Thursday, September 21, 2023
SpyBiotech, a biotechnology company known for its groundbreaking vaccine platform technology effective against infectious diseases, cancer, and chronic conditions, has announced the submission of a Clinical Trial Application (CTA) to the U.K.'s Medicines and Healthcare products Regulatory Agency (MHRA). This application marks the initiation of the assessment process for SPYVLP01, a vaccine designed to target human cytomegalovirus (HCMV) using SpyBiotech's Hepatitis B virus-like-particle platform technology. Notably, there is currently no approved HCMV vaccine available.
Sumi Biswas, Ph.D., President and Chief Scientific Officer at SpyBiotech, emphasized the significant step taken with the submission of their clinical trial application for SPYVLP01 in addressing the HCMV virus. She underscored HCMV's role as a major cause of congenital abnormalities. Dr. Biswas expressed confidence in the potential of SpyBiotech's SpyVLP vaccine platform, highlighting its versatility for creating vaccines targeting a wide range of pathogens and therapeutic areas.
Mark Leuchtenberger, Chief Executive Officer of SpyBiotech, highlighted the importance of the MHRA trial application as a critical advancement in their cost-effective and scalable vaccine technology. He noted the pressing need for progress against HCMV, emphasizing the absence of an approved vaccine for this betaherpesvirus, which can lead to lifelong infections in humans.
The phase 1 clinical trial's primary goal is to assess various formulations of the HCMV vaccine, with an enrollment target of approximately 120 participants. The first participant is expected to receive the vaccine later this year, and clinical data is anticipated in the first half of 2024.
SpyBiotech's innovative SpyVLP vaccine platform relies on proprietary protein "superglue" technology that securely binds antigens to vaccine delivery platforms, minimizing delivery risks while enhancing immunogenicity and effectiveness.
Human cytomegalovirus (HCMV) is a betaherpesvirus that causes persistent infections in humans. Its prevalence varies from 55% to 100% within the human population, depending on socio-economic and geographical factors. While primary HCMV infection typically shows no symptoms in healthy individuals, it can lead to severe and sometimes fatal diseases in immunocompromised individuals and newborns. HCMV is the primary infectious cause of congenital abnormalities in the Western world, potentially resulting in health issues like low birth weight, hearing loss, visual impairment, and microcephaly when intrauterine infection occurs.
