The move follows the merger it announced late last month with the NASDAQ listed, Longevity, a special purpose acquisition company (SPAC). 4D Pharma will become dual-listed and ordinary shares will continue to be traded on AIM.
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.
The merger is set to be completed and effective in early 2021, said the UK firm. But it is subject to approval by 4D Pharma and Longevity shareholders and it is also bound by the SEC review process.
The US listing is set to support and accelerate ongoing development of its live biotherapeutics, said the CEO, Duncan Peyton.
“It is a big step for 4D Pharma, it is a big step for any European biotech business to step across the Atlantic and become a US listed business. It is something we have worked on for a while,” he told BioPharma-Reporter.
The benefits are evident, he said. “We get access to strong healthcare funds that understand innovative technologies like live biotherapeutics, we get access to more capital."
4D Pharma, which was officially founded in 2014, is at a pivotal time in its growth and development, said the CEO.
4D Pharma's live biotherapeutic products (LBPs) are orally delivered single strains of bacteria that are naturally found in the healthy human gut, and it has developed a proprietary platform, MicroRx (R), that identifies live biotherapeutics based on a deep understanding of function and mechanism.
Its clinical programs target cancer, including a clinical collaboration with Merck, respiratory diseases such as COVID-19 and asthma, gastrointestinal diseases, and pre-clinical programs targeting neurological diseases like Parkinson’s disease and auto-immune diseases. It is also engaging in a vaccine research collaborative alliance with Merck.
Peyton said that despite the operational and economic challenges in 2020 created by the global pandemic, the biotech has made significant strides on several fronts.
“This includes 4D Pharma presenting clinical data for live biotherapeutics for the treatment of cancer in combination with Merck’s Keytruda, as well as positive Phase II results for the first drug candidate able to treat both IBS-C and IBS-D. In addition, earlier in 2020, 4D Pharma was able to quickly instigate a Phase II clinical trial in COVID-19 based on our detailed understanding of our asthma program.”
What are the big next steps, and what is the regulatory approval timeline looking like for 4D Pharma’s live biotherapeutics?
“That really depends on the pathway we take, in the coming weeks and months, in relation to our oncology program, in particular.
“We want to expand on the data we have seen recently in relation to oncology and IBS and take that through to approval trials.
“The IBS trial will probably take longer, as there is need to address a large patient population. The oncology space is slightly different, and there is [an option] to get an accelerated approval.”
Product registration is within reach then. “I would say we are just a couple of years, not a decade, away from approval.”
'A leader in the field'
4D Pharma is a leader in the field, he said. “From a research point of view, we are streets ahead.”
The company understands the mechanisms of action of its strains and can demonstrate that preclinically and in patients, he said.
Those capabilities are supported by nearly 1,000 granted patents. “I think we have a similar number of patents in development, and all of our IP is generated in-house, our team is pushing forward mechanistic understanding.”
And Merck’s engagement is a validation of 4D’s clinical pipeline and research capabilities, he added.
The company’s platform, he said, goes beyond just addressing diseases of the gut, to explore oncology and immune system related areas. “We are also starting to understand and unpick how our bacteria actually act on the gut-brain axis,” continued Peyton.
Such insights could potentially lead to innovation in the neurodegenerative disease field, he said.
Big Pharma involvement
And the CEO sees Big Pharma's attitudes to the live biotherapeutics field changing.
“We have been working with Merck, who I believe to be one of the most innovative of Big Pharma companies, for the past two and half years. We have been working with them on Keytruda, which is probably the biggest selling drug in the world right now, we are looking at how we can expand the patient groups into which Keytruda is active or regenerate a response for the drug, as it does not work in all patients. That is a signal of Merck’s belief in the microbiome.
“On top of that, Merck asked us to explore what we could do for it in relation to its vaccine business. We have that vaccine program [set up] now, we are doing all the research, and Merck will take it on from the preclinical stage.
“As we publish more data on oncology and IBS, we are getting more incoming calls.
“The landscape continues to change, some Big Pharma companies want to wait and see, others want to get involved and Merck is one of those.”
Clinical programs
4D Pharma has six clinical programs, namely a Phase I/II study of MRx0518 in combination with Keytruda (pembrolizumab) in solid tumors, a Phase I study of MRx0518 in a neoadjuvant setting for patients with solid tumors, a Phase I study of MRx0518 in patients with pancreatic cancer, a Phase I/II study of MRx-4DP0004 in asthma, a Phase II study of MRx-4DP0004 in patients hospitalized with COVID-19, and Blautix (R) in Irritable Bowel Syndrome (IBS) which has completed a successful Phase II trial.
Preclinical stage program include candidates for CNS disease such as Parkinson's disease and other neurodegenerative conditions.
