Drugs, Diagnostics, Vaccines, Preventive Technologies, Research toward a cure, and immune-based and gene therapies in development
htb supplement: 2018 Vol 19:(1)
New drugs in development
July 2018
www.i-Base.info
The pre-clinical pipeline shows more innovation and diversity, with 252 agents being developed to treat WHO priority pathogens.
However, these products are in the very early stages of development and still need to be proven effective and safe. The optimistic scenario, the report indicates, is for... the first two to five products to become available in about 10 years.
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Of the 50 antibiotics in the pipeline, 32 target WHO priority pathogens but the majority have only limited benefits when compared to existing antibiotics. Two of these are active against the multi-drug resistant Gram-negative bacteria, which are spreading rapidly and require urgent solutions.
Gr...am-negative bacteria, such as Klebsiella pneumoniae and Escherichia coli, can cause severe and often deadly infections that pose a particular threat for people with weak or not yet fully developed immune systems, including newborns, ageing populations, people undergoing surgery and cancer treatment.
The report highlights a worrying gap in activity against the highly resistant NDM-1 (New Delhi metallo-beta-lactamase 1), with only three antibiotics in the pipeline. NDM-1 makes bacteria resistant to a broad range of antibiotics, including those from the carbapenem family, which today are the last line of defence against antibiotic-resistant bacterial infections.
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Overuse and misuse of antibiotics in animals and humans is contributing to the rising threat of antibiotic resistance. Some types of bacteria that cause serious infections in humans have already developed resistance to most or all of the available treatments, and there are very... few promising options in the research pipeline
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This tracker, developed by the Vaccine Centre at the London School of Hygiene & Tropical Medicine, will follow COVID-19 vaccine candidates as they progress through the development pipeline. We will update it weekly. An overview of the different vaccine types as well as the phases of clinical develo...pment is provided in the Summary tab.
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Many in-house and commercial assays that detect the COVID-19 virus have been developed or are currently under development. Many of these molecular assays are currently being validated in partner laboratories. An overview of assays that have applied to FIND for participation in their assay assessment... work can be found here
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The COVID-19 vaccine tracker and landscape compiles detailed information of each COVID-19 vaccine candidate in development by closely monitoring their progress through the pipeline.
The COVID-19 vaccine tracker:
Provides summary tables of COVID-19 vaccine candidates in both clinical and pre-...clinical development;
Provides analysis and visualization for several COVID-19 vaccine candidate categories;
Tracks the progress of each vaccine from pre-clinical, Phase 1, Phase 2 through to Phase 3 efficacy studies and including Phase 4 registered as interventional studies;
Provides links to published reports on safety, immunogenicity and efficacy data of the vaccine candidates;
Includes information on key attributes of each vaccine candidate and
Allows users to search for COVID-19 vaccines through various criteria such as vaccine platform, schedule of vaccination, route of administration, developer, trial phase and clinical endpoints.
The database is updated regularly - twice a week (Tuesday and Friday, 17:00 CET).
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How do vaccines work to protect us? What are the vaccine technologies in the pipeline and how do we ensure safe vaccines? Dr Katherine O’ Brien explains in Science in 5 !
29 April 2022
What are the new vaccines in the pipeline? What are the challenges to turning vaccines into vaccination ? What timelines can we expect for future vaccines? WHO’s Dr Katherine O’Brien explains in Science in 5.
This report presents an analysis of antibacterial agents in preclinical (third annual review) and clinical (fifth annual review) development. The analysis covers traditional (direct-acting small molecules) and non-traditional antibacterial agents in development worldwide. It evaluates to what extent... the present pipeline addresses infections caused by WHO Priority Pathogens, Mycobacterium tuberculosis and Clostridioides difficile. The report also provides an assessment of the traditional agents with respect to whether they meet a set of predefined criteria for innovation, namely absence of known cross-resistance, new target, mode of action and/or class. It also includes an overview of the agents that obtained authorization since 1 July 2017.
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The development of this target product profile (TPP) was led by the WHO Department of Control of Ne-
glected Tropical Diseases (NTD) following standard WHO guidance for TPP development. In order to
identify and prioritize diagnostic needs, a WHO NTD Diagnostics Technical Advisory Group (DTAG)
was... formed, and different subgroups were created to advise on specific NTDs, including a subgroup
working on the human African trypanosomiasis (HAT) diagnostic innovation needs. This group of in-
dependent experts included leading scientists, public health officials and endemic-country end-user rep-
resentatives. Standard WHO Declaration of Interest procedures were followed. A landscape analysis of
the available products and of the development pipeline was conducted, and the salient areas with unmet
needs were identified
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Antimicrobial resistance (AMR) as a serious public health threat was globally acknowledged by WHO in 2015, through the launch of the Global Action Plan (GAP). With a limited number of new antibiotics in the developmental pipeline, many countries are in the process of establishing strategies for anti...microbial stewardship (AMS). Within each country, different healthcare challenges have
contributed to AMR. This has also shaped individual AMS strategies and policies. In South Africa (SA), there is a high burden of infectious diseases, mainly of bacterial origin. In addition, SA also has the highest number of people living with
human immunodeficiency virus (HIV) globally. According to the 2019 statistics, there are approximately 7.97 million people living with HIV in SA. Together with this, SA has the fourth largest tuberculosis population globally.
Other important challenges include poverty, malnutrition, a high burden of non-communicable diseases, and a dire shortage of trained healthcare professionals (e.g. clinicians, pharmacists, and nurses).
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Chagas disease is a neglected tropical disease caused by the protozoan parasite Trypanosoma cruzi. It is a significant public health problem, affecting millions of people worldwide. And although it was described 110 years ago, only two old nitroheterocyclic drugs, benznidazole and nifurtimox, are cu...rrently available for the treatment of Chagas disease and both have several limitations. Besides the clear unmet medical need, many challenges preclude the development of new treatments, some of them related to a lack of understanding of the pathophysiology of the disease and parasite-host interactions. New knowledge and tools are becoming available, but the number of new chemical entities progressing through the preclinical pipeline is inadequate. Therefore, it is still uncertain whether safe, effective and accessible new drugs will be available in the near future. The Chagas disease research community must commit to even greater collaboration to ensure that patients eventually benefit from better treatments.
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Accessed on 22.04.2023
To target helminth elimination, a new consortium of research institutes, universities, not-for-profit organizations, and pharmaceutical companies have joined forces and expertise to establish a research and development pipeline for the development of anthelminthics targeti...ng nematodes. The focus is on STH as well as onchocerciasis.
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Despite the development of point-of-care diagnostic tests for syphilis, chlamydia, gonorrhoea, and trichomoniasis, none comply with all WHO criteria. This analysis overviews landscape analyses of point-of-care diagnostic technologies for Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vagi...nalis and syphilis, available and in the pipeline. The target audience for the target product profiles is broad and includes clinicians, researchers working on diagnostics, laboratory experts, including, microbiologists and virologists, public health experts, epidemiologists, developers, and representatives for manufactures, including biotech engineers, policy-and decision-makers as well as representatives from regulatory bodies and agencies, donor agencies and international organizations.
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In 2021 ACT-Accelerator will intensify its drive for equity and scale in the delivery of essential COVID-19 tools, while managing emerging viral risks. To address these major shifts and maintain momentum, ACT-Accelerator has defined four strategic priorities for 2021: Rapidly scale up the delivery o...f at least 2 billion doses of vaccines. Bolster R&D, evaluations & regulatory pathways to optimize products and address variants. Stimulate rapid and effective uptake and use of COVID-19 tests, treatments, and PPE. Ensure a robust pipeline of essential tests, treatments, and PPE.
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Pathogen genomic surveillance has become a priority for public health systems in recent years. Genomic sequencing is increasingly being used to characterize pathogens and monitor important public health priorities (e.g. poliovirus, influenza virus, Mycobacterium tuberculosis and Vibrio cholerae, ant...imicrobial resistance (AMR)). The decrease in cost and time of sequencing and the exponential development of bioinformatic pipelines have played a critical role in integrating pathogen genomics into routine public health surveillance. The coronavirus disease 2019 (COVID-19) pandemic has highlighted the role that sequencing plays in the surveillance of infectious diseases. Sequencing facilitates earlier detection, more accurate investigation of outbreaks, closer real-time monitoring of pathogen evolution and tailored development and evaluation of interventions to inform local to global public health decision-making and action. However, there remains a need to coordinate efforts, leverage and link existing surveillance and laboratory networks and capabilities, and systematically integrate genetic sequence data (GSD) with clinical and epidemiological data to strengthen its utility.
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