#China #Shanghai #RSV Vaccine #Clover Biopharma #PIV3 vaccine

Clover Biopharmaceuticals Reports Positive Phase I Clinical Results for New Combination RSV Vaccines

Clover Biopharmaceuticals, a Hong Kong-based biotechnology firm, has made waves in the medical community with their recent announcement of positive preliminary outcomes from Phase I clinical trials examining two novel combination vaccines targeting Respiratory Syncytial Virus (RSV), human metapneumovirus (hMPV), and parainfluenza virus type 3 (PIV3). This development promises to enhance respiratory disease protection in older adults, particularly for those who have previously received RSV vaccinations.

Key Findings from the Trials

The results show that the RSV+hMPV±PIV3 combination vaccines are not only safe but also exhibit considerable immunogenic properties. Significant increases in neutralizing antibodies were observed, which could indicate a robust immune response. Specifically, the trials revealed:

• - A geometric mean fold rise (GMFR) of approximately 6-8 for RSV and hMPV, and 4 for PIV3.
• - Evidence suggesting that the combination vaccines can effectively re-vaccinate individuals who had previously received approved RSV vaccines, aiming to restore and broaden their overall protection.

These findings are especially crucial given the ongoing public health challenge posed by various respiratory viruses. Joshua Liang, Clover's CEO, stated, "We are excited about the indication that our candidates could be best-in-class solutions for RSV-related respiratory diseases. The potential to re-vaccinate will address significant gaps in current vaccine offerings."

Trial Details

Australia Phase I Trial

The Phase I trial conducted in Australia enrolled older adults aged 60-85, examining the immunogenicity, safety, and reactogenicity of three vaccine candidates:
1. SCB-1022 (RSV+hMPV)
2. SCB-1033 (RSV+hMPV+PIV3)
3. SCB-1019 (RSV) as a control.

Preliminary data from 144 participants indicated that both SCB-1022 and SCB-1033 produced significant increases in RSV A and B neutralizing antibodies. Notably, there was no observable immune interference when the additional hMPV and PIV3 targets were introduced, and safety profiles remained favorable.

U.S. Renvaccination Trial

In a separate trial in the United States, Clover is investigating the efficacy of re-vaccinating older adults with their RSV vaccine SCB-1019 in comparison to GSK's AREXVY vaccine. Preliminary data from this interim analysis suggests superior performance of Clover’s vaccine in boosting RSV neutralizing antibodies. Specifically:

• - The SCB-1019 re-vaccination induced a 1.6-1.8x higher trend in neutralizing antibody levels in comparison to AREXVY.
• - A significantly higher percentage of participants receiving SCB-1019 exhibited marked increases in their RSV neutralizing antibodies.

This trial aims to demonstrate the potential for Clover's vaccine to not only restore but also enhance protection among older adults who are particularly vulnerable to respiratory infections.

Future Directions

Clover is committed to advancing their newly developed combination vaccines to Phase II clinical trials slated for the first half of 2026. These upcoming trials are expected to further assess immunogenicity in larger populations while establishing comprehensive safety data necessary for regulatory approval.

CEO Joshua Liang noted, "The data from both trials reaffirms our belief in the potential of our innovative vaccine candidates to address significant gaps in current public health responses to RSV and related respiratory illnesses."

In conclusion, Clover’s promising results from Phase I trials mark an essential step toward advancing effective vaccination strategies against RSV and its related viruses, potentially transforming the landscape of respiratory disease prevention in older adults. Anticipation builds as further data becomes available in the coming year, possibly heralding a new era in immunization and public health.

About Clover

Clover Biopharmaceuticals is dedicated to improving global health through the development of innovative vaccines. By leveraging advanced biotechnological capabilities and strategic partnerships, Clover aims to address significant health challenges and mitigate the impacts of vaccine-preventable diseases.