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AIM ImmunoTech (AIM) investor relations material
AIM ImmunoTech Corporate Connect Webinar Series summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.Strategic focus and clinical progress
Ampligen is being repurposed from chronic fatigue syndrome to oncology, with a primary focus on pancreatic cancer based on strong safety and efficacy data from multiple solid tumor studies in collaboration with major industry partners.
The pancreatic cancer program began in 2017 with Dutch government approval for an early access program, treating 57 late-stage patients and progressing to a phase II trial with AstraZeneca's Imfinzi at Erasmus Medical Center.
Ampligen's mechanism of action involves converting immunosilent (cold) tumors into immunoresponsive (hot) tumors by altering the tumor microenvironment, supported by specific immunological biomarkers.
The safety profile is robust, with over 100,000 IV doses administered and additional safety data from intranasal and intraperitoneal studies.
The company is prioritizing new drug approval for late-stage metastatic pancreatic cancer, addressing a significant unmet need.
Intellectual property and market exclusivity
Ampligen benefits from both patent and orphan drug designations, providing market exclusivity in the US and EU, with a recent US patent covering Ampligen plus PD-L1 valid until 2039.
Orphan drug exclusivity periods begin upon drug approval, offering up to 10 years of protection in the EU.
A Netherlands patent has also been granted for the Ampligen plus checkpoint inhibitor combination.
Clinical outcomes and data highlights
In the Dutch early access program, Ampligen extended median overall survival to 19.7 months versus 12.5 months for standard care, an 8.6-month benefit.
Patients reported significant improvements in quality of life, a critical factor in late-stage pancreatic cancer.
Biomarker analysis, including neutrophil-lymphocyte ratio and CA 19-9 levels, correlates with improved survival and progression-free survival.
Ongoing phase II DURIPANC trial interim results show positive safety, efficacy, and quality of life data, supporting advancement to phase III.
Next AIM ImmunoTech earnings date
Next AIM ImmunoTech earnings date
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