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.

Step 1

Target Discovery:

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

STEP 2

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

STEP 3

Pre-clinical Development:

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

STEP 4

Clinical Development:

Phases I, II and III, until approval

ACNE BX001

Step 1

Target Discovery:

STEP 2

Prototype Discovery:

STEP 3

Pre-clinical Development:

STEP 4

Clinical Development:

WE ARE AT STEP 3

Pre-clinical Development:

BX001 is a phage cocktail comprised of a natural phage capable of eradicating P. acnes, which is a main cause of acne. 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 specifically eradicates P. acnes and does not affect other bacteria beneficial to the skin. It has demonstrated the efficient eradication of a broad host range of P. acne bacteria lines, including antibiotic resistant lines. cGMP manufacture of BX001 is underway and preclinical development has commenced. Formulation studies have been initiated through collaboration with a multinational pharma company for testing of various storage methods and formulations.

Inflammatory Bowel Disease (IBD) BX002

Step 1

Target Discovery:

STEP 2

Prototype Discovery:

STEP 3

Pre-clinical Development:

STEP 4

Clinical Development:

WE ARE AT STEP 3

Pre-clinical Development:

BX002 is a naturally occurring 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 to eradicate, have been exclusively provided to BiomX for phage eradication 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 in the cocktail showed phage diversity and indicated multiple mechanisms to eradicate the target bacteria. BX002 is now advancing to Pre-clinical development stage.

Inflammatory bowel diseases (IBD), which include 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.

GI Tract Associated Cancers
Harnessing Synthetic Biology

Step 1

Target Discovery:

STEP 2

Prototype Discovery:

STEP 3

Pre-clinical Development:

STEP 4

Clinical Development:

WE ARE AT STEP 2

Prototype Discovery:

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 the company.

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).

Immuno-oncology
Checkpoint Inhibitors

Step 1

Target Discovery:

STEP 2

Prototype Discovery:

STEP 3

Pre-clinical Development:

STEP 4

Clinical Development:

WE ARE AT STEP 1

Target Discovery:

Since the approval of the first checkpoint inhibitor therapy for cancer treatment in 2011, such approaches have 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.

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 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 project 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).

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