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GHIT Will Invest 539 Million Yen (US$4.7 Million) for the Development of Monoclonal Antibodies (MAbs) for Malaria Prevention

Sourced from the press release with the same date: "GHIT Fund Announces New Investments: A Total of 740 Million Yen for Malaria Drugs and Vaccine"


TOKYO, March 30, 2022 /PRNewswire/ -- The Global Health Innovative Technology (GHIT) Fund announced today a total of approximately 740 million yen (US$6.4 million*) to invest in three partnerships to develop new lifesaving tools for malaria.** (Appendix 1 & 2)


"We are very pleased to invest in new product development for malaria. Existing innovations alone are not sufficient to combat malaria," said GHIT CEO Osamu Kunii. "Continuous R&D efforts for new innovations are essential for malaria elimination. We hope that these new innovations will be important tools in the malaria elimination strategy and bring greater impact for patients."


Preclinical development of a monoclonal antibody to prevent P. falciparum malaria


GHIT will invest 539 million yen (US$4.7 million) for the development of monoclonal antibodies (mAbs) for malaria prevention. The project is enabled by access to a panel of potent anti-CSP mAbs, identified from volunteers who were protected against P. falciparum challenge following immunization with RTS,S/AS01 (RTS,S), the world's first malaria vaccine recommended for use in young children living in areas of moderate to high malaria transmission by the World Health Organization (WHO). RTS,S functions primarily by inducing high titer antibodies to the invariant repeat region of the P. falciparum CS protein. Highly potent monoclonal antibodies (mAbs) in protective antisera are likely to be promising tools for malaria intervention.


As of March 31, there are 61 ongoing projects, including 28 discovery, 21 preclinical and 12 clinical trials, in the GHIT portfolio (Appendix 3). The total amount of investments since 2013 is 27.6 billion yen (US$239 million).


* USD1 = JPY¥115.59, the approximate exchange rate on February 28, 2022. 
** These awarded projects were selected from a number of proposals to the RFP2021-002 for Target Research Platform, Screening Platform, Hit-to-Lead Platform, and Product Development Platform, which was open for applications from June 2021 to January 2022. The GHIT board conducted in February 2022 approved these new investments.


The GHIT Fund is a Japan-based international public-private partnership fund (PPP) 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 and manages an R&D portfolio of development partnerships aimed at neglected diseases, such as malaria, tuberculosis and neglected tropical diseases that afflict the world's vulnerable and underserved populations. The GHIT Fund mobilizes the Japanese industry, academia, and research institutes to create new drugs, vaccines, and diagnostics for malaria, tuberculosis, and neglected tropical diseases, in collaboration with global partners.


Appendix.1 New Investments



























ID/Status



Project Title



Collaboration Partners



Disease/Intervention



Stage



Awarded Amount



G2021-111


New project



Preclinical development of a monoclonal antibody to prevent P. falciparum malaria



Ehime University, Eisai Co., Ltd., GlaxoSmithKline, PATH



Malaria


Drug



Lead Optimization



¥538,661,663


(US$4,660,106)



H2021-201


New project



Hit-to-Lead development of novel Astellas compounds with antimalarial activity



Astellas Pharma Inc., TCG Lifesciences Private Limited. (TCGLS), Medicines for Malaria Venture (MMV)



Malaria


Drug



Lead Identification



¥131,743,584


(US$1,139,749)



T2021-256


New project



Development of a Plasmodium vivax multistage vaccine effective both for protection and transmission blocking 



Hokkaido University, Jichi Medical University, Kanazawa University, Kyoto University, University of Toyama, University of Cambridge, Instituto Leônidas & Maria Deane (ILMD) and The Fundação de Medicina Tropical Doutor Heitor Vieira Dourado (FMT-HVD)



Malaria
Vaccine



Antigen Identification



¥69,817,000


(US$604,006)







*All amounts are listed at the exchange rate of USD1 = JPY¥115.59, the approximate exchange rate on February 28, 2022.


Appendix.2 Project Details


G2021-111





















Project Title



Preclinical development of a monoclonal antibody to prevent P. falciparum malaria



Collaboration Partners



Ehime University, Eisai Co., Ltd., GlaxoSmithKline, PATH



Disease



Malaria



Intervention



Drug



Stage



Lead Optimization



Awarded Amount



¥538,661,663 (US$4,660,106)



Status



New project



Summary



[Project objective]


The objective of this project is to complete preclinical development work to support future IND submission for a proof-of-concept clinical trial including controlled human malaria infection (CHMI). The long-term goal of this project is to secure a WHO policy recommendation and financing for a monoclonal antibody that prevents P. falciparum malaria in young children, and potentially pregnant women, living in areas of seasonal transmission in sub-Saharan Africa.


1) Manufacture a cell bank for the lead mAb production, and demonstrate the efficacy of the lead mAb in a mouse challenge model


2) Complete process development and manufacture the lead mAb suitable for a GLP toxicology study


3) Complete a pre-IND meeting with the US FDA


4) Complete preliminary Cost-of-Goods (COGs) analysis for anti-malaria infection mAbs, and develop an initial integrated product development and policy plan (iPDPP).


 


[Project design]


The project is built on successful completion of prior work including 1) in vitro and in vivo screening for a lead panel of mAbs; 2) engineering the lead panel mAbs to enhance potency and serum stability, and to minimize development risk identified by in silico analyses; 3) minimizing risk of selected mAbs with cross-reactivity to human tissues by early screening for binding to human tissues and human membrane proteins; 4) confirming in vivo protective efficacy and pharmacokinetics of the selected mAbs in mouse models; 5), initiate cell line development and select one to advance; and 6) established capabilities of mAb production process development, optimization, and production. The proposed work will start with production and release of a pre-master cell bank for production of the mAb of final selection. The manufacture process for the mAb will be developed and optimized to confirm conditions for production of the mAb lot suitable for GLP toxicity studies, and to enable future scale up of production for clinical trial materials. In addition, formulation development will be conducted to enable stability of the mAb at high concentration to accommodate potential subcutaneous injection. The mAb materials produced during process development and the mAb lot for the GLP toxicity studies will be evaluated in mouse challenge model to confirm protective efficacy. A pre-IND meeting will be conducted with the US FDA. We will also conduct IND-enabling GLP-toxicology studies to evaluate repeated dose toxicity and tissue-cross reactivity of the mAb. In parallel, a COGs analysis will be conducted with information on methods of production, product configuration (vial type and size), and a competitive landscape analysis will be conducted with information on mAbs in development for malaria prevention. Finally, an iPDPP will be drafted for alignment among clinical, regulatory, manufacturing, and policy strategies for global health deployment of mAbs and alike.



Project Detail



https://www.ghitfund.org/investment/portfoliodetail/detail/201/en


*All amounts are listed at the exchange rate of USD1 = JPY¥115.59, the approximate exchange rate on February 28, 2022.


Appendix.3 Investment Overview (As of March 31, 2022)


1. Investment to date 
Total investments 27.6 billion yen (US$239 million*) 
Total invested projects 114, active projects 61, completed projects 53


*All amounts are listed at the exchange rate of USD1 = JPY¥115.59, the approximate exchange rate on February 28, 2022.


To know more about GHIT investments, please visit 
Investment Overview: https://www.ghitfund.org/investment/overview/en
Portfolio: https://www.ghitfund.org/investment/portfolio/en
Advancing Portfolio: https://www.ghitfund.org/investment/advancingportfolio/en
Clinical Candidates: https://www.ghitfund.org/investment/clinicalcandidates/en


For more information, contact:
Katy Lenard at 1-301-280-5719 or [email protected] 
Bumpei Tamamura at 81-36441-2032 or [email protected]


SOURCE Global Health Innovative Technology (GHIT) Fund