CureVac, the renowned biotech company, has made a significant stride in its quest to develop an mRNA influenza vaccine. While the biotech remains tight-lipped about the specific data, it has chosen a promising candidate for advancement into the crucial phase 2 of clinical trials.
This pivotal selection was based on interim analysis results from the ongoing phase 1/2 study, which involves assessing a range of flu vaccine candidates. CureVac’s press release, though concise, underscores the candidate’s exceptional performance, emphasizing its ability to provide broad antigen coverage against the flu strains recommended by the World Health Organization (WHO). The chosen candidate will now progress to the phase 2 stage, with dosing scheduled for the fourth quarter of this year, targeting older adults aged 65 to 85 years.
“We are very pleased with the interim results from the Phase 1 part of the study, which provided a strong basis to move our clinical development forward into Phase 2. The power, flexibility and speed of our mRNA technology platform offers tremendous potential to overcome the current challenges associated with providing seasonally updated and highly effective influenza vaccines. We feel confident that our differentiated vaccine candidate has the potential to offer people broad protection and will advance us on the path to transforming public health.”
– Dr. Myriam Mendila, Chief Development Officer of CureVac
One critical aspect of the chosen candidate is its capacity to combat all WHO-recommended strains—a lesson underscored by Moderna’s experience in February. The renowned COVID-19 vaccine manufacturer faced challenges when its flu candidate demonstrated lower efficacy against two influenza B strains, while the WHO advises protection against not only the two A subtypes, H1N1 and H3N2 but also the influenza B Victoria and Yamagata lineages in annual flu shots. Moderna had to recalibrate its candidate to enhance its effectiveness against these B strains, but positive data remains elusive.
CureVac’s update, while not providing in-depth data, indicates that the phase 2 candidate has at least met the WHO’s criteria, offering optimism for the future.
CureVac’s mRNA vaccines, developed in collaboration with GSK, feature up to eight mRNA constructs per candidate. The phase 1 portion of the trial encompassed 270 healthy volunteers aged 18 to 50. Impressively, there were no safety concerns detected during the interim analysis across all dose levels for the multivalent candidates. These shots were rigorously tested against an approved seasonal flu vaccine comparator, further underlining their potential. CureVac also has plans to conduct additional midstage testing involving younger adults.
GSK initially partnered with CureVac in July 2020, during the early stages of the global pandemic, to venture into the promising field of mRNA technology.
CureVac’s reserved approach to data disclosure has drawn both curiosity and criticism from analysts in the past. However, despite the secrecy, the company’s commitment to groundbreaking mRNA approaches for flu and COVID has consistently generated excitement among investors. This recent development saw CureVac’s stock trading at $8.39, experiencing a slight dip of just over 1% from the previous day’s close.
