Almost two-thirds of Americans living with Alzheimer’s disease are women. Women in their 60’s are more than twice as likely to develop this disease over the rest of their lives. Alzheimer’s disease is already such a perplexing disease and the reason why women develop the condition more than men is still not well understood. The biological differences, fluctuation in hormones, major life events can contribute to the risk factor of Alzheimer’s disease.
Many previous studies examining the sex and gender differences in Alzheimer’s Disease have recognized that women have higher levels of tau protein than in men. Tau protein is found in the entorhinal cortex, the area of the brain involving memory and helps to stabilize the internal skeleton of neurons in the brain, also known as microtubules. In the diseased brain, there is an abnormal form of tau that builds up and fails to maintain the microtubules. The abnormal form of the protein also clings to other tau proteins forming “tau tangles.” These tau tangles and along with beta-amyloid plaques are typically the two main indicators of Alzheimer’s Disease
New research in Alzheimer’s Disease is making it easier to identify these indicators. Up until recently, tau and beta-amyloid levels could only be measured after the person had died. Now there are new methods of analyzing samples of cerebrospinal fluid and PET scans to analyze the tau tangles and plaques in the brain. A 2020 study at University of California – San Francisco found that the brain imaging of these pathological tau-protein “tangles” can predict the location of future brain damage in Alzheimer’s patients a year more in advance.
Currently many different avenues are being explored to help treat Alzheimer’s disease. Conducting clinical trials in this disease state can be difficult due to it being difficult to diagnose, hard to measure outcomes, and lack of awareness among patients and families. AC Immune and Lundbeck are two women-led pharmaceutical companies with tau-focused drug discovery in their pipeline.
AC Immune is a clinical-stage biopharmaceutical company developing precision medicine for neurodegenerative disease which includes Parkinson’s disease, a certain rare indication along with Alzheimer’s disease. One of the agents in their pipeline is an anti-pTau vaccine, ACI-35.030, which was designed to elicit antibodies against the abnormal, phosphorylated Tau (pTau) to prevent and reduce the spread of tau pathology. This agent is currently in the second phase of clinical trials and is collaborating with Janssen Pharmaceuticals. Another agent currently in phase 2 pipeline is Semorinemab, a high-affinity monoclonal antibody to bind all forms of Tau. This was designed to mediate and stop cell-cell spread of pathological Tau. AC Immune is collaborating with Genentech with this agent. AC Immune’s phase 3 agent, the Tau-PET tracer, PI-2620 is a high binding affinity and selectivity for aggregated Tau. This tracer has also appears to be a useful tool for non-AD tauopathies such as progressive supranuclear palsy (PSP) and corticobasal degeneration (CBD), as stated by Andrea Pfeifer, CEO of AC Immune.
Dr. Andrea Pfeifer co-founded AC Immune in 2003 which she has since then held the position of CEO. Dr. Pfeifer holds a Ph.D. in Toxicology, Cancer Research from University of Wurzburg, Germany. Prior to founding AC Immune, she was the Head of Nestle Research Center where she co-founded the Life Science focused Nestle Venture Capital Fund. Under her leadership AC Immune has built multiple transformative partnerships yielding the companies potential value of up to CHF 3.3 billion plus additional royalties.
Lundbeck is a biopharmaceutical company with a pipeline 100% targeted to brain disease. Currently they have one anti-tau agent in phase 1, an anti-Tau mAb, Lu AF87908. This is a monoclonal antibody targeting the pathological form of tau which will help reduce the development and progression of Alzheimer’s disease and other neurodegenerative disorders.
Dr. Deborah Dunsire is the president and CEO of Lundbeck since September 2018. She has over 30 years of clinical, commercial, and international management experience from the biotech and pharmaceutical industry. She has also served as President and CEO of XTuit Pharmaceuticals, FORUM Pharmaceuticals, and Millennium Pharmaceuticals. She graduated from University of the Witwatersrand, South Africa and is trained as a medical doctor.