The University of Oxford and ReciBioPharm Advanced Bio have expanded an existing collaboration to manufacture two blood-stage malaria vaccine candidates – R78C and RH5.1 – for phase I/II clinical trials.
The vaccines are being developed at Oxford’s Draper Lab in the Department of Pediatrics, which has run 25 proof-of-concept malaria vaccine trials to date. Recipharm Advanced Bio will be producing drug substance, drug product, and handling large-scale fill and finish for both candidates.
The expanded collaboration comes as malaria continues to cause a significant global health burden. According to the WHO’s World Malaria Report 2023, there was an estimated 249 million cases of malaria worldwide in 2022, resulting in 608,000 deaths. Children under 5 accounted for 76 percent of malaria deaths in the WHO African Region.
We spoke with Recipharm Advanced Bio's Bárbara Cunha (tech transfer and project management director) and Raquel Fortunato (CEO) to learn more about the partnership and why malaria is so difficult to tackle from a drug development point of view.
Malaria is a well-discussed health threat, but breakthroughs have been limited. Why is this such a challenging area to work in?
Malaria is unlike many other infectious diseases. The parasite responsible for malaria has an unusually complex life cycle, moving through several stages inside both mosquitoes and humans. At each stage, it changes its form and even the proteins on its surface, making it a moving target for the immune system. It continues to evolve.
Developing a vaccine that provides durable, broad immunity across different strains and in various populations is challenging. Unlike viral vaccines, where targeting a single antigen can be effective, malaria requires a multi-antigen or multi-stage approach, complicating testing, regulation and manufacturing.
Ultimately, vaccine development is a long, collaborative journey, and it’s encouraging to see so many people dedicated to making a real impact. We're proud to play our part in this area.
The collaboration has produced six vaccine candidates. What can you tell us about the two candidates that will be moved forward?
While we can’t share full details yet, we can confirm that the two candidates advancing to clinical trials demonstrated strong results in preclinical models and met key manufacturability criteria. Both target the blood stage of the malaria parasite, with the goal of reducing disease severity by blocking red blood cell invasion.
Early safety profiles have been promising, and both candidates are now being scaled up under GMP conditions for further clinical evaluation. One of the candidates has already completed a phase I trial, demonstrating excellent safety and the ability to generate high levels of functional antibodies with parasite growth-inhibitory activity. These findings supported progression into a IIb field trial, which has shown moderate efficacy and no serious adverse events. Both candidates are now in scale-up for further clinical evaluation.
By 2028, we aim to have robust phase I/II data for both candidates in Africa to support progression into later-stage trials.
What are you allowed to tell us about the manufacture of the vaccines?
Manufacturing malaria vaccines presents some unique challenges. The vaccine candidates often go beyond standard protein expression, involving highly complex structures that require specialized formulations and are sensitive to process conditions. We have had to adapt purification strategies to maintain both stability and potency. At the same time, we have focused on ensuring the process is scalable and robust in anticipation of global demand should the vaccines move forward.
Is working with a university different from working with a company? What are the big differences, and why is it important for a CDMO to understand such differences?
Collaborating with a university differs significantly from working with companies in ways that are both complementary and deeply rewarding. Academic teams, like those at the University of Oxford, bring exceptional depth to vaccine design. They are often at the very cutting edge of immunology, molecular biology, and structural vaccinology, developing novel antigen constructs, innovative protein designs, and emerging expression systems that may not yet be fully industrialized.
For a CDMO, understanding and supporting that dynamic ambition is essential. Unlike biotech companies, academic groups may prioritize scientific discovery over commercial considerations. Our role is to provide the bridge between the two, translating early-stage innovations into scalable, compliant, and robust manufacturing processes.
The field of vaccine science has had a boost since COVID-19. How are you seeing the field of vaccine science expand and what other breakthroughs would you like to see?
There’s no doubt that COVID-19 accelerated interest and investment in vaccine science. We’re seeing innovations not just in platforms, such as mRNA, but also in novel delivery systems, thermostability, and rapid manufacturing technologies. The focus has shifted toward global equity and pandemic preparedness, ensuring vaccines are accessible worldwide and production can scale quickly in response to emerging threats. Breakthroughs in vaccines for neglected tropical diseases such as dengue, and continued progress in malaria, would represent meaningful advancements. These are areas where innovation can have a transformative impact.
Malaria still kills hundreds of thousands of people each year, most of them children under five. While progress has been made with first-generation vaccines, diagnostics, prevention, and treatment, a more effective second-generation vaccine could significantly shift the trajectory of global malaria control. Continued investment in this space isn't just a scientific imperative, it’s a moral one.
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