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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-center 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.
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.
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: Imneskibart combined 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
Expanded Access Policy
Aulos development resources are focused on conducting clinical studies required by regulatory authorities to fully answer important scientific questions about the potential risks and benefits of imneskibart, and to obtain regulatory approval.
Due to limited resources, imneskibart expanded access is currently not available to patients outside of clinical trial participation and post-trial access.
Patient Eligibility Criteria
To be eligible for post-trial access to imneskibart, patients must meet the following criteria:
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Participated in study CP-AU-007-01.
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Continues to benefit from and tolerate treatment with imneskibart.
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In the medical judgment of the treating Investigator, will continue to obtain benefit from imneskibart post-trial access.
Investigational Product Criteria
Imneskibart will be made available to eligible patients upon approval of an Expanded Access Request.
Treating Physician Criteria and Responsibilities
The physician(s) attending to the patient(s) who is/are receiving an investigational product through expanded access participated in study CP-AU-007-01 and is/are properly licensed and fully qualified to administer the product. The physician must agree in writing to comply with:
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Any applicable country-specific legal and regulatory requirements related to providing an investigational product under expanded access.
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Any Aulos Bioscience requirements in terms of medical criteria, safety reporting, drug supply/use and protection of intellectual property.
Requests for Post-Trial Access
A treating physician may submit questions or requests regarding expanded access to Aulos General inquiries at info@aulosbio.com.
