- First clinical observation of tumor localized CD40 activation provided by MP0317
- No systemic or dose-limiting toxicities observed, a key parameter for CD40 agents
- Dose escalation remains ongoing with study recruitment anticipated to complete in 1H 2023
While holding promise, the development of CD40 agonists for cancer therapy has faced challenges due to systemic CD40 activation leading to dose-limiting toxicity (DLT). MP0317 is designed to resolve these limitations by activating immune cells specifically within the tumor microenvironment through the simultaneous binding of the immune stimulator CD40 as well as a protein highly expressed within tumors named fibroblast activation protein, or FAP.
“This first clinical data supports the potential of MP0317 as a candidate able to achieve the goal of restricting CD40 activity to tumors. We are now progressing into dosages well above those that produced dose-limiting toxicities with non-DARPin CD40 agents, a significant achievement we hope to translate into observed clinical effect,” said
This Phase 1, first-in-human, multicenter, open label, dose escalation study enrolling patients with relapsed/refractory advanced solid tumors is intended to evaluate the safety of MP0317 and investigate a range of other biomarkers to better characterize the candidate’s mechanism and activity. At the point of data cutoff, 4 cohorts had received an intravenous dose of MP0317 every 3 weeks until disease progression, unacceptable toxicity, or other discontinuation criteria were met.
Key reported data:
- MP0317 was seen to be safe and well tolerated with no dose limiting CD40-related systemic toxicities having been observed to date, and no signs of inflammatory cytokine release.
- The most frequent adverse events were grade 2 infusion related reactions (e.g., rapidly resolved infusion site inflammation) in 3/13 dosed patients at the time of data cutoff, with no DLT observed. This spans cohorts 1-4, with dosages ranging from 0.03 mg/kg to 1 mg/kg.
- Tumor biopsies from the earlier cohorts (1-3) already show evidence of MP0317 co-localization with both CD40 and FAP, in 3 of the 5 tumor biopsies available for analysis.
- In addition, early PD data show signs of CD40-mediated immune activation.
- These data support that MP0317’s mechanism is working as intended.
These results will be presented at SITC 2022 in a poster, the details of which can be found below. The poster will be made available on
Poster: “A phase 1 study to characterize the safety and tolerability of MP0317, a tumor targeting FAP dependent CD40 agonist DARPin, in patients with relapsed/refractory solid tumors”
Number: 1475
Timing:
Presenter: Paul Baverel, PhD
The dose escalation of the Phase 1 remains ongoing and
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