CARLSBAD, Calif.–(BUSINESS WIRE)–$LCTX #COVID19—Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs, announced today that it has applied for grant funding from the California Institute for Regenerative Medicine (CIRM) to support the use of VAC, Lineage’s allogeneic dendritic cell therapy, toward the development of a potential vaccine against SARS-CoV-2, the virus which causes COVID-19.
In response to the COVID-19 pandemic, CIRM recently approved emergency funding and the allocation of $5 million for peer-reviewed regenerative medicine and stem cell research that could quickly advance treatments for COVID-19. The funding would be awarded as part of an expedited approval process.
Lineage has had several lines of clinical evidence that made them to apply the use of the VAC technology to the development of a prophylactic vaccine against SARS-CoV-2 and other coronaviruses, said Brian M. Culley, Lineage CEO.
He noted that recent publications have reported that patients infected with coronaviruses can exhibit modest neutralizing antibody titers and diminished T cell responses, suggesting it may be difficult for traditional vaccine approaches to generate long-term protection via the cellular immune response.
Culley believes that dendritic cells, the body’s most potent antigen-presenting cell, can present viral antigens to the immune system to prime a robust immunological memory and provide durable, multi-year protection against the severe consequences of infection. He said that this would be especially beneficial for front-line healthcare workers and others at risk of repeated exposure.
Culley said that clinical data in patients with various cancers collected by Duke University Medical Center in early clinical trials of VAC1, the first product candidate from the VAC platform, showed nearly all patients developed evidence of antigen-specific T cell immune responses. He noted that that signal was confirmed in a majority of patients enrolled in a subsequent phase 2 study of VAC1 reported in 2016 by Asterias Biotherapeutics, which Lineage acquired in 2019.
He believes that these and additional data provide validation of the underlying mechanism of using dendritic cells to present antigens to the body’s immune system. Culley considers his company to be unique among cell therapy companies that are evaluating solutions to the COVID-19 pandemic because we Lineage is focused on late-stage critical care, but on providing long-term prophylactic protection against infection, which may help reduce the need for hospitalization and address a critical gap among the critical care and humoral immunity approaches currently in development.
For Culley, the ideal scenario is that protection against COVID-19 in high-risk individuals would become durable, similar to measles or pertussis, rather than influenza, which requires an annual vaccination.
Culley said that presenting a viral antigen by means of Lineage’s allogeneic dendritic cell platform will require manufacturing process development and creating a new expression construct prior to submitting an Investigational New Drug (IND) application to enable clinical evaluation. He said that it will entail a modest investment of capital. We feel that we are able to manage this new program alongside our existing programs in dry AMD and spinal cord injury,” Culley said.
The company has recently raised $3.8M of cash from the sale of OncoCyte shares and this capital, alongside the translational research grant application submitted to CIRM, should it be approved. Culley also said that the company intends to seek additional opportunities to obtain non-dilutive backing for this program.