This week, AchilleS Vaccines S.r.l., Magnetrap SA, KELTIC Pharma Therapeutics Ltd and Sumaya Biotech GmbH & Co. KG. concluded contracts with the EU Malaria Fund (EUMF) to receive a total of €17.6 million for their innovative Malaria vaccines, diagnostics and therapeutics research programmes.
Our Approach
“Sumaya” means “malaria” in Bambara, a dialect spoken in Mali. Our scientific founder, the late Prof. Hermann Bujard, travelled to Africa for many years, searching for suitable targets for malaria vaccines. Experiencing the immense suffering caused by this deadly disease first-hand made him truly passionate about saving young children’s lifes. As research progressed, Sumaya Biotech was spun off from Heidelberg University in 2014.
Our lead product, SUM-101 (SumayaVac1), successfully completed two clinical trials in 2019 and 2024, demonstrating safety and immunogenicity in Malaria non-exposed volunteers in Germany and in a Malaria pre-exposed population in Tanzania. SUM-101 is an innovative malaria vaccine based on the recombinant, full-length merozoite surface protein 1 (MSP1). SUM-101 is expected to target both the asymptomatic liver stages and the blood stages of the human malaria parasite Plasmodium falciparum, by eliciting a humoral and cellular immune response. Two further clinical studies with SUM-101 sponsored by EVI (European Vaccine Initiative) are about to be launched: a study in Burkina Faso to evaluate safety and immunogenicity of the vaccine in young children in Africa, and a study in Tanzania with adults exposed to a controlled human malaria infection (CHMI) for proof of efficacy.
In 2021, Sumaya Biotech’s approach was validated by the EU Malaria Fund, who selected Sumaya Biotech as one of 8 companies to receive funding.
In 2024 Sumaya Biotech received the Seal of Excellence from the European Innovation Council.
EXECUTIVE Management
ADVISORS
Our Founder
Prof. Dr. Dr. h.c. Hermann Bujard
Hermann Bujard pioneered work on transcriptional control in bacteria and phages, which eventually led to the discovery of the Tet technology for gene control in mammals and the founding of TET Systems.
Hermann Bujard was instrumental in shaping the ZMBH (Zentrum für Molekulare Biologie der Universität Heidelberg), he helped bring the EMBL to Heidelberg, and he served as the acting director of EMBO. These achievements proved quintessential for Heidelberg‘s standing as an international molecular biology hub.
As a true believer in social responsibility, he used some of his revenues from TET Systems to fund his Malaria research, which ultimately led to the founding of Sumaya Biotech in 2014, the same year he won the Robert Koch Medal in Gold for his life achievement.
Herman Bujard passed away in 2020.
Malaria, an ancient scourge of mankind, causes a heavy burden of mortality and morbidity in populations living in tropical and subtropical regions around the globe. According to the World Health Organization (WHO Malaria report 2023), about 263 million clinical malaria cases were reported in 2023 and about 597,000 patients, primarily children below the age of 5, died from malaria – more than 1,600 young lives lost every single day.
Countries where malaria is endemic face serious public health problems. The disease causes not only severe individual suffering, it has also a deleterious impact on people’s lifes including education, worker productivity, fertility and medical costs. Importantly and increasingly urgent, malaria severely impedes travel to endemic areas, and, concomitantly, investments and exchange of experts, crucial preconditions for infrastructural and economic development.
Global programs to fight malaria, including eradication of the mosquito carrier, bednets, etc. have been somewhat successful, particularly during the past decade. However, in spite of political commitment, much of the success relies on a high degree of compliance.
The ultimate success in any malaria elimination (local) or eradication (global) program will depend on the development of effective malaria vaccines and medication, especially in light of growing resistances against available malaria treatments.
A moving target
Malaria is caused by parasites, which are transmitted by mosquito bites. The first target of the parasite after the infective bite is the liver. Massive multiplication of the parasite in the liver and its release into the blood stream leads to the blood stage of the infection, where parasites infect red blood cells. Here, they multiply again, subsequently killing the host cells and re-infecting new red blood cells. It is this blood stage cycle that causes all pathophysiological symptoms and frequently leads to death in unprotected, “naive“ individuals.
Soon an European Challenge?
Concerning the situation in Europe, malaria was eliminated in the 1970s but imported malaria cases persist. According to the European Centre for Disease Prevention and Control (ECDC), in 2019, 30 European countries reported 8,537 cases of malaria, nearly all of which were imported. The highest numbers were seen in France, UK, and Germany, signifying the importance of effective malaria vaccines for travellers from European countries to malaria-endemic regions. Malaria's historical presence in Europe hints at its potential to re-emerge, particularly given the existing or potential reintroduction of the responsible insect vectors in specific regions. Contemporary instances, like the locally transmitted cases recently cited by the U.S. Centers for Disease Control and Prevention (CDC), underscore this threat of resurgence[1]. Moreover, based on the European Climate and Health Observatory, the impact of global warming on malaria transmission extends to an anticipated shift in the distribution of Anopheles mosquitoes northwards and to higher altitudes (Hertig et al., 2019), within regions in Europe, primarily Southern Europe. The combination of higher temperatures, increased precipitation intensity, and elevated air humidity is expected to create more favourable conditions for larger Anopheles mosquito populations, thereby increasing their capacity to transmit the disease leading to locally transmitted infections. In fact, certain species have already been detected in Spain, Portugal, Italy, and the Balkans. Events like this have already occurred in the US with five cases of locally transmitted malaria in Florida and Texas.[2]
[1]https://www.bmj.com/content/381/bmj.p1484.full
[1] World Malaria Report 2023, WHO, https://www.who.int/publications/i/item/9789240064898
[1]https://www.bmj.com/content/381/bmj.p1484.full
[1]Tanne JH. CDC reports locally acquired malaria in two US states. BMJ. 2023 Jun 28;381:1484. doi: 10.1136/bmj.p1484. PMID: 37380189.
[2]Tanne JH. CDC reports locally acquired malaria in two US states. BMJ. 2023 Jun 28;381:1484. doi: 10.1136/bmj.p1484. PMID: 37380189.
Further Information
For further information on Malaria, please find a small selection of links below. We take no responsibility for the content of these pages.
Malaria Vaccines
Sumaya’s vaccines aim at alerting the human immune system towards two crucial stages of the parasite’s infectious cycle: the liver and the blood stage. This is a key competitive differentiator against most existing approaches.
The basis of our vaccine candidates is the large, membrane anchored “Merozoite Surface Protein 1” (MSP1), which is exposed on the surface of merozoites, the form of the parasite that invades red blood cells.
SUM-101 is based on the full-length, recombinant, 200kDa MSP1 protein together with an adjuvant and was successfully tested in a first-in-human trial in Heidelberg. It was shown to be safe, well tolerated and immunogenic, with all vaccinees sero-converting. A second clinical trial, performed in Tanzania confirmed the safety and sero-conversion of Malaria pre-exposed volunteers.
SUM-102 is an Adenovirus expressing MSP1 and is planned to be used together with SUM-101 in a prime-boost scheme targeting travelers to Africa. Pivotal toxicological studies are completed and the vaccine is ready to start a first-in-human study.
MALARIA THERAPY
Our third development project is a small molecule intended for the treatment of severe malaria. SUM-201 (SC83288) has a completely new mechanism of action, making it a most interesting candidate for second line treatment in the face of increasing resistance against other Malaria therapeutics.
In addition, preclinical tests suggest that SUM-201 has a significantly better safety profile than currently used treatments against severe malaria, such as artemisins.
SUM-201 is ready to start a first-in-human study.
Pipeline
SUM-101
(MSP-1)
Discovery
Preclinical
Phase 1
Phase 2
Phase 3
SUM-102
(Ad6-MSP-1)
Discovery
Preclinical
Phase 1
Phase 2
Phase 3
SUM-201
(SC83288)
Discovery
Preclinical
Phase 1
Phase 2
Phase 3
African SUM-101 trial: dosing completed
Sumaya's second clinical trial of SUM-101 is currently taking place in Bagamoya, Tanzania in collaboration with Swiss Tropical and Public Health Institute and Ifakara Health Institute. We are very happy to announce that dosing of all 40 volunteers with three vaccinations each has now been completed and no serious adverse events have been observed. First results on immune response are expected for April. More information on the trial can be found on Swiss TPH's homepage.
Sumaya presenting at the 20th International Congress for Tropical Medicine and Malaria in Bangkok
We presented the latest results on SUM-101 (SumayaVac1) at ICTMM2020 in October 2022. Our vaccine elicited FC-mediated effector functions through both IgG and IgM. Results on the high degree of multi-functionality of antibodies against the highly conserved N-terminal p83 subunit were discussed. Notably, we showed the ability of SUM-101 to elicit a recall memory T cell response and induce cellular cytotoxicity through CD8+ T cells.
Sumaya presenting at BioMalPar XVII
On 23 - 25 May 2022, Sumaya-Biotech participated at the XVIII BioMalPar Conference on the Biology and Pathology of the Malaria Parasite in Heidelberg. Richard Thomson Luque presented the results of the SUM-101 (SumavaVac1) first-in-human clinical trial and in particular introduced our latest results showing that IgG and IgM of vaccinees are capable of deploying a wide spectrum of long-lasting FC-mediated effector functions comparable to that of the natural immunity achieved by endemic exposed population.
EU Malaria Fund: AchilleS Vaccines, Magnetrap, KELTIC Pharma and Sumaya receive a total of EUR 17.6 million to develop malaria vaccines, diagnostics and therapeutics
Hermann Bujard, a passionate scientist, an inspiring mentor and a generous friend.
In August 2020, our founder passed away.
Beyond his merits in science, university policy and as an entrepreneur, we will remember Hermann Bujard as a great mentor, and a person who fought passionately for his goals.
We are honoured and proud to be able to continue his work.
New vaccine candidate sucessfuly tested in first-in-human clinical trial
A phase 1a clincal trial at the University Clinic Heidelberg showed: The vaccine candidate is very well tolerated and safe. All volunteers developed functional antibodies. SumayaVac1 of Heidelberg biotech company Sumaya Biotech was developed at the Centre for Molecular Biotechnology of Heidelberg University.
Publications
Sumaya Biotech GmbH & Co. KG
Vangerowstrasse 20
69115 Heidelberg / GERMANY
Phone: +49 (6221) 588 04 05
Fax: +49 (6221) 588 04 04
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