What is Equillium all about?
We started the company four years ago around our lead drug program itolizumab. My colleague, Steve Connelly, who is our chief scientific officer, realized the importance of itolizumab and the drug target CD6. The strategic partnership with Biocon, from whom we license the program, came about through our other co-founder, Dan Bradbury, who’s a longtime leading San Diego biotech executive. And it was really that connectivity to Biocon and Steve’s insights around the program that gave us the opportunity to start Equillium.
What was quite a value add from our perspective was that Biocon had heavily de-risked the program through prior clinical development work in the field of psoriasis, where they actually received approval in India based on a Phase 3 study. Biocon had also completed the scale-up manufacturing of the antibody, and so we didn’t have to raise a lot of money to do manufacturing ourselves.
We focused very quickly on identifying indications where we felt the drug could be a best-in-class therapeutic agent. We completed our IPO in 2018, where we raised around a little over $72 million proceeds that enabled us to embark on our three clinical programs – acute GVHD (graft-versus-host disease), lupus and lupus nephritis, and study in uncontrolled asthma.
Tell us a bit about your clinical trial developments
We have seen what we believe are some very compelling results from the acute GVHD program. We are treating patients with itolizumab in the first-line treatment setting on initial presentation of acute GVHD. Today there are no drugs approved in the first-line treatment setting. So that’s a very important aspect of this program. We are among the very small number of drugs that are evaluated in the first-line treatment setting. The standard of care today is high-dose corticosteroids, which is obviously not a great long-term treatment option for patients.
What we’ve seen so far in terms of our response rates in our Phase 1b open-label study is north of 60% complete response rates, which is a very meaningful outcome compared to prior historical data where you have seen response rates in the 27-35% range. And that has led us to take the program into advanced studies, where we are poised to initiate a Phase 3 pivotal study.
In Lupus and LN (lupus nephritis), we’ve completed the first part of our program. We are now enrolling our lupus nephritis portion of our study and we expect to have data from that program by mid-2022. And then in uncontrolled asthma, we have been conducting a Phase 1b study. It’s been very difficult to enroll based on issues of Covid-19, but we are expecting to have the top-line data from that program imminently.
What’s your target market opportunity across these indications?
In the acute GVHD segment, there are roughly 10,000 or so bone marrow transplants that lead to acute GVHD in the US, which is our core market. So there are roughly 6,000 or so patients per year presenting with acute GVHD. You know this is a therapeutic area based on other programs that are approved in the GVHD study where they have an annual pricing model that is well north of $100-150 dollars per patient.
So that represents a total addressable market of $500 million-plus range. We are contemplating pricing and reimbursement strategies for the program but ultimately, the data from the program dictate the value of the program. I think what’s important to note here is that the majority of these patients present at a relatively small number of leading transplants. So the sales and commercialization effort required to address that market is quite focused and small. So it’s a really attractive market and if we’re successful with this program, I think it fully sustains the company.
If you look at lupus and LN opportunity, there are hundreds of thousands of patients in the US. So a very large total addressable market. There is more competition here, but we think we have a highly differentiated mechanism. In uncontrolled asthma, patient count is probably north of a million and a half or so in the US. Up until this week, there were no drugs approved to treat those patients. Interestingly, we just saw Amgen’s tezepelumab get approval just this week. But otherwise not really well served by existing therapies.
How do you see your existing balance sheet?
I think we have a very good existing balance sheet. We reported over $90 million in cash at the end of Q3. Our operating burn rate is going up as we’re building the company a bit and poised to launch the GVHD program, which obviously is going to be a significant undertaking.
We, like all of our biotech peers, will be raising money at some point. The question is when and how we do that. We’re currently funded into the 2023 time frame. So we don’t feel any immediate pressure to go out and raise capital.
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