On July 13, 2021 Nascent Biotech, Inc. (OTCQB:NBIO) ("Nascent Biotech", "Nascent", or the "Company"), a biotechnology company pioneering innovative medicines to overcome difficult-to-treat cancers and viral infections, and its collaboration partner, Manhattan BioSolutions (together, the "Partners"), reported that promising new preliminary preclinical results for the COVID-19 vaccine candidate now progressing under joint development by the Partners (Press release, Nascent Biotech, JUL 13, 2021, View Source [SID1234584829]).
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Under a research collaboration agreement signed in 2020, Nascent Biotech and Manhattan BioSolutions partnered to discover and develop a safe and affordable COVID-19 vaccination platform based on modifying licensed BCG vaccine technology originally developed for Tuberculosis ("TB"), but with broader utility in protecting against infection from other types of viruses, some of which may have the potential to cause major outbreaks in humans. The vaccine candidate currently in development is based on genetically engineered BCG bacteria, which have been modified by the addition of SARS-CoV-2 protein fragments. Next-generation vaccine candidates, each representing a different combination of a receptor binding domain ("RBD") fragment of a spike protein ("S") and a conserved nucleocapsid ("N") antigen, have been successfully constructed and validated for the expression of viral protein fragments in the BCG bacteria.
In a preclinical murine model, a single subcutaneous immunization of synthetic BCG-S generated cellular immune responses in BALB/c mice. T-cells from splenocytes isolated from BCG-S-immunized mice showed statistically significant antigen-specific IFN‐γ secretion, according to direct Enzyme-Linked ImmunoSpot ("ELISpot") T-cell analysis.
Based on this promising preliminary data, additional experiments are underway to better understand protective efficacy and other characteristics of the related immune response that follows immunization with the most promising BCG-vectored vaccine candidate demonstrated in mouse models.
Dr. Boris Shor, CEO of Manhattan BioSolutions, commented: "We successfully generated a versatile ‘plug-and-play’ BCG system that allows the expression of a large set of rationally selected SARS-CoV-2 polypeptide fragments previously identified to be immunogenic in a substantial study population. Current vaccine efforts are primarily focused on generation of humoral responses to vaccines. Our BCG-vectored vaccine candidates are designed to generate safe T-cell immunity against SARS-CoV-2, and these initial results are highly encouraging."
Sean Carrick, CEO of Nascent Biotech, added: ‘Published evidence suggests that BCG vaccination is safe and might be associated with a decrease in the incidence of sickness during the COVID-19 pandemic, and lower incidence of extreme fatigue. Through grant funding and additional investments, we are making progress toward building a Viral Infection business platform and providing meaningful treatment for patients. We continue to be excited about our partnership with Manhattan BioSolutions, and we look forward to working together to deliver innovative therapies with the power to improve patient outcomes."