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.

Target Discovery:

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

Prototype Discovery:

Prototypes consist of either a phage if target eradication is required, or a set of bacteria or small molecule if alterations to a bacteria’s function are necessary

Pre-clinical Development:

Prototype in-vitro/in-vivo trials, as well as testing and formulation development for clinical trials

Clinical Development:

Phases I, II and III, until approval

Inflammatory Bowel Disease (IBD) BX002

Target Discovery:

Prototype Discovery:

Pre-clinical Development:

Clinical Development:

BX002 is a phage cocktail aimed at eradicating several proprietary bacteria targets associated with the onset of IBD. The associated IBD bacteria are resistant to antibiotics and necessitate revision of current approaches. BX002 offers a novel means to eradicate these bacteria and provides a unique therapeutic approach to the disease. The proprietary bacterial targets, which BX002 has been designed against, have been exclusively provided to BiomX and have been shown to directly induce inflammation and disease (colitis) in in-vivo models. In addition, BX002 has demonstrated excellent efficacy and eradication specificity in-vitro. Genetic analysis of components of the cocktail showed phage diversity and indicated multiple mechanisms to eradicate the target bacteria. 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. As many as 70,000 new cases of IBD are diagnosed in the US each year. 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:

Prototype Discovery:

Pre-clinical Development:

Clinical Development:

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.

Immuno-oncology
Checkpoint Inhibitors

Target Discovery:

Prototype Discovery:

Pre-clinical Development:

Clinical Development:

Since the approval of the first checkpoint inhibitor therapy for cancer treatment in 2011, this class of drugs has revolutionized treatment for several malignancies. However, while these new drugs offer cancer patients more hope than ever before, response to therapy is highly variable between individuals and on average only a third of patients respond to therapy. Recently, researchers discovered that the composition of the gut microbiome is an important factor determining responsiveness to checkpoint inhibitor drugs. These publications implied that the gut microbiome impacts pathways in the immune system and affect drug responsiveness. However, the mode of action of the microbiome and the specific driving bacteria involved in drug response modulation are largely unknown. Our target discovery program in immuno-oncology is aimed at developing microbiome-based products to be co-administered with checkpoint inhibitor drugs to improve response rates and/or efficacy. We focus on identifying key bacteria (and genes) that when added to, or eradicated from, the microbiome would improve the outcome of treatment with checkpoint inhibitor drugs. Most approaches to identify target bacteria in the gut microbiome mainly focus on abundance, using 16S or shotgun metagenomics to identify bacteria whose presence or abundance is correlated with drug response. Our immune-oncology program is unique in the sense that it utilizes our proprietary target discovery platform measuring the direct dynamic response of the gut microbiome to the drug administration, in this case checkpoint inhibitors, in addition to measuring bacterial abundance. This approach measures which genes are activated in the microbiome in response to the drug (at the level of RNA expression), thus identifying key driver bacteria and key driver genes reacting to administration of a given trigger (in this case checkpoint inhibitor drugs).

GI Tract Associated Cancers
Harnessing Synthetic Biology

Target Discovery:

Prototype Discovery:

Pre-clinical Development:

Clinical Development:

Our GI tract cancer program develops phage cocktails that eradicate bacteria in the gastrointestinal microbiome that are associated with cancer. Continuing discoveries are being made that establish the association between harmful bacteria in the stomach and gut with these lethal cancers. We are utilizing in-house or exclusively licensed synthetic biology approaches to precisely engineer phage that are specific and lethal to these bacteria. Synthetic biology is required in cases where natural phage are not identified. 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. Prof. Lu is a pioneer in this ground-breaking field, and his innovative proprietary technologies have been licensed exclusively by BiomX. In 2017, an estimated 135,000 Americans will be diagnosed with colorectal cancer and about 50,000 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, 2017-2019).

LEARN MORE ABOUT BIOMX MISSION FOR HEALTH
OUR PARTNERS