TOKYO, May 8, 2024
/PRNewswire/ -- The Global Health Innovative Technology (GHIT)
Fund announced today a total investment of approximately
JPY 1.64 billion (USD 10.8 million1) in four projects
for the development of new drugs for malaria and neglected tropical
diseases (NTDs).2
The GHIT Fund invests in the development of new drugs, vaccines,
and diagnostics for neglected infectious diseases such as malaria,
tuberculosis, and NTDs, which predominantly affect the world's
vulnerable and underserved populations. These R&D projects must
involve partnerships between Japanese and non-Japanese
organizations, and the four new projects consist of diverse
partnerships including Japanese pharmaceutical companies and
universities, as well as non-Japanese research institutions and
universities.
The GHIT Fund will invest approximately JPY 444 million (USD 2.9
million1) in two malaria projects: the
development of malaria chemoprevention drug through a partnership
among Shionogi & Co., Ltd., Nagasaki University, National Institute of
Infectious Diseases, and Medicines for Malaria Venture (MMV), and
therapeutic drug development led by Eisai Co., Ltd., the
Scripps Research Institute, and
International Centre for Genetic Engineering and Biotechnology
(ICGEB).
For NTDs, the GHIT Fund will also invest approximately
JPY 1.2 billion (USD 7.9 million1) in two projects:
drug development for onchocerciasis and lymphatic filariasis led by
Eisai Co., Ltd., University Hospital Bonn, and Helmholtz Centre for
Infection Research, and the development of a treatment for Chagas
disease led by Mitsubishi Tanabe Pharma Corporation and Drugs for
Neglected Diseases initiative (DNDi).
The GHIT Fund plays a catalytic role in matching Japanese and
global partners to accelerate R&D resulting in the support of
over 180 development partners since 2013. Through global
partnerships, the GHIT Fund aims to promote open innovation in
R&D and create an environment that enables the rapid delivery
of products to patients in need.
Please refer to Appendix 1 for a detailed description of each
project and its development stage.
As of March 31, 2024, the GHIT
Fund invested in 36 projects, including 12 discovery projects, 16
preclinical projects, and 8 clinical trials3 in the
portfolio. The total amount of investments since 2013 is
JPY 33.2 billion (USD 219 million) (Appendix 2).
1 USD1 = JPY151.33, the approximate exchange rate on
March 31, 2024.
2 These awarded projects were selected and approved as
new investments from among proposals to RFP2023-001 for the Product
Development Platform, which was open for applications from
November 2022 to July 2023.
3 This number includes projects in the registration
phase.
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, 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 disease s.
https://www.ghitfund.org/en
Appendix 1. Project Details
G2023-218
Project
Title
|
Lead optimization and
candidate selection of a novel long-acting injectable which targets
malarial electron transport chain for malaria chemoprevention and
prophylaxis
|
Collaboration
Partners
|
1. Shionogi & Co.,
Ltd. (Japan)
2. Nagasaki University
(Japan)
3. National Institute
of Infectious Diseases (Japan)
4. Medicines for
Malaria Venture (MMV) (Switzerland)
|
Disease
|
Malaria
|
Intervention
|
Drug
|
Stage
|
Lead
Optimization
|
Awarded
Amount
|
JPY 332,074,377 (USD 2.2
million)
|
Status
|
New project
|
Summary
|
[Project
objective]
The objective of this
project is to identify a preclinical candidate for long-acting
injectables (LAI) in malaria chemoprevention. A promising lead
series has been identified, in collaboration with Nagasaki
University, Shionogi, National Institute of Infectious Diseases,
and Medicines for Malaria Venture (MMV), which targets malarial
electron transport chain, a well validated target for antimalarial
medications. The project aims to optimize the lead and obtain a
preclinical development candidate that meet MMV's preclinical
candidate criteria.
[Project
design]
The project aims to provide a preclinical
candidate in two years. A frontrunner compound will be evaluated
for the in vivo safety and DMPK studies. In parallel, a lead
optimization study will be conducted in search for the second
runner candidate with even greater promise than the frontrunner
candidate. The most promising compounds will be subjected to
extensive in vivo safety and pharmacokinetics studies to
satisfy MMV's preclinical candidate criteria.
|
Project
Detail
|
https://www.ghitfund.org/investment/portfoliodetail/detail/221/en
|
G2023-108
Project
Title
|
Preclinical development
of a novel mechanism-of-action antimalarial
|
Collaboration
Partners
|
1. Eisai Co., Ltd.
(Japan)
2. The Scripps Research
Institute (USA)
3. International Centre
for Genetic Engineering and Biotechnology (ICGEB)
(India)
|
Disease
|
Malaria
|
Intervention
|
Drug
|
Stage
|
Lead
Optimization
|
Awarded
Amount
|
JPY 112,000,000 (USD 0.7
million)
|
Status
|
Continued
project
|
Summary
|
[Project
objective]
The goal of this
proposal is to evaluate the safety, pharmacokinetic and efficacy
profiles of next-generation cPheRS-inhibitor antimalarials, with
potentially lower cost of treatment and improved safety
profiles.
[Project
design]
Promising, recently
generated novel antimalarial compounds will be synthesized and
profiled in in vivo efficacy studies, exploratory safety
studies and multi-species pharmacokinetic studies with the goal of
selecting a preclinical development candidate.
|
Project
Detail
|
https://www.ghitfund.org/investment/portfoliodetail/detail/218/en
|
G2023-211
Project
Title
|
Pre-clinical
development of the macrofilaricide corallopyronin A (CorA) to treat
onchocerciasis and lymphatic filariasis.
|
Collaboration
Partners
|
1. Eisai Co., Ltd.
(Japan)
2. University Hospital
Bonn (UKB) (Germany)
3. Helmholtz Centre for
Infection Research (HZI) (Germany)
|
Disease
|
Onchocerciasis
Lymphatic
filariasis
|
Intervention
|
Drug
|
Stage
|
Pre-Clinical
Development
|
Awarded
Amount
|
JPY 904,017,487 (USD 5.9
million)
|
Status
|
New project
|
Summary
|
[Project
objective]
The objective of this
project is to progress CorA through final preclinical development
activities to prepare for the first in human trial (phase
1).
[Project
design]
To achieve this goal,
we will conduct the following studies to improve our knowledge of
CorA and produce GMP drug substance that will be used in the phase
1 trial. Because CorA is a predicted substrate of enzymes that
detoxify substances in the body, we will determine the metabolism
of CorA by the enzymes that are predicted to metabolize CorA. Prior
to applying for a phase 1 trial authorization, new drugs must be
shown to be nontoxic. Therefore, we will conduct a GLP toxicity
study, including measuring plasma levels of CorA. With the latter
data, we will refine our PK/PD model that will allow us to
determine the best human dose and regimen for the phase 1 trial.
Our research and innovation packages will provide us with a better
understanding of the chemical nature of CorA (e.g., can it be
crystalized or co-crystallized?) that may be used to improve the
production or stability of CorA. With the GHIT funding we will also
produce CorA material for the phase 1 study, including highly pure
standards needed for bioanalysis of plasma samples in the phase 1
study.
|
Project
Detail
|
https://www.ghitfund.org/investment/portfoliodetail/detail/220/en
|
G2023-209
Project
Title
|
Lead optimization of a
novel chemical series for Chagas disease
|
Collaboration
Partners
|
1. Mitsubishi Tanabe
Pharma Corporation (Japan)
2. DNDi – Drugs for
Neglected Diseases initiative (Switzerland)
|
Disease
|
Chagas
Disease
|
Intervention
|
Drug
|
Stage
|
Lead
Optimization
|
Awarded
Amount
|
JPY 294,532,531 (USD 1.9
million)
|
Status
|
Continued
project
|
Summary
|
[Project
objective]
The main objective of
this two-year project is to deliver optimized lead candidate(s)
meeting the efficacy and in vitro safety requirements described in
the DNDi Target Candidate Profile (TCP). Fulfilling the TCP
efficacy criteria compound(s) would be ready to enter preclinical
development enabling studies addressing the complementary safety,
DMPK (Drug Metabolism and Pharmacokinetics) and CMC (Chemistry,
Manufacturing, and Controls) criteria of the TCP. The lead
optimization efforts will focus on a novel spirocyclic series
(Spiro 5) active against T. cruzi infection. In addition, this
project aims at identifying the mechanism of action of this new
series.
[Project
design]
DNDi and Mitsubishi
Tanabe Pharma Co. (MTPC) aim at developing through a two-year lead
optimization collaboration a novel and very promising T.
cruzi active series identified from a high throughput screening
of a 51,200 MTPC proprietary library and progressed to date to lead
stage. The project partners plan to chemically derivatize the lead
series using a well-defined and diversified medicinal chemistry
strategy to improve its in vitro T. cruzi potency, maintain
its favorable DMPK properties while mitigating any safety
liabilities. In parallel DNDi and MTPC plan to elucidate the
mechanism of action of the series notably with the expert support
of University of Dundee and make use of this information to guide
the lead optimization program.
|
Project
Detail
|
https://www.ghitfund.org/investment/portfoliodetail/detail/219/en
|
*All amounts are listed at an exchange rate of USD1 = JPY151.33,
the approximate exchange rate on March 31,
2024.
Appendix 2. Investment Overview (as of March 31, 2024)
Investments to date
Total investments:
33.2 billion yen (USD 219
million1)
Total invested
projects: 125 (36 active projects and 89 completed projects)
To learn more about GHIT Fund's 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:
Nancy Moss, 254-729-991-028,
nmoss@burness.com
Mina Ohata at +81-36441-2032 or
mina.ohata@ghitfund.org
View original
content:https://www.prnewswire.com/news-releases/approximately-usd-10-8-million-invested-in-new-drug-development-for-malaria-and-ntds-in-partners-including-japanese-pharma-shionogi-mitsubishi-tanabe-and-eisai-and-europe-based-institutions-302140073.html
SOURCE Global Health Innovative Technology Fund (GHIT Fund)