Bill & Melinda Gates Medical Research Institute

What Bill & Melinda Gates Medical Research Institute does

Bill & Melinda Gates Medical Research Institute (Gates MRI) is a non-profit, Cambridge, Massachusetts-based biomedical research organization founded in 2017 and opened in March 2018 as an affiliate of the Bill & Melinda Gates Foundation. The institute was created to bridge the translational gap for drugs, biologics, and vaccines targeting diseases disproportionately affecting low- and middle-income countries (LMICs)—particularly tuberculosis and malaria—where traditional biopharmaceutical investment incentives are limited. It operates with approximately 125 employees and an integrated development model spanning pre-clinical work through Investigational New Drug (IND) filing and clinical development to Proof of Concept.

Gates MRI's pipeline comprises eight active programs across four disease areas: the lead asset M72/AS01E (a tuberculosis vaccine candidate licensed from GSK in 2020, currently in a fully enrolled Phase 3 trial at 54 sites across five countries with ~20,000 participants), BCG revaccination, pan-TB regimen candidates through the PAN-TB Collaboration with Janssen, Otsuka, and TB Alliance, malaria biologics (MAM01 monoclonal antibody with Atreca and MAV02 nanoparticle vaccine), the RSV antibody RSM01 out-licensed to SK bioscience, and TB treatment compounds CLB073 (licensed from Calibr/Scripps) and MK-7762/MK-3854 (licensed from Merck). Technologies combine novel mechanisms—e.g., CLB073 modulates cholesterol catabolism in Mycobacterium tuberculosis—with established modalities such as adjuvanted subunit vaccines and monoclonal antibodies, drawing on licensed IP from GSK, Merck, Calibr, and Adimab alongside internal discovery led by a Head of Translational Discovery with Harvard microbiology credentials.

The business model is grant-style rather than commercial: Gates MRI is wholly funded by the Bill & Melinda Gates Foundation, does not generate product sales revenue, and operates under a Global Access commitment ensuring affordable distribution via WHO, Gavi, and national LMIC health systems. Its go-to-market in the operational sense is event-driven—anchored by clinical trial enrollment, regulatory milestones, and licensing transactions—rather than enterprise sales. Supplier and procurement operations run on Coupa, and clinical operations in Africa and Asia are increasingly executed through an expanded strategic collaboration with IQVIA. Filings are consolidated into the Gates Foundation's audited financials, with annual Form 990s posted on the institute's website.

Name

Bill & Melinda Gates Medical Research Institute

Legal name

Bill & Melinda Gates Medical Research Institute

Website

https://gatesmri.org

Company type

Private

Founded year

2018

Operating status

Operating

Headcount range

101–250 employees

Short description

Gates MRI is a non-profit Cambridge, MA-based medical research institute and Gates Foundation affiliate that develops drugs, biologics, and vaccines for tuberculosis, malaria, and other diseases disproportionately affecting low- and middle-income countries.

Ownership category

akta.pro rank

Product category

Biopharmaceutical Research and Development

NAICS

Research and Development in Biotechnology (except Nanobiotechnology) (541714), Scientific Research and Development Services (5417)

SIC

Biological Products, (No Disgnostic Substances) (2836), Services-Commercial Physical & Biological Research (8731)

akta.pro primary industry

Clinical Trial Monitoring Support (On-site/Remote) (HLAGACAG)

akta.pro secondary industry

Clinical Trial Site Operations & Study Coordination (HLAGACAE)

Keywords

• Tuberculosis vaccine development
• Malaria biologics research
• Monoclonal antibody therapeutics
• Global health pharmaceuticals
• Translational medicine research

Headquarters

HQ city

Cambridge

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Services

Cost components

Technology or R&D, Personnel, Operations, Infrastructure

Revenue model

1. Foundation Funding: Gates MRI is a non-profit medical research organization and affiliate of the Bill & Melinda Gates Foundation, funded by the foundation. The institute does not generate commercial revenue from product sales.

Go-to-market motion2 records

Distribution channels2 records

Marketing channels5 records

Core offering

Gates MRI is a non-profit biotechnology organization that develops novel drugs, biologics, and vaccines for diseases disproportionately affecting low-and-middle-income countries. The institute operates integrated development teams spanning pre-clinical research through Investigational New Drug (IND) filing and clinical development through Proof of Concept, with a primary focus on tuberculosis and malaria interventions.

Product overview

Gates MRI operates as a non-profit medical research organization developing a portfolio of drug, biologics, and vaccine candidates for diseases disproportionately impacting low- and middle-income countries. The pipeline includes the M72/AS01E tuberculosis vaccine (Phase 3), MAM01 and MAV02 malaria candidates, RSM01 RSV antibody, and multiple TB treatment compounds (CLB073, MK-7762, MK-3854). Gates MRI also conducts translational medicine services, managing the full spectrum of biopharmaceutical development from preclinical through clinical proof of concept, with programs executed through partnerships including PAN-TB Collaboration and licensing agreements with Calibr, Merck, and SK bioscience.

Differentiator

Problem solved

Functional benefit

Products and services

• M72/AS01E Investigational tuberculosis vaccine candidate using AS01E adjuvant, being evaluated in Phase 3 clinical trial for prevention of pulmonary TB in adolescents and adults aged 15-44. Licensed from GSK in 2020.
• BCG Revaccination Second dose of Bacillus Calmette-Guérin vaccine evaluated in Phase 2b trial for prevention of Mycobacterium tuberculosis infection in adolescents.
• Pan-TB Regimen Candidates Novel TB drug regimens under development through PAN-TB collaboration for treatment of drug-susceptible and drug-resistant tuberculosis, capable of treating nearly all TB patients including those with drug-resistant forms.
• CLB073 Novel investigational tuberculosis treatment compound discovered by Calibr/Scripps Research that modulates cholesterol catabolism to eliminate Mtb's carbon source, using a novel mechanism to weaken intramacrophage survival.
• MK-7762 Preclinical antibacterial candidate licensed from Merck for evaluation as component of TB combination regimens, with potent activity against Mycobacterium tuberculosis including drug-resistant strains.
• MK-3854

Quantifiable outcome

• M72/AS01E demonstrated approximately 50% protection against progression to active pulmonary TB for three years in Mtb-infected HIV-negative adults in Phase 2b trials
• +2 more outcomes

Segments3 records

Ideal customer profiles2 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Integration1 record

Feature7 records

Partnerships

Nine partnerships are on record, tiered core.

• IQVIAcoreImplementation/ SI/ Consulting Partner · 25 June 2026Expanded strategic collaboration where IQVIA provides operational delivery of local clinical and laboratory operations, data management and analytics across Africa and Asia. This partnership enables faster study execution and sustainable infrastructure in these regions.
• SK biosciencecoreStrategic or Co-development Partner · 3 February 2026SK bioscience licensed RSM01, a clinical-stage monoclonal antibody for RSV prevention in infants, from Gates MRI. SK bioscience has exclusive worldwide rights to commercialize in high-income countries with non-exclusive supply rights in India and Gavi-eligible countries. Technology originally designed by Adimab.
• Calibr (Scripps Research)coreStrategic or Co-development Partner · 15 February 2023Calibr granted Gates MRI exclusive license to continue development of CLB073, a novel investigational compound for tuberculosis treatment discovered through TB Drug Accelerator collaboration. The compound uses novel mechanism modulating cholesterol catabolism to target Mtb's intramacrophage survival.
• MerckcoreStrategic or Co-development Partner · 18 October 2022Merck granted Gates MRI exclusive global license for MK-7762 and MK-3854, two preclinical antibacterial candidates for TB treatment discovered as part of TB Drug Accelerator. Candidates have potent antibacterial activity against Mtb including drug-resistant strains.
• GSKcoreStrategic or Co-development Partner · 1 January 2020GSK licensed M72/AS01E investigational TB vaccine to Gates MRI in 2020 for further development for most LMICs. GSK continues to provide technical assistance and supplies the AS01 adjuvant component for Phase 3 trials. The collaboration exemplifies leveraging diverse partners' expertise to address TB.
• PAN-TB Collaboration (Janssen, Otsuka, TB Alliance)coreStrategic or Co-development PartnerProject to Accelerate New Treatments for Tuberculosis collaboration working to develop pan-TB regimen capable of treating nearly all TB patients including those with drug-resistant forms. Gates MRI executes Phase 2b/2c clinical trials for promising new regimens.
• Atreca, Inc.coreStrategic or Co-development PartnerCollaboration with Atreca to develop MAM01, a candidate prophylactic monoclonal antibody targeting Plasmodium falciparum circumsporozoite protein for malaria prevention in children.
• PAN-TB CollaborationcoreStrategic or Co-development PartnerJoint development agreement among Janssen Pharmaceutica NV, Otsuka, TB Alliance and Gates MRI supporting progression of two investigational TB combination treatment regimens into Phase 2 clinical development.
• TB Drug AcceleratorcoreStrategic or Co-development PartnerPartnership for TB drug discovery and development funded by Gates Foundation, involving biopharma companies, research organizations and universities to accelerate novel TB therapeutic candidates.

Scale indicators21 records

Recent moves6 records

Expansion highlights5 records

Direct peers

• TB Alliance: Non-profit product development partnership exclusively focused on developing and delivering faster, simpler, and affordable TB treatments. Comparable to Gates MRI as a non-profit PDP running late-stage TB clinical trials and partnering with global manufacturers for LMIC access.
• Medicines for Malaria Venture (MMV): Swiss-based product development partnership leading the discovery, development, and delivery of new antimalarial drugs. Directly comparable to Gates MRI's malaria programs (MAM01, MAV02) as a non-profit malaria R&D organization funded by foundations and government grants.
• IAVI: Non-profit scientific research organization developing vaccines and antibodies for infectious diseases including HIV, TB, and emerging pathogens. Comparable as a non-profit biotech with translational capabilities and global clinical operations funded by philanthropy and government grants.
• Drugs for Neglected Diseases initiative (DNDi): International non-profit developing treatments for neglected diseases including TB, malaria, and leishmaniasis. Similar to Gates MRI in mission, non-profit structure, foundation/government funding model, and pipeline of late-stage clinical assets.
• International Vaccine Institute (IVI): International organization dedicated to developing and introducing new vaccines for global health, with strong LMIC clinical trial infrastructure across Asia and Africa. Comparable vaccine development focus and global health mission.

Broad incumbents

• PATH: Large global health non-profit with vaccine, drug, diagnostics, and device programs across multiple diseases. Overlaps with Gates MRI on malaria and TB vaccine introduction, but operates a much broader portfolio of health system interventions.
• Coalition for Epidemic Preparedness Innovations (CEPI): Global partnership funding and coordinating vaccine development against epidemic threats. Adjacent to Gates MRI's vaccine development work in mission and funding model, though focused on outbreak pathogens rather than endemic LMIC diseases.

Emerging players

• Atreca, Inc. Clinical-stage biotech developing antibody-based therapeutics using its immune repertoire capture technology. Direct collaboration partner with Gates MRI on the MAM01 malaria monoclonal antibody program, providing technology overlap in antibody discovery.

Others

• Novavax: Commercial vaccine developer using recombinant nanoparticle and Matrix-M adjuvant technology — the same adjuvant approach relevant to Gates MRI's MAV02 malaria program. Different commercial model but comparable vaccine platform technology.
• Sabin Vaccine Institute: Non-profit focused on vaccine development and immunization advocacy, including efforts against emerging and neglected infectious diseases. Adjacent mission to Gates MRI's global health vaccine work, though more advocacy-oriented.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat6 records

Key risks7 records

Key highlights7 records

Customer concentration

• Xtwitter.com/GatesMRI
• LinkedInlinkedin.com/company/bill-melinda-gates-medical-research-institute

Revenue estimate

Valuation estimate

Number of profiles

Profiles12 records

Funding overview

Funding rounds

Investors

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M&A

Investments

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