US-based biotechnology company AIM ImmunoTech has reported significant progress in its Phase Ib/II DURIPANC trial, which is assessing the combination of Ampligen and Imfinzi for treating late-stage pancreatic cancer patients.
The trial did not observe any severe adverse events or dose-limiting toxicities at the initial dose level.
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Staff at the Erasmus Medical Center in the Netherlands have concluded the safety assessment for the first dose level within the study’s dose escalation design.
The findings indicate that the combination therapy is generally well-tolerated, enabling dose escalation in line with the study protocol.
AIM ImmunoTech expects to begin dosing the subsequent patient cohort shortly, having dosed the first patient in the trial earlier this year.
The trial subjects will undergo treatment for a period of up to 48 weeks, or until disease progression confirmation or another discontinuation criterion is met.
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By GlobalDataTheir responses to the treatment will be monitored based on the Response Evaluation Criteria in Solid Tumours (RECIST 1.1).
AIM ImmunoTech’s lead product is Ampligen (rintatolimod), a first-in-class investigational drug that has broad spectrum activity in studies for various forms of cancer, as well as viral diseases and immune system disorders.
A dsRNA and highly selective TLR3 agonist immuno-modulator, Ampligen has shown therapeutic synergy with checkpoint inhibitors when used alongside checkpoint blockade therapies.
It has been proven to increase survival rates and efficacy in animal tumour treatment.
Ampligen’s synergistic potential with checkpoint blockade therapeutics was first observed in pre-clinical mouse models of melanoma and pancreatic cancers.
More recent clinical studies in triple-negative breast cancer and advanced recurrent ovarian cancer have supported the drug’s potential to increase checkpoint blockade therapy efficacy.
Last year, AIM ImmunoTech signed an externally sponsored collaborative clinical research agreement with Erasmus MC and AstraZeneca.
Erasmus MC agreed to conduct an investigator-initiated clinical study involving the use of study drugs provided by AstraZeneca and AIM ImmunoTech.
