The Bill & Melinda Gates Foundation is a nonprofit organization based in Seattle, WA, with domestic subsidiaries. Founded by William H. Gates and Melinda French Gates, the foundation operates with a non-profit mission. Guided by the principle that every life holds equal value, the Bill & Melinda Gates Foundation is dedicated to working towards the goal of enabling all individuals to lead healthy and productive lives. In developing countries, the foundation concentrates on enhancing people's health and providing them with opportunities to overcome hunger and extreme poverty. In the United States, the foundation strives to ensure that all individuals, particularly those with limited resources, have access to the opportunities necessary for success in both education and life.

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Infectious Diseases

Small molecule drug

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Drugs associated with Bill & Melinda Gates Foundation

SMD-5053

Target-

Mechanism-

Active Org.

Bill & Melinda Gates Foundation [+1]

Originator Org.

Sirenas Marine Discovery LLC

Active Indication

Malaria

Inactive Indication-

Drug Highest PhasePreclinical

First Approval Ctry. / Loc.-

First Approval Date-

451

Clinical Trials associated with Bill & Melinda Gates Foundation

NCT06743204 / Not yet recruitingNot ApplicableIIT

The Integrated Female Sexually Transmitted Infection Testing for HIV Epidemic Control Through PrEP (IN-STEP) Study

Globally, new HIV infections are concentrated in eastern and southern Africa where the infections are largely acquired by women outside of known key populations. Identifying African women at high risk for HIV acquisition and successfully engaging them in HIV prevention services, particularly pre-exposure prophylaxis (PrEP) programs, is an urgent global health priority. The U.S. President's Emergency Plan for AIDS Relief program in Africa typically relies on self-reported risk screening tools (SRST) to target HIV testing and refer individuals for PrEP. However, these tools have low to moderate sensitivity, missing many women at high risk for HIV. This is partly due to underreporting of risk factors, but also because many African women are at heightened HIV risk solely through relationships with high-risk male partners. Moreover, many African women enrolled into PrEP programs stop using PrEP within months of initiation. Decades of research shows that curable sexually transmitted infections (cSTI) are objective markers of future HIV risk, but cSTI testing largely has been omitted from African HIV programs. With the advent of lower cost multiplex cSTI testing and point of care diagnostics, there is new opportunity to determine whether integrating female cSTI testing services into HIV programs can improve HIV epidemic control. Here, the investigators will conduct an individually randomized effectiveness implementation trial of SRST plus cSTI diagnostic testing for chlamydia, gonorrhea, trichomonas, and syphilis compared to SRST alone to increase PrEP use among cis-gender African women aged 15-39 years. The investigators hypothesize that cSTI testing will increase PrEP use primarily through (i) improved identification of women at high risk for HIV and (ii) enhancement of self-perceived HIV risk. The proposed research will be nested within the Rakai Community Cohort Study, a population-based HIV surveillance cohort in Uganda. In Aim 1,
4,500 HIV-negative women will be individually randomized 1:1 to PrEP screening based on SRST plus cSTI diagnostic testing (intervention) versus PrEP screening based on SRST alone (control arm). Both arms will be offered syndromic case management for cSTIs and syphilis testing for pregnant women (standard of care). The primary outcomes will be PrEP uptake, adherence, and persistence, assessed through clinical records and drug level testing. In Aim 2, the investigators will perform a mixed-methods, implementation science evaluation of female cSTI testing for HIV prevention and control. The investigators will use qualitative and quantitative methods to assess the mechanisms, barriers, and facilitators to improving PrEP outcomes through cSTI testing and how this varies by cSTI pathogen, SRST outcomes, and demographic profiles. In Aim 3, the investigators will use mathematical models to evaluate different cSTI testing approaches to reduce HIV incidence at a population level by considering what cSTIs to screen for, in what health care settings, and at what cost thresholds. The investigators will also model broader health benefits of cSTI testing. Results from this study will provide actionable, population-level information to inform strategic delivery of high impact HIV prevention through integrated HIV and cSTI programming in Africa.

Start Date01 Apr 2025

Sponsor / Collaborator

The Johns Hopkins University

[+3]

NCT06694753 / Not yet recruitingPhase 1IIT

A Phase 1, Placebo-controlled, Blinded, Dose-escalation Study to Evaluate the Safety and Immunogenicity of MRNAs Encoding HIV Immunogens (eOD-GT8 60mer, Core-g28v2 60mer, N332-GT5 Gp151) in Adult Participants Without HIV and in Overall Good Health in South Africa

The purpose of this study is to evaluate the safety and immunogenicity of mRNAs encoding HIV immunogens (eOD-GT8 60mer, core-g28v2 60mer, N332-GT5 gp151) in adult participants without HIV and in overall good health in South Africa.

Start Date19 Feb 2025

Sponsor / Collaborator

HIV Vaccine Trials Network

[+6]

NCT06588790 / Not yet recruitingNot ApplicableIIT

Diagnostic Access to Self-Care and Health Services in Low and Middle Income Countries (DASH) - Phase II

Our primary goal is to determine if on-demand, home-based rapid testing, or rapid testing done by a community health worker (CHW) results in people testing for diseases more frequently and getting care more quickly. These two testing approaches will be compared to how individuals would normally test if they were concerned about certain diseases.
The main questions the study aims to answer are:
* Do either of the testing approaches result in more people testing themselves for certain diseases when needed?
* Does self-testing at home or testing done by a community health worker increase the number of individuals receiving test results and getting care/treatment more quickly?
* Does at-home screening for high blood pressure and diabetes result in lower blood pressure and hemoglobin A1c levels (an indicator for diabetes)?

Start Date01 Oct 2024

Sponsor / Collaborator

University of Washington

[+3]

100 Clinical Results associated with Bill & Melinda Gates Foundation

0 Patents (Medical) associated with Bill & Melinda Gates Foundation

1,679

Literatures (Medical) associated with Bill & Melinda Gates Foundation

01 Feb 2025·JOURNAL OF CONTROLLED RELEASE

White paper: Understanding, informing and defining the regulatory science of microneedle-based dosage forms that are applied to the skin

Article

Author: Henry, Sebastien ; Coulman, Sion A ; Hernandez, Carmen Amelia Rodriguez ; Henke, Stefan ; Zehrung, Darin ; Dick, Lisa ; Alali, Mohammed ; Eakins, Michael N ; Speaker, Tycho Joseph ; Shin, Juyeop ; Forster, Angus Harry ; Frivold, Collrane ; Jarrahian, Courtney ; Lewis, Hayley ; Strasinger, Caroline ; Creelman, Benjamin Paul ; Burke, Matthew Douglas ; Prausnitz, Mark R ; Dul, Maria ; Park, Jung-Hwan ; Gilbert, Philippe-Alexandre ; Robinson, David Kenneth ; Birchall, James C ; Taylor, Kevin M G ; Donnelly, Ryan F ; Hunt, Desmond ; Mistilis, Jessica Joyce ; Ameri, Mahmoud

The COVID-19 pandemic has accelerated pre-clinical and clinical development of microneedle-based drug delivery technology. However the regulatory science of this emerging dosage form is immature and explicit regulatory guidance is limited. A group of international stakeholders has formed to identify and address key issues for the regulatory science of future products that combine a microneedle device and active pharmaceutical ingredient (in solid or semi-solid state) in a single entity that is designed for application to the skin. Guided by the principles of Quality by Design (QbD) and informed by consultation with wider stakeholders, this 'White Paper' describes fundamental elements of the work in an effort to harmonise understanding, stimulate discussion and guide innovation. The paper discusses classification of the dosage form (combination/medicinal product), the regulatory nomenclature that is likely to be adopted and the technical vocabulary that best describes its form and function. More than twenty potential critical quality attributes (CQAs) are identified for the dosage form, and a prioritisation exercise identifies those CQAs that are most pertinent to the dosage form and that will likely require bespoke test methods (delivered dose, puncture performance) or major adaptions to established compendial test methods (dissolution). Hopefully the work will provide a platform for the development of dosage form specific guidance (from regulatory authorities and/or international pharmacopoeias), that expedites clinical translation of safe and effective microneedle-based products.

31 Dec 2024·Global Health Action

‘Health Camp’ model: a unique approach for child vaccination in non-state armed actor controlled, inaccessible geographies in Somalia

Article

Author: Kahow, Mohamed Hussein ; Shah, Rashed ; Ali, Asma ; Halane, Salad Ahmed

18 Dec 2024·Health Systems & Reform

Objective-Oriented Health Systems Reform

Article

Author: Earle, Alexandra J. ; Sparkes, Susan P. ; Kutzin, Joseph ; Ravishankar, Nirmala ; Gatome-Munyua, Agnes

This paper emphasizes the importance of orienting health system reforms to address underlying system-level performance problems. Too often in practice, the objective-orientation that is stressed in health system frameworks gets lost in relation to policies or schemes that are promoted without plausible linkages to the actual objectives of the reforms. The objective-orientation can also get subsumed by political agendas that are disconnected, or can even detract from, people's health needs. There are three core attributes to objective-oriented health system reform: (i) problem-oriented; (ii) consistent (extent to which reforms are connected to the problems they are meant to address and reflect lessons from global and national experience); and (iii) continuously evaluated. Country experiences reviewed in the paper, and presented in this special issue, illustrate how taking an objective-orientation led reformers to alter the details of implementation. Continuous learning also informed adaptations needed to strategically sequence and link reforms with objectives. An objective-oriented approach enables reformers to: (i) seize windows of opportunity; (ii) find room to maneuver under the label of the reform; (iii) integrate applied research into reform implementation; and (iv) skillfully interpret political statements to align with technical best practices. The approach and attributes laid out in this paper put forward considerations for policy makers as they design, implement, evaluate, and adapt policies to feasibly improve health system performance. They also, importantly, help guard against a rush toward policies or schemes that may sound good in speeches or declarations but do not have a plausible link to objectives.

News (Medical) associated with Bill & Melinda Gates Foundation

18 Dec 2024

·www.biopharmadive.com

Tessera gets sickle cell funding; Corvus shares slide on eczema data

Today, a brief rundown of news involving Tessera Therapeutics and Corvus Pharmaceuticals, as well as updates from Sarepta Therapeutics, Cara Therapeutics and Johnson & Johnson that you may have missed.The Bill & Melinda Gates Foundation will invest as much as $50 million to support Tessera Therapeutics development of a curative genetic treatment for sickle cell disease that can work without the intensive preparatory regimens needed for drugs like Casgevy and Lyfgenia. Tessera, which specializes in technology it says can change single DNA letters as well as add whole genes, is developing its sickle cell therapy as an in vivo treatment, meaning it does its modification to cell genes directly inside the body. Casgevy and Lyfgenia are ex vivo, built from editing patient cells in a laboratory. Simpler in vivo therapies could be an important to bringing genetic medicine to parts of the world without advanced healthcare infrastructure. Ned PagliaruloShares in Corvus Pharmaceuticals collapsed Wednesday, shedding nearly half of their value following the companys release of study data for its drug soquelitinib in people with eczema. Results came from the first portion of a Phase 1 study involving 12 participants given Corvus drug and four who received placebo. The data showed roughly similar skin clearance in both groups through 15 days, but greater clearance for soquelinitib-treated volunteers than those on placbeo through 28 days. Ned PagliaruloSarepta Therapeutics on Wednesday said it has finished enrolling a Phase 3 study of a gene therapy its developing for a type of limb-girdle muscular dystrophy. The company expects data from the trial in the first half of next year and, if positive, anticipates that theyd support an approval application to the Food and Drug Administration. Sarepta is also developing gene therapies for other forms of the muscle-weakening disease. Ned PagliaruloCara Therapeutics and private biotechnology firm Tvardi Therapeutics have agreed to merge, giving Tvardi an entry to public markets to help fund development of medicines for fibrotic diseases. Once the deal closes, the new company will operate under Tvardis name and a new ticker, TVRD. Its combined cash on hand will fund operations into the second half of 2026, before which Tvardi expects data from two Phase 2 studies of its experimental STAT3 blocker in idiopathic pulmonary fibrosis and hepatocellular carcinoma. Separately, Cara has reached a deal with Vifor Fresenius Medical Care Renal Pharma to sell rights to its approved drug Korsuva. Delilah AlvaradoThe Food and Drug Administration has rejected Johnson & Johnsons application for a subcutaneous form of its lung cancer drug Rybrevant. The complete response letter cited findings from a pre-approval inspection of a manufacturing facility and did not flag concerns with the drug product, or its safety and efficacy, J&J said. The company plans to work closely with the agency to bring the under-the-skin shot to market. The approved intravenous formulation of Rybrevant is not affected by the complete response letter. Delilah Alvarado '

Clinical ResultPhase 3Phase 1Phase 2Gene Therapy

11 Dec 2024

·www.prnewswire.com

Partnership Established to Advance WHO's Road Map for Neglected Tropical Diseases 2021-2030

TOKYO and GENEVA, Dec. 10, 2024 /PRNewswire/ -- The Global Health Innovative Technology (GHIT) Fund and the World Health Organization (WHO) have signed a memorandum of understanding (MoU) to further expand their partnership to promote access to safe, effective and affordable drugs, vaccines and diagnostics in the area of neglected tropical diseases (NTDs). The MoU makes provisions for four areas of collaboration: (i) research and development aimed at strengthening the arsenal of innovative tools, treatments and interventions for NTDs; (ii) resource mobilization, notably through the development of an NTD investment case toolkit and sustainable procurement systems; (iii) advocacy and awareness, to raise the profile of NTDs within global and local health agendas; and (iv) participation of GHIT as observers in NTD working groups and task forces convened by WHO. "This new partnership between GHIT and WHO represents a significant step forward in the fight against neglected tropical diseases," said Dr. Ibrahima Socé Fall, Director, WHO Global Neglected Tropical Diseases Programme. "By joining forces, we are not only accelerating research and development but also building sustainable frameworks and funding mechanisms needed to eliminate these diseases." The GHIT Fund and WHO have been actively involved in discussions and collaborations focused on developing and launching new products targeting neglected tropical diseases in low- and middle-income countries (LMICs). Through this partnership, GHIT and WHO will continue to work in close collaboration to advance the goals and targets in WHO's roadmap for neglected tropical diseases 2021–2030, in addition to the Sustainable Development Goals (SDGs). WHO's roadmap for NTDs sets global targets and milestones for the prevention, control, elimination and eradication of 21 NTDs and disease groups by 2030 and beyond. The GHIT Fund invests in new product development of drugs, vaccines and diagnostics for malaria, tuberculosis and NTDs and contributes to global health by facilitating collaborations between Japanese technology and innovation and global institutions to address these diseases. Dr. Osamu Kunii, CEO of the GHIT Fund, states, "Through this new partnership with WHO, we aim to advance the efforts of the Nagasaki Outcome Statement developed at the Symposium for G7 Health Ministers' Meeting in May 2023 to accelerate R&D, access and delivery for NTDs efforts." About WHO Founded in 1948, the World Health Organization (WHO) is the directing and coordinating authority on international health within the United Nations system. The objective of WHO is the attainment by all peoples of the highest possible level of health. Health, as defined in the WHO Constitution, is a state of complete physical, mental and social well-being and not merely the absence of disease or infirmity. Working with 194 Member States across 6 regions and on the ground in 150+ locations, the WHO team is dedicated to improve everyone's ability to enjoy good health and well-being. About the GHIT Fund The GHIT Fund is a Japan-based international public-private partnership (PPP) fund that was formed between the Government of Japan, multiple pharmaceutical companies, the Bill & Melinda Gates Foundation, the Wellcome, and the United Nations Development Programme (UNDP). The GHIT Fund invests in and manages an R&D portfolio of development partnerships aimed at addressing neglected diseases, such as malaria, tuberculosis, and neglected tropical diseases, which afflict the world's vulnerable and underserved populations. In collaboration with global partners, the GHIT Fund mobilizes Japanese industry, academia, and research institutes to create new drugs, vaccines, and diagnostics for malaria, tuberculosis, and neglected tropical diseases. For more information, contact: Katy Lenard at +1-202-494-2584 or [email protected] Mina Ohata at +81-36441-2032 or [email protected] SOURCE Global Health Innovative Technology Fund (GHIT Fund) WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

19 Nov 2024

·www.prnewswire.com

Women's Health Company Freya Biosciences Announces Key $10.4 Million Strategic Investment

Strategic investment from the Bill & Melinda Gates Foundation with additional investment from EIFO brings the total to $11.8 million The new investment extends Series A investment to about $50 million Funds will be used to expand Freya's DYSCOVERTM platform to identify and develop microbial immunotherapies to treat bacterial vaginosis and prevent pre-term birth COPENHAGEN, Denmark and BOSTON, Nov. 19, 2024 /PRNewswire/ -- Freya Biosciences (Freya or the Company), a transatlantic biotech company specializing in women's health, today announces a $10.4 million strategic investment from the Bill & Melinda Gates Foundation (the foundation) with $1.4 million additional financing from current investor Export and Investment Fund of Denmark (EIFO). The funds will be used to develop microbial immunotherapies for the treatment of bacterial vaginosis (BV) to address pre-term birth and potentially other indications affecting maternal and newborn health. Freya is developing microbial immunotherapies to regulate the immune system and inflammatory responses in the vaginal tract using its DYSCOVERTM platform. Freya has identified Lactobacillus strains that are capable of engrafting in the vaginal tract thereby displacing the existing dysbiotic vaginal microbiome and reducing key inflammation biomarkers. To date the platform has yielded Freya's lead candidate, FB301 for improving pregnancy success in IVF. Freya will now leverage the DYSCOVER platform to develop and bring to the clinic a microbial immunotherapy for BV. BV is a common condition that occurs when the vagina is infected with bacteria, causing an imbalance in the local microbiome resulting in unpleasant but usually mild symptoms. However, it can have serious consequences in pregnant women, raising the chance of premature rupture of membranes, preterm birth, intra-amniotic infection, low birth weight and miscarriage. BV is treatable with antibiotics, but often BV redevelops shortly after antibiotic treatment has been completed, eventually leading to chronic recurrence and increased inflammation in the reproductive tract. BV is a critically underserved condition, with prevalence among women of reproductive age between 23–29% and higher rates in certain low-and middle-income countries. Women in these regions face disproportionately high risks of preterm birth and associated complications, underscoring the global need for effective, accessible treatments. Thus, there is an urgent need to develop a therapeutic that can serve populations around the world, especially those in resource-constrained settings where the health burden is most acute. Colleen Acosta, PhD, Chief Executive Officer of Freya Biosciences, said: "We are thrilled that the Bill & Melinda Gates Foundation has placed its trust and financing in Freya to address major unmet global health challenges. This is an important validation of our work and the potential of the DYSCOVER platform, enabling Freya to develop critically needed therapeutic candidates for women's and infant health." Peter Bisgaard, Chairman of the Board of Freya Biosciences, added: "Freya's mission is to develop innovative solutions that can transform the health outcomes for millions of women globally, including in low-resource settings. This strategic investment from the Bill & Melinda Gates Foundation empowers us to take on one of the most pressing issues in maternal and infant health – bacterial vaginosis, its associated inflammation and connection to preterm birth. We are committed to ensuring that the benefits of our breakthrough therapies extend to women everywhere." In connection with the financing, Chris Chen, Partner, Strategic Investment Fund at the Bill & Melinda Gates Foundation, will join the Freya Biosciences board of directors as an observer, effective immediately. About Freya Biosciences Freya Biosciences is a clinical-stage biotech company with headquarters in Copenhagen, Denmark and Boston, Massachusetts dedicated to developing microbial immunotherapies for high unmet medical needs in women's health. Freya addresses immune drivers underlying a range of reproductive health conditions to create a future where everyone is empowered with optimal reproductive health. For more information, please visit or visit us on LinkedIn. About EIFO EIFO is the national promotional bank and export credit agency of Denmark combined in one financial institution. Active in over 100 countries, and with a total business volume of more than EUR 20 billion, EIFO provides financial solutions for Danish companies and their global partners, while also investing in startups and funds. We exist to open doors for Danish global business, accelerate the green transition, promote new technologies and develop the Danish defense industry. With our willingness to take risks in financing, EIFO paves the way for those who dare to think bigger. SOURCE Freya Biosciences WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Immunotherapy

100 Deals associated with Bill & Melinda Gates Foundation

100 Translational Medicine associated with Bill & Melinda Gates Foundation

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Pipeline Snapshot as of 30 Dec 2024

The statistics for drugs in the Pipeline is the current organization and its subsidiaries are counted as organizations,Early Phase 1 is incorporated into Phase 1, Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3

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Drug(Targets)	Indications	Global Highest Phase

SMD-5053	Malaria More	Preclinical
Circumsporozoite vaccine (fowlpox virus vector, malaria), London School of Hygiene and Tropical Medicine(University of Oxford)	Malaria More	Discontinued
KY-7006	Infectious Diseases More	Discontinued
KY-7003	Infectious Diseases More	Discontinued
KY-7004	Infectious Diseases More	Discontinued

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