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Breakthrough in Malaria Treatment and Vaccines: Novartis' GanLum and Promising Blood-Stage Vaccine Candidates
A significant breakthrough was announced this week in the global fight against malaria, with new developments in both malaria drug therapies and vaccines making headlines. Novartis revealed successful results from a major Phase III clinical trial of its new antimalarial therapy, GanLum, marking what could be the first major advancement in malaria treatment in over 25 years. The trial compared GanLum, a novel non-artemisinin combination of ganaplacide and lumefantrine, to Novartis’s established treatment, Coartem, involving 1,688 patients across 34 sites in 12 African countries where malaria is prevalent. The results demonstrated that GanLum was highly effective, not only matching the performance of existing therapies but also showing potent activity against mutant malaria parasites that are developing resistance to standard treatments, as well as rapidly reducing mature gametocytes—the form responsible for spreading the parasite between humans.
According to the company and experts involved in the trial, the rise of drug-resistant malaria strains in Africa has made the need for new treatments urgent. GanLum offers an important advantage in this regard, with its mechanism targeting the parasite's internal protein transport system crucial for survival. It is administered as a sachet of granules once daily for three days, simplifying dosing. Following the Phase III success, Novartis intends to seek regulatory approval worldwide, with hopes that GanLum will become a cornerstone in modern malaria management. The drug had previously received Fast Track and Orphan Drug Designations from the US Food and Drug Administration in acknowledgment of its potential impact.
The same period has seen promising news in the malaria vaccine field. In Burkina Faso and the UK, the blood-stage vaccine candidate RH5.1/Matrix-M has completed a Phase IIb trial, showing 55 percent effectiveness against clinical malaria when a delayed third-dose schedule is applied, and 80 percent efficacy in reducing high levels of parasites in the blood. Stephanie Kurdach, an infectious disease analyst with GlobalData, noted that RH5.1/Matrix-M could become the first blood-stage vaccine to reach market, serving as a vital addition to the malaria prevention toolkit and complementing existing vaccines. Current vaccines, such as GSK’s Mosquirix (recommended by the World Health Organization in 2021) and Serum Institute of India’s R21/Matrix-M (endorsed by WHO in 2023), target the early sporozoite stage of the parasite.
Expanding the vaccine landscape further, BioNTech’s mRNA malaria vaccine candidate, BNT165e, has resumed clinical trials after a temporary hold by the US FDA earlier this year. This trial is expected to report results in 2026.
These recent findings, presented at the annual meeting of the American Society of Tropical Medicine and Hygiene, have been widely seen as signals of renewed momentum in malaria research. With malaria still a leading cause of child mortality in Africa, the introduction of more effective drugs and vaccines offers hope that the burden of this ancient disease may soon be dramatically reduced.
This content was created in partnership and with the help of Artificial Intelligence AI
According to the company and experts involved in the trial, the rise of drug-resistant malaria strains in Africa has made the need for new treatments urgent. GanLum offers an important advantage in this regard, with its mechanism targeting the parasite's internal protein transport system crucial for survival. It is administered as a sachet of granules once daily for three days, simplifying dosing. Following the Phase III success, Novartis intends to seek regulatory approval worldwide, with hopes that GanLum will become a cornerstone in modern malaria management. The drug had previously received Fast Track and Orphan Drug Designations from the US Food and Drug Administration in acknowledgment of its potential impact.
The same period has seen promising news in the malaria vaccine field. In Burkina Faso and the UK, the blood-stage vaccine candidate RH5.1/Matrix-M has completed a Phase IIb trial, showing 55 percent effectiveness against clinical malaria when a delayed third-dose schedule is applied, and 80 percent efficacy in reducing high levels of parasites in the blood. Stephanie Kurdach, an infectious disease analyst with GlobalData, noted that RH5.1/Matrix-M could become the first blood-stage vaccine to reach market, serving as a vital addition to the malaria prevention toolkit and complementing existing vaccines. Current vaccines, such as GSK’s Mosquirix (recommended by the World Health Organization in 2021) and Serum Institute of India’s R21/Matrix-M (endorsed by WHO in 2023), target the early sporozoite stage of the parasite.
Expanding the vaccine landscape further, BioNTech’s mRNA malaria vaccine candidate, BNT165e, has resumed clinical trials after a temporary hold by the US FDA earlier this year. This trial is expected to report results in 2026.
These recent findings, presented at the annual meeting of the American Society of Tropical Medicine and Hygiene, have been widely seen as signals of renewed momentum in malaria research. With malaria still a leading cause of child mortality in Africa, the introduction of more effective drugs and vaccines offers hope that the burden of this ancient disease may soon be dramatically reduced.
This content was created in partnership and with the help of Artificial Intelligence AI
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By Inception Point AiA significant breakthrough was announced this week in the global fight against malaria, with new developments in both malaria drug therapies and vaccines making headlines. Novartis revealed successful results from a major Phase III clinical trial of its new antimalarial therapy, GanLum, marking what could be the first major advancement in malaria treatment in over 25 years. The trial compared GanLum, a novel non-artemisinin combination of ganaplacide and lumefantrine, to Novartis’s established treatment, Coartem, involving 1,688 patients across 34 sites in 12 African countries where malaria is prevalent. The results demonstrated that GanLum was highly effective, not only matching the performance of existing therapies but also showing potent activity against mutant malaria parasites that are developing resistance to standard treatments, as well as rapidly reducing mature gametocytes—the form responsible for spreading the parasite between humans.
According to the company and experts involved in the trial, the rise of drug-resistant malaria strains in Africa has made the need for new treatments urgent. GanLum offers an important advantage in this regard, with its mechanism targeting the parasite's internal protein transport system crucial for survival. It is administered as a sachet of granules once daily for three days, simplifying dosing. Following the Phase III success, Novartis intends to seek regulatory approval worldwide, with hopes that GanLum will become a cornerstone in modern malaria management. The drug had previously received Fast Track and Orphan Drug Designations from the US Food and Drug Administration in acknowledgment of its potential impact.
The same period has seen promising news in the malaria vaccine field. In Burkina Faso and the UK, the blood-stage vaccine candidate RH5.1/Matrix-M has completed a Phase IIb trial, showing 55 percent effectiveness against clinical malaria when a delayed third-dose schedule is applied, and 80 percent efficacy in reducing high levels of parasites in the blood. Stephanie Kurdach, an infectious disease analyst with GlobalData, noted that RH5.1/Matrix-M could become the first blood-stage vaccine to reach market, serving as a vital addition to the malaria prevention toolkit and complementing existing vaccines. Current vaccines, such as GSK’s Mosquirix (recommended by the World Health Organization in 2021) and Serum Institute of India’s R21/Matrix-M (endorsed by WHO in 2023), target the early sporozoite stage of the parasite.
Expanding the vaccine landscape further, BioNTech’s mRNA malaria vaccine candidate, BNT165e, has resumed clinical trials after a temporary hold by the US FDA earlier this year. This trial is expected to report results in 2026.
These recent findings, presented at the annual meeting of the American Society of Tropical Medicine and Hygiene, have been widely seen as signals of renewed momentum in malaria research. With malaria still a leading cause of child mortality in Africa, the introduction of more effective drugs and vaccines offers hope that the burden of this ancient disease may soon be dramatically reduced.
This content was created in partnership and with the help of Artificial Intelligence AI
According to the company and experts involved in the trial, the rise of drug-resistant malaria strains in Africa has made the need for new treatments urgent. GanLum offers an important advantage in this regard, with its mechanism targeting the parasite's internal protein transport system crucial for survival. It is administered as a sachet of granules once daily for three days, simplifying dosing. Following the Phase III success, Novartis intends to seek regulatory approval worldwide, with hopes that GanLum will become a cornerstone in modern malaria management. The drug had previously received Fast Track and Orphan Drug Designations from the US Food and Drug Administration in acknowledgment of its potential impact.
The same period has seen promising news in the malaria vaccine field. In Burkina Faso and the UK, the blood-stage vaccine candidate RH5.1/Matrix-M has completed a Phase IIb trial, showing 55 percent effectiveness against clinical malaria when a delayed third-dose schedule is applied, and 80 percent efficacy in reducing high levels of parasites in the blood. Stephanie Kurdach, an infectious disease analyst with GlobalData, noted that RH5.1/Matrix-M could become the first blood-stage vaccine to reach market, serving as a vital addition to the malaria prevention toolkit and complementing existing vaccines. Current vaccines, such as GSK’s Mosquirix (recommended by the World Health Organization in 2021) and Serum Institute of India’s R21/Matrix-M (endorsed by WHO in 2023), target the early sporozoite stage of the parasite.
Expanding the vaccine landscape further, BioNTech’s mRNA malaria vaccine candidate, BNT165e, has resumed clinical trials after a temporary hold by the US FDA earlier this year. This trial is expected to report results in 2026.
These recent findings, presented at the annual meeting of the American Society of Tropical Medicine and Hygiene, have been widely seen as signals of renewed momentum in malaria research. With malaria still a leading cause of child mortality in Africa, the introduction of more effective drugs and vaccines offers hope that the burden of this ancient disease may soon be dramatically reduced.
This content was created in partnership and with the help of Artificial Intelligence AI