And we’re dosing that in patients who have been newly diagnosed with solid tumours. We’re seeing the ability for MRx0518 here, which is our lead oncology programme, to reengage the immune system to work in combination with Keytruda when it stops working – but we’re also seeing quite a nice profile for 0518 as a monotherapy. What we’re able to do is reengage the immune system, so the drug works again. And if it does work, what quite often happens is the response wanes or stops, and the drug stops working. It’s a fantastic therapy for things like non-small cell lung and renal cell carcinoma, but it only works in a certain percentage of patients. If we can see how the bacteria is interacting with the host and turning the immune system on or off, we can then dive into the bacteria itself and start to figure out, how is it doing that? Really just unpicking what the bacteria does.ĭJ: What diseases are 4D’s live therapeutic products being developed for? Have any areas shown particular promise?ĭP: Where we’re really pushing forward is in oncology, particularly in combination with checkpoint inhibitors such as Keytruda. You need a library of bacteria to be able to screen, so a lot of work and a lot of time and effort has gone into isolating the strains of bacteria that we put to our library, which is the beginning of the MicroRx process, if you like. And that’s really the crux of the engine. So, what we’re able to do is look at how the single strand of bacteria interacts with host cells what gene patterns are switched on, what cytokine patterns it switches on or off, what the bacteria produces, and how that interacts with the host cell. I’m interested in the functionality and the mechanism of action, not of a small molecule, not of a protein or a biologic, but of a single strand of bacteria. So, that was the reason that we got into it, we wanted to deliver to clinicians and to patients drugs that were effective, but also really safe.ĭJ: How does the company’s MicroRx platform work?ĭP: Really simply, it’s exactly like the normal drug development process. We’ve over 500 patients now, and we haven’t seen any serious adverse events, so it’s got a really nice, clean, safety and toxicity profile. Our thesis was, if they’re using the microbiome, and it was a single strain harvested from a healthy human, it should be safe and it should be well tolerated. We saw some research from a group at Aberdeen University, and they showed that the microbiome could modulate the immune system. And we were thinking, wouldn’t it be great if you could develop a drug that didn’t have those off-target effects, or any toxicity issues? It’s a fantastic drug, worked really well, except for some side effects and some toxicity issues. Alex, who’s the other founder of the business, and I were developing a drug for Dravet syndrome, which is this extreme form of epilepsy. Why did 4D Pharma choose to pursue this area?ĭuncan Peyton: We started looking into this, probably, in 2011. Darcy Jimenez: Research into microbiome-based therapies is still in the early stages.
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