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Gsk’s Sotrovimab retains activity against key Omicron mutations

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Gsk’s Sotrovimab retains activity against key Omicron mutations

December 02, 2021: “GlaxoSmithKline plc and Vir Biotechnology, Inc. announced an update to bioRxiv, a preprint server, with preclinical data demonstrating that sotrovimab, an investigational monoclonal antibody, retains activity against key mutations of the new Omicron SARS-CoV-2 variant (B.1.1.529), including those found in the binding site of sotrovimab.

These data were generated through pseudo-virus testing of specific individual mutations found in Omicron.

To date, sotrovimab has demonstrated ongoing activity against all tested variants of concern and interest defined by the World Health Organization (WHO).

The companies are now completing in vitro pseudo-virus testing to confirm the neutralising activity of sotrovimab against the combination of all the Omicron mutations with the intent to provide an update by the end of 2021.

George Scangos, PhD, Chief Executive Officer of Vir, said: “Sotrovimab was deliberately designed with a mutating virus in mind. By targeting a highly conserved region of the spike protein that is less likely to mutate, we hoped to address both the current SARS-CoV-2 virus and future variants that we expected would be inevitable. This hypothesis has borne out again and again – with its ongoing ability to maintain activity against all tested variants of concern and interest to date, including key mutations found in Omicron, as demonstrated by preclinical data. We have every expectation that this positive trend will continue and are working rapidly to confirm its activity against the full combination sequence of Omicron.”

Dr Hal Barron, Chief Scientific Officer and President R&D, GSK, said: “Since the beginning of the pandemic, we have been working with Vir to combine our scientific expertise and technologies to deliver an enduring treatment option for patients with COVID-19. Though early, these pre-clinical data support our long-held view on the potential for sotrovimab to maintain its activity as the virus continues to mutate. We are pleased that this treatment option is available to patients in the US and many other countries, and are working to expand access worldwide.”

About sotrovimab
Sotrovimab is an investigational SARS-CoV-2 neutralising monoclonal antibody. The antibody binds to an epitope on SARS-CoV-2 shared with SARS-CoV-1 (the virus that causes SARS), indicating that the epitope is highly conserved, which may make it more difficult for resistance to develop. Sotrovimab, which incorporates Xencor’s Xtend™ technology, has also been designed to achieve high concentration in the lungs to ensure optimal penetration into airway tissues affected by SARS-CoV-2 and to have an extended half-life.

Updated in vitro data, published in bioRxiv, demonstrate that sotrovimab retains activity against all current tested variants of concern and interest of the SARS-CoV-2 virus as defined by WHO, plus others, including but not limited to Delta (B.1.617.2), Delta Plus (AY.1 or AY.2), Mu (B.1.621) and key mutations of Omicron (B.1.1.529).

About the sotrovimab clinical development programme

  • COMET-ICE: a Phase III, multi-centre, double-blind, placebo-controlled trial investigated an intravenous (IV) infusion of sotrovimab in adults with mild-to-moderate COVID-19 at high risk of progression to severe disease, who are not hospitalised and not requiring oxygen. The final COMET-ICE trial results in the full trial population of 1,057 participants demonstrated a 79% reduction (adjusted relative risk reduction) (p<0.001) in hospitalisation for more than 24 hours or death due to any cause by Day 29 compared to placebo, meeting the primary endpoint of the trial. Interim data were published in The New England Journal of Medicine on 27 October 2021 and final data were pre-published on 8 November 2021 on medRxiv.
  • COMET-TAIL: a Phase III, randomised, multi-centre, open-label, non-inferiority trial of intramuscular (IM) versus IV administration of sotrovimab for the early treatment of mild-to-moderate COVID-19 in high-risk non-hospitalised adult and paediatric patients (12 years of age and older). The trial’s primary endpoint was met, and headline data demonstrated that intramuscularly administered sotrovimab was non-inferior and offered similar efficacy to intravenous administration for high-risk populations. The companies plan to submit the complete COMET-TAIL data set to a peer-reviewed journal for publication in the first quarter of 2022.
  • COMET-PEAK: a Phase II, randomised, multi-centre, parallel-group trial evaluating IV and IM administration of sotrovimab in outpatients with mild-to-moderate COVID-19. Data available to date from open-label Part B of the trial (500mg IV vs. 500mg IM) demonstrated equivalence on the virological response between the IM and IV arms. The companies plan to submit the complete COMET-PEAK data set to a peer-reviewed journal for publication in due course.
  • GSK and Vir are also partnering to investigate the use of sotrovimab in uninfected immunocompromised adults to determine whether sotrovimab can prevent symptomatic COVID-19 infection. GSK and Vir are supporting investigator-sponsored studies and fostering scientific collaborations with experienced investigators and networks involved in the continuum of care of immunocompromised patients, to understand the role sotrovimab for prophylaxis could play in this population. Discussions with regulatory authorities regarding the prophylaxis programme will take place in due course.

About global access to sotrovimab

  • Sotrovimab is authorised for emergency use in the United States. Xevudy (sotrovimab) received a positive scientific opinion under Article 5(3) of Regulation 726/2004 from the Committee for Human Medicinal Products (CHMP) in the EU, has been granted a provisional marketing authorisation in Australia, and conditional marketing authorisation in Saudi Arabia. In Japan, it has been approved via the Special Approval for Emergency Pathway. Temporary authorisations for sotrovimab have been granted in a dozen countries.
  • GSK and Vir also recently submitted the Marketing Authorisation Application (MAA) to the European Medicines Agency for Xevudy (sotrovimab) for the treatment of adults and adolescents (aged 12 years and over and weighing at least 40 kg) with coronavirus disease 2019 (COVID-19) who do not require oxygen supplementation and who are at risk of progressing to severe
    COVID-19.
  • Sotrovimab is supplied in several countries worldwide, including through national agreements in the United States, United Kingdom, Japan, Australia, Canada, Singapore, Switzerland and United Arab Emirates. We have also signed a Joint Procurement Agreement with the European Commission to supply doses of sotrovimab.
  • Additional agreements are yet to be announced due to confidentiality or regulatory requirements.”

    https://www.gsk.com/en-gb/media/press-releases/preclinical-data-demonstrate-sotrovimab-retains-activity-against-key-omicron-mutations-new-sars-cov-2-variant/

Novartis holds an investor event focussing in advancing its industry-leading R&D engine.

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Novartis holds an investor event focussing in advancing its industry-leading R&D engine.

December 2, 2021: “Novartis holds an investor event to provide a comprehensive overview of the company’s progress in advancing its industry-leading R&D engine.

Vas Narasimhan, CEO of Novartis, said “Novartis has transformed to become a focused medicines company, building depth in our core therapeutic areas and strength across key technology platforms.

We expect to continue delivering strong operational performance, with 4%+ CAGR through to 2026*, driven by the momentum of our multi-billion dollar in-market growth drivers.

Up to 20 new assets with significant sales potential could be approved by 2026, which will fuel the next phase of growth and address major unmet needs.

We are building the foundation for long-term differential growth by investing in advanced technology platforms and data science.

Novartis remains disciplined and shareholder focused in its capital allocation priorities, as we continue to deliver on our strategy”.

New announcements at R&D Day 2021:

Cosentyx, our largest medicine by sales, showed topline results in moderate to severe hidradenitis suppurativa (HS), a potential new indication. 

Two Phase 3 studies (SUNRISE and SUNSHINE) met their primary endpoint, with more patients treated with Cosentyx achieving a HS Clinical Response (HiSCR), compared with placebo, at week 16.

The safety of Cosentyx in HS was consistent with the therapy’s known safety profile. The trials are ongoing to 52 weeks and are expected to complete in H2 2022. Regulatory filings are planned for 2022.

Novartis presents T-Charge™, a next generation CAR-T cell therapy platform, expected to increase CAR-T potency and have important process efficiencies to reduce turnaround time.

In first-in-human trials to be presented at ASH 2021, lead candidates YTB323 and PHE885 showed 75% Complete Response in Diffuse Large B-Cell Lymphoma (DLBCL) at three months and 100% Best Overall Response (BOR) in multiple myeloma, respectively.

Novartis is developing T-Charge™ as the foundational platform for a wave of potentially transformative CAR-T cell therapies.

Phase 3 study starts planned or ongoing across 5 core therapeutic areas include:

  • Cardio-Renal: Leqvio (CVRR-LDL-C), pelacarsen (CVRR-Lp(a)), iptacopan (C3G; IgAN) 
  • IHD: Cosentyx (HS; GCA; lupus nephritis), ligelizumab (CSU; food allergy; CINDU), ianalumab (Sjögren’s syndrome), remibrutinib (CSU)
  • Neuroscience: Zolgensma (SMA IT), remibrutinib (MS)
  • Oncology: Kisqali (HR+/HER2- BC adjuvant), 177Lu-PSMA-617 (mCRPC, pretaxane; mHSPC), canakinumab (adjuvant NSCLC), NIS793 (PDAC), JDQ443 (NSCLC, 2/3L)
  • Hematology: Iptacopan (aHUS; PNH), Scemblix® (CML 1L), sabatolimab (HR-MDS), and YTB323 (2L DLBCL)

(for abbreviations, see below)

Novartis announces a global co-development and co-commercialization agreement with UCB to bring disease-modifying therapies to people living with Parkinson’s Disease. 

The agreement covers UCB0599, a potential first-in-class, small molecule, alpha-synuclein misfolding inhibitor currently in Phase 2 clinical development.

In addition, upon completion of the ongoing Phase 1 program, there is an opt-in to co-develop UCB7853, an anti-alpha-synuclein antibody.

Both assets could transform care for 10 million people living with Parkinson’s Disease worldwide given the lack of disease-modifying therapies.

Novartis also provides a comprehensive overview of its mid- and late-stage pipeline assets in five core therapeutic areas, highlighting: Leqvio, pelacarsen, iptacopan, Cosentyx, ligelizumab, remibrutinib, ianalumab, LNA043, branaplam, Zolgensma, Kisqali, 177Lu-PSMA-617, sabatolimab, JDQ443, TNO155, Scemblix and NIS793.

Additionally, Novartis highlights the continued expansion of its pipeline and capabilities in advanced technology platforms that are expected to drive multiple waves of biopharmaceutical innovation.

These include: T-Charge™, Targeted Protein Degradation, Cell Therapy, Gene Therapy, Radioligand Therapy and xRNA.”

https://www.novartis.com/news/media-releases/novartis-rd-day-spotlights-attractive-growth-profile-underpinned-strong-market-brands-20-potential-high-value-pipeline-assets-and-technology-platforms

World AIDS Day 2021 – Step up, be bold, end AIDS, end inequalities and end pandemics

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World AIDS Day 2021 – Step up, be bold, end AIDS, end inequalities and end pandemics

December 01, 2021: “With millions of lives on the line, UNAIDS and WHO World AIDS Day event saw global partners, including Prince Harry, the Duke of Sussex, urgently call for expanded access to health treatments and technologies and for human rights to be upheld.

On the occasion of World AIDS Day 2021, UNAIDS, the World Health Organization (WHO) and partners came together at a special event in Geneva, Switzerland, to highlight the urgent need to end the economic, social, cultural and legal inequalities that drive the AIDS pandemic and other pandemics around the world.

“We are issuing an urgent warning. Only by moving fast to end the inequalities that drive the AIDS pandemic can we overcome it,” said Winnie Byanyima, Executive Director of UNAIDS. “World leaders must work together urgently to tackle the challenges head-on.

I urge you: be courageous in matching words with deeds. It is outrageous that every minute that passes, we lose a precious life to AIDS. We don’t have time to waste.”

The world is off track from delivering on the shared commitment to end AIDS by 2030. In 2020 there were 37.7 million people living with HIV, 1.5 million new HIV infections and 680 000 AIDS-related deaths. Around 65% of HIV infections globally were among key populations, including sex workers and their clients, gay men and other men who have sex with men, people who inject drugs and transgender people, and their sexual partners.

“Even before the COVID-19 pandemic hit, many of the populations most at risk were not being reached with HIV testing, prevention and care services,” said Tedros Adhanom Ghebreyesus, WHO Director-General.

“The pandemic has made things worse, with the disruption of essential health services, and the increased vulnerability of people with HIV to COVID-19. Like COVID-19, we have all the tools to end the AIDS epidemic, if we use them well.

This World AIDS Day, we renew our call on all countries to use every tool in the toolbox to narrow inequalities, prevent HIV infections, save lives and end the AIDS epidemic.”

If the world does not tackle discrimination and inequalities, UNAIDS and WHO warn that the next decade could see 7.7 million AIDS-related deaths.

A powerful video narrated by Prince Harry, the Duke of Sussex, and Ms Byanyima was screened at the event demonstrating the disturbing parallels between access to HIV treatment and access to COVID-19 vaccines.

Between 1997 and 2006, it is estimated that 12 million people died of AIDS-related illnesses in low- and middle-income countries as the price of medicines rendered them out of reach for many of the countries most affected by HIV.

Today, 10 million people around the world still do not have access to the life-saving HIV medicines.

The Duke of Sussex urged the world to learn from the history of AIDS and overcome the inequitable access to COVID-19 vaccines and to ensure that new HIV medicines and technologies are available to all.

A letter from the Duke of Sussex to WHO and UNAIDS was read out, in which he commemorated the 40 years of AIDS and expressed his gratitude for the work accomplished to date.

In the letter he stressed the need for COVID-19 vaccine equity, drawing from the lessons learned from HIV.

Speakers highlighted the impact of HIV on young people. “Young people continue to be stigmatized, especially those in key populations, and inequalities continue to compromise the quality of our lives,” said Joyce Ouma, from the Global Network of Young People Living with HIV.

“Young people are the future of nations and the cornerstone of the global AIDS response,” said Anutin Charnvirakul, Deputy Prime Minister and Minister of Public Health, Thailand. “Eradicating all kinds of stigma must be our full global commitment with immediate action.”

During the event, the participants commemorated the lives of the 36 million people who have died from AIDS since the start of the pandemic and highlighted the urgent need to do more for the people most affected by HIV.

The Ambassador of Namibia, Julia Imene-Chanduru, representing the UNAIDS Programme Coordinating Board Chair, said, “AIDS remains an emergency that we must not forget in our response to COVID-19.”

Speakers urged all countries, partners and civil society to be bold in taking forward the commitment made in the Political Declaration on AIDS adopted at the 2021 United Nations High-Level Meeting on AIDS and in the Global AIDS Strategy 2021–2026: End Inequalities, End AIDS, both having ending inequalities at their core.

“We can see the importance of UNAIDS’ strategy, with an emphasis on ending inequalities,” said Stephanie Seydoux, French Ambassador for Global Health. “This is what allows us to make progress in the fight against this pandemic, and to ensure health for everyone.”

“We know how to beat AIDS and we know how to beat pandemics,” added Ms Byanyima. “The policies to address the inequalities standing in the way of progress can be implemented, but they require leaders to step up and be bold.”

https://www.who.int/news/item/01-12-2021-world-aids-day-2021—step-up-be-bold-end-aids-end-inequalities-and-end-pandemics

Tripartite and UNEP support OHHLEP’s definition of “One Health”

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Tripartite and UNEP support OHHLEP’s definition of “One Health”

December 01, 2021: “The Food and Agriculture Organization of the United Nations (FAO), the World Organisation for Animal Health (OIE), the United Nations Environment Programme (UNEP) and the World Health Organization (WHO) welcome the newly formed operational definition of One Health from their advisory panel, the One Health High Level Expert Panel (OHHLEP), whose members represent a broad range of disciplines in science and policy-related sectors relevant to One Health from around the world.  

The four organizations are working together to mainstream One Health so that they are better prepared to prevent, predict, detect, and respond to global health threats and promote sustainable development.

The One Health definition developed by the OHHLEP states:

One Health is an integrated, unifying approach that aims to sustainably balance and optimize the health of people, animals and ecosystems.

It recognizes the health of humans, domestic and wild animals, plants, and the wider environment (including ecosystems) are closely linked and inter-dependent.

The approach mobilizes multiple sectors, disciplines and communities at varying levels of society to work together to foster well-being and tackle threats to health and ecosystems, while addressing the collective need for clean water, energy and air, safe and nutritious food, taking action on climate change, and contributing to sustainable development.

The importance of establishing a One Health definition was first raised by OHHLEP, and later agreed by the four Partners, to develop a common language and understanding around One Health.

The new comprehensive OHHLEP One Health definition aims to promote a clear understanding and translation across sectors and areas of expertise.

While health, food, water, energy, and environment are all wider topics with sector-specific and specialist concerns, the collaboration across sectors and disciplines will contribute to protecting health, addressing health challenges such as the emergence of infectious diseases and antimicrobial resistance and promoting health and integrity of our ecosystems.  

Moreover, One Health, linking humans, animals and the environment, can help to address the full spectrum of disease control – from disease prevention to detection, preparedness, response, and management – and to improve and promote health and sustainability. 

The approach can be applied at community, subnational, national, regional, and global levels, and relies on shared and effective governance, communication, collaboration and coordination.

With the One Health approach in place, it will be easier for people to better understand the co-benefits, risks, trade-offs and opportunities to advance equitable and holistic solutions.

Through combined energies of the four organizations, a comprehensive Global Plan of Action for One Health is in development, supported and advised by OHHLEP.

This Plan aims to mainstream and operationalize One Health at global, regional, and national levels; support countries in establishing and achieving national targets and priorities for interventions; mobilize investment; promote a whole of society approach and enable collaboration, learning and exchange across regions, countries, and sectors.

As we acknowledge the importance of the One Health approach and welcome the OHHLEP One Health definition, the Tripartite and UNEP will continue to coordinate and implement One Health activities in line with the spirit of the new OHHLEP definition of One Health.”

https://www.who.int/news/item/01-12-2021-tripartite-and-unep-support-ohhlep-s-definition-of-one-health

Scotland’s Drive to speed up booster programme after more Omicron cases

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Scotland’s Drive to speed up booster programme after more Omicron cases

November 30 2021: “Three new cases of the Omicron variant of coronavirus have been identified in Scotland, prompting a drive to deliver more than a million booster jabs by Christmas.

Humza Yousaf, the health secretary, said there were now five cases in the Lanarkshire area and four in NHS Greater Glasgow and Clyde, up from the six across both areas announced on Monday.

The vaccination booster programme would be accelerated but workforce issues were the “biggest constraining factor”, he added.

Booster vaccinations are being extended to all over-18s in Scotland, in line with the UK’s Joint Committee on Vaccination and Immunisation (JCVI) recommendation to cut the interval between the second and third dose from six to three months.”

https://www.thetimes.co.uk/article/covid-in-scotland-drive-to-speed-up-booster-programme-after-omicron-cases-hit-nine-39576j9j2

Sanofi to acquire Origimm Biotechnology in first move to treat acne with vaccine-based immunotherapy

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Sanofi to acquire Origimm Biotechnology in first move to treat acne with vaccine-based immunotherapy

December 1, 2021: “Sanofi announced it entered into an agreement to acquire Origimm Biotechnology GmbH, an Austrian privately owned biotechnology company specializing in the discovery of virulent skin microbiome components and antigens from bacteria causing skin disease, such as acne.

With this acquisition, Sanofi continues executing its global Play to Win strategy, pursuing growth opportunities and building an industry-leading vaccines pipeline.

The transaction will add ORI-001 to Sanofi’s early-stage pipeline.

ORI-001 is a therapeutic vaccine candidate for acne vulgaris based on recombinant proteins, which entered preliminary clinical studies in Q3 2021.

In parallel, Sanofi is working to develop additional antigen versions and expects to leverage its next-generation mRNA platform in a comprehensive Ph1/2 trial to start in 2023.  

“The acquisition of Origimm further broadens our vaccines R&D pipeline with a first vaccine candidate against acne, a high medical need for millions of teenagers and adults,” says Thomas Triomphe, Executive Vice President, Global Head of Sanofi Pasteur.

“Welcoming Origimm within Sanofi expands our area of expertise by bringing extensive know-how in the field of skin microbiome and skin immunology. We look forward to unlocking the full potential of this candidate”.

Acne is a widespread and stigmatizing condition for millions of people globally, causing substantial psychological burden for teenagers but also adults – over 10% of them still experiencing acne after age 50.

The Cutibacterium acnes bacterium plays a central role in the development of moderate to severe acne. There is today no satisfactory treatment against acne combining high efficacy and acceptable safety.

“We are looking forward to combining our expertise and strengths to continue developing innovative solutions for prevention and treatment of the skin microbiome-associated diseases, such as common acne” says Sanya Selak, PhD, Founder & CEO/CSO of Origimm. 

“Together with such a strong partner like Sanofi, we will strive to creating a paradigm shift in treatment of skin diseases and many other microbiome-associated disorders and infections, for which current medical solutions are inadequate.”

The acquisition is expected to close early December 2021.”

https://www.sanofi.com/en/media-room/press-releases/2021/2021-12-01-07-00-00-2343720

Joint Statement on Dose Donations of COVID-19 Vaccines to African Countries

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Joint Statement on Dose Donations of COVID-19 Vaccines to African Countries

November 29, 2021: “Building on lessons learned from our collective experience with dose donations over the past several months, the African Vaccine Acquisition Trust (AVAT), the Africa Centres for Disease Control and Prevention (Africa CDC) and COVAX wish to draw the attention of the international community to the situation of donations of COVID-19 vaccines to Africa, and other COVAX participating economies, particularly those supported by the Gavi COVAX Advance Market Commitment (AMC).

AVAT and COVAX complement each other’s efforts to support African countries to meet their immunisation targets, recognising the global goal of immunising 70% of the African population.

Dose donations have been an important source of supply while other sources are stepping up, but the quality of donations needs to improve.

AVAT and COVAX are focused on accelerating access to and rollout of COVID-19 vaccines in Africa.

Together we are rapidly expanding supply to the continent, and providing countries with the support to be able to utilise the doses they receive.

To date, over 90 million donated doses have been delivered to the continent via COVAX and AVAT and millions more via bilateral arrangements.

However, the majority of the donations to-date have been ad hoc, provided with little notice and short shelf lives. This has made it extremely challenging for countries to plan vaccination campaigns and increase absorptive capacity.

To achieve higher coverage rates across the continent, and for donations to be a sustainable source of supply that can complement supply from AVAT and COVAX purchase agreements, this trend must change.

Countries need predictable and reliable supply. Having to plan at short notice and ensure uptake of doses with short shelf lives exponentially magnifies the logistical burden on health systems that are already stretched.

Furthermore, ad hoc supply of this kind utilises capacity – human resources, infrastructure, cold chain – that could be directed towards long-term successful and sustainable rollout.

It also dramatically increases the risks of expiry once doses with already short shelf-lives arrive in country, which may have long-term repercussions for vaccine confidence.

Donations to COVAX, AVAT, and African countries must be made in a way that allows countries to effectively mobilise domestic resources in support of rollout and enables long-term planning to increase coverage rates.

We call on the international community, particularly donors and manufacturers, to commit to this effort by adhering to the following standards, beginning from 1 January 2022:

  • Quantity and predictability: Donor countries should endeavour to release donated doses in large volumes and in a predictable manner, to reduce transaction costs.

    We acknowledge and welcome the progress being made in this area, but note that the frequency of exceptions to this approach places increased burden on countries, AVAT and COVAX.
  • Earmarking: These doses should be unearmarked for greatest effectiveness and to support long-term planning. Earmarking makes it far more difficult to allocate supply based on equity, and to account for specific countries’ absorptive capacity.

    It also increases the risk that short shelf-life donations utilise countries’ cold chain capacity – capacity that is then unavailable when AVAT or COVAX are allocating doses with longer shelf lives under their own purchase agreements.
  • Shelf life: As a default, donated doses should have a minimum of 10 weeks shelf life when they arrive in-country, with limited exceptions only where recipient countries indicate willingness and ability to absorb doses with shorter shelf lives.
  • Early notice: Recipient countries need to be made aware of the availability of donated doses not less than 4 weeks before their tentative arrival in-country.
  • Response times: All stakeholders should seek to provide rapid response on essential information.

    This includes essential supply information from manufacturers (total volumes available for donation, shelf life, manufacturing site), confirmation of donation offer from donors, and acceptance/refusal of allocations from countries.

    Last minute information can further complicate processes, increasing transaction costs, reducing available shelf life and increasing risk of expiry.
  • Ancillaries: The majority of donations to-date do not include the necessary vaccination supplies such as syringes and diluent, nor do they cover freight costs –  meaning these have to be sourced separately – leading to additional costs, complexity and delay.
    Donated doses should be accompanied with all essential ancillaries to ensure rapid allocation and absorption.

AVAT, Africa CDC and COVAX remain committed to collaborate with donor countries, vaccine manufacturers and partners on ensuring these standards are upheld, as we continue to work together towards achieving Africa’s vaccination goals.”

https://www.who.int/news/item/29-11-2021-joint-statement-on-dose-donations-of-covid-19-vaccines-to-african-countries

FDA Approves New Imaging Drug to Help Identify Ovarian Cancer Lesions

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FDA Approves New Imaging Drug to Help Identify Ovarian Cancer Lesions

November 29, 2021: “The U.S. FDA approved Cytalux (pafolacianine), an imaging drug intended to assist surgeons in identifying ovarian cancer lesions.

The drug is designed to improve the ability to locate additional ovarian cancerous tissue that is normally difficult to detect during surgery.

Cytalux is indicated for use in adult patients with ovarian cancer to help identify cancerous lesions during surgery.

The drug is a diagnostic agent that is administered in the form of an intravenous injection prior to surgery.

“The FDA’s approval of Cytalux can help enhance the ability of surgeons to identify deadly ovarian tumors that may otherwise go undetected,” said Alex Gorovets, M.D., deputy director of the Office of Specialty Medicine in the FDA’s Center for Drug Evaluation and Research.

“By supplementing current methods of detecting ovarian cancer during surgery, Cytalux offers health care professionals an additional imaging approach for patients with ovarian cancer.”

The American Cancer Society estimates there will be more than 21,000 new cases of ovarian cancer and more than 13,000 deaths from this disease in 2021, making it the deadliest of all female reproductive system cancers.

Conventional treatment for ovarian cancer includes surgery to remove as many of the tumors as possible, chemotherapy to stop the growth of malignant cells or other targeted therapy to identify and attack specific cancer cells.

Ovarian cancer often causes the body to overproduce a specific protein in cell membranes called a folate receptor.

Following administration via injection, Cytalux binds to these proteins and illuminates under fluorescent light, boosting surgeons’ ability to identify the cancerous tissue.

Currently, surgeons rely on preoperative imaging, visual inspection of tumors under normal light or examination by touch to identify cancer lesions. Cytalux is used with a Near-Infrared fluorescence imaging system cleared by the FDA for specific use with pafolacianine.

The safety and effectiveness of Cytalux was evaluated in a randomized, multi-center, open-label study of women diagnosed with ovarian cancer or with high clinical suspicion of ovarian cancer who were scheduled to undergo surgery.

Of the 134 women (ages 33 to 81 years) who received a dose of Cytalux and were evaluated under both normal and fluorescent light during surgery, 26.9% had at least one cancerous lesion detected that was not observed by standard visual or tactile inspection.

The most common side effects of Cytalux were infusion-related reactions, including nausea, vomiting, abdominal pain, flushing, dyspepsia, chest discomfort, itching and hypersensitivity.

Cytalux may cause fetal harm when administered to a pregnant woman. The use of folate, folic acid, or folate-containing supplements should be avoided within 48 hours before administration of Cytalux.

There is a risk of image interpretation errors with the use of Cytalux to detect ovarian cancer during surgery, including false negatives and false positives.

The FDA previously granted Cytalux orphan-drug, priority and fast track designations.

The FDA granted the approval to On Target Laboratories, LLC.”

https://www.fda.gov/news-events/press-announcements/fda-approves-new-imaging-drug-help-identify-ovarian-cancer-lesions

FDA Actively Working to Investigate, Address Potential Impacts of Omicron Variant; Urges Vaccination and Boosters

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FDA Actively Working to Investigate, Address Potential Impacts of Omicron Variant; Urges Vaccination and Boosters

November 30, 2021: “As we have with previous emerging COVID-19 variants, the U.S.FDA is actively working with our federal partners, international regulators and medical product companies to quickly address any potential impacts of the new omicron variant on the tools to fight the pandemic. 

The agency is working as quickly as possible to evaluate the potential impact of this variant on the currently available diagnostics, therapeutics and vaccines. We are closely monitoring the situation and are committed to communicating with the public as we learn more. 

Historically, the work to obtain the genetic information and patient samples for variants and then perform the testing needed to evaluate their impact takes time. However, we expect the vast majority of this work to be completed in the coming weeks.

The FDA has been actively monitoring for the possible emergence of SARS-CoV-2 variants since early in the pandemic and has worked with medical product developers when a new variant (or mutation) emerges that could impact product performance. 

  • With industry guidance laid out in February and contingency plans already in place, we are well-positioned and committed to working with companies to evaluate and expeditiously address the potential impact of emerging and future viral mutations on COVID-19 tests, therapeutics and vaccines.
  • We’ve taken a number of steps to adapt to emerging variants thus far in the pandemic, such as requiring companies to actively monitor for and evaluate the impact of variants on their products as a condition of authorization, and quickly taking appropriate action.
  • The agency has previously limited the scope of use of certain monoclonal antibodies depending on variants circulating in certain areas, updated fact sheets for health care providers with information about how known variants impact certain therapeutics, and communicated with the public about tests affected by viral mutations. 
  • We anticipate having more information from the ongoing evaluation regarding if and how well the current vaccines work against this variant in the next few weeks. If a modification to the current vaccines is needed, the FDA and companies will work together to develop and test such a modification quickly.
  • On preliminary review, we believe high-volume polymerase chain reaction (PCR) and antigen (rapid) tests widely used in the U.S. show low likelihood of being impacted and continue to work. However, the FDA will continue to closely review and adjust course as needed.

The FDA is committed to continuing to use every tool in our toolbox to fight this pandemic, including pivoting as the virus adapts, to arm ourselves with the best available diagnostics, and life-saving therapeutics and vaccines to fight this virus.

At this time, the current vaccines remain highly effective at preventing COVID-19 and serious clinical outcomes associated with a COVID-19 infection, including hospitalization and death.

Additionally, currently available data from our international partners and vaccine manufacturers that has been evaluated by the FDA, suggests that an additional booster shot following the completion of a primary vaccination (six months for Pfizer-BioNTech and Moderna and two months for Janssen (Johnson & Johnson)) provides further protection against a COVID-19 infection.

Getting vaccinated or receiving a booster with one of the currently available vaccines is the best thing that you can do right now (in addition to standard precautions like wearing a mask) to help protect yourself, your family and friends.”

https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-actively-working-investigate-address-potential-impacts-omicron

WHO Update on Omicron

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WHO Update on Omicron

November 28, 2021: “On 26 November 2021, WHO designated the variant B.1.1.529 a variant of concern, named Omicron, on the advice of WHO’s Technical Advisory Group on Virus Evolution (TAG-VE).  

This decision was based on the evidence presented to the TAG-VE that Omicron has several mutations that may have an impact on how it behaves, for example, on how easily it spreads or the severity of illness it causes. 

Here is a summary of what is currently known.  

Current knowledge about Omicron 

Researchers in South Africa and around the world are conducting studies to better understand many aspects of Omicron and will continue to share the findings of these studies as they become available.  

Transmissibility: It is not yet clear whether Omicron is more transmissible (e.g., more easily spread from person to person) compared to other variants, including Delta.

The number of people testing positive has risen in areas of South Africa affected by this variant, but epidemiologic studies are underway to understand if it is because of Omicron or other factors.  

Severity of disease: It is not yet clear whether infection with Omicron causes more severe disease compared to infections with other variants, including Delta.  

Preliminary data suggests that there are increasing rates of hospitalization in South Africa, but this may be due to increasing overall numbers of people becoming infected, rather than a result of specific infection with Omicron.  

There is currently no information to suggest that symptoms associated with Omicron are different from those from other variants.  

Initial reported infections were among university students—younger individuals who tend to have more mild disease—but understanding the level of severity of the Omicron variant will take days to several weeks.  

All variants of COVID-19, including the Delta variant that is dominant worldwide, can cause severe disease or death, in particular for the most vulnerable people, and thus prevention is always key. 

Effectiveness of prior SARS-CoV-2 infection 

Preliminary evidence suggests there may be an increased risk of reinfection with Omicron (ie, people who have previously had COVID-19 could become reinfected more easily with Omicron), as compared to other variants of concern, but information is limited.

More information on this will become available in the coming days and weeks. 

Effectiveness of vaccines: WHO is working with technical partners to understand the potential impact of this variant on our existing countermeasures, including vaccines.

Vaccines remain critical to reducing severe disease and death, including against the dominant circulating variant, Delta. Current vaccines remain effective against severe disease and death.   

Effectiveness of current tests: The widely used PCR tests continue to detect infection, including infection with Omicron, as we have seen with other variants as well.

Studies are ongoing to determine whether there is any impact on other types of tests, including rapid antigen detection tests.  

Effectiveness of current treatments:   Corticosteroids and IL6 Receptor Blockers will still be effective for managing patients with severe COVID-19.

Other treatments will be assessed to see if they are still as effective given the changes to parts of the virus in the Omicron variant.  

Studies underway 

At the present time, WHO is coordinating with a large number of researchers around the world to better understand Omicron.

Studies currently underway or underway shortly include assessments of transmissibility, severity of infection (including symptoms), performance of vaccines and diagnostic tests, and effectiveness of treatments.    

WHO encourages countries to contribute the collection and sharing of hospitalized patient data through the WHO COVID-19 Clinical Data Platform to rapidly describe clinical characteristics and patient outcomes.  

More information will emerge in the coming days and weeks. WHO’s TAG-VE will continue to monitor and evaluate the data as it becomes available and assess how mutations in Omicron alter the behaviour of the virus.  

Recommended actions for countries 

As Omicron has been designated a Variant of Concern, there are several actions WHO recommends countries to undertake, including enhancing surveillance and sequencing of cases;  sharing genome sequences on publicly available databases, such as GISAID; reporting initial cases or clusters to WHO; performing field investigations and laboratory assessments to better understand if Omicron has different transmission or disease characteristics, or impacts effectiveness of vaccines, therapeutics, diagnostics or public health and social measures.  

More detail in the announcement from 26 November.  

Countries should continue to implement the effective public health measures to reduce COVID-19 circulation overall, using a risk analysis and science-based approach. 

They should increase some public health and medical capacities to manage an increase in cases.  WHO is providing countries with support and guidance for both readiness and response.  

In addition, it is vitally important that inequities in access to COVID-19 vaccines are urgently addressed to ensure that vulnerable groups everywhere, including health workers and older persons, receive their first and second doses, alongside equitable access to treatment and diagnostics.  

Recommended actions for people 

The most effective steps individuals can take to reduce the spread of the COVID-19 virus is to keep a physical distance of at least 1 metre from others; wear a well-fitting mask; open windows to improve ventilation; avoid poorly ventilated or crowded spaces; keep hands clean; cough or sneeze into a bent elbow or tissue; and get vaccinated when it’s their turn.  

WHO will continue to provide updates as more information becomes available, including following meetings of the TAG-VE. In addition, information will be available on WHO’s digital and social media platforms.”

https://www.who.int/news/item/28-11-2021-update-on-omicron

New UKHSA study provides more safety data on COVID-19 vaccines in pregnancy

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New UKHSA study provides more safety data on COVID-19 vaccines in pregnancy

 November 25, 2021: “Analysis by the UK Health Security Agency in women giving birth has reinforced international evidence that COVID-19 vaccines have good safety record in pregnant women.

This is the first data published in England and it showed that those women who had received coronavirus (COVID-19) vaccination had good birth outcomes.

In the 8-month period between January and August 2021, 355,299 women gave birth – of whom 24,759 had received at least one dose of COVID-19 vaccine prior to delivery. Existing evidence shows women with COVID-19 disease in later pregnancy are at increased risk of severe disease requiring hospital and intensive care admission.

Vaccines are effective at preventing severe disease – no fully vaccinated pregnant women were admitted to intensive care with COVID-19 in England between February and the end of September 2021 (UK Obstetric Surveillance System data).

COVID-19 vaccines have now been administered to thousands of pregnant women in this country.

The analysis looked at women who gave birth up to August this year and, reassuringly, found that there is a similar very low risk of still birth, prematurity and low birth weight in vaccinated and unvaccinated women.

However, people who are vaccinated are far more protected against serious COVID-19 than those who are unvaccinated.

The preliminary data showed that:

  • the stillbirth rate for vaccinated women who gave birth was approximately 3.35 per 1,000, a similar rate for unvaccinated women (3.60 per 1,000) seen in January to August 2021
  • in the same period, the proportion of vaccinated women giving birth to babies with low birthweight (5.28%) was similar to the proportion for unvaccinated women (5.36%)
  • the proportion of premature births was 6.51% for vaccinated and 5.99% for unvaccinated women

The small differences between groups may be explained by differences in the women eligible for and taking up the vaccine.

Women first eligible for vaccination were more likely to be older and to have an underlying medical condition.

These groups are at higher general risk of certain pregnancy outcomes, such as prematurity.

The data also showed that women living in the most deprived areas in England were least likely to have been vaccinated with at least one dose of COVID-19 vaccine before they gave birth.

Just 7.8% of women living in more deprived areas of England had a vaccine while pregnant, compared to 26.5% in less deprived areas.

Pregnant women of Black ethnicity were also the least likely to be vaccinated at the time of birth (5.5%), followed by women of Asian ethnicity (13.5%) and Mixed ethnicity (14.0%) – with women who were from a White background being the most vaccinated (17.5%).

Dr Mary Ramsay, Head of Immunisation at UKHSA, said:

We already know that getting vaccinated is the best way to protect yourself from serious illness. If you haven’t already been vaccinated, this new information should add to the reassuring safety data.

Every pregnant woman who has not yet been vaccinated should feel confident to go and get the jab, and that this will help to prevent the serious consequences of catching COVID-19 in pregnancy.

This accumulating evidence will also allow midwives and other health professionals to provide better information to pregnant women and help to drive uptake higher.

Our figures also highlight stark inequalities in uptake with many of the most vulnerable women in our society going unvaccinated.

It is vital that women of all backgrounds accept their offer of their vaccine in order to protect themselves.

https://www.gov.uk/government/news/new-ukhsa-study-provides-more-safety-data-on-covid-19-vaccines-in-pregnancy

WHO publishes updated guidance on validation of elimination of mother-to-child transmission of HIV, syphilis and hepatitis B virus

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WHO publishes updated guidance on validation of elimination of mother-to-child transmission of HIV, syphilis and hepatitis B virus

November 26, 2021: “WHO has updated its Global guidance on criteria and processes for validation: elimination of mother-to-child transmission of HIV, syphilis and hepatitis B virus.

This third version of global guidance incorporates EMTCT of HBV towards validation of ‘triple elimination’ and provides standardized processes and criteria to both validate EMTCT of HIV, syphilis and HBV, and to recognize high burden countries that have made significant progress on the path to elimination (PTE). 

The similarity of the critical interventions necessary to prevent transmission adds to the feasibility and benefit of an integrated approach to EMTCT of all three infections as triple elimination.

Building on an integrated maternal and child health platform, WHO has moved to operationalize universal health coverage in the context of integrated communicable disease prevention.

The guidance strongly emphasizes country-led accountability, rigorous analysis, intensive programme assessment and multilevel collaboration, including the involvement of communities of women living with HIV or HBV, or affected by syphilis.

A harmonized approach to triple elimination is encouraged within a public health, rights-based and person-centred approach but depending on readiness, countries may choose to pursue validation of single, dual or triple EMTCT. 

Since the efforts to establish criteria for validation began in 2007, two editions of the document have been published, and as of November 2021, 15 countries and territories have been validated for EMTCT of HIV and syphilis and one country has been certified on the silver tier in the path to elimination.

The two previous editions for this guidance document supported the standardization and formal approach to EMTCT validation, including criteria, indicators and targets to be achieved. 

The third version was developed by WHO and the Global Validation Advisory Committee.

It is intended for use by national, regional and global validation committees as they prepare or review national and regional submissions for validation of EMTCT of HIV, syphilis and HBV.

Mother-to-child transmission, or vertical transmission, is a significant contributor to the HIV pandemic, accounting for 9% of new infections globally in 2017 (1).

“With renewed focus to end the epidemics of HIV, viral hepatitis and sexually transmitted infections, we are convinced that setting the bar high for validation will result in the best results for all and, in particular, for women and children at risk for HIV, syphilis and HBV,” said Dr Meg Doherty, Director of WHO’s Department of Global HIV, Hepatitis and STI Programmes.”

https://www.who.int/news/item/26-11-2021-who-publishes-updated-guidance-on-validation-of-elimination-of-mother-to-child-transmission-of-hiv-syphilis-and-hepatitis-b-virus

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