While sexism exists in all strands of society, where in 2023, women earn 77 cents for every dollar earned by men, studies estimate that it will take the world 257 years to close the gender gap. And the global healthcare industry is partly to blame when it comes to the gaping gender gap.
Women have been underrepresented in clinical trials, and research hasn’t always been designed with women in mind, which has led to poor healthcare outcomes. As the reason for why one in 10 women undergo a miscarriage, and conditions like endometriosis are poorly understood, there is a need for women’s healthcare to move to the front lines.
As these issues demand attention, over the years, some companies have pioneered in shifting the focus towards bridging the gap in healthcare. With femtech gaining momentum, like the U.K.-based smart breast pump company Elvie which also sells its virtual pelvic floor trainers and American fertility care provider Kindbody, pulling investors, the industry is moving from niche to mainstream. As we celebrate Women’s Health Month in May, let us take a look at some biotech companies that prioritize healthcare for women.
Atossa Therapeutics
As 2.3 million women were diagnosed with breast cancer in 2020, according to the World Health Organization (WHO), U.S.-based Atossa Therapeutics, which was established in 2008, focuses on developing therapies for premenopausal women diagnosed with estrogen receptor-positive (ER+) / human epidermal growth factor receptor 2 negative (HER2-) breast cancer. But unlike other treatment methods, Atossa’s candidate does not suppress ovarian function.
The company’s proprietary drug (Z)-endoxifen is a tamoxifen metabolite (hormone therapy drug). Tamoxifen, according to past studies, has depicted anti-estrogenic effects. (Z)-endoxifen also has the potential to target PKCβ1, an oncogene protein – a protein encoded by oncogenes which can cause cancer. Atossa’s oral compound is devised to bypass the stomach, as this can lead to (Z)-endoxifen being converted to the inactive (E)-endoxifen.
In a phase 1 trial for breast cancer, the candidate proved its tolerability. Along with Quantum Leap Healthcare Collaborative, the company is investigating the efficacy of the (Z)-endoxifen compound in patients with newly diagnosed ER+ invasive breast cancer, for whom chemotherapy has been of no benefit.
The women’s health company Atossa Therapeutics has obtained $32.6 million in investments over four rounds, with the last one being a post-IPO equity round in 2015.
Biomilq
Even today, there exists stigma around formula feeding, and mothers who do not breastfeed experience this greatly. With the motive to overcome the shame associated with formula feeding, and to expand options for women who do not breastfeed, adoptive parents, parents in the LGBTQ community, women who have lost their breasts to cancer, and women who have HIV, the women-owned biotech Biomilq is developing cell-cultured human milk.
The U.S.-based startup cultures mammary epithelial cells outside the body where the cells are fed nutrients – similar to those in the bloodstream – to accelerate growth. The cells – a few million of them – are then placed in a bioreactor that simulates the microenvironment similar to that of the breast, after which they arrange themselves in a layer in the bioreactor, a formation like in the breasts, where cells absorb nutrients from the mother’s bloodstream and secretes milk into the mammary gland lobules. After a few weeks in the bioreactor, the hormone prolactin is added to the cells, upon which milk is synthesized.
Founded in 2020, this women’s health company is yet to commercialize its product, and aims to do so in a few years’ time. In addition to its current formula, Biomilq plans on developing different batches of milk, including ones suitable for a vegetarian diet as well as cells biopsied from peoples’ breasts.
In over three funding rounds, the biotech has secured a total of $24.5 million, with the latest investment from a series A round in 2021.
Celmatix
As one in three females are affected by poor ovarian health, there is an unmet need, specifically for those diagnosed with cancer, to ensure the proper functioning of the ovaries. Celmatix, a women’s health biotech company based in the U.S., has developed a pipeline that aims to protect the ovaries from chemotherapy-induced ovarian failure (CIOF).
Targeting ovarian senescence (ovarian aging often associated with a decline in ovarian follicles) to prevent premature menopause in individuals undergoing chemotherapy, the company’s lead AMHR2 agonist compound has demonstrated robust activity in multiple preclinical assays. Presently in its early drug discovery stage, Celmatix is also looking to develop its compound to treat female infertility as part of in vitro fertilization (IVF).
The company has partnered with German biotech Evotec to progress in women’s healthcare to validate targets for conditions like endometriosis, polycystic ovarian syndrome (PCOS) and ovarian senescence. PCOS, which affects millions of women, is typically managed with contraceptive pills. Part of Celmatix’s collaboration with Evotec is a PCOS drug programme, which targets melatonin receptors outside the central nervous system (CNS), currently in development.
Founded in 2009, the company has amassed a total of $53.7 million over 10 funding rounds.
HERA Biotech
Affecting around 190 million females across the world, endometriosis is a condition where tissues that are similar to the ones on the uterine lining, grow outside the uterus. The disease causes acute pain during periods, sexual intercourse and bowel movements. While magnetic resonance imaging (MRI) is a means to detect the disease, one of the only ways to be certain if you have endometriosis is to do a laparoscopy surgery. However, the procedure still fails to detect lesions in certain cases, and millions of women are undiagnosed. HERA Biotech aims to change that.
Seeking to uncover more ways of diagnosing endometriosis, the U.S.-based women’s health biotech company is developing a non-surgical, tissue-based test to diagnose the disease. MetriDx is a uterine tissue biopsy, which is similar to a pap smear, that uses single-cell microfluidic analysis of biomarkers to speedily diagnose endometriosis.
In January 2023, the company announced that it had enrolled its first patient in clinical studies for MetriDx. Established in 2020, HERA Biotech raised $1.9 million in a seed round in 2022, to support its commercialization strategy for MetriDx, with its most recent investors being venture capital firms Coyote Ventures and Althea Ventures.
Juno Bio
The vaginal microbiome is a dynamic ecosystem that is rich in Lactobacillus, which enhances antimicrobial activity. However, an overgrowth of bacteria in the vagina due to a microbiome imbalance, can lead to conditions like bacterial vaginosis, which causes an abnormal vaginal discharge which can smell unpleasant. The disease increases the chances of infertility, preterm birth and contracting sexually-transmitted infections (STIs). Detecting the disruption to the microbiome quickly can address the measures that need to be taken to restore a healthy microflora. U.K.-based Juno Bio has developed at-home vaginal microbiome tests to make this possible.
Having built vaginal microbiome repositories based on over 1000 samples from women, the tests were created to decode the microbiome in the vagina. The do-it-yourself kit contains a Q-tip which is to be swabbed across the walls of the vagina for 20 seconds which is then sealed in a tube and returned to the lab for testing. The company is then able to provide a personalized microbiome profile to the individual, which could be a step towards vaginal wellness.
Sold at $149 per kit, the startup which was founded five years ago, raised $251,000 in funding over one round, with Acequia Capital as its lead investor.
ObsEva
Babies who are born prematurely are more likely to develop long-term health issues and are at a high risk of sudden infant death syndrome (SIDS). The condition in which the birthing process is characterized by uterine contractions, dilation of the cervix and the rupture of the fetal membranes prior to 37 weeks of gestation, is called preterm labor. As a result, around 13.4 million babies were born premature in 2020, according to WHO. Although treatment methods include tocolytics, which are meant to delay the delivery for up to 48 hours – during which corticosteroid injections can be given to help mature the baby’s lungs – exist, the FDA’s recent revocation of progestin drug Makena’s approval, the only preterm labor drug that was authorized by the FDA, has left pregnant people high and dry without safe treatment options. However, Swiss-based biopharma ObsEva’s investigational drug could change the current scenario.
The oral drug ebopiprant is a prostaglandin F2a (PGF2a) receptor antagonist. As prostaglandin inhibitors have been known to prevent preterm birth, ebopiprant when in combination with hormone inhibitor atosiban, was found to reduce delivery in singleton pregnancies (the birth of only one child during a pregnancy) at 48 hours by 55% when compared to dosage with only atosiban, in a phase 2a clinical trial.
In 2021, the women’s health company licensed the global development, manufacturing and commercial rights of ebopiprant to American pharmaceutical Organon.
The company is also advancing nolasiban, an assisted reproductive technology (ART) to battle infertility. The drug is an oral oxytocin receptor antagonist which aims to improve the receptivity of the endometrium to implantation of the embryo, to increase the chances of a pregnancy. However, despite the drug obtaining favorable results in the first phase 3 trial, the study that followed did not meet its primary endpoint, leading to the discontinuation of the nolasiban IVF program, and instead, repositioning the candidate.
Formed in 2012, ObsEva has obtained financing of $228.4 million in over five rounds, with the company raising $75 million in a post-IPO debt round in 2019.
