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Imneskibart (AU-007) is a novel investigational immune therapy being evaluated for the treatment of solid cancers.
The clinical trial is an open label, multi-centre Phase 1/2 study to evaluate the safety, tolerability and initial efficacy of imneskibart in patients with unresectable locally advanced or metastatic cancer. Eligible cancers include cutaneous melanoma and non-small cell lung cancer. Patients must either be ineligible for or have progressed on prior standard of care therapy. Potential study participants may be eligible if they have failed or progressed on anti-PD-1 or anti-PD-L1 therapy.
Study Details
Phase 1 (complete) consisted of three dose escalation arms evaluating imneskibart either as a monotherapy, in combination with a single loading dose of low-dose, subcutaneous human IL-2, or with both imneskibart and low-dose, subcutaneous human IL-2 administered once every two weeks (Q2W). The Phase 2 portion of the trial evaluates imneskibart in combination with a loading dose of subcutaneous human IL-2 in cutaneous melanoma and non-small cell lung cancer to define the safety and initial efficacy of imneskibart. The Phase 2 portion of the trial also evaluates this regimen of imneskibart and IL-2 in combination with the anti-PD-L1 avelumab in PD-L1-positive non-small cell lung cancer and imneskibart and IL-2 in combination with the anti-PD-1 nivolumab in cutaneous melanoma. For additional details, visit clinicaltrials.gov (NCT05267626).
Study Arms and Interventions
Arm
Intervention/Treatment
COMPLETE
Experimental: Imneskibart Monotherapy
Imneskibart (Q2W) will be administered intravenously (IV) as a monotherapy in sequential ascending doses with each Dose Escalation Cohort.
Drug: Imneskibart
Monoclonal Antibody Targeting IL-2​
COMPLETE
Experimental: Imneskibart combined with a subcutaneous, low dose of human IL-2
​
Imneskibart (Q2W) will be administered IV in combination with a single, subcutaneous, low dose of human IL-2 with the initial Imneskibart dose. The low-dose, subcutaneous human IL-2 dose will be escalated with each Dose Escalation Cohort.
Drug: Imneskibart
Monoclonal Antibody Targeting IL-2
​
Drug: Low-dose, subcutaneous human IL-2
COMPLETE
Experimental: Imneskibart combined with low-dose, subcutaneous human IL-2 given concomitantly
​
Imneskibart will be administered IV in combination with low-dose, subcutaneous human IL-2, both administered Q2W. The low-dose, subcutaneous human IL-2 dose will be escalated with each Dose Escalation Cohort.
Drug: Imneskibart
Monoclonal Antibody Targeting IL-2
​
Drug: Low-dose, subcutaneous human IL-2​
Recruiting
Experimental: Imneskibart combined with a subcutaneous, low dose of human IL-2
​
Imneskibart will be administered IV Q2W in combination with a single subcutaneous, low dose of human IL-2.
Drug: Imneskibart
Monoclonal Antibody Targeting IL-2
​
Drug: Low-dose, subcutaneous human IL-2​
Recruiting
Experimental: Imneskibartcombined with low-dose, subcutaneous human IL-2 and avelumab concomitantly
​
Imneskibart will be administered IV in combination with low-dose, subcutaneous human IL-2 in a single dose. Both administered with avelumab.
Drug: Imneskibart
Monoclonal Antibody Targeting IL-2
​
Drug: Low-dose, subcutaneous human IL-2
​
Drug: IV avelumab targeting PD-L1
Recruiting
Experimental: Imneskibart combined with low-dose, subcutaneous human IL-2 and nivolumab concomitantly
​
Imneskibart will be administered IV Q2W in combination with a single, subcutaneous low dose of human IL-2. Both administered with nivolumab.
Drug: Imneskibart
Monoclonal Antibody Targeting IL-2
​
Drug: Low-dose, subcutaneous human IL-2
​
Drug: IV nivolumab targeting PD-1
What is Imneskibart?
Imneskibart is a human IgG1 monoclonal antibody designed with the assistance of artificial intelligence. Preclinical studies have shown that it can bind human interleukin-2 (IL-2) with picomolar affinity and precisely block IL-2’s binding to CD25, without hindering IL-2’s binding to CD122/CD132. Through this unique mechanism of action, imneskibart has the potential to transform the IL-2 negative feedback loop into a positive one, tipping the balance toward immune activation and away from immune suppression.
