4D Pharma expanding clinical data in multiple indications

By Jane Byrne contact

- Last updated on GMT

© GettyImages/Design Cells
© GettyImages/Design Cells

Related tags: Bacteria, Microbiome, Oncology, neurodegenerative diseases, MSD

Live biotherapeutic product (LBP) developer, 4D Pharma, says it is building a ‘strong body of evidence’ for its portfolio of bacterial strains in relation to cancer, asthma, and neurodegenerative diseases, while the company also calls its recent dual listing a ‘transformational milestone’.

We are bringing the company to the next level,”​ said CEO, Duncan Peyton, referencing both the growing scientific data, new partnerships, and a NASDAQ listing in March this year for 4D Pharma.

“We are now dual listed. It was a big start to the year. We started that process in summer 2020 and it culminated on March 22 with our name up in lights in Times Square.”

Quite an achievement then given the constraints imposed on business during the past 18 months:

“If you had asked me whether I could list a company on NASDAQ without having met any bankers or fund managers face to face and without being in the US at least twice a month, I would have said we couldn’t. But we did it. In fact, I think it was much more efficient in how it was done, even if there were a lot of online meetings with advisers late into the night, using Teams and Zoom. When the meetings were finished, we got straight into drafting documents, etc. It was time effective, and there was no travelling involved. I really recommend doing it that way.”

And during the past year, 4D Pharma has made further strides in applying its microbiome research to areas such as oncology and neurodegenerative diseases, he said.

Live biotherapeutics, a novel class of drug derived from the microbiome, are defined by the US Food and Drug Administration (FDA) as being biological products that contain a live organism, such as a bacterium, that is applicable to the prevention, treatment or cure of a disease.

Preclinical-stage programs include candidates for CNS diseases such as Parkinson's disease and other neurodegenerative conditions; the company has been doing a lot of work with the Michael J Fox Foundation, and in April it announced a collaborative alliance with Parkinson’s UK, a non-profit organization, to establish a patient advisory board.

It continues to progress plans for a first-in-human clinical trial in Parkinson’s disease patients of its oral single strain LBP.

The company has been building clinical data in multiple indications: “We really think [the focus] on the microbiome is [enabling] a revolution in drug development, being able to discover and develop safe and innovative new drugs. What we are doing in oncology is a great example of that and what we are going to do in neurodegeneration will further prove the point. That is a disease area where we’ve, historically, as an industry, failed and yet it is a huge problem, and we are really excited by what we are seeing there.”

Collaboration with Merck KGaA and Pfizer

The LBP developer also continues to strengthen its alliances with leading industry players.

In February this year, 4D pharma announced a clinical trial collaboration and supply agreement with Germany’s Merck KGaA and Pfizer to evaluate its MRx0518 in combination with BAVENCIO (avelumab) for the treatment of locally advanced or metastatic urothelial carcinoma.

MRx0518 is single strain LBP in development for the treatment of cancer. The product is currently being evaluated in three clinical trials in patients with cancer.

MRx0518-I-001 is a neoadjuvant monotherapy study in a variety of solid tumors and is being conducted at Imperial College London. MRx0518-I-002 is in combination with KEYTRUDA (pembrolizumab) in patients whose disease has previously progressed on anti-PD-1 therapies. It is being conducted in collaboration with MSD; the coordinating investigator of that study is based at the University of Texas MD Anderson Cancer Center, Houston, and there are multiple additional sites in the US.  The study - MRx0518-I-003 - is assessing the LBP in combination with preoperative radiotherapy in resectable pancreatic cancer.  

“What we are demonstrating is that MRx0518 has this really unique property to enhance the innate and adaptive immune system and increase tumor infiltrating lymphocytes (TILs), to stimulate systemic proinflammatory cytokines and chemokines, and upregulate a number of the biological pathways that are associated with an anti-tumor response.

“We have seen that in the KEYTRUDA setting, where patients have pretty much failed everything else, they have had a checkpoint inhibitor, they have stopped responding to that, and what we are able to do is reignite the immune system, to help the checkpoint inhibitor be more effective,” ​said Peyton.

The application will be the same in terms of the BAVENCIO study, which is at an earlier treatment stage, and is scheduled to go ahead early next year.

“It will add to the weight of evidence that we are already building with MRx0518 and we have got other bacteria coming through directed at the oncology setting as well.”

The data, so far, shows that the microbiome “is and will play a significant role in how we think about and how we treat [cancer] going forward,”​ said Peyton.

Asthma treatment

Earlier this month, 4D Pharma also announced the completion of its target enrollment of 30 patients for Part A of its Phase I/II clinical trial of its MRx-4DP0004 strains in patients with partly-controlled asthma.

“We have a data readout coming out on those patients over the summer period, and that is going to be interesting. Clearly, we are looking at safety, but we understand it is going to have a strong safety profile. We will be looking at other markers as well to get an indication of whether it is having the desired effect on the immune system. The data readout should give us an idea as to whether what we saw in the pre-clinical work is translating into the clinic.”

MRx-4DP0004 is an oral, immunomodulatory, single strain LBP. 4D Pharma said it has demonstrated MRx-4DP0004's ability to reduce airway inflammation in a pre-clinical model of severe asthma; that is achieved through a concurrent reduction in both neutrophilic and eosinophilic infiltration and inflammation, it added.

The company is also continuing to build its IP portfolio: “We have over 1,000 granted patents now.”

As regards its vaccine work with MSD, using its MicroRx platform, to discover and develop LBPs as novel vaccine, he said that company gained some really useful insights into the microbiome, its potential. “Over the next year, we will refocus that work, as we have finished a major part of that project with MSD.” ​He anticipates application in additional pharmaceutical areas. “So, overall, an exciting year ahead.”

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