation to enable female same-sex couples wishing to donate eggs to each other to undergo the same testing requirements as heterosexual couples.

Under current rules, female same-sex couples hoping to conceive via reciprocal IVF must first go through screening for syphilis and genetic screening, such as cystic fibrosis, which can cost over £1,000, while heterosexual couples do not need to undergo this screening.

Julia Chain, chair of the Human Fertilisation and Embryology Authority (HFEA), said: “The HFEA welcomes the news that legislation regarding partner donation in relation to reciprocal IVF, and gamete donation from those who have HIV with an undetectable viral load, has now been proposed in Parliament.

“Fertility treatment is helping more people than ever to create their family, and everyone undergoing fertility treatment should be treated fairly.

“For known donation from individuals with undetectable HIV, we anticipate that the first clinics may be able to begin to offer this treatment around 3 months following a change in the law.

“We encourage any patients or donors who may be affected by these changes to visit the HFEA website to find out free and impartial information, including about how to choose a fertility clinic.”

Minister for equalities, Stuart Andrew MP, added: “Treatment for HIV has improved significantly, saving countless lives, but the stigma surrounding it persists – a stigma which often prevents people from getting tested and seeking treatment.

“These changes will help to reduce that stigma, making it clear that people with HIV can live full and happy lives. I am delighted by these changes which will enable more people to experience the joy of becoming parents.”

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Portfolia invests total of US$65m into women’s health companies

The platform has invested in 47 femtech start-ups to date

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Trish Costello, founder and CEO of Portfolia

The US venture investing platform Portfolia has announced it has invested a total of US$65m into women’s health companies and solutions.

Portfolia aims to create, educate and support the largest community of women investors in the world.

The company says it was amongst the first to recognise the “immense” potential of women’s wealth, with women’s health at the forefront.

To date, Portfolia has made investments in 112 companies with 47 of those women’s health companies being femtech and active aging specific.

Some of these include Madison Reed, Maven, Everly Health, Bone Health, Veana, Your Choice, Future Family, Willow, Hey Jane, Lighthouse Pharma, L-Nutra and JoyLux.

The total companies Portfolia has invested in are estimated to serve over 102 million customers in 115 countries worldwide.

These companies have a combined value of over US$17bn, with over US$1bn in revenue and 10,000 employees worldwide.

According to Portfolia, almost 70 per cent of these businesses are led by female CEOs, and 49 per cent are led by BIPOC individuals.

“At Portfolia, we believe in the power of activating our wealth for returns and impact,” said Trish Costello, founder and CEO of Portfolia.

“Today, women in the United States have unprecedented access to wealth – with over US$25tn of wealth in the US and almost 50 per cent of it owned by women.

“This wealth is power – power to create financial change and invest in the companies and businesses that matter to us and meet our needs/desires.”

She added: “Our commitment goes beyond traditional venture capital – we’re pioneering change, saving lives, and creating opportunities for all, while creating the most powerful community of women investors globally, and the first to activate our wealth to shape the future of healthcare.”

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