ReiThera Discusses Vaccine Nimbleness Amidst Emerging Threats

As vaccines are buffeted by political pressures, the CDMO discussed its growth approach and some of its key collaborations. Vaccines play a central role in protecting public health by buttressing national and regional resilience as well as strengthening health security, but they are also at the mercy of external forces. The seeds sown by Dr Andrew Wakefield’s debunked study linking the measles, mumps and rubella (MMR) vaccine to autism, published in 1998 but not formally withdrawn until 2010, continue to affect health outcomes. Vaccine coverage around the world is declining and outbreaks have been seen this year in more than 100 countries. Late last year Canada lost its official measles elimination status and the US could be next. The country was already recorded its highest number of cases in three decades and the Centers for Disease Control and Prevention has linked two huge outbreaks in Arizona and Utah, with the New York Times reporting that the US was about two months away from losing its own elimination status. Clear lines can be traced between flawed research, vaccine hesitancy, the policisation of science and declining vaccine coverage, with all the negative health outcomes that the latter heralds. Political actions also have ramifications for pharmaceutical advances. The decision over the summer by US Health and Human Services Secretary Robert F Kennedy Jr, a vaccine sceptic, to cut mRNA vaccine research worth $500 million had serious repercussions. Not only did it incite the rejection, cancellation or restructuring of projects by companies such as Pfizer, CSL Seqirus, Sanofi, AstraZeneca and Moderna, it also hugely deprioritised – for now at least – a Nobel Prize-winning field of research widely lauded for its role in helping tackle COVID-19. Pandemic pressures Hesitancy about, and political pressure on, vaccines is certainly not solely a stateside phenomenon; the pandemic hugely stretched the global industry and society alike. In Italy, the Rome-based contract development and manufacturing organisation (CDMO) ReiThera found itself drawn into its country’s response. As a company that focuses on the development and GMP manufacturing of viral vectors for gene therapies, advanced medicinal products and vaccines, that was perhaps to be expected. Hesitancy about, and political pressure on, vaccines is certainly not solely a stateside phenomenon; the pandemic hugely stretched the global industry and society alike” Nevertheless, this decision came with a huge amount of pressure to perform, as Chief Executive Officer Stefano Colloca candidly acknowledged at an invite-only media event in September, held at the firm’s headquarters: “COVID, for us, was a challenge. We were pushed by the Italian government to start the project to be ready to deliver one million [vaccine] doses, but then the financial support was not given. So, we did everything by ourselves, and this put ReiThera in danger for a couple of years. Fortunately, we managed to increase our client portfolio and overcome the difficulties.” Nevertheless, Colloca said that the time was also an energising one for his company, prompting it to expand its manufacturing capabilities and facilitate its current state of being ready to support commercial production. “So, really, we ran very fast and of course this was dedicated to COVID,” he said. “But, thinking ahead, we built up the facility in a flexible way in order to accommodate, not only a very rapid upscale product for a pandemic vaccine, but also medium scale – the 200-litre scale that is the most common scale we are requested to perform. Now, this is going to be the facility where the commercial product will be produced.” It represents a direction of travel for the company towards future support for process validation and the transition from phase III to registration phases for a new drug, marking continued progress since being founded in 2007 as a spinout from Merck Laboratories’ Rome research centre. Originally named Okairos, the company was subsequently acquired by GlaxoSmithKline in 2013 when its name changed to ReiThera. Its research work during the pandemic years saw ReiThera’s gorilla adenovirus (GRAd) technology for inducing CD8 T-cell responses clinically validated for COVID-19, with its candidate vaccine GRAd-COV2 shown to be safe and immunogenic in younger and older adults in a phase I study. From COVID to HIV ReiThera recently partnered with the Ragon Institute and IAVI to develop a T cell-focused HIV vaccine (GRAd‑HIV) using the same technology in an effort conducted under the umbrella of the Gates Foundation as part of its drive to develop efficacious and affordable vaccines against AIDS. Marco Soriani, Project Director at ReiThera, explained: “As part of the collaboration, if you decide as a company to work with the Foundation, you have to provide global access. Your technology needs to be given for free to low-income countries that are in need, so the Foundation is supporting your study and developing the programme, but then you offer the technology.” In August the Gorilla Adenovirus Vectored HIV Networked Epitopes Vaccine (GRAdHIVNE1) vaccine candidate began phase I clinical trials at the Mutala Trust clinical trial site in Harare, Zimbabwe. The vaccine’s immunogenicity will also be assessed by a network of a trio of research institutes in South Africa. The programme for the IAVI C114 trial is sponsored by IAVI, with ReiThera manufacturing the vaccine candidate, the Ragon Institute designing the immunogen and the Gates Foundation providing funding. “From ReiThera’s perspective, there is not only interest clearly for the platform technology (the GRAd), which is an important element of the vaccine, but also our capabilities to eventually transfer our manufacturing expertise, the scalability process and also our quality control phase to manufacturing companies in Africa. This is the goal and a very nice aspect of this sort of partnership – that it puts ReiThera on the front line to eventually have a vaccine in Africa and not [just] for Africa. So it’s a good opportunity,” Soriani said. Responding to active outbreaks Those efforts also form part of a multifaceted response from the firm to active outbreaks of Ebola and the similar Marburg virus, as part of its 2029 collaboration with the Washington, DC-based non-profit Sabin Vaccine Institute to produce clinical-grade virus vaccines. Delivering doses of the ChAd3 Ebola Sudan vaccine to Uganda during an Ebola Sudan outbreak to support a World Health Organization-supported trial in 2022, the partners worked in 2024 on the rapid management of a Marburg outbreak in Rwanda; manufacturing, labelling and shipping vaccine doses for a phase II trial in frontline workers. Thinking about a future pandemic situation, it was a way to demonstrate that it’s possible to intervene if you have stockpiled vaccines and you immediately monitor, and there’s a good diagnostic system supporting monitoring – the intervention can be really fast” “In ten days we were able to have the doses in Rwanda of the vaccine that we produced and to start the trial,” Soriani said. “We immunised roughly 1,000 people, but then the outbreak was considered to have ended. But, thinking about a future pandemic situation, it was a way to demonstrate that it’s possible to intervene if you have stockpiled vaccines and you immediately monitor, and there’s a good diagnostic system supporting monitoring – the intervention can be really fast.”