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Our Pipeline

ADVANCED MICROBIOME THERAPIES

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

OUR PIPELINE

Target Discovery:

Investigating the bacteria to be added or eradicated to cure a disease

Phage Discovery:

Discovery and design of a customized phage therapy eradicating the target bacteria

Pre-clinical Development:

Additional testing, CMC, formulation and other activities for phage therapy entry into clinical trials

Clinical Development:

Phases I, II and III, until approval

Acne BX001

Inflammatory Bowel Disease (IBD) BX002

Liver Diseases

Colorectal Cancer (CRC)

Acne BX001

Target Discovery:

Phage Discovery:

Pre-clinical Development:

Clinical Development:

Pre-clinical Development:

BX001 is a topical gel of a phage cocktail comprised of natural phage capable of eradicating P. acnes, one cause of acne disease. Acne is the most common skin condition in the United States, affecting up to 50 million people of all ages. For most people, acne diminishes over time and tends to disappear or decrease by age 25. However, some individuals continue to suffer from acne well into their 30s, 40s and later. The market for acne therapies in the US and 5 largest EU countries is expected to reach over $2.8 billion in 2018.

BX001 is superior over existing antibiotics in the following aspects:

  • Active on antibiotic resistant P. acnes strains
  • Breaks down biofilm
  • Not harmful to bacteria other than P. acnes
  • Self-amplifying – 50-100 phage produced from each bacteria eradicated

Manufacturing and formulation activities are underway. Clinical trials are expected initiate H1 2019.

Inflammatory Bowel Disease (IBD) BX002

Target Discovery:

Phage Discovery:

Pre-clinical Development:

Clinical Development:

Pre-clinical Development:

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. The global IBD market is valued at over $8 billion.

Liver Diseases

Target Discovery:

Phage Discovery:

Pre-clinical Development:

Clinical Development:

Phage Discovery:

In recent years, studies investigating the liver-gut axis suggest that the gut microbiome represents a significant environmental factor contributing to development of liver disease. One such microbiome-associated mechanism is dysbiosis induced disruption of the gut endothelial barrier function which facilitates systemic bacterial translocation followed by intestinal and hepatic inflammation. Additionally, an increased level of microbiome-modulated metabolites such as lipopolysaccharides (LPS), short chain fatty acids (SCFAs), bile acids, and ethanol may reach the liver through the portal circulation and cause liver inflammation and pathology. However, the mode of action and particular bacteria driving these effects remain unknown. We aim to elucidate these mechanisms, by identifying key bacteria driving the pathogenesis of liver disease. In a second step we design phage therapies against the pathogenic bacterial targets. Under the project, a set of previously identified target bacteria candidates are currently undergoing validation and new target bacteria discovery is presently underway by applying unique approaches and novel computational platforms.

Colorectal Cancer (CRC)
Harnessing Synthetic Biology

Target Discovery:

Phage Discovery:

Pre-clinical Development:

Clinical Development:

Phage Discovery:

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).

LEARN MORE ABOUT BIOMX MISSION FOR HEALTH

OUR PARTNERS