Oxford, UK-based vaccine company SpyBiotech is planning to start dosing subjects for a Phase I trial of its lead vaccine candidate against human cytomegalovirus (HCMV) infection in H2 2023, says chief scientific officer (CSO) Sumi Biswas.
The preparations for the trial are moving ahead and manufacturing is already completed, says Biswas. Additionally, the company has already selected a CRO for this trial, with toxicity studies well underway, confirms CEO Mark Leuchtenberger. The study, which features a six-month dosing schedule, will be carried out in the UK, he adds.
The Phase I trial will test three doses of the vaccine, says Biswas. While the trial size has not been finalised, the biotech expects to enroll 120 subjects, she adds.
The trial will feature the company’s vaccine candidate that is based on its “protein superglue” approach, which can be used to efficiently attach different antigens to virus-like particle (VLP)-based vaccines. Designing new vaccines for different pathogens becomes much faster once this “superglue” is incorporated into a specific platform, explains Biswas.
Leuchtenberger likens SpyBiotech’s approach to a car chassis. This chassis can be modified based on needs, which is more efficient than building a car up from scratch every time.
SpyBiotech aims to have immunogenicity and safety data ready by the end of 2023 or the start of 2024, says Leuchtenberger. While this data will not be shared with the public at the time, it will help the company with deciding the next steps for plans related to financing and partnerships, he adds.
Plans for funding and other candidates in the works
Though the company remains in a financially stable position in a challenging environment, it may start considering potential partnerships and a Series B fundraise in Q1 2024, says Leuchtenberger. The company previously raised $32.5 million in a Series A round, based on a February 2021 press release. This round extended the company’s reserves until H2 2025, adds Leuchtenberger.
In addition to its plans for an HCMV vaccine, the company is exploring vaccines in other indications, including cancer. SpyBiotech recently decided to go ahead with the development of a vaccine candidate for Epstein-Barr virus, says Leuchtenberger. There are no approved vaccines for this condition.
Additionally, the company’s technology will be featured in an Oxford University-sponsored malaria vaccine trial, says Leuchtenberger. Further in the works, negotiation is currently underway for the development of a mosaic-8 Covid-19 vaccine, which features the company’s technology, the CEO says. While Biswas did not give concrete timelines for when these enter the clinic, she hopes it will be soon.
Note: Paragraph 2 was updated to reflect new context provided on the Phase I plans after publication.