BiomX has had a very rapid growth back in 2020, and this allowed the company to move towards addressing unmet medical conditions. The company’s rapid development was fueled by the capabilities of their novel BOLT (BacteriOphage Lead to Treatment) platform, which uses bacteriophages, instead of antibiotics, in bacteria-targeting therapies. BOLT develops phages within six to eight weeks, which target specific bacteria in a tailormade manner to be administered to patients. As a result, their product pipeline programmes have expanded.
BX004 for Cystic fibrosis (CF)
BX004 is a carefully selected phage cocktail aimed to target Pseudomonas aeruginosa, the main contributor of chronic lung infections in cystic fibrosis patients. In the preclinical in vitro studies, the BX004 showed to be active against the antibiotic-resistant Pseudomonas aeruginosa strains, as well as demonstrating the ability to penetrate the biofilm.
The Phase 2 proof-of-concept trial will be testing the BX004 as a nebulized therapeutic treatment, against a placebo in 40 cystic fibrosis patients with chronic Pseudomonas aeruginosa infections. The treatment would be given for 7 to 10 days. The efficacy would be evaluated through changes in bacterial counts, measures of lung function, and quality of life in patients. Results of Phase 2 clinical trials assessing safety and efficacy of BX004, to be published by end of 2021.
BX005 for Atopic dermatitis (AD)
The BX005 bacteriophage cocktail contains a selection of phages that target Staphylococcus aureus, which develops and exacerbates the inflammation in patients with atopic dermatitis, the most common type of eczema. In the preclinical in vitro studies, the BX005 showed to be active against over 90% of Staphylococcus aureus strains, including those that were antibiotic-resistant, that were isolated from the skin of patients in the US and Europe.
Phase 2 proof-of-concept clinical study expected to initiate in the second half of 2021.
BX003 for Inflammatory bowel disease (IBD) and Primary sclerosing cholangitis (PSC)
BX003 is an oral phage cocktail containing carefully selected phages that target Klebsiella pneumoniae, known to be the main pathogen causing irritable bowel disease, as well as another chronic condition that affects the bile ducts, known as primary sclerosing cholangitis. The Phase 1 clinical trial of BX002 was evaluated in 18 healthy volunteers. 14 of the participants were given investigational therapy twice a day for three days, the remaining 4 participants were given a placebo. All participants were monitored for a week and additional follow-up safety assessments were done at weeks 2 and 4 after treatment.
The safety-related results of the investigational study were positive, with no serious adverse events reported during and after the study. The results of the study also demonstrated that the oral administration of approximately 10 billion plaque-forming units of phages into the gut was successful, as it is 1,000 times more than the amount of Klebsiella pneumoniae found in the stool samples of patients suffering from irritable bowel disease or primary sclerosing cholangitis.
Based on the positive results of BX002, Phase 1b/2a study of BX003 will evaluate a similar bacteriophage oral cocktail targeting Klebsiella pneumoniae. The results of this study are expected by mid-2022.
BX001 for Acne-prone skin
The BX001 is a bacteriophage cocktail in a topical gel formulation targeting Cutibacterium acnes (C. acnes). Phase 2 cosmetic clinical trials initiated and the results expected in Q3 2021. Read more about BX001.
Treatment for Colorectal cancer
The company is also exploring phage-mediated delivery payload for the treatment of colorectal cancer, such as; immune-stimulating protein, GM-CSF, and IL-15 to target Fusobacterium nucleatum, commonly found in colorectal tumors. In December 2020, preclinical results confirmed the presence of Fusobacterium nucleatum in 80% of tumor samples collected from patients suffering from colorectal cancer, at the European Society of Medical Oncology (ESMO) Immuno-Oncology Virtual Congress. BiomX has successfully engineered an IL-15 gene payload into Fusobacterium nucleatum phage and disclosed data from preclinical models that demonstrate the efficiency of the intravenously administrated phage, to have the ability to target Fusobacterium nucleatum, inside colorectal tumors.
Preclinical results from animal studies that evaluate the use of phage therapy in combination with checkpoint inhibitors are expected to be published in the second and third quarters of 2021.
BiomX Inc. is a clinical-stage microbiome company that is advancing novel natural and engineered bacteriophage therapies that target specific pathogenic bacteria. Additional information is available at https://www.biomx.com/.