First in Human Episode #25 featuring Dr. Paul Lammers 

For episode 25, we sit down with Dr. Paul Lammers, CEO of Triumvira Immunologics. Stay tuned to learn why having multiple programs in clinical trials can provide a safety net should one program fail and how it adds additional value for investors. First In Human is a biotech-focused podcast that interviews industry leaders and investors to learn about their journey to in-human clinical trials. Presented by Vial, a tech-enabled CRO, hosted by Simon Burns, CEO & Co-Founder & guest host Co-Founder, Andrew Brackin. Episodes launch weekly on Tuesdays & Thursdays.

Simon Burns: [00:00:00] Dr. Paul Lammers, thank you for joining us on First in Human.

Dr. Paul Lammers: You’re welcome, Simon, great to be here.

Simon Burns: First off, tell us a little about yourself and what you’re up to with Triumvira Therapeutics, and what you’ve been building. 

Dr. Paul Lammers: Yeah, that’s great. Just a quick background, I’m a physician and biologist by training. But, I’ve been in pharma biotech for 34 years now in 2023. I’ve been involved in a lot of different therapeutic areas, but also, I was involved in quite a few products who got FDA approval, which is exciting.

The last 12-13 years, I’ve been really focused on oncology and cancer therapies, because at the end of the day, the reason you’re in drug development is you want to make a difference in a patient’s life. What better way to do it than try to solve a disastrous disease like cancer? So it’s great to do that.

At Triumvira, I was initially thinking about joining the company. I was intrigued by cell therapy, which is up-and-coming right now; one of the hottest areas in immuno-oncology. The reason it makes it so interesting is that it’s almost the ideal personalized medicine.

I joined Triumvira in January 2018. At that time, there were two scientists in McMaster University in Hamilton, Ontario out of the lab of Jonathan Bramson where the technology came forth. Right now, we have 75 people spread. We have 60% US, 40% in Canada. It’s great to build a team and keep moving.

The nice thing is we’re basically developing both, autologous or patient-derived and allogeneic or off-the-shelf, donor-derived cell therapies directed especially against solid. tumors. Which is a very difficult area to work and operate in, but it has the greatest opportunity. Initially, we started off looking at hemolytic disease with targets like CD19 and BCMA. However, those areas became so crowded that especially with our investors, with our directors on the board decided, why don’t we switch directions, and make solid tumors our primary target?

Our first programs in the clinic were targeting HER2, which is a very well-known target expressed on solid tumors, especially breast cancer or gastric cancer and other cancer types. Later this year, we’re starting our first clinical trial against CLDN18.2. That is an interesting new target especially in gastric cancer, pancreatic cancer, and gastroesophageal cancers. And we have two others behind that in GUCY2C and GPC3 in the coming years. We’ll do quite a few clinical trial launches this year and the next few years.

Right now, we’re still working autologous, patient-derived. Also, next year we hope to bring our first allo, or off-the-shelf, program into the clinic as well.

Simon Burns: It’s so very exciting. You announced recently a partnership to do some work in combination with Keytruda with Merck. Tell us a little bit more about that, and then for small biotech companies hoping to partner with pharma, what advice do you have for them on navigating that ecosystem? 

Dr. Paul Lammers: There is a good scientific rationale why you want to combine a cell therapy like ours with Keytruda or pembrolizumab, that’s the name of the drug. Tumors are really smart. What they do normally is they try to minimize the patient’s own immune system to be effective against cancer cells. So, they put these brakes in place. The brake minimizes the chance that your own lymphocytes, your own immune system cells, can actually attack the cancer cells.

So what this pembrolizumab and Keytruda does, or Opdivo, is another product in the same category. They take that brake away. We hope, we’ll show is that we can extend the effect of our cell therapy that we’re administering to the patients by giving Keytruda.

We’ve been in touch with Merck, for a long time now. They’re intrigued by our technology platform, about the progress. They have agreed to work with us and provide Keytruda free of charge to the patients that will participate in that specific arm of the trial.

In terms of working with pharma, it’s just like working with potential investors, right? You need to meet often with them. You need to show progress, initially pre-clinically, but once you’re in the clinic it’s all about the next set of data, and the next set of data, and it keeps going.

We need to realize that these big pharma companies, whether it by Merck, Pfizer, or you go down the list, are being inundated with requests from companies that want to work with them, so they’ve been very picky. And, for the right reasons, because all these research collaborations are very expensive, clinical trials are very expensive. But, we’re very happy that Merck is interested in the progress, and was able to provide Keytruda for our trial, which is awesome.

Simon Burns: Fantastic. You’re one of very few biotech companies to get as many programs into the clinic as you are. Take us through some of the thinking there. How you thought about your path into the clinic? 

Dr. Paul Lammers: It’s a great question, Simon. As we all know in life, you learn the most from the things that go wrong. At my previous company, we had one program in the clinic. Once you become a bit of a single-trick pony, it gets dangerous, because if the pony stumbles the whole company comes down, and that’s exactly what happened. I like to get multiple programs in the clinic as soon as we can, because it adds strong additional legs onto the company, right? So, that’s the reason that we started with HER2, we’re ongoing with that trial, we’re adding CLODIN, we’re adding GUCY, et cetera.

It will also give [00:05:00] investors a reason to believe not only in our platform and technology, but also realizing that, God forbid, something goes wrong with the lead program, there is a second program or a third program. At the end of the day, you want to do best for your shareholders, for your investors, so they can have a nice return on their investment. So, value inflection points across multiple programs is the way to go.

Simon Burns: This is not your first biotech bear market. You’ve seen this before. You’ve navigated how to allocate capital through it?

Dr. Paul Lammers: Yeah, it’s really tough. It gets back to one of your questions about a challenging funding environment. What do you do as a CEO of a startup? First off I would tell them, and in fact I’ve given some talks to CEOs of startups here in Texas, is take a deep breath and hold on for the ride

Simon Burns: [laughs]. 

Dr. Paul Lammers: It’s a tough road, right? You need to meet with a lot of folks. You need to meet very often with these folks. Because sometimes it takes a while for the coin to drop. Do they truly understand the benefit of what you’re trying to do? But, as I said, they’re always asking for, “Hey, you have money, why don’t you do the experiments and come back in six months,” right? I mean, you hear that a lot, right?

So, I think you need to hold onto it for the ride. You need to make sure also that you develop a bit of an elephant skin, because they can tell you things that are not so nice, but you should not let that deter you from being on this road, trying to raise that funding. There’s a lot of fish in the ocean, so to say, and there’s people interested. Please, don’t get sidetracked because somebody makes a nasty comment about your technology, the company, whatever it is. That just happens, that’s life, right?

Once you do have investors or inside investors, it’s very important that they’re willing to stay on for the ride, as well. Are they sometimes willing to re-invest? Obviously, right now in biotech, financing is really tough. So if they’re willing to make sure that you have adequate runway to get to this next value inflection point, that is absolutely key. Also, they’re very helpful because, mostly they’re VC, so they have their own buddies, their own network also to make introductions and do follow up with some of these key investors themselves as well.

Simon Burns: I love this, Paul. Very pragmatic advice. We’re in the clinical trial business, we think a lot about how to make clinical trials more efficient. Where do you think there’s room to make clinical trials more efficient? When you’re advising early stage biotech companies who speak to you, what advice do you have on running clinical trials in terms of just structuring it, planning it, and making sure that execution goes to plan?

Dr. Paul Lammers: Clearly, you cannot do it all yourself unless you build up a huge organization, right? What happens is you need service providers, you need a clinical research organization that knows the business, that knows the site, that is easy to work with, easy in communicating, responsive to your questions, to your needs.

Obviously there’s a tendency, because some people say, “Well, if you go to a big CRO, they have all this experience.” And, I say, “Yes, that’s so true, but there’s a downside to that as well.” Just from a cost perspective, they have a huge overhead, and guess what? You’re paying part of that overhead. The other thing that happens is if you are a small biotech company, and, for instance, you have a number of CRAs that they’re using for your study, suddenly big pharma comes along and says, “Hey, send me all the resumes of the CRAs you have, and I’m going to pick the best ones.” As a small company, it’s like where the hell did my CRAs go [laughing]? And they just went to another project.

That is very frustrating. You have turnover in people, which is normal because it happens, but, if you have two or three project managers in a year that gets really frustrating because you have to take this person through the whole role again, you’re starting from scratch.

Working with a smaller motivated group of people is extremely useful, and I think that pays off. Also you need to realize, from a sponsor perspective, if you outsource it, you also need people to manage the outsourcers. A lot of people say, “Well, I gave it to a CRO, and I expect it to come back in six months, 12 months, with a beautiful study report that I can submit to the FDA.” It reminds me of the Hertz commercial, “not really,” right?

Because, you need to make sure that you stay on top of that. You need to have a small team of experienced people in your company that can talk on a daily basis with those service providers. Whether that is for animal studies, you need to have a pre-clinical pharmacology person in the company who can talk to the study director when they’re doing a mouse study and say, “Hey, were the mice injected today? Was anything happening today with the mice?” It sounds like simple questions, but they are absolutely critical for conduct.

And the same on the clinical trials side. You need to make sure that they follow what the FDA is asking for from the rules and regulations. Everything is done, A-okay. There are three key things in biotech, or in clinical research, it’s cost, quality, and time. You cannot create time as a biotech, but it has to be quality.

The good old Ford slogan was, “Time is job number one.” Your quality should never be questioned. It needs to stand up to any kind of scrutiny that the FDA will do or partners will do. Cost is important, but also don’t just ask for multiple RFPs for projects. Don’t go with the smallest bid because you may end up getting what you pay for, basically.

It’s an interesting balance. Of course experience pays off. If you were to ask any head of R&D, or clinical at a pharma company, working with CROs, they may say, “With a single CRO, you may have [00:10:00] good, better, or ugly experiences.” That’s just also the nature of the beast, right? If you have work with people that you like, who are responsive, at the end of the day, your project becomes their project. They need to have the feeling of ownership in your success, as well.

Simon Burns: I can’t agree more. The challenge of going between a big CRO to a small CRO is exactly how you describe it. When you pick a small CRO, the real challenge is are they going to scale? Can they manage the scale? If mom and pop works well, you can always be hands-on, but the question is can you manage the scale.

One of the key things that biotech CEOs are always asking us is, how do I know what to look for in the team? The CRO presents a team, what are you looking for on your side of the table when you’re looking for the right team to partner with?

Dr. Paul Lammers: First off, you look at the experience. The type of studies that they’ve done. How many times have they done them? When it comes to the medical reviewer; the clinical operations side of things. If you’re running a cancer trial, do they have medical oncologists on the staff? Or, an on-call that has been there and knows how to deal with it, that understand how also how the FDA thinking is.

Your trial management, right? As I mentioned, the CRA’s already, the design of the study helps there. Great communication is key in everything in life, including working with a CRO, and obviously in direction with the trial side personnel. The study coordinators, the principal investigators, all that is absolutely critical.

Looking at safety. Safety happens, right? Adverse events happen. It’s really good to have that expertise on the CRO side to say, “Look, this is something that is part of the patient’s disease and not directly related to your drug that you’re administering.” That’s really important. Write up those narratives adequately and submit them on time to the agency.

Knowing the biomarkers is another thing. If people have experience you can connect them with another CRO or a lab that has experience in doing that type of biomarkers that you’re looking for.

At the end of the day, it needs to be a really well-oiled machine between the different service providers. If you run a clinical trial, you may end up having 20 or 30 different service providers involved in various aspects of it. That coordination, and making it into that well-oiled machine, will pay off big time in the time spent with far fewer frustrations when running your trial, and getting ultimately to the results and the end points that you’re looking for. 

Simon Burns: Very wise advice. Well, Paul, with that, best of luck with, Triumvira, and we’ll keep watching as you guys progress into the clinic later this year and into the future years. Thank you again for joining us.

Dr. Paul Lammers: Hey, you’re welcome, Simon. Great to chat.

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