Our Pipeline

Customized phage therapies to eradicate
harmful bacteria in chronic diseases

Phage Discovery
Pre-Clinical
Phase I
Phase II
Phase III
Acne BX001 Phase II

Product Candidate Overview

BX001 is a topical gel formulation of a cocktail of naturally-occurring phage targeting Cutibacterium acnes (C. acnes) to improve the appearance of acne-prone skin.

In March 2020, BiomX announced positive topline results from its Phase 1 cosmetic placebo controlled clinical study of BX001 in subjects with acne-prone skin (see press release). The study met its primary endpoint of safety and tolerability for two doses of BX001, as well as a statistically significant (p=0.036) reduction of C. acnes levels for the high dose of BX001 compared to placebo. BiomX initiated a Phase 2 cosmetic clinical study with results from the 8-week time point expected in the third quarter of 2021 and full analysis including the 12-week time point expected in the fourth quarter of 2021. 

Unmet Need

Acne lesions are believed to result from an interaction of multiple pathogenic factors that bring about a perturbation of the balance of the skin microbiome. These include excessive sebum secretion due to hormonal triggers and clogging of hair follicles due to hyperkeratinization of pore openings. Both create optimal conditions for proliferation of C. acnes which then triggers inflammation of the pilosebaceous glands. Traditionally, both topical and oral antibiotics have been used in the treatment of acne. However, extensive use of antibiotics for acne in the last decades has caused an increase in antibiotic resistance with many countries reporting that over 50% of C. acnes strains are resistant to common topical antibiotics.

Mode of Action

BX001 targets C. acnes which are bacteria implicated in the pathophysiology of acne vulgaris. BX001 has been shown to be active on antibiotic resistant C. acnes strains and does not target other, potentially beneficial, bacteria on the skin. Furthermore, it has been observed to penetrate biofilms, a matrix secreted by the bacteria which surrounds them and makes them less accessible to substances such as antibiotics. Biofilms exist in the pilosebaceous unit, where undesirable C. acnes are found.

IBD/PSC BX003 Phase I

Product Candidate Overview

BX003 is an orally administered phage cocktail targeting a bacterial target present in the gut of IBD and PSC patients and thought to be associated with the onset or exacerbation of these diseases. Although different organs are affected in IBD and PSC (gut in IBD and liver in PSC) the two diseases are thought to be related since approximately 70% of PSC patients also suffer from IBD. Results from a pharmacokinetic and safety Phase 1a study demonstrated safety and tolerability with successful delivery of a high concentration of viable phage to the lower gastrointestinal tract. A Phase 1b/2a study aimed at evaluating the efficacy of BX003 in reduction of bacterial target with expected results by the end of H2 2022.

Unmet Need

Current IBD treatments address disease symptoms and consist mainly of anti-inflammatory and immunosuppressive therapies, depending on the patient’s disease severity. Response rates to the most advanced biological therapies are about 40-60%. In addition, many of the patients that do respond initially become refractory to a given therapy within 12-18 months and are required to switch to an alternative biological therapy.

PSC is a rare progressive liver disorder with no FDA-approved treatment. PSC affects approximately 30,000 patients in the U.S. It is characterized by inflammation and fibrosis of the bile ducts, which often results in the obstruction or interruption of bile flow from the liver, a condition known as cholestasis. Without a liver transplant, patients with PSC have a median survival period after diagnosis of nine to eighteen years. Even following liver transplantation, approximately 40% of patient experience recurrence of PSC disease

Mode of Action

BX003 targets bacterial strains of Klebsiella pneumoniae present in the gut of IBD and PSC patients. In two separate animal studies, different Klebsiella pneumoniae strains were shown to increase disease severity: colitis in IBD models and elevated liver enzymes and fibrosis in PSC models. The suggested underlying mechanism is induction of pro-inflammatory responses characteristic of these diseases, suggesting that these strains may have a role in the onset and aggravation of these diseases (see publication in Science and in Nature Microbiology  ). These strains were also shown to cause gut permeability or a “leaky gut” that may lead to inflammation in gut in IBD patients and microbial infection of bile ducts, resulting in inflammation and fibrosis within the liver of PSC patients. BX003 is characterized by a broad bacterial host range targeting Klebsiella pneumoniae strains present in the gut of both IBD and PSC patients.

Cystic Fibrosis BX004 Pre-Clinical

Product Candidate Overview

We are developing BX004, a phage therapy for CF patients with chronic Pseudomonas aeruginosa (P. aeruginosa) respiratory infections, a main contributor to morbidity and mortality in this disease. Results from a Phase 2 clinical study in CF patients aimed to demonstrate safety and efficacy are expected in Q4 2021.

Unmet Need

There are an estimated 30,000 CF patients in the US and 80,000 worldwide. The launch of new medications such as Trikafta and Symdeko, have improved the quality of life for CF patients; however, chronic, antibiotic resistant bacterial infection remains a main contributor to morbidity and mortality. P. aeruginosa is the most common and detrimental bacteria in lung infections of CF patients and it is estimated that approximately 30-50% of these patients suffer from chronic infections due to this bacterium.

Mode of Action

Chronic P. aeruginosa infection leads to epithelial surface damage and airway plugging, progressively impairing pulmonary function. CF patients chronically infected by P. aeruginosa show a steeper lung function decline, a higher number of pulmonary exacerbations, more hospital admissions and higher mortality than P. aeruginosa -free patients. P. aeruginosa infections usually start in childhood and following prolonged and repeated broad-spectrum antibiotic courses, enhanced resistance to antibiotics develops and leads to the appearance of multidrug-resistant (MDR) strains. In preclinical in vitro studies, BX004 was shown to be active against antibiotic resistant strains of P. aeruginosa and demonstrated the ability to penetrate biofilm, an assemblage of surface-associated microbial cells enclosed in an extracellular polymeric substance and one of the leading causes for antibiotic resistance.

Atopic Dermatitis BX005 Pre-Clinical

Product Candidate Overview

We are developing BX005, a topical phage cocktail that targets Staphylococcus aureus (S. aureus), a bacteria associated with the manifestation of the disease. This program leverages know-how and capabilities acquired under our program for acne-prone skin with regard to topical formulation and clinical testing. In preclinical in vitro studies, BX005 was shown to be active against over 90% of strains of S. aureus isolated from the skin of subjects from U.S. and Europe, including antibiotic resistant strains. Results from a Phase 2 clinical study in AD patients aimed to demonstrate safety and efficacy are expected in the first half of 2022.

Unmet Need

Companies active in the dermatology space are aware of the enormous patient potential in the AD market. The approval of Dupixent has transformed the treatment of AD and has addressed the unmet need of treating severe refractory patients. Nevertheless, systemic treatments have multiple side effects and there remains an enormous opportunity in the topical treatment arena for patients who are not candidates for systemic therapies, including patients suffering from mild to moderate disease and pediatric patients whose parents are particularly wary of the safety aspects of treatment and are seeking safe and natural alternatives.

Mode of Action

The relationship between AD and skin bacteria has led to different anti-microbial treatment approaches including the use of bleach baths. On the background of predisposing factors, Staphylococcus aureus (S. aureus) is thought to contribute to development and exacerbation of inflammation in AD skin through release of various virulence factors that affect both keratinocytes and immune cells. S. aureus is more abundant on the skin of AD patients than non-AD individuals and in lesional skin than non-lesional skin. It also increases in abundance, becoming the dominant bacteria, when patients experience flares. By reducing the load of S. aureus, our phage therapy is intended to shift the skin microbiome composition to its ‘pre-flare’ state and provide a clinical benefit.

Colorectal Cancer Pre-Clinical

Product Overview

Our colorectal cancer program utilizes engineered phage with various payloads (such as immunostimulatory payloads) that are administered intravenously to target Fusobacterium nucleatum bacteria residing within the tumor microenvironment. The aim of payload delivery is to convert cold tumors to hot tumors with activated immune responses. Proof of concept in animal models for our colorectal cancer phage therapy approach in combination with checkpoint inhibitors is expected in Q2 and Q3 of 2021.

Unmet Need

The majority of colorectal cancer tumor types are cold tumors, meaning that they respond poorly to most immuno-oncology therapies because they are largely devoid of immune cells. Various methods are being investigated with the intent of turning ‘cold’ tumors into ‘hot’ tumors. The underlying premise behind most of these methods is to both induce immune activity in the tumor and expose tumor antigens that can be recognized by the immune system.

Mode of Action

Recent studies have shown that Fusobacterium nucleatum is enriched in colorectal cancer tumors, binds to tumor cells and may play a pathologic role by protecting the tumor from the host’s immune system. We have demonstrated that IV-administered Fusobacterium-targeting phage could reach and successfully infect intra-tumoral F. nucleatum in a mouse model of colorectal cancer. We are currently engineering these phage to carry various therapeutic payloads with the aim of converting ‘cold’ tumors to ‘hot’.

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