Rare Daily Staff

BiomX, a clinical-stage microbiome company advancing novel natural and engineered phage therapies that target specific pathogenic bacteria, said it will receive a Therapeutics Development Award of up to $5 million from the Cystic Fibrosis Foundation.

“The funding provided by the CF Foundation will be used to support the development of our phage therapy product candidate for CF patients, BX004, through its phase 1b/2a study and represents a continuation of the CF Foundation’s mission to bring potentially life-saving medicines to patients,” said Jonathan Solomon, CEO of BiomX.

Under the terms of the agreement with the CF Foundation, BiomX will receive up to $5 million in two tranches. In the first tranche, which closed on December 21, 2021, the CF Foundation invested $3 million as initial equity investment. Upon completion of patient dosing in Part 1 of the company’s phase 1b/2a study of BX004, BiomX would have the right to receive the second tranche of $2 million, also as an equity investment.

Cystic fibrosis (CF) is a rare, life-shortening genetic disease. It is caused by mutations in the CFTR gene that lead to a defective or missing cystic fibrosis transmembrane conductance regulator (CFTR) protein. Children must inherit two defective CFTR genes—one from each parent—to have CF. There are approximately 2,000 known mutations in the CFTR gene. The defective function or absence of CFTR protein results in poor flow of salt and water into and out of the cell in a number of organs. In the lungs, this leads to the buildup of abnormally thick, sticky mucus that can cause chronic lung infections and progressive lung damage in many patients that eventually leads to death. The median age of death is in the early 30s.

BiomX is developing BX004 for the treatment of chronic respiratory infections in CF patients caused by Pseudomonas aeruginosa, a main contributor to morbidity and mortality in patients with CF. In September 2021, BX004 was cleared by the U.S. Food and Drug Administration to initiate a phase 1b/2a trial in CF patients with chronic respiratory infections caused by Pseudomonas aeruginosa.

The phase 1b/2a trial of BX004 is composed of two parts and is expected to start imminently. Part 1 of the trial 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 second quarter of 2022. Part 2 of the trial 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 by the third quarter of 2022.

Photo: Jonathan Solomon, CEO of BiomX

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