A phase 1 clinical trial is underway for Biomica's new cancer drug BMC128, which is expected to help patients who do not respond to immunotherapy.

A clinical trial has been launched by an Israeli company to test the effectiveness of a microbiome-based therapy on cancer patients.

The microbiome is a collection of trillions of bacteria that live in the intestine and play a key role in digestion, immunity, and other health functions.

Last month at Rambam Health Care Campus in a Phase I clinical trial, Biomica, a subsidiary of Evogene, administered its first patients with a new drug - BMC128 - intended to help patients who cannot respond to immunotherapy. The company hopes to demonstrate the safety, tolerability, and preliminary clinical effectiveness of its BMC128 immuno-oncology drug candidate in combination with immune checkpoint inhibitors (ICIs).

According to its parent company's "MicroBoost AI" tech engine and big-data platform, BMC128 includes a "rationally designed consortium of microbes" -- four unique bacterial strains. Microbes are designed to restore a variety of microbial communities in the patient's body, improving the immune system's response to immunotherapy.

"This drug has a similar concept to probiotics but uses a smaller, more precise number of bacteria, allowing it to be more effective and safer," Biomica CEO Dr Elran Haber said. "ICIs have demonstrated their effectiveness in prolonging the lives of cancer patients," he added. However, many patients who receive ICI are resistant, and it has been shown that their gut microbiome plays a major role in this. Having achieved compelling preclinical results, we are eager to evaluate BMC128 in a clinical setting for the first time."

Haber also mentioned that BMC128 is administered as a pill. Patients receive the drug daily in conjunction with their immunotherapy treatments, which are usually administered every four weeks.

Around a dozen patients with non-small cell lung cancer, melanoma, or renal cell carcinoma are expected to participate in the trial. As the trial is open-label, preliminary results are expected in 2023 and full results in 2024.

A successful preclinical trial in mice kicked off the trial. BMC128 combined with immunotherapy reduced tumour volume and improved survival of animals compared to treatment with immunotherapy alone, according to those experiments.

The drug also activated immune cells known to destroy cancerous tumours when given to patients.

"In the past, most cancer patients were treated with chemotherapy, which is not very efficient and has aggressive side effects," Haber said. "Immunotherapy was a revolution for cancer patients when it was introduced. However, many cancer patients do not respond to this treatment. We need to know why. There is reason to believe that a person's microbiome affects their response to immunotherapy."

Furthermore, the company is evaluating microbiome treatments for gastrointestinal diseases, such as inflammatory bowel disease, irritable bowel syndrome, and infectious diseases. The convergence of computational science and AI makes Biomica unique.

Haber compared the way Biomica identifies microbes to understanding the staff at a coffee shop. Haim, Yossi, and Adi work in a coffee shop, and Biomica knows their roles: shift manager, waiter, or bartender. It also knows that Yossi can fill in for Haim if he is absent.

According to Haber, "Each bacterium in a microbiome has a different role based on the total mix of bacteria in which it is found, as well as a specific function. By using our computational technology, we can identify the specific bacteria and what they do."

Evogene was one of the first Israeli computational biology companies listed on Nasdaq. Today, it is leading a revolution in discovering and developing products for industries based on life sciences, not just in the human health arena, but also in agriculture.

Haber said microbiome drugs are miraculous because of the fact that they do not require genetic modification. There have been almost no reports of serious adverse effects or adverse reactions to the treatments so far. The next step is for Biomica to be able to predict if patients will respond to immunotherapy and then start their treatment with BMC128 and immunotherapy. If the Phase I, Phase II, and Phase III trials are successful, it should take between five and ten more years for BMC128 to reach the market.

It's just the beginning

US Food and Drug Administration has yet to approve a microbiome drug, but American-based Seres Therapeutics has applied for approval.

The FDA is expected to approve Biomica's drug by mid-2023. There are several microbiome drug companies conducting Phase II and Phase III trials now, and Haber expects that other companies will be approved soon.

As Seres' senior clinical advisor, Dr. Roger Pomerantz developed 12 approved small and large molecules.

A new-born’s microbiome is inherited through the mother when he or she is delivered vaginally, but scientists didn't fully comprehend its significance until about 15 years ago. As a result, they now see it as an organ. According to him, the microbiome plays a crucial role in bodily functions. "Keeping a person's microbiome sterile will not make them sick but it will kill them, your microbiome is just as important as any other organ," he added.

Microbiomes have been shown to affect tumours, autoimmune diseases, gastrointestinal disorders, and even some neurological disorders over the years. The objective of companies like Seres is to develop entirely new classes of potential medicines based on microbiomes.

"The big question is what else we can do with this organ," Pomerantz said. "The microbiome is just the tip of the iceberg. More is to come, I believe."

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