Our Pipeline

We harness our technology to deliver novel microbiome-focused phage
therapeies to alleviate conditions such as IBD, cancer, and skin disorders.

Acne-prone Skin BX001

BX001 is our topically administered product candidate intended to improve the appearance of acne-prone skin. It contains a cocktail of phage that helps control skin microflora by targeting P. acnes, or Cutibacterium acnes, a bacteria associated with acne. BX001 has been shown to be active on antibiotic resistant P. acnes strains and does not target other bacteria on the skin. Furthermore, it penetrates biofilms, a matrix secreted by the bacteria which surrounds them and makes them inaccessible to substances such as antibiotics.
Inflammatory Bowel Disease (IBD) BX002

BX002 is a customized phage cocktail aimed at eradicating proprietary bacterial targets associated with the onset of IBD. These targets, discovered by Dr. Kenya Honda, Professor of Microbiology and Immunology at Keio University School of Medicine, were shown to be pro-inflammatory and may have a role in the onset and aggravation of IBD (Atarashi et al., Science, 2017 https://www.ncbi.nlm.nih.gov/pubmed/29051379). 

BX002 offers a groundbreaking approach for treating IBD as it targets a possible underlying cause for the disease, whereas existing medications offer only symptomatic relief to this chronic, lifelong condition. BiomX plans to file an IND application with the US FDA for BX002 in 2019. Inflammatory bowel disease (IBD), which includes Crohn’s disease and ulcerative colitis, affect as many as 1.6 million Americans, most of whom are diagnosed before age 35. Medications today offer symptomatic relief to these chronic, lifelong conditions, but do not cure them. IBD can significantly affect a patient’s quality of life and may have a high financial burden.

Primary Sclerosing Cholangitis (PSC) BX003
PSC is a rare progressive liver disorder with no FDA-approved treatment. PSC is characterized by inflammation and fibrosis within the bile ducts which often result in the obstruction or interruption of bile flow from the liver, a condition known as cholestasis. The strong linkage between the microbiome composition and IBD, and the overlap in patients with both PSC and IBD (70% of PSC patient also have IBD), suggest that the microbiome may also influence the development of PSC.

BX003 is a customized phage cocktail being developed against specific strains of Klebsiella pneumoniae (Kp) that were isolated from the gut microbiome of PSC patients and were shown to disrupt the epithelial barrier (cause a ‘leaky gut’) and translocate outside the gut. These targets, which potentially affect progression of the disease, were discovered by Professor Takanori Kanai of Keio University School of Medicine and were published in Nature Microbiology (https://www.nature.com/articles/s41564-018-0333-1)

Colorectal Cancer (CRC)
Harnessing Synthetic Biology
Growing evidence that the presence of bacteria within tumors promotes tumor growth and resistance to cancer therapeutics provides an opportunity for phage therapy (Geller et al. Science 2017, Pushalkar et al. Cancer Discovery 2018 and Gur et al. Cell Immunity 2015). Our CRC program is developing customized phage cocktails to eradicate Fusobacterium nucleatum (F. nucleatum), bacteria that were shown to be enriched in colorectal cancer (CRC). Continuing discoveries show the active role of F. nucleatum in promoting CRC resistance to cancer therapeutics (Yu et al. Cell 170 2017 and Rubinstein et al. Cell Host Microbiome 2013). Thus, conventional therapeutics in combination with a customized phage cocktail against F. nucleatum may provide better treatment care for CRC patients. BiomX is utilizing synthetic biology approaches to precisely engineer phage that are specific and lethal to F. nucleatum bacteria. Synthetic biology is required in cases where natural phages identified require optimization. This may include, for example, “re-programming” lysogenic phage to enter a strictly lytic mode (killing the target bacteria). Other synthetic biology approaches are used to expand a host range of phage, allowing them to eradicate a wider array of bacterial strains or to overcome bacterial resistance to phage. These approaches have been developed by one of our scientific founders, Prof. Timothy K. Lu of MIT who has published extensively on phage engineering. In 2018, an estimated 140,000 Americans will be diagnosed with colorectal cancer and about 50,630 people will die from the disease. Colorectal cancer is the third most commonly diagnosed cancer in both men and women. One in 22 men and one in 24 women will be diagnosed with colorectal cancer in their lifetime (source: American Cancer Society’s Colorectal Cancer Facts and Figures, 2018).

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