Twelve Israeli cancer patients will start taking pills containing fecal bacteria as part of a clinical trial aimed at seeing if the novel therapy will boost the effectiveness of immunotherapy.
Scientists from the Rehovot-based pharmaceutical company Biomica studied data on the bacterial balance in feces of a large number of cancer patients.
They concluded that certain bacteria are lacking in the guts of many of those who show a poor response to immunotherapy, and developed pills that contain the bacteria in question.
Biomica’s pills contain the same bacteria that were shown to be lacking in the feces studies — but grown in a lab environment.
The pills showed positive results in both animal testing and a pre-clinical trial with humans, and in the coming days will start a formal Phase I clinical trial at Rambam Health Care Campus in Haifa.
“In a sense we were assembling an A-Team of bacteria, and we’re optimistic about its potential,” Dr. Elran Haber, CEO of Biomica, told The Times of Israel.
The trial, which will test only the safety of the therapy, will focus on melanoma, kidney cancer and non-small cell lung cancers.
“We believe that by adding bacteria to the microbiome which boosts the immune system, we will enable doctors to use immunotherapy more effectively,” Haber said.
There is growing interest among doctors in the notion that altering the microbiome has the potential to fight cancer or improve the chances of cancer treatments working. In December 2020 research unconnected to Biomica’s doctors at Sheba Medical Center near Tel Aviv reported that three terminal cancer patients treated with pills of fecal matter saw their tumors shrink, and in one case disappear completely.
“The trial we are about to kick off at Rambam is for a drug based on a combination of four bacteria that normally live in the human body, and which perform certain functions in biological processes,” Haber said. “By providing the bacteria to patients who lack them, we are activating their immune system in a much more efficient manner, and we believe increasing the chance of immunotherapy proving effective.”
He said that his company started working on its drug soon after a flurry of research on the microbiome and cancer five years ago.
“In 2017 a number of papers were published exploring why, though immunotherapy revolutionized treatment for cancer patients, some respond and some don’t respond to it,” he said. “There was a focus on possible significance of the microbiome.”
“We decided we would like to add research. We did so by working with big data, which meant we were able to see a significant difference between microbiomes of people who respond and who don’t respond to immunotherapy, and look for ways to correct that.”