BiomX Announces Publication in Cell of Research Demonstrating Proof-of-Concept Evaluation of Orally-Administered Phage Therapy in a Preclinical Model of Inflammatory Bowel Disease

BRANFORD, Conn. & NESS ZIONA, Israel–(BUSINESS WIRE)–BiomX Inc. (NYSE American: PHGE) (“BiomX”), a microbiome company developing novel natural and engineered phage therapies that target specific pathogenic bacteria, today announced the publication of a scientific article entitled “Targeted suppression of human IBD-associated gut microbiota commensals by phage consortia for the treatment of gut inflammationin the review, Cell. The research was conducted at several organizations, including scientists from BiomX and the Weizmann Institute of Science (Rehovot, Israel).

This research is based on previous work by Professor Honda et al. from Keio University (Tokyo, Japan) identifying strains of Klebsiella pneumoniae (“Kp”) as a potentially pathogenic bacterium in IBD. By examining four geographically distinct cohorts of IBD (n=537), the researchers identified a clade of kp strains, showing unique antibiotic resistance and a mobilome signature strongly associated with IBD exacerbation and severity. These strains were then transferred into germ-free and colonized colitis-prone mice to improve gut inflammation. The researchers then demonstrated a proof-of-concept assessment of Kp-targeting phages by generating an orally-administered 5-lytic phage combination product specifically designed to target members of the Kp clade associated with susceptible and resistant IBD through mechanisms distinct. The 5-phage lytic treatment provided effective suppression of Kp in colitis-prone mice and attenuated inflammation and disease severity.

Additionally, the research initially tested the Kp-targeting phage in a ex-vivo human intestinal system and then in a first-in-man, randomized, single-blind, placebo-controlled clinical trial. Both phage therapies were stable, resistant to changing biophysical conditions along the human gastrointestinal tract, resulting in accumulation of viable phage at doses thought to suppress Kp2 in patients with IBD.

IBD is a chronic inflammatory autoimmune disease affecting the gastrointestinal tract and 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 patients with IBD and primary sclerosing cholangitis (“PSC”). As stated in the research, the results of the Phase 1a study demonstrated the safety and tolerability of the administered phages as well as the successful delivery of a high concentration of viable phages to the lower gastrointestinal tract, consistent with data generated in a human gut-like system.

“We are very pleased to announce the publication of these validating research results in one of the world’s leading scientific publications,” said Professor Eran Elinav, MD, of the Weizmann Institute and scientific co-founder of BiomX. “This research not only supports our BX003 program in IBD, which also targets Kp bacteria, but also demonstrates how industry and leading academic researchers can effectively collaborate to help develop new treatment approaches for challenging diseases. treat.”

About BX003

BX003 is an orally administered phage cocktail targeting a bacterial target present in the gut of patients with IBD and PSC and thought to be associated with the onset or exacerbation of these diseases. Although different organs are affected in IBD and PSC (bowel in IBD and liver in PSC), the two diseases are believed to be related since approximately 70% of patients with PSC also suffer from IBD. Results from a Phase 1a pharmacokinetic and safety study demonstrated safety and tolerability with successful delivery of a high concentration of viable phage to the lower gastrointestinal tract. Currently, development efforts on BX003 are temporarily suspended.

About BiomX

BiomX is a clinical-stage microbiome company that develops natural and artificial phage cocktails designed to target and destroy bacteria in the treatment of chronic diseases. BiomX discovers and validates proprietary bacterial targets and customizes phage compositions against those targets.

Additional information is available at www.biomx.comthe content of which does not form part of this press release.

safe port

This press release contains express or implied “forward-looking statements” within the meaning of the “safe harbor” provisions of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by words such as: “target “, “believe”, “expect”, “will”, “may”, “anticipate”, “estimate”, “would”, “position”, “future”, and other similar expressions that predict or indicate future events or trends or which are not statements of historical matters. For example, when BiomX discusses the potential ability of BX003 to target bacterial strains of Kp, as well as the resumption of BX003 development efforts, their timing, and any potential results in future clinical trials of BX003, BiomX makes forward-looking statements. Forward-looking statements are neither historical facts nor guarantees of future performance. Instead, they are based solely on the current beliefs, expectations and assumptions of BiomX management. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and many of which are beyond BiomX’s control. Actual outcomes and results may differ materially from those indicated in the forward-looking statements. Accordingly, investors should not rely on any such forward-looking statements and should consider the risks and uncertainties described under “Risk Factors” in BiomX’s Annual Report on Form 10-K filed with the Securities and Exchange. Commission (the “SEC”) on March 30, 2022 and additional disclosures BiomX makes in its other filings with the SEC, which are available on the SEC’s website at Forward-looking statements are made as of the date of this press release and, except as otherwise required by law, BiomX expressly disclaims any obligation or undertaking to update any forward-looking statements.

Jacob L. Thornton