Business Of Biotech

BoB Live At BIO: Amber Salzman, Ph.D., Epicrispr Biotechnologies

• Ben Comer • Episode 261

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This week's episode is one from the road, recorded in front of a live audience in Boston's Seaport neighborhood during the BIO conference (special thanks to MasterControl for making it happen). Amber Salzman, Ph.D., CEO of Epicrispr Biotechnologies (aka 'Epic Bio') explains how epigenetic editing is revolutionizing genetic medicine by controlling gene expression, without cutting DNA like traditional CRISPR technologies. Amber talks about FSHD, a progressive muscular dystrophy, how the company raised $68 million in Series B funding despite challenging market conditions, her partnership with Springbok Analytics for AI analysis of MRI images, working with a CDMO to manufacture a new treatment modality, and navigating the FDA during a time of disruption. 

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Ben Comer:

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Ben Comer:

Welcome back to the Business of Biotech. I'm your host, Ben Comer, chief editor at Life Science Leader and today, thanks to MasterC ontrol, we are recording from Boston during the BIO convention, in front of a live studio audience. Yeah, don't take my word for it. Make some noise, thank you.

Ben Comer:

Joining me for this special episode taping is Amber Salzman, Ph. D,, CEO and President of Epicrisper Biotechnologies, aka Epic Bio, a company that's using epigenetic modulators to control gene expression and treat complex diseases. Amber is an experienced life science executive who was most recently president and CEO at Ohana Biosciences, working in reproductive health, and before that she worked as president and CEO at Adverium Biotechnologies, a company formed through the merger of Avalanche Biotechnologies and Annapurna SAS, the latter a gene therapy company that she also led as CEO. Amber began her career at GSK and was a member of the R&D executive team and was also a CEO at CardioKind, which was sold to Cornerstone Therapeutics. I'm not including all of her professional experiences here for the sake of time, but suffice it to say that Amber knows what it takes to lead and build a successful startup from the earliest stages. Thank you so much for being here live and in person, Amber.

Amber Salzman:

Now. Thank you for having me Really appreciate it.

Ben Comer:

We typically start off the business of biotech with a little bit of background. We typically start off the business of biotech with a little bit of background. What initially interested you about the biopharmaceutical industry and maybe why you decided to join Epic Bio as CEO?

Amber Salzman:

Sure, in some ways it's a little bit I got lucky. I mean, as we know, you have to be lucky and flexible. But I liked science and medicine and ended up working at GSK. Well, I started at SmithKline in French, ended up through mergers becoming GSK and I was really surrounded by brilliant drug developers and that's where I really felt privileged to be putting amazing medicines out for patients. I mean, whenever we would get these letters from patients I mean one that stood in my mind was after 9-11, because you know we did a lot in COPD After 9-11, we got a letter from a patient saying that if it wasn't for our drug they wouldn't have been able to escape.

Amber Salzman:

So those kind of letters when you hear from families really got me going. Then, unfortunately, diseases struck my family in a pretty harsh way, with a rare neurodegenerative disease and having worked on all very common diseases, I will admit that I didn't fully appreciate that there was this whole other side of drug development and rare disease that was different. And when I learned that my nephew was going to pass away and then we tested the family and my son tested positive, as did another nephew I realized, oh my God, I have a few years before the bomb goes off, and then we got to do something. So that really launched me into look, I have to do something, I know I can do something, there's no other option and really pushed me into driving things on my own and I ended up leaving GSK and starting more small biotechs and really feeling such excitement being able to do something for so many patients that are in need.

Ben Comer:

So what about Epic Bio?

Amber Salzman:

Yeah. So when I talked about my family having a genetic disease, I started working in genetic medicine and this is a little more than 20 years ago and there were a lot of limitations in what was available. I mean not to put down what was there, but there were limitations in what capabilities existed. And then when I interviewed, I remember, with the scientific founder Stanley Qi of Epicrispr, I still, when I think about it, I'm not sure why they hired me. I was like, yeah, but you can't do this, you can't do that. And then still, when I think about it, I'm not sure why they hired me. I was like, yeah, but you can't do this, you can't do that.

Amber Salzman:

And they were kind of on my ass saying you did something for your family's disease because we did end up getting a product to market. Like what about us? And it is actually an epigenetic disease by nature. And when I interviewed with the team at Epicrispr, there were a few really great people that were there before I even joined. They mentioned how they could address FSHG and I was like, oh my God, now I got to do that. I mean, it was just, it was had my name on it, and I will say the team was amazing. I mean, we went from nothing to having an IND cleared in a new modality in a little over three years. So I'm I definitely made the right decision in joining the team.

Ben Comer:

Right, I want to just let everyone know if you have a question for Amber. I'd love to get the audience involved. Raise your hand and I'll look up periodically and call on you. So let me know if you have a question. You've been mentioning epigenetics. You've been mentioning epigenetics. I wonder if you could explain the difference between epigenetic editing and CRISPR editing, which people may be more familiar with.

Amber Salzman:

Sure. So first, just for the easy explanation of the epigenome. So I will say I have the same DNA that I had when I was 18 and I don't look 18. I don't feel 18. And that's because of the epigenetics that sit above the DNA. And the reason why I give that example is that you can really control what your DNA does through the epigenome, and that's super, super powerful.

Amber Salzman:

The original CRISPR applications that came out used this CRISPR-Cas molecule to bind to the location of the DNA that needed to be corrected and then it would cut the DNA sometimes double strand, sometimes single strand and that was an approach to fix the DNA problems.

Amber Salzman:

What epigenetic editing does? It was we still use that Cas molecule to bind to the right location in a very rapid and precise way, but in epigenetics we deactivate the nucleus of that Cas molecule so we no longer cut the DNA and that's really important, and I'll get to that in a minute and instead we fuse a gene regulator to the Cas molecule so it tells the DNA what to do so it could say don't express that protein or do express the protein at a higher level. So you're controlling what the DNA does rather than cutting it, and the reason why that's super important is when you cut DNA, you really risk genomic instability. So this is a safe way to control what your DNA does and it also gives you a lot of precise modulation. So you don't have to just cut it out completely. Sometimes you just have to lower the expression, not cut it out. Or you want to like for an haploid-sufficient disease, you want to double what the good allele does and not more, because it can be toxic because it can be toxic.

Ben Comer:

I want to switch over to funding, because I was in a session yesterday on cancer and funding for cancer therapies and it was a panel of big pharma folks BD development and they essentially said we're not looking at it if it's not phase three or marketed product. I don't need to tell the audience of Business of Biotech that it's a very challenging time for funding early stage companies. However, epic Bio was able to raise $68 million in a Series B last March with a novel modality and despite this incredibly hard funding funding environment, how did you do that, amber?

Amber Salzman:

Well, part of it was that while we were, we had this wonderfully differentiated platform. You know, a few years ago that was sort of in vogue, had this wonderful huge platform that can do anything. What we did and part of it is just my drive to go after patient needs. So when I joined the company, I'm like great platform, what are we doing for patients? So it just worked out well that we were going to actually have indications in the pipeline.

Amber Salzman:

So investors really, in particular last year and more recently, they don't want to just see the hype of what a platform can do. They want to see it applied to indications. So that was one thing that really helped us that we had really phenomenal preclinical data that we could talk about and that we have other indications behind it. Also, we were super and are super capital efficient. So there's other people in our space who raised earlier a lot of money and it's not good that they're able to show that they have the indications moving forward. I mean there's other things they're doing that is great. It was just they got kind of caught in the crash. But we have always, from the start, been very capital efficient and really focused on how do we quickly and safely get transformational medicine out there. So I think that that's what really helped.

Ben Comer:

How do you target investors for a company? I mean, do you, do you have relationships from previous companies that you reach out to first? Can you give us, I guess, just a sense of how you collect that investor base?

Amber Salzman:

Yeah, I mean I always joke when I say if you make an investor money, you could be an expert or they think you're great. So I don't depend on that though, but I do so. Clearly, investors that I've worked with in the past reach out to them and see if what this company is doing fits their investment profile. So I will say, reaching out to investors, you know there's I hate to say it the usual suspects and talk to them, but I will say we're in an environment where, as I say to the team, after we are kind of exhausted from all the pitching. You got to kiss a lot of frogs in this environment and that's how we did it. You just talk to people and you know, I'll be honest.

Amber Salzman:

Sometimes you get the feedback of like, wow, your data is amazing, your platform is amazing, but I don't know, it's not the right climate. We want to only do publics now. Like it's tough right now. We have our own portfolios to worry about, but then you do get investors who are looking at it and saying, wow, the data is amazing, when you can be is amazing. I want to get in now so that when you have all the data come out, I'm in with the winning company and it takes.

Amber Salzman:

I mean, I don't, I'm not being critical of investors it takes a lot of guts to, you know, not just follow what everyone else is doing and really say like, wow, I did the diligence, this is amazing, I'm going to go with it. So you, just as I said, kiss a lot of frogs. I don't want to say it in a derogatory way. Look, there'll be other times. We have relationships with them and a lot of them. I know that as we move forward at later stage we'll go back. It's always a good engagement and they're excited about what we're doing, so we'll use a middle later funding round.

Ben Comer:

EPI 321 is EPIC's lead development candidate. It targets FSHD, which you mentioned. I was not familiar with that disease prior to learning about Epic Bio. I wonder if you could just I don't know briefly tell us about the disease and the unmet need.

Amber Salzman:

It's really a debilitating disease. It starts as the name says usually and there's a variability in the face. So you hear people who, as they start to get worse, say oh, my mom told me when I was a baby I never closed my eyes or I couldn't smile. So it starts in the face, where you lose muscles there, and then it works down to your upper body, your scapula, and then in many of the patients they end up non-ambulating and needing wheelchairs. But it's interesting because in some ways it can be an invisible disability, like I was at an FSHD meeting last week and you know I would sit next to a few patients and just sitting at the table, you're like there's nothing wrong with them and then you see how they have to like drink a cup of water. They can't just lift their arm, they need help. They can't brush their hair. Somebody's got to help them.

Amber Salzman:

I mean, I know that sounds like a big deal, but it's really tough. It changes your whole quality of life and how you think about things. And I can say in my family in particular one of my cousins-in-laws who really had a wonderful career in NFL films as a film director. As he lost more and more ability, you know, they let him work from home. He was in a wheelchair, worked remotely and then he just he. He had to stop working at a reasonably young age, a career that he loved. So it's very debilitating, I mean as a wonderful wife who does so much for him. But it's hard to like be so dependent on your family to be able to do things. So it's variable, but it is really affects your quality of life.

Ben Comer:

I'm switching, I'm bouncing around here a little bit. I hope that's okay. I did want to ask you about Epic's partner, springbok Analytics. This is something that just stuck out to me when I read about it, because it's in, it's a I think it's an AI partnership and it's looking at I think it's analyzing MRI muscle imaging. But let me, let me let you explain it.

Amber Salzman:

So, as I said, I kind of gave the typical manifestation. But some patients progress faster in their legs than their upper body and it varies. So if you're running a clinical trial, imagine an endpoint that measures how quickly they do a 10-meter walk run. Well, that may be a really good endpoint for people who it affects the lower body, but you may not see anything in people that it's more rapid in their upper body. Just use that as an example.

Amber Salzman:

What's nice about head-body imaging is what Springbok has done is they've made use of natural history data from FSHG patients and they're able to look overall for all of your muscles how has the fat fraction changed? How's the inflammation, muscle mass and then they correlated that data with functional measures not just 10 meter walk run, but timed up and go a whole bunch of different measures to see how does the fat fraction relate to functional outcomes. And where that's super powerful for us is that we can then have quote unquote a digital twin for the patients on treatment. Now it's early days and they have to obviously spend more time refining their model. Good news is that there's more data coming in that they can do the machine learning so that they can even be more predictive. Do the machine learning so that they can even be more predictive. So that's where the machine learning comes in to really understand overall for this kind of profile of muscle. How does that relate to functional?

Ben Comer:

measure.

Amber Salzman:

And our aspiration is to be able to use that to go to regulatory agencies and say this is how we impacted fat fraction, for example. And you know, the agency wants to know that you made somebody a little longer feel better and address the disease in a measurable way. It's like how does this MRI mean anything to a patient? This does that kind of tie in. Now we have other measures that we're looking at as biomarkers, but that's just one of the approaches to help us see what's going on.

Ben Comer:

Have you had any initial conversations with regulators about potentially using that data?

Amber Salzman:

So we have not talked to them about using the MRI data. We have talked to them about using methylation data. So just to pull us back to epigenetics, so when I said you want to change the way the DNA behaves, well, when it comes to FSHD, there's a certain region that expresses this Dux4 protein, which has been known to be toxic to the muscles. What we do is we go in and methylate that region, which means we tighten it up so that the Dux4 doesn't leak out. What's known about this disease is that your disease severity is linked to how much methylation you have. So what we did when we spoke to the and there's cohorts of hundreds of patients where there's tight correlation. This has been published in the last 10, 15 years. So when we spoke to the regulators, we said, given all of this and we showed them the publications if we increase methylation, would you agree that's a good biomarker and predictive of clinical benefit? And we got a reasonable answer. They said, yeah, we buy that more methylation means less disease severity and potentially no disease.

Amber Salzman:

But nobody has shown us that if you change methylation it changes the course of the disease. So we encourage you to use your person-to-human study to do that. So we did talk to I mean again, reasonable, since nobody has shown it yet. So that is one measure that we can use with them. We did not have the data in hand. This was when we did our pre-IND. We did not have the data in hand. This was when we did our pre-IND. We did not have the data in hand from Springbok. Also, like I said, there's more work that needs to be done, but we're very encouraged where it's going.

Ben Comer:

What about the development process for manufacturing? This is something new. Epigenetic editing.

Amber Salzman:

I don't know what that looks like. Did you work with a CDMO? Or first, if you don't mind, describe just the manufacturing process early and we're trying to move quickly. We always have to design with. You know quality by design. So what she has cautioned me because I'm like don't you think that's too much for just a phase one? She's like no, because if you switch anything later on you're going to have to end up redoing the trial. So let's build in the quality now so that when we then commercialize it we're set up. So she really built those principles in and worked with the CDMO, had a great partnership with them so that when we went to the FDA we could make use of their CMC process along with our approach. We put together the different assays for material release et cetera. But it was kind of like the end goal in mind when we worked with them and we had a good partner with the CDMO and I think that's what led to a really good feedback from the FDA.

Ben Comer:

And that was your process. Development person, internal person that you were mentioning. What's her name?

Amber Salzman:

Dipali Patel, nobody ever go after. She's amazing. No, she's amazing, um, no, she's. She's great, and and part of it was also the partnership with the cdmo, because we're, you know, we're small. I guess that we're capital efficient. We're 35 people, um, and she at the time I mean since then she's hired more people and blood in the bioreactors but she didn't have the stuff to do so, but she had the idea, so she worked really well with the cMO to make it.

Ben Comer:

And the CDMO helped get you to the IND. It's interesting my colleague led a panel on. You know small versus large companies working with CDMOs. Sometimes the small companies feel like they're shafted a little bit, not getting equal treatment. I mean you, your process.

Amber Salzman:

Yeah, well, I will add. Add, I've been around a long time so I know a lot of people. So, like I knew the ceo of the company and I'm not afraid to pick up the phone and use it um, knew a lot of people there, we and I also. We also treated them like they were part of the team so we would talk about the patients and really like patients are waiting. You know we always bring patients and talk to the team and really try to get the people on the team at the CDML working with us. So I totally hear what you're saying, that you sometimes get shafted, but I think part of it was.

Amber Salzman:

I give a lot of credit to Dipali because of the way she basically I learned this from her when she met with them. She goes, yes, we want you to be a good partner, but I want to be a good partner, like that was her whole thing. She goes how could? Because a lot of times they're complaining about us just as much as we're complaining about them. I mean, that's how it works. So she's like you tell me how I can be the best partner. I want you to cite me as the person that you want to work with, so that I think just set the stage that when you partner and you know respect each other and there were times where she's like I don't think you should be doing it, here's what I recommend. They were like this, very skeptical, and then she would do small scale stuff in-house and show them the data and we had results like nobody else had working with them really good results.

Ben Comer:

Are you at a stage of scaling up at this point?

Amber Salzman:

Yeah, so we scale, I mean you do stuff smaller. We went through the FIOSC all the way up to 200 liter, then 500 liter and our clinical trial we did 1,000 liter and it turns out we didn't even have to go to 1,000 liter because our titers were so good and then so from there we'll have to look to see because she's getting. He shows ideas on how to improve the scale up as to whether we'll stick with 1,000 liter, but our CDMO also has 5,000 liter bioreactors.

Ben Comer:

And you'll likely stay with that CDMO.

Amber Salzman:

Right now everything's going well, so yeah, With the 68 million Series B.

Ben Comer:

What kind of runway does that give you?

Amber Salzman:

We don't usually disclose a runway. I mean I will say we will have already early next year we'll have our first clinical data because we'll have the first patient's muscle biopsies to show that our product is doing what it's supposed to. So we're excited to be able to get the data.

Ben Comer:

Yeah, that's very exciting. What advice would you give to other biotechs about engaging with regulators, particularly the FDA, around an IND for a brand new drug modality?

Amber Salzman:

It's a great question. I will say that we because we were so small when we first started, we didn't even have our internal regulatory person. We went to some consulting companies and they Our team knows what our product really well. And they were like this is what we should be doing. And I mean, I'll give the bad example to learn from. And the consulting company was like no, this is what the how the FDA does it all the time, this is how you should do it. And we're like but it doesn't make sense. But we know in our heart of hearts this is the right way to show that it's safe. We know in our heart of hearts this is the right way to show that it's safe. And we basically went.

Amber Salzman:

I say follow the data, follow the science, and if you in your heart know that that's the right way to do it, they can always say no. So engage with them. We engage with them very early on. I mean just to give you an example. So you know we have to go after it. It's a human construct. We're going after human DNA. So when you do a safety study, that gene sequence we're going after doesn't exist. So it's not exactly a like-for-like test.

Amber Salzman:

So we were getting advice from one firm who we'd ended up working with oh, you have to come up with a mouse construct so that you can bind to the right location the mouse, and I'm like, but then we're testing a drug that is not the drug we're going to use in humans. Like it just didn't feel right. And you know I'm not a regulatory guru, I've been around a long time, done a lot, but I just like scientifically, I'm just logically it didn't feel right. And they were insisting, insisting I think they were even a former FDA person. I'm like I just don't like that. So the team, we all kind of brainstormed on it and we said let's just talk to the FDA, let's put it forward. If they tell us to use the mouse construct, we'll do it, but we just don't think scientifically that makes sense. So we went with them with our proposal.

Amber Salzman:

So if you ask advice, I would say do what you really believe you can defend scientifically and that if you were dosing your family member, this is what you would want done. And if you feel that strongly about it, you could talk to the agency. I mean, there's smart people there For the most part, most people you talk to at the FDA. They're there because they care about patients. They want to get safe and effective medicine to patients, so they'll heal you for the most part. So I not that I mean, look, humans like the rest of us and some are better, some are worse. That's the way it is. But for the most part there's really good people there. And I say you know, if you follow the science, follow the data and do what you think is right and talk about it.

Ben Comer:

I mentioned. We're a bio. John Crowley, who's a current executive chief executive of bio, interviewed FDA Commissioner Martin McAree today. We were chatting about it a little bit just before we started recording. But what's your kind of sense about the status of the FDA currently? Are you concerned? Are you confident? How do you feel about the status of the FDA currently? Or are you concerned? Are you confident? How do you feel about the current FDA?

Amber Salzman:

I will say right now I'm feeling rather optimistic. When I first saw some of the changes and look, we all love Peter Marks, like those kind of changes kind of got me unnerved. But then when I saw where things landed and some of the stuff McAbee is saying, I mean he's definitely shaking stuff up but I think in a constructive like we got to be creative. I mean he said things which I'm like God, that's so obvious. Why didn't they do it before? He was talking about when you submit a drug for approval, there's a lot of stuff that you have in your hands like for a while and then you're just waiting for the study to end and put the data in. So he was saying like give us the CMC section and a bunch of other stuff early, because you're just sitting on that, and then you make us review it all in 30 days and we're like heads down, you know, trying to well for a 90, but for, obviously, for an approval it's much longer.

Amber Salzman:

But those type of ideas where he's like let's do what makes sense and try to be outside the box, the way he said we should be taking advantage of AI and things like that, so that I can't disagree with we have engaged. What can we do differently to speed things up and do well by patients combined with people who've been at the FDA for a long time. They understand what you got to do to keep things safe and all. I think they'll end up. I mean, I think it will be a healthy you shouldn't you shouldn't always have groupthink. So this will avoid groupthink and I think it could ultimately put us in a better place. Look, there are clearly some places where I'm nervous, but at least at a big picture and in the spaces where we play right now, I'm actually optimistic.

Ben Comer:

All right. Well, before I get to my last question, I wanted to ask you here. Anyone from the audience want to ask Amber a question while we've got her? This is Ben Comer cutting in after the taping at bio. With an apology, I failed to capture the audience questions on microphone and they weren't audible on the recording, so I'm reading the questions and myself. Here's the first one Can you safely multiplex with an epigenetic editing therapy, or in other words, make more than one edit or change with a single construct?

Amber Salzman:

No, it's a really good question. So when it comes to epigenetics, it's the same type of thing. You'll target a specific locus that you want to change and we can do multiplexing and in a way it's much safer than doing that with cutting, because then you're cutting all over the place. In a way it's much safer than doing that with cutting because then you're cutting all over the place. So we can. You know, if you want to upregulate one gene and downregulate another, you can put that all in the same construct.

Amber Salzman:

I mean, it's not trivial. I mean, obviously doing one at a time is easier, but you can do that all at the same time. Again, you have to caution which cells do you need to make the changes in? So, for example, right now for FSHD, we're targeting skeletal muscle cells. If you wanted me to change everything in the skeletal muscle, great. But if you wanted me to change something in the skeletal muscle and in I don't know hepatocytes, because it's a disease, it gets a little bit trickier in terms of your delivery and we'd have to think about the best way to do it. But absolutely, you can multiplex in a very safe way.

Ben Comer:

Amber, what are your top priorities for Epic Bio for the second half of 2025?

Amber Salzman:

Yeah, we're super excited to be in the clinic and to be able to deliver what could be a transformative medicine to FSHD patients liver what could be a transformative medicine to FSHD patients. So we're very laser focused on getting that trial, you know, successfully moving forward. You know we're already screening patients and we'll be dosing shortly. So really, laser focused on that. We have other indication in the pipeline. We need to move forward and then, I'll say it, you have to keep kissing frogs, like you always have to worry about, you know, your next dollar. So we'll be spending time making sure that we can raise more. I think we have an amazing story. We've heard that from so many. So now's a good time to make sure that we can go forward constructively and help patients.

Ben Comer:

All right, last call, anyone. Have a question for Amber? Before we wrap up here, one more Sure Is there any concern about target population size for epigenetic editing therapies in terms of a ceiling for manufacturing quantity or competition from different modalities?

Amber Salzman:

This hasn't been a challenge right now, in particular because our lead indication is I mean, fshd is a fairly common rare disease, so it's, you know, going to be billions in commercialization. So that hasn't been an issue. I will say that when we were reviewing the pipeline it was a consideration of how big the population was and of course we got to make sure the cost of goods stays pretty low so that it's not going to be millions. I will say there's more of those conversations now, but we're in a good position. I mean, in FSHD there's been like three deals in the last I don't know nine, 12 months. You know Sanofi put whatever it was 80 million down up front on a real gamble.

Ben Comer:

So there's been a lot going on in this indication space, all right. Well, I think we're going to wrap up here. Amber, thank you so much for being here. Master Control, thank you for hosting us in this beautiful space right down here in the seaport in Boston.

Amber Salzman:

Thank you. Thank you for having me. I appreciate everybody coming and attending.

Ben Comer:

We've been speaking with Amber Salzman, phd, and that's a PhD in mathematics, I believe. Ceo at Epicrisper Biotechnologies, I'm Ben Comer and you've just listened to the Business of Biotech live from the Bio Conference. Find us and subscribe anywhere you listen to podcasts and be sure to check out new weekly video casts of these conversations every Monday under the Business of Biotech tab at Life Science Leader. We'll see you next week and thank you, as always, for listening.

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