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At ESMO, three studies show promise of antibody-drug conjugates in breast cancer

The American Society of Clinical Oncology, or ASCO, conference is just around the corner, but one subgroup of
The post At ESMO, three studies show promise…

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The American Society of Clinical Oncology, or ASCO, conference is just around the corner, but one subgroup of cancer researchers just had their own gathering, as breast cancer researchers came together in person for the first time since the start of the pandemic at the ESMO Breast Cancer congress.

pharmaphorum sat down with Sunil Verma, global head of oncology, medical, at AstraZeneca, to discuss three studies that were presented at the show, which demonstrate a few of the ways oncology is advancing through precision medicine and targeted therapies.

The Trojan horse

All three of the studies Verma mentioned involved antibody-drug conjugates (ADCs), a treatment modality that’s now about a decade old but still ripe for innovation.

“An antibody-drug conjugate is where you connect and link a chemotherapy to an antibody,” Verma said. “That antibody-drug conjugate then docks on the cancer cell receptor. And once it’s present there, it’s taken up by the cancer cell. So there’s a Trojan horse-like mechanism to deliver chemotherapy right to the cancer cell.”

Directing the chemotherapy directly to the cells that need it is a huge step forward from traditional chemotherapy, which comes with a host of side effects from radiation hitting healthy cells. While directed chemotherapy isn’t totally free of side effects, it reduces them. Furthermore, it allows for sustained treatment, whereas traditional chemotherapy can hit limits where treatment has to be stopped.

The challenge is that the crucial receptors, where the docking occurs, are not one size fits all. So researchers have to explore a number of different receptor candidates to make drugs that work for the highest number of patients.

The Daisy Study – ADCs in HER2-expressive patients

As industry and academic researchers push forward in the fight against cancer, precision medicine is one of their most important frontiers. But in order to develop more and more effective targeted therapies, sometimes researchers have to first adjust their understanding of different conditions and how they’re classified.

One study, called the Daisy study, pointed to a new way of thinking about classification in breast cancer, where typically patients are defined as either HER2 positive or HER2 negative based on the presence or absence of the human epidermal growth factor receptor 2 (HER2) protein.

“Traditionally, when we talk about HER2 targeted treatments, they work for HER2 positive breast cancer, accounting for about 15% to 20% of all breast cancer,” Verma told pharmaphorum. “But up to 50% of breast cancer has what we call HER2 expression, that is traditionally not classified as HER2 positive disease, and therefore previously was not considered to be targetable. The data that was shared at this ESMO Breast meeting shows that there is potential activity in not only the traditional HER2 positive patients, but also in HER2 expressing patients.”

Further studies need to be conducted (and indeed are set to be presented at ASCO next month), but these findings could essentially triple the eligible patient pool for the class of antibody-drug conjugates that use HER2 receptors to deliver targeted chemotherapy.

The Tuxedo Study – Can HER2 cross the blood-brain barrier?

Another exciting study dealt with patients whose breast cancer has metastasised, or spread, to the brain. These patients normally have a poor prognosis because traditional therapies can’t cross the blood-brain barrier to attack those tumors.

The Tuxedo Study demonstrated that HER2-targeted ADCs, in this case AZ’s Enhertu, could be effective in those patients.

“The response rate was close to 74% and the median progression pre survival was close to 14 months,” Verma said. “That’s a pretty remarkable finding, suggesting that Enhertu can cross the blood brain barrier and can help patients with both stable brain metastates and potentially also in patients with active brain metastases. So we are doing a large study (Destiny Breast 12) to further learn about HER2’s activity in patients with active brain metastases.”

The Begonia Study – Promising combination therapies

The final study Verma discussed dealt with a different class of ADCs – Trope2 ADCs rather than HER2 ADCs. The study looked at the use of Dato-DxD, a Trope2 ADC developed in partnership between AstraZeneca and Daichii-Sankyo, in patients with metastatic triple negative breast cancer. The study looked at potential benefits of combining an ADC with an immunotherapy, in this case, a drug called durvalumab.

“The combination, when given to patients, showed quite an impressive response rate of around 74%. Many of these patients were still responding, even though the follow up was quite short, but there appears to be a maintained benefit,” Verma said. “This is one of the highest reported response rates that we have seen in this setting of first line triple negative breast cancer. The other unique attribute, of course, is that by combining an antibody-drug conjugate with an immunotherapy, we may be able to initiate the immune cascade to make these cancer cells more sensitive to immunotherapies.”

Precision medicine opens up many new options for patients with cancer, but it also complicates oncology, as researchers must focus on each distinct form of cancer, in order to ultimately provide working treatments for every patient.

“To me, personalised medicine is when we have the patient at the center to make sure that their patient experience is improved, which it has, and their quality of life and their side effects will also be better than traditional medicine,” Verma said. “So I think we need to go increasingly from precision medicine to personalized medicine so that the patients’ lives continue to get better.”

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Sex work is real work: Global COVID-19 recovery needs to include sex workers

Societally, we need to recognize that sex workers have agency and deserve the same respect, dignity and aid as any other person selling their labour.

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Globally, sex workers have been left to fend for themselves during the pandemic with little to no support from the government. (AP Photo/Bikas Das)

During the pandemic, business shifted from in person to work-from-home, which quickly became the new normal. However, it left many workers high and dry, especially those with less “socially acceptable” occupations.

The pandemic has adversely impacted sex workers globally and substantially increased the precariousness of their profession. And public health measures put in place made it almost impossible for sex workers to provide any in-person service.

Although many people depend on sex work for survival, its criminalization and policing stigmatizes sex workers.

Research shows that globally, sex workers have been left behind and in most cases excluded from government economic support initiatives and social policies. There needs to be an intersectional approach to global COVID-19 recovery that considers everyone’s lived realities. We propose policy recommendations that treat sex work as decent work and that centre around the lived experiences and rights of those in the profession.

Sex work and the pandemic

The United Nations Population Fund (UNFPA) recently reported that apart from income-loss, the pandemic has increased pre-existing inequalities for sex workers.

In a survey conducted in Eastern and Southern Africa, the UNFPA found that during the pandemic, 49 per cent of sex workers experienced police violence (including sexual violence) while 36 per cent reported arbitrary arrests. The same survey reported that more than 50 per cent of respondents experienced food and housing crises.

Lockdowns and border closures adversely impacted Thailand’s tourism industry which relies partially on the labour of sex workers.


Read more: Sex workers are criminalized and left without government support during the coronavirus pandemic


In the Asia Pacific, sex workers reported having limited access to contraceptives and lubricants along with reduced access to harm reduction resources. Lockdowns also disrupted STI or HIV testing services, limiting sex workers’ access to necessary healthcare.

In North America, sex workers have been excluded from the government’s recovery response. And many began offering online services to sustain themselves.

A woman stands backlit next to a dimly lit bus that reads 'Thailand' with green lighting.
Sex workers stand in a largely shut-down red light area in Bangkok, Thailand on March 26, 2020. (AP Photo/Gemunu Amarasinghe)

Government vs. community response

Globally, sex workers have been left to fend for themselves during the pandemic with little to no support from the government. But communities themselves have been rallying.

Elene Lam, founder of Butterfly, an Asian migrant sex organization in Canada, talks about the resilience of sex wokers during the pandemic.

She says organizations like the Canadian Alliance for Sex Work Law Reform are working in collaboration with Amnesty International to mobilize income support and resources to help sex workers in Canada.

Organizations in the United Kingdom, Germany, India and Spain have also set up emergency support funds. And some sex worker organizations have developed community-specific resources for providing services both in person and online during the pandemic.

Global recovery needs to include sex workers

The International Labour Organization’s “Decent Work Agenda” emphasizes productive employment and decent working conditions as being the driving force behind poverty reduction.

Sociologist Cecilia Benoit explains that sex work often becomes a “livelihood strategy” in the face of income and employment instability. She says that like other personal service workers, sex workers also should be able to practice without any interference or violence.

In order to have an inclusive COVID-19 recovery for all, governments need to work to extend social guarantees to sex workers — so far they haven’t.

As pandemic restrictions disappear, it is crucial to ensure that everyone involved in sex work is protected under the law and has access to accountability measures.

A woman stands wearing a mask with a safety vest on in front of a collage of scantily clad women and a sign that reads 'nude women non stop'
A volunteer helps out at Zanzibar strip club during a low-barrier vaccination clinic for sex workers in Toronto in June 2021. THE CANADIAN PRESS/Frank Gunn

Recommendations

As feminist researchers, we propose that sex work be brought under the broader agenda of decent work so that the people offering services are protected.

  1. Governments need to have a legal mandate for preventing sexual exploitation.

  2. Law enforcement staff need to be trained in better responding to the needs of sex workers. To intervene in and address situations of abuse or violence is critical to ensure workplace safety and harm reduction.

  3. Awareness and educational campaigns need to focus on destigmatizing sex work.

  4. Policy-makers need to incorporate intersectionality as a working principle in identifying and responding to the different axes of oppression and marginalization impacting LGBTQ+ and racialized sex workers.

  5. Engagement with sex workers and human rights organizations need to happen when designing aid support to ensure that an inclusive pathway for recovery is created.

  6. Globally, there needs to be a steady commitment towards destigmatizing sex workers and their services.

Despite the gradual waning of pandemic restrictions, sex workers continue to face the dual insecurity of social discrimination and loss of income support. Many are still finding it difficult to stay afloat and sustain themselves.

Societally, we need to recognize that sex workers have agency and deserve the same respect, dignity and aid as any other person selling their labour.

The authors do not work for, consult, own shares in or receive funding from any company or organisation that would benefit from this article, and have disclosed no relevant affiliations beyond their academic appointment.

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OU researchers award two NSF pandemic prediction and prevention projects

Two groups of researchers at the University of Oklahoma have each received nearly $1 million grants from the National Science Foundation as part of its…

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Two groups of researchers at the University of Oklahoma have each received nearly $1 million grants from the National Science Foundation as part of its Predictive Intelligence for Pandemic Prevention initiative, which focuses on fundamental research and capabilities needed to tackle grand challenges in infectious disease pandemics through prediction and prevention.

Credit: Photo provided by the University of Oklahoma.

Two groups of researchers at the University of Oklahoma have each received nearly $1 million grants from the National Science Foundation as part of its Predictive Intelligence for Pandemic Prevention initiative, which focuses on fundamental research and capabilities needed to tackle grand challenges in infectious disease pandemics through prediction and prevention.

To date, researchers from 20 institutions nationwide were selected to receive an NSF PIPP Award. OU is the only university to receive two grants to the same institution.

“The next pandemic isn’t a question of ‘if,’ but ‘when,’” said OU Vice President for Research and Partnerships Tomás Díaz de la Rubia. “Research at the University of Oklahoma is going to help society be better prepared and responsive to future health challenges.”

Next-Generation Surveillance

David Ebert, Ph.D., professor of computer science and electrical and computer engineering in the Gallogly College of Engineering, is the principal investigator on one of the projects, which explores new ways of sharing, integrating and analyzing data using new and traditional data sources. Ebert is also the director of the Data Institute for Societal Challenges at OU, which applies OU expertise in data science, artificial intelligence, machine learning and data-enabled research to solving societal challenges.

While emerging pathogens can circulate among wild or domestic animals before crossing over to humans, the delayed response to the COVID-19 pandemic has highlighted the need for new early detection methods, more effective data management, and integration and information sharing between officials in both public and animal health.

Ebert’s team, composed of experts in data science, computer engineering, public health, veterinary sciences, microbiology and other areas, will look to examine data from multiple sources, such as veterinarians, agriculture, wastewater, health departments, and outpatient and inpatient clinics, to potentially build algorithms to detect the spread of signals from one source to another. The team will develop a comprehensive animal and public health surveillance, planning and response roadmap that can be tailored to the unique needs of communities.

“Integrating and developing new sources of data with existing data sources combined with new tools for detection, localization and response planning using a One Health approach could enable local and state public health partners to respond more quickly and effectively to reduce illness and death,” Ebert said. “This planning grant will develop proof-of-concept techniques and systems in partnership with local, state and regional public health officials and create a multistate partner network and design for a center to prevent the next pandemic.”

The Centers for Disease Control and Prevention describes One Health as an approach that bridges the interconnections between people, animals, plants and their shared environment to achieve optimal health outcomes.

Co-principal investigators on the project include Michael Wimberly, Ph.D., professor in the College of Atmospheric and Geographic Sciences; Jason Vogel, Ph.D., director of the Oklahoma Water Survey and professor in the Gallogly College of Engineering School of Civil Engineering and Environmental Science; Thirumalai Venkatesan, director of the Center for Quantum Research and Technology in the Dodge Family College of Arts and Sciences; and Aaron Wendelboe, Ph.D., professor in the Hudson College of Public Health at the OU Health Sciences Center.

Predicting and Preventing the Next Avian Influenza Pandemic

Several countries have experienced deadly outbreaks of avian influenza, commonly known as bird flu, that have resulted in the loss of billions of poultry, thousands of wild waterfowl and hundreds of humans. Researchers at the University of Oklahoma are taking a unique approach to predicting and preventing the next avian influenza pandemic.

Xiangming Xiao, Ph.D., professor in the Department of Microbiology and Plant Biology and director of the Center for Earth Observation and Modeling in the Dodge Family College of Arts and Sciences, is leading a project to assemble a multi-institutional team that will explore pathways for establishing an International Center for Avian Influenza Pandemic Prediction and Prevention.

The goal of the project is to incorporate and understand the status and major challenges of data, models and decision support tools for preventing pandemics. Researchers hope to identify future possible research and pathways that will help to strengthen and improve the capability and capacity to predict and prevent avian influenza pandemics.

“This grant is a milestone in our long-term effort for interdisciplinary and convergent research in the areas of One Health (human-animal-environment health) and big data science,” Xiao said. “This is an international project with geographical coverage from North America, Europe and Asia; thus, it will enable OU faculty and students to develop greater ability, capability, capacity and leaderships in prediction and prevention of global avian influenza pandemic.”

Other researchers on Xiao’s project include co-principal investigators A. Townsend Peterson, Ph.D., professor at the University of Kansas; Diann Prosser, Ph.D., research wildlife ecologist for the U.S. Geological Survey; and Richard Webby, Ph.D., director of the World Health Organization Collaborating Centre for Studies on the Ecology of Influenza in Animals and Birds with St. Jude Children’s Research Hospital. Wayne Marcus Getz, professor at the University of California, Berkeley, is also assisting on the project.

The National Science Foundation grant for Ebert’s research is set to end Jan. 31, 2024, while Xiao’s grant will end Dec. 31, 2023.


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GSK and IQVIA launch platform of US vaccination data, showing drop in adult rates

Throughout the Covid-19 pandemic, the issue of vaccine uptake has been a point of contention, but a new platform from GSK and IQVIA is hoping to shed more…

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Throughout the Covid-19 pandemic, the issue of vaccine uptake has been a point of contention, but a new platform from GSK and IQVIA is hoping to shed more light on vaccine data, via new transparency and general awareness.

The two companies have launched Vaccine Track, a platform intended to be used by public health officials, medical professionals and others to strengthen data transparency and display vaccination trends. According to the companies, the platform is intended to aid in increasing vaccine rates and will provide data on trends to assist public health efforts.

Judy Stewart

The platform will also allow users to identify vaccination trends for adults in the US across multiple vaccine types. Users will also be able to scan claims data nationally to track trends alongside pre-Covid metrics.

“For the first time, Vaccine Track brings quarterly data tracking and trends together in a comprehensive platform for immunization partners, decision-makers and stakeholders. Our goal for Vaccine Track is to support the return to pre-pandemic vaccination rates for adults and to go beyond by empowering the vaccine and public health community with frequently updated, actionable information to get ahead of disease together,” said Judy Stewart, GSK’s head of vaccines in a statement.

This move comes as vaccination rates in adults were already low even before the pandemic, with a CDC report stressing that vaccine coverage in adults was low across all age groups.

So far the platform’s data show a decline in adult immunizations, excluding flu vaccinations, across the country during the pandemic. The platform currently only has information from January 2019 to December 2021 on hand but will be updated every quarter.

The data itself observed that rates were especially low in minority populations, which were already showing lower rates of immunization pre-pandemic.

The platform also showed that national trends for adults aged 19 and older are still low, with an average decrease of 18% through last year in overall claims. Average monthly claims through 2021 for recommended vaccines were between 12% and 42% below 2019 rates, with nearly half of the states in the US facing greater than 30% reductions in overall claims for recommended vaccines from pre-pandemic levels.

In Medicare patients, the platform’s analysis found a more than 30% reduction in overall claims for recommended vaccines among Black and Hispanic populations between 2019 and 2021.

The information itself is sourced from medical claims data and longitudinal prescription data, the companies said.

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