ESMO 2025 | EXPAND-1: Phase I/II study of ANV600 in advanced solid tumors
Martina Imbimbo, MD, Ente Ospedaliero Cantonale, Lugano, Switzerland, describes the Phase I/II EXPAND-1 study (NCT06470763) of ANV600, a PD-1–targeted IL-2Rβ/γ agonist, as monotherapy and in combination with pembrolizumab in patients with advanced solid tumors. ANV600 selectively stimulates PD-1+ CD8+ T cells, promoting antitumor immunity while minimizing IL-2–related toxicities. Early results show a manageable safety profile with mostly low-grade adverse events, supporting its potential as a novel immunotherapy for checkpoint-refractory tumors. This interview took place at the European Society for Medical Oncology (ESMO) 2025 Congress in Berlin, Germany.
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Transcript
Yeah, so ANV600 is a bispecific anti-PD-1 to bias the receptor agonist. And we are doing a monotherapy part with those escalations that we presented in the poster, as well as a combination with pembro. Interestingly, with the data that we had, we started to understand that maybe at dose intensification, so giving the product weekly in the beginning was better than giving it weekly as before...
Yeah, so ANV600 is a bispecific anti-PD-1 to bias the receptor agonist. And we are doing a monotherapy part with those escalations that we presented in the poster, as well as a combination with pembro. Interestingly, with the data that we had, we started to understand that maybe at dose intensification, so giving the product weekly in the beginning was better than giving it weekly as before. So we have this dose intensification part that we are also showing. And we see how it really works very well on the immune system. We are looking at it in the peripheral blood. So we see how the CD8 PD1 positive cells are responding preferentially compared to the other cells. And clinically wise, we see that we are avoiding all those collateral effects that we have with high-dose interleukin-2. So especially we have no capillary leak syndrome. We see, of course, immune system activation with fever, sometimes fever with hypotension, and quite a bit of liver toxicity, but actually, this was self-resolving. So there were really no meaningful toxicities, even if there were a few DLTs, because all toxicities were self-resolving. And activity-wise, of course, this is a dose escalation which is quite early. We have not reached yet the biological dose that we wanted, but still, we see a response of disease in the monotherapy arm and the response in the combination. Even if now we have more data, we’re seeing even more responses that we’re going to present at the ESMO IO Congress.
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