Immunome, Inc. H.C. Wainwright 28th Annual Global Investment Conference
Review the key takeaways and the transcript of this earnings call.
- Immunome's goal is to develop targeted therapies for cancer patients, focusing primarily on antibody-drug conjugates (ADCs) with novel targets and advanced technology.
- The company has at least 10 ADCs in clinical development and is also developing a radioligand therapy.
- Immunome acquired Varigasistat, a gamma secretase inhibitor with promising phase two data, completed phase three trials, and has submitted it for regulatory approval with a pending PDUFA date.
- Varigasistat is intended for desmoid tumors, a rare and painful sarcoma subtype, with an average treatment duration in trials of 20 months, though real-world use may be closer to 16 months.
- The drug shows rapid pain relief within weeks and high tumor response rates of about 95% in patients.
- Immunome is conducting a retreatment study to support potential label expansion and better inform treatment duration.
- The company is preparing for a broad launch of Varigasistat globally, prioritizing medical affairs engagement before commercial sales.
- Immunome's ADC pipeline includes IM1021 targeting ROR1, a receptor expressed on both liquid and solid tumors, with a validated diagnostic tool in development to improve patient selection for solid tumors.
- Previous ROR1 ADC programs faced challenges due to lack of diagnostic tools, toxicity, and suboptimal antibodies; Immunome aims to improve on these with a novel ADC technology featuring rapid internalization and bystander activity.
- IM1021 has shown approximately 20% response rate in heavily pretreated patients, but Immunome plans to optimize dose, schedule, and patient population to achieve higher efficacy and durability.
- The company intends to present IM1021 data at ASH and pursue breakthrough designation with the FDA, following a development strategy used successfully in prior drug launches.
- Immunome's ADC platform centers on the HC74 Topo 1 payload, engineered to overcome resistance mechanisms, improve tumor penetration, reduce aggregation and toxicity, and enable bystander killing.
- The HC74 payload represents an evolution beyond older Topo 1 payloads and antimitotic ADCs, aiming for better safety and efficacy profiles.
- Immunome has a highly experienced team with roots in CGEN and continues to advance multiple ADC candidates alongside its first drug submission.
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Transcript
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I'd like to welcome everybody back to the H.C. Wainwright's 28th Annual Global Investment Conference. My name is Andres Maldonado, I'm a senior biotech analyst here at the firm, and it's my pleasure to welcome you. Continuing with our morning session, our next fireside is with Immunome, and it is my pleasure to welcome President and CEO Clay Siegall. Clay, wonderful to see you, as always.
Thank you very much. Enjoy being here.
To start, for investors less familiar with the Immunome name, can you walk us through the pipeline and how you're prioritizing the portfolio today?
Sure. The goal of Immunome is to make targeted therapies for cancer patients. I've made quite a few drugs that are on the market around the world in my career, and it's my passion to help cancer patients. Working with lawyers and accountants, maybe not so much of a passion, but making cancer therapies is. I really enjoy it, and what I decided with Immunome is to make a big pipeline and think big. I know a lot about ADCs. I made a lot of ADCs on the market, and so what I wanted to do was make ADCs that solve some of the problems of ADCs historically, that were made. I can go through that in a moment. We have at least 10 ADCs, novel targets, the best ADC technology, in my opinion, out there in the world.
We're pumping them into the clinic, one after another, after another. While doing that, I also wanted to build a company, so I looked at dozens of small molecule drugs. When I ran Seagen for 25 years, I looked around at small molecule drugs, and I brought in tucatinib, which became TUKYSA, in 72 countries approved. A great drug helping women with breast cancer. I went out and looked at loads of dozens of drugs, most of them from little companies that either were underfunded or didn't know how to develop it, or whatever. A lot of the drugs I looked at were not acceptable. I found one, like I did with tucatinib, when I was at Seagen, I found varegacestat. It was, we thought, based on the phase II data, the real deal.
When I look at gamma secretase inhibitors, I looked at it and the varegacestat had great pharmacokinetics, and that was really the difference between that and nirogacestat, which is the only gamma secretase inhibitor on the market. That led us to look at all the data and everything and bring that in. We did all the CMC. There was no CMC done. We invested in it, met with the doctors, got all the phase III done, and the data was fantastic. It's the best drug out there, and we submitted for approval. We're filed. We have a PDUFA date. I'm very pleased with our ability that we're going to help patients around the globe, and we have good plans to launch it everywhere and get it to the patients in need.
It's very similar to the tucatinib story, to bring in a drug with phase II data from a company that was underfunded, no CMC, problematic, but make it into a real drug while I'm working on ADCs. We have tons of ADCs. We even have one radioligand that we're developing, but mainly ADCs. I'm really excited for our future and helping cancer patients.
Great. Before we touch on the ADC program, maybe a couple quick follow-ups on varegacestat. I guess, can you talk to us a little bit more about, given that desmoid tumors are a chronic treatment journey, how are you thinking about the optimal duration of therapy so us, as analysts, can model it correctly?
I have done as much study of desmoid cancer. It is a subtype of a sarcoma. It is treated at SARC centers. They call them S-A-R-C centers around the U.S. And internationally, there are sarcoma centers as well. These are interesting tumors. They do not kill patients. It is like pancreatic cancer kills patients fast. This does not. This is just really painful, really difficult for a patient. You do not want it. You do not want your enemy to have this disease. It is not fun at all. I have talked to a lot of doctors, a lot of patients about it. The pain is the biggest thing in dealing with it. There are 1,650 new patients a year in the U.S., about the same when you look at the whole EU, as a group. There is 11,000 prevalence. A lot of them are doing what is called watch and wait.
Sometimes doctors will give them radiation. Sometimes they will give them SUTENT. None of that, it is just barely doing anything. The first gamma secretase approved was nirogacestat from SpringWorks, now Merck KGaA. That was the first step. When we looked at this, we talked to doctors, and we think about it. In our phase III trial, our average duration of treatment was 20 months. That is something. I will tell you that I have developed a lot of drugs that are a lot approved. In real life, it is always less.
Every drug, I like to lie to you and tell you it is going to be more or whatever, but every drug I have ever made, and that is a lot of them, are always a little less than what you would see in a clinical trial. So I do not know what it is going to be. If I had to guess, I am going to say 16 months, not 20. Something like that. It is not way less, but it is always a little less.
Yeah. Doctors ask us all the time.
They go, "Clay, can we retreat with this? Can we put someone on for a year and a half, and then let them live their life, and then if we need it, come back?" I faced the same thing with ADCETRIS.
and with PADCEV and all these others. I've done retreatment studies with other drugs, and if you get good data, you get a label for it with the FDA.
We listen to doctors. They ask a lot of questions, and we're doing a retreatment study. I don't have that answer for you. I think it's going to work just fine.
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