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BiomX announced positive results from Part 1 of the Phase 1b/2a trial evaluating the Company's novel phage cocktail, BX004, for the treatment of chronic pulmonary infections caused by Pseudomonas aeruginosa, or P. aeruginosa, in patients with cystic fibrosis, or CF. "We are very excited to share these positive results from Part 1 of our Phase 1b/2a CF study," said Jonathan Solomon, CEO of BiomX. "Although Part 1 of the study was designed primarily to assess safety and tolerability of BX004, a goal that was achieved, we are highly encouraged to see preliminary evidence of efficacy in patients treated with BX004 despite the small sample size and short duration of treatment. At Day 15, mean P. aeruginosa burden was reduced by 1.42 log10 CFU/g compared to 0.28 log10 CFU/g in those receiving placebo. The BiomX Phase 1b/2a clinical trial is the first reported double blind placebo-controlled study evaluating a cocktail-based phage product to demonstrate notable reductions in bacterial burden in cystic fibrosis. Based on the favorable safety profile in Part 1, as confirmed by the Data Monitoring Committee, we have already dosed patients in Part 2 of the Phase 1b/2a study and expect to report results in the Q3 of 2023. Highlights Included: No safety events related to treatment with BX004, Mean P. aeruginosa colony forming units at Day 15: -1.42 log10 CFU/g vs. -0.28 log10 CFU/g. This reduction was seen on top of standard of care inhaled antibiotics; Phages were detected in all patients treated with BX004 during the dosing period, including in several patients up to Day1; no phages were detected in patients receiving placebo; There was no emerging resistance to BX004 during or after treatment with BX004.

BiomX announced the publication of a scientific paper titled "Targeted suppression of human IBD-associated gut microbiota commensals by phage consortia for treatment of intestinal inflammation" in the journal, Cell. The research was conducted across several organizations, including scientists from BiomX and the Weizmann Institute of Science. This research is based on prior work by Prof. Honda et al. from Keio University identifying strains of Klebsiella pneumoniae as potentially disease-causing bacteria in IBD. Looking across four geographically distinct IBD cohorts, researchers identified a clade of Kp strains, featuring a unique antibiotics-resistance and mobilome signature that were strongly associated with IBD disease exacerbation and severity. These strains were then transferred into colitis-prone germ-free and colonized mice to enhance intestinal inflammation. Researchers then demonstrated proof-of-concept assessment of Kp-targeting phages by generating an orally administered, lytic 5-phage combination product specifically designed to target sensitive and resistant IBD-associated Kp clade members through distinct mechanisms. The lytic 5-phage treatment enabled effective Kp suppression in the colitis-prone mice and drove attenuated inflammation and disease severity. Furthermore, the research initially tested Kp-targeting phage in an ex-vivo human gut system and then in a first-in-human, randomized, single-blinded, placebo-controlled clinical trial. Both phage therapies were stable, withstanding shifting biophysical conditions along the human gastrointestinal tract, resulting in accumulation of viable phages in doses expected to enable Kp2 suppression in IBD patients. IBD is a chronic, inflammatory autoimmune disease impacting the gastrointestinal tract, and the bacteria, Klebsiella pneumoniae, has been implicated in the pathogenesis of the disease. BiomX's novel phage candidate, BX003, targets bacterial strains of Kp present in the gut of IBD and primary sclerosing cholangitis patients. As outlined in the research, results from Phase 1a study demonstrated safety and tolerability of the administered phages as well as successful delivery of a high concentration of viable phage to the lower gastrointestinal tract, in alignment with data generated in a human-gut like system.

BiomX announced that it is voluntarily delisting its shares of common stock from trading on the Tel Aviv Stock Exchange, or TASE. Based upon a review of the recent trading volume of BiomX's common stock on the TASE and the costs associated with maintaining a presence on more than one stock exchange, BiomX's management and its board of directors have concluded that it would be in the best interests of shareholders to have BiomX's common stock listed on a single stock exchange. Under applicable Israeli law, the delisting of BiomX's shares of common stock from trading on the TASE is expected to become effective in three months, on October 6. During this time, BiomX's shares will continue to be traded on the TASE. Following the delisting of BiomX's shares of common stock on the TASE, BiomX's shares will continue to be listed on the NYSE American and all BiomX shares now traded on the TASE are expected to be transferred to the NYSE American where they can continue to be traded.

BiomX announces a new collaboration with Boehringer Ingelheim to identify biomarkers for inflammatory bowel disease, or IBD. BiomX is a clinical-stage microbiome company advancing novel natural and engineered phage therapies that target specific pathogenic bacteria. Under the collaboration BiomX will utilize its XMarker microbiome-based biomarker discovery platform with the goal of identifying biomarkers for a pathogenic bacterium thought to be associated with IBD. Such biomarkers could help identify IBD patients that would benefit from potential therapies targeted at the microbiome. In September 2020, Boehringer Ingelheim and BiomX entered into their first collaboration, which focused on identifying biomarkers associated with patient phenotypes in IBD. The terms of the collaboration entitle BiomX to research payments and also include an option for Boehringer Ingelheim to negotiate an exclusive right to biomarkers discovered under the collaboration. BiomX retains the right to utilize the biomarkers as companion diagnostics for phage therapy.

BiomX announced the dosing of the first two patients in the Company's Phase 1b/2a study evaluating BX004 for the treatment of chronic respiratory infections in patients with cystic fibrosis, CF. "We are pleased to reach this important clinical milestone in our cystic fibrosis program," said Jonathan Solomon, Chief Executive Officer of BiomX. "In prior in vitro studies, BX004, a novel phage cocktail targeting P. aeruginosa, demonstrated activity against antibiotic resistant strains of P. aeruginosa, as well as enhanced biofilm penetration compared to antibiotic therapies. In the first part of this study, we will assess the safety, pharmacokinetics, and clinical activity of BX004 in eight CF patients, and we look forward to discussing these data in the third quarter of 2022." BiomX is developing BX004 for the treatment of CF patients with chronic respiratory infections caused by Pseudomonas aeruginosa, a main contributor to morbidity and mortality in patients with CF. The Phase 1b/2a study of BX004 is composed of two parts. Part 1 of the study will evaluate the safety, pharmacokinetics, and microbiologic/clinical activity of BX004 in eight CF patients in a single ascending dose and multiple dose design, with results expected in the third quarter of 2022. Part 2 of the study will evaluate the safety and efficacy of BX004 in 24 CF patients randomized to a treatment or placebo cohort in a 2:1 ratio. Results from Part 2 are expected in the first quarter of 2023.