Trellis Bioscience LLC has been awarded a Small Business Innovation Research (SBIR) fast-track grant to advance its native human antibody against cytomegalovirus (CMV), CMV345, through preclinical development towards an Investigational New Drug (IND) application filing.
The four-year, $3.3 million grant is administered by the National Institute of Allergy and Infectious Disease (NIAID) and will support manufacturing, toxicity testing, and further documentation of efficacy including mechanism of action studies.
"Trellis has successfully deployed our proprietary CellSpot technology to discover four superlative antibodies targeting high-impact infectious diseases, including CMV, RSV and Group 1 and Group 2 Influenza," said Stote Ellsworth, president and CEO of Trellis. "This substantial SBIR funding provides validation of the strength of our programme and allows us to advance our CMV product candidate towards human clinical testing, building value and reducing risk. By staying focused on rare antibody discovery and preclinical development, we stick with what we do best."
CMV infection in pregnant women who have not previously been exposed to the virus is the leading non-genetic cause of birth defects. To date, none of the multiple vaccine efforts have yielded a product with better than 50 per cent reduction in fetal transmission. Trellis' lead high-affinity native human monoclonal antibody for this indication, CMV345, is intended to neutralize transmission of CMV to the foetus.
Recently published research established striking efficacy for hyperimmune globulin enriched for antibodies against CMV, reducing the incidence of birth defects in sero-negative (previously uninfected) mothers who became infected early in pregnancy from 43 per cent to 13 per cent with a P-value of less than 0.01 in this prospectively randomized trial. In studies that supported the company's SBIR grant application, Trellis' single antibody CMV345 demonstrated dramatically greater potency and breadth of activity when compared to the same commercial immune globulin product. These initial data suggest that single antibody therapy such as CMV345 is capable of blocking viral infection of all relevant cell types, including critical fibroblast cell types which other published antibodies fail to protect.
CMV345 is also applicable in transplant indications where CMV is the leading infectious disease cause of morbidity and transplant loss. Published studies point to favourable transplant outcomes for patients who are fortunate to have even low concentrations of CMV345-like antibodies in their serum antibody repertoire.
CMV345 was discovered utilizing Trellis' CellSpot platform, which excels at rapidly identifying and isolating ultra-rare, high-quality native human antibodies directly from blood samples as well as other antibody library sources. The CellSpot technology enables high-throughput screening of human B cells in a multiplexed format based on predetermined selection criteria such as specificity, affinity and cross-reactivity. Leveraging CellSpot, Trellis has successfully discovered monoclonal antibody candidates addressing CMV, respiratory syncytial virus (RSV), and Influenza Group 1 and Group 2. Current CellSpot discovery programs are addressing methicillin-resistant Staphylococcus aureus (MRSA), Streptococcus A (GAS), and a new anti-cancer target in collaboration with the National Cancer Institute (NCI).
Trellis is a venture-funded therapeutic antibody company formed around a breakthrough, high throughput discovery platform capable of isolating ultra-rare therapeutic-grade antibodies directly from the blood cells of humans and other antibody library sources.