C4 Therapeutics, Inc. Wells Fargo 21st Annual Healthcare Conference
Review the key takeaways and the transcript of this earnings call.
- C4 Therapeutics is a targeted protein degrader company focusing on unmet medical needs, with their lead program being Simcitomide, a Cereblon modulating degrader of IKZF1/3 for multiple myeloma treatment.
- Simcitomide is being advanced in multiple myeloma across various lines of treatment, including a phase II momentum study and a phase IB dose escalation study in combination with L-Renatumab.
- Data presented at EHA and IMS show robust efficacy with a 53% overall response rate at 100 micrograms and durable responses with a median duration of response of 7.9 months, along with an excellent tolerability profile.
- Neutropenia is observed in about one-third of patients but is manageable and mostly occurs in the first two cycles; no discontinuations due to safety have been reported.
- The registrational phase II momentum study in the fourth-line setting is enrolling about 100 patients and aims to demonstrate a 40% response rate versus a 20% background rate, with enrollment expected to complete by the end of Q1 2025.
- The commercial opportunity for Simcitomide in late-line multiple myeloma is estimated at about $1 billion, with a growing patient population due to more effective earlier-line therapies extending patient survival.
- Simcitomide is being studied in combination with Pfizer’s L-Renatumab BCMA bispecific T-cell engager in a phase IB study to enhance depth and durability of response, with safety data expected mid-2027 and interim safety updates before year-end 2024.
- Additional combination studies are planned, including a phase IB evaluating Simcitomide with Daratumumab and Colfazimib to assess broad combinability.
- C4 is shifting its discovery focus toward inflammation, neuroinflammation, and neurodegenerative diseases, targeting clinically validated pathways with first-in-class degrader opportunities.
- The company has collaborations with Roche and Merck KGaA, including a Roche collaboration to develop degrader antibody conjugates (DACs).
- C4 has runway through the end of 2028 to execute clinical trials and advance discovery programs, with additional funding anticipated for future phase III studies.
STOCKNOW INSIGHTS
Continue with outlook and guidance.
Log in to unlock executive comments and Q&A highlights.
Log in for the full summaryStockNow uses AI to translate and summarize earnings calls. Accuracy and completeness are not guaranteed.
Transcript
Preview the first fifteen paragraphs, organized by speaker.
All right. Good morning, everybody. Thank you so much for joining us for the next fireside here. My name's Derek Archila. I'm one of the senior biotech analysts here at Wells. Very excited to have the C4 Therapeutics team up here with us. From the team, we have Andrew Hirsch, President and CEO, Scott Boyle, Chief Business Officer, as well as Kendra Adams, Chief Financial Officer. Team, welcome. Great. Thanks for joining us.
Thanks for having us. Great.
Well, Andy, maybe just to start off, give us a little bit of an introduction to C4, what you guys are working on, and then we can get into the Q&A.
Sure, happy to do that. Actually, I will have Kendra do that.
Happy to. We are- That is delegation.
Yes. Practicing delegation. I have done it a lot, and I feel like give somebody else a turn.
We are a targeted protein degrader company, and we have a portfolio of degraders that we're looking to bring to patients with unmet needs. I'll start with our lead program, which is cemsidomide. This is a cereblon modulating degrader of IKZF1/3. These are transcription factors that are critical in the treatment of multiple myeloma. We are advancing that program across multiple lines of treatment in the myeloma setting, both in the later line setting as well as the earlier line. That includes a phase II study, which is the MOMENTUM study I'm sure we'll talk about. That's enrolling now, as well as a phase I-B dose escalation or dose exploration study, cemsidomide in combination with elranatamab, which I'm sure we'll also get into that. Beyond the clinical portfolio, we also have an internal discovery portfolio that's focused on inflammation, neuroinflammation, neurodegenerative diseases.
We also have active discovery collaborations with Roche and Merck KGaA. One of those is focused on DACs, which I'm sure we'll talk about. We're progressing things across research and clinical development.
Excellent. Maybe to start off, working on your lead program, cemsidomide, I guess, how has your thinking evolved over the last 12 months? I guess what data today gives you the greatest confidence that it can be a pretty meaningful player in the multiple myeloma space?
Sure. The last 12 months have actually been quite exciting for myeloma patients in general and the field. Actually, the data and regulatory events that have happened over the last 12 months have really, I think, at a high level served to validate our approach. It's really emboldened us that we think we're headed in the right direction. I think there's really three things to think about there, right? The first is our data. We updated our data at EHA this year, and I think our data continues to support our perspective that we think we have a best-in-class asset in this space. The data didn't really change much from our initial presentation at IMS last year.
But we did see some deepening responses over time, and the profile continues to look like it really has the best of both worlds, really robust efficacy at multiple doses, as well as an excellent tolerability profile, which really positions it as a backbone therapy in myeloma, like the class has been, and we believe it will continue to be. In addition, there has been some positive clinical developments around the space, notably from the Bristol Myers Squibb CELMoD portfolio, that we think validates both the need and the efficacy for next-gen degraders of IKZF1, as well as, importantly, the recent approval of iberdomide with MRD negativity. That is really important, not just for cemsidomide, but also for the field, because as we are seeing newer and more effective therapies, patients are living longer. They are living longer progression-free.
That makes development harder because you have to do longer studies if you want a time to event endpoint. So having a really robust surrogate endpoint like MRD negativity that FDA has accepted based on the 2024 ODAC that really provides a surrogate for PFS benefit is really critical to enable future development, and we intend to use that. Then I think the third element of data over the last 12 months has been all the data coming out around T-cell engagers. That is something that we are very bullish on. We think T-cell engagers are going to be moving into the second-line setting, and there has been a host of readouts, both pivotal studies as well as earlier from all three of the originators of those drugs that really suggest that is a space where TCEs are going to play.
And obviously, as you know our development plan, we think it is important that we think cemsidomide can really enhance the activity, both depth and durability of remission. So when you look together, we really think it has validated our approach, and emboldened us to continue development because it is really supportive of where we are headed with cemsidomide.
Excellent. So maybe to start off in terms of your development plan, so maybe you can give us a sense of the recent updates from the monotherapy data set for cemsidomide, and I guess over this period of time that you guys have been developing it, what you really have learned between the relationship with dose efficacy, durability, and I guess the tolerability of this molecule.
Yeah. I will start with the relationship between dose and really actually exposure, right? That is what really matters. Actually, this was data that was presented at IMS, but when we look at the correlation of exposure and reductions in light chains, there is a very clear trend that obviously more exposure is better and drives deeper remissions, right? That is what got us as well as the clinical data to support the 100 microgram dose as our recommended phase II dose, right? It was clearly better. At the same time, we did see robust response rates at the lower doses from the phase I. At the 100, we had a 53% ORR, but at 75, we had a 40% ORR.
FULL TRANSCRIPT
Continue the full translated transcript in StockNow.
Log in to unlock every statement, the English original, and speaker-by-speaker history.
Log in for the full transcriptCall participants
4 people spoke on this call — only 2 are shown here.
PARTICIPANT LIST
View participant details in StockNow.
Log in to see executives and analysts, their roles, and complete speaking history.
Log in to view all participantsKeep exploring
