Capricor Therapeutics Announces Development of Serology Test to Confirm Activity of SARS-CoV-2 Vaccines

Capricor Therapeutics, a clinical-stage biotechnology company focused on the discovery, development and commercialization of first-in-class cell- and exosome-based therapeutics for the treatment and prevention of a variety of diseases and disorders, announced today that it has received from Johns Hopkins University a  non-exclusive license to intellectual property, know-how and data related to a new imaging-based serology test platform for COVID-19. This platform, which is amenable to a vast array of serology applications, has been applied to the analysis of patient antibodies to multiple SARS-CoV-2 proteins, including spike, nucleocapsid, and membrane. Posted on the BioRXiv preprint server and soon to be submitted for publication, this study conducted by Johns Hopkins University researchers marks a new approach to serology testing that harnesses the unique ability to human cells to present viral proteins in their native context and native conformation, and thereby captures and quantifies the true spectrum of patient antibodies to pathogen-encoded proteins.

“Capricor’s dedication to developing its exosome-based RNA delivery platform is enhanced by the invention, development and access to new, cutting-edge approaches to companion diagnostics. Nowhere is this need more apparent than in vaccine research, which remains heavily reliant on decades-old technologies, many of which are prone to false positive and negative signals, few of which display antigens in their native context, and none of which report on the full spectrum of antibody responses to more than one or two viral proteins,” said Dr. Linda Marbán, Ph.D., CEO of Capricor. “The world is now faced with multiple challenges that require ever more sophisticated SARS-CoV-2 serology tests, including the emergence of new viral strains and the need to carefully evaluate vaccine-induced immune responses.  Capricor is enthusiastic about facing these challenges while it also advances its SARS-CoV-2 vaccines, which are designed to potentially elicit long-lasting, broad-based, humoral and cellular immunity that extends beyond the Spike protein alone. We are planning on meeting with FDA soon to discuss next steps in the clinical development of this program as well as announce further developments as they become available.”

The technology as described in the publication demonstrates several key advantages of imaging-based serology, which includes in-sample negative controls and gating of signal strength by specificity of signal pattern, capture of antibodies to proteins in their native conformations and environment within human cells, and the potential for simultaneous interrogation of multiple target proteins.

Key findings of this study include:

  • Validation of imaging-based serology
  • Two-dimensional gating eliminates false positives
  • Use of optically-coded coded test and control cells to allow for multiplexed analysis
  • No false negatives
  • Detection of antibodies to Nucleocapsid, Spike, Membrane and other viral proteins
  • Identification of anti-Membrane antibodies as a marker for deep and broad humoral immune responses to COVID-19 infection

Dr. Marbán continued, “Over the last few years, Capricor has worked diligently to build our exosome platform to deliver biologics, primarily nucleic acids. The published work reflects our commitment to the development of companion diagnostics that allow us to accurately evaluate the effects of our vaccines and therapeutics. In the present example, know-how in the areas of basic cell biology and imaging was used to develop a new approach to antibody testing that can provide COVID-19 patients, SARS-CoV-2 vaccine recipients with valuable insights into the array of SARS-CoV-2 antibodies they possess. Furthermore, we plan to convert the current version of the serology test to a multiplexed imaging test for clinical applications within and beyond the scope of SARS-CoV-2, and we intend to explore the potential for partnership opportunities for our COVID-19 technology.”

Study Design

The study was designed to interrogate the utility of an imaging-based serology testing platform. Patient plasmas were interrogated for the presence of antibodies to the SARS-CoV-2 spike (S), nucleocapsid (N), membrane (M), and other virus-encoded proteins, using genetically engineered cells as solid-phase support for antigen display in their native conformations and environment. The initial focus on detecting antibodies to S, N, and M proteins reflects their importance for the viral replication cycle, their abundance in virus particles, and the inclusion of all multiple proteins in Capricor’s potential SARS-CoV-2 exosome/RNA vaccine and VLP vaccine products.

Guo C, Tsai SJ, Ai Y, Li M, Pekosz A, Cox A, Atai N, Gould SJ. (2020) The D614G Mutation Enhances the Lysosomal Trafficking of SARS-CoV-2 Spike. bioRxiv [Preprint]. [abstract]

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