Research and Development Status of Single-Strain LBPs

Single-strain LBP has been reported in various research areas, including cancer and digestive tract diseases. In cancer treatment, an LBP called MRx0518 has been developed based on Enterococcus gallinarum, which can be used in combination with the monoclonal antibody pembrolizumab to treat solid tumors. The mechanism of action involves the flagellin of MRx0518 activating TLR5 and nuclear factor kappa-B (NF-κB) receptors and inducing IL-8 production, leading to a strong anti-tumor response. An ongoing phase Ⅰ/Ⅱ clinical trial has shown promising results. MRx0518 has also been shown to be effective in combination with radiation therapy for pancreatic cancer, with patients taking MRx0518 daily before and during radiation treatment until tumor resection surgery, and the study is currently in phase Ⅰ clinical trial.

In the field of digestive tract diseases, researchers have developed a drug called SK08 based on Bacteroides fragilis, which can effectively treat irritable bowel syndrome (IBS) and ulcerative colitis (UC), and has shown good efficacy and safety in preclinical studies. Previous studies have shown that the polysaccharides produced by Bacteroides fragilis can regulate the Th1/Th2 balance of helper T cells, enhance the function of T cells in the body, induce differentiation of Treg cells, and produce IL-10, while inhibiting the inflammation factor IL-17, to achieve the effect of regulating the immune function of the body. Thetanix, an LBP drug for the treatment of Crohn's disease (CD), was developed, which consists of Bacteroides thetaiotaomicron. Its mechanism of action is to inhibit the activation of NF-κB, which is related to a variety of inflammatory diseases. Pirin-like proteins produced by the drug have become candidate effectors, and the drug has shown good safety in phase Ⅰclinical trials

In addition, single-strain LBP has also been reported in the treatment of respiratory, gynecological and neurological diseases. MRx-4DP0004, made from Bifidobacterium breve, is a single-strain drug used to treat asthma, and researchers are further evaluating its safety, tolerability, and immune-modulating effects through phase Ⅰ/Ⅱ clinical trials. Scientists have developed a live biotherapeutic product called Lactin-V based on Lactobacillus crispatus, which can treat recurrent vaginitis. It was applied to the vaginas of 228 patients who had received metronidazole vaginal gel treatment, and after 11 weeks, the probability of recurrent vaginitis significantly decreased. Two single-strain LBPs, MRx-0029 made from Megasphaera massiliensis and MRx-0005 made from Parabacteroides distasonis, have both shown potential in preclinical studies for treating Parkinson's disease. These two strains can reduce neuroinflammation, protect neurons from oxidative stress damage, and restore intestinal barrier integrity. The investigational new drug (IND) applications for these two LBPs have been approved and will soon enter clinical trial phase.

In summary, single-strain LBPs have promising prospects as adjunct therapies for cancer immunotherapy. Its characteristics of oral administration in the digestive tract make it particularly advantageous in the treatment of digestive tract-related diseases. In addition, compared to antibiotics, single-strain LBPs are safer, less likely to develop resistance, and can quickly restore balance between microbial communities, reducing the physical and psychological burden on patients. The approval of the IND applications for MRx-0029 and MRx-0005 also marks the expansion of LBP clinical projects to the field of neurological diseases.

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For Research Use Only. Not intended for use in food manufacturing or medical procedures (diagnostics or therapeutics). Do Not Use in Humans.