Clover Begins U.S. RSV Vaccine Study After IND Clearance

Clover Biopharmaceuticals, a prominent player in the biotechnology sector, has recently achieved a significant milestone with the clearance of an Investigational New Drug (IND) by the U.S. Food and Drug Administration (FDA). The company has successfully enrolled the first participants in a Phase I revaccination clinical trial for its RSV PreF vaccine candidate, SCB-1019. This vaccine is a non-adjuvanted, bivalent RSV prefusion-stabilized F (PreF)-Trimer subunit vaccine, which is built on Clover's proprietary Trimer-Tag technology platform.

According to Joshua Liang, CEO and Board Director of Clover, the U.S. IND clearance and the commencement of the revaccination trial underscore the potential global impact of Clover's RSV PreF vaccine. The vaccine aims to fill crucial gaps in the current market for RSV vaccines. While existing protein-based vaccines are effective initially, they often fall short in providing long-term protection, necessitating revaccination. Moreover, these vaccines do not offer protection against other respiratory viruses similar to RSV, such as human Metapneumovirus (hMPV) and Parainfluenza Virus Type 3 (PIV3). Clover's ongoing clinical trial aims to examine the efficacy of SCB-1019 in a revaccination context and its potential as part of a combination vaccine addressing multiple respiratory viruses.

Preliminary results released by Clover in October 2024 from a separate Phase I trial involving 70 RSV vaccine-naïve older adults (aged 60-85) showed promising outcomes. The non-adjuvanted SCB-1019 demonstrated a potentially superior immunogenicity and tolerability profile compared to GSK's adjuvanted RSV vaccine, AREXVY. These findings set an optimistic tone for the current Phase I revaccination trial, which involves up to 160 older adults who had previously received GSK's AREXVY vaccine at least two seasons earlier. Participants in this trial will be randomized to receive either a heterologous dose of SCB-1019, a homologous revaccination dose of AREXVY, or a saline placebo. The trial is designed to evaluate the safety, reactogenicity, and immunogenicity of these interventions.

Looking ahead, Clover is also preparing to initiate Phase I trials for SCB-1019 as part of a combination Trimer-Tagged PreF vaccine that would address RSV, hMPV, and potentially PIV3. This development is anticipated to commence in 2025 and represents a strategic step towards broadening the protective scope of Clover’s vaccine offerings.

Clover Biopharmaceuticals is dedicated to leveraging innovative vaccine technologies to significantly reduce the burden of vaccine-preventable diseases worldwide. The company has established a robust pipeline and forged strong partnerships globally, underscoring its commitment to improving global health outcomes through advanced vaccine solutions.

In summary, Clover Biopharmaceuticals is making strides in the development of its RSV PreF vaccine, SCB-1019, aiming to address critical gaps in current RSV vaccine offerings. With the initiation of a U.S.-based Phase I revaccination trial and plans for a combination vaccine trial, Clover is poised to enhance its role in combating respiratory diseases globally.