8-K: AIM ImmunoTech Plans Clinical Study Combining Ampligen and AstraZeneca's FluMist to Combat Avian Flu

AIM ImmunoTech announces a planned follow-up clinical study evaluating a combination treatment of AIM's Ampligen and AstraZeneca's FluMist to address the recent avian influenza outbreaks.

Summary

• AIM ImmunoTech is planning a clinical study to evaluate a combination treatment of Ampligen and AstraZeneca's FluMist for avian influenza.
• The company has engaged Amarex Clinical Research to manage the Investigational New Drug (IND) application for the study.
• AIM is seeking collaborative grants from government and industry to fund the study.
• Previous research at the University of Alabama-Birmingham (UAB) showed that intranasal delivery of Ampligen with FluMist increased the immune response to seasonal flu variants and induced cross-reactive antibodies against avian influenza strains.
• Pre-clinical work demonstrated that Ampligen, when administered with a seasonal flu vaccine, showed cross-reactivity against H5N1 in mice.
• In mice challenged with H5N1 variants, 50% survival protection from influenza A Vietnam strain was observed compared to 0% in uninoculated mice.
• 100% survival from influenza A Hong Kong strain and influenza A Indonesia strain viruses, compared to 60% and 20% respectively in nave controls.
• Intranasal delivery of Ampligen combined with H5N1 vaccine protected non-human primates from H5N1 symptoms.
• A previous AIM-sponsored study found that repeated administration of intranasal Ampligen in humans was generally well-tolerated.
• AIM believes the pre-clinical and clinical work supports moving forward with the Ampligen and FluMist study.

Sentiment

Score: 7

Explanation: The announcement is positive due to the planned clinical study and previous positive research, but it also contains cautionary statements about risks and uncertainties.

Positives

• Previous clinical research at UAB indicated that intranasal delivery of Ampligen after FluMist increased the immune response to seasonal variants in the vaccine by greater than four-fold.
• Pre-clinical work showed that Ampligen manifested cross-reactivity of mucosal and serum antibodies against H5N1 in mice.
• Intranasal delivery of Ampligen in combination with H5N1 vaccine conferred serum and mucosal antibodies and protected non-human primates from H5N1 symptoms.
• A previous AIM-sponsored study found that repeated administration of intranasal Ampligen in humans was generally well-tolerated.

Risks

• The press release contains forward-looking statements that involve risks and uncertainties.
• Data, pre-clinical success and clinical success seen to date do not guarantee that Ampligen will be approved as a therapy or vaccine adjuvant for any variant of influenza.
• The company urges investors to consider the risk factors identified in its filings with the SEC.

Future Outlook

AIM ImmunoTech plans to advance Ampligen as a vaccine adjuvant for avian influenza and is seeking collaborative grants to defray the cost of the study.

Management Comments

• AIM CEO Thomas K. Equels stated: 'The avian flu has emerged as a serious and ever-growing public health threat.'
• Thomas K. Equels stated: 'We believe there is the potential for an influenza vaccination program that provides broader coverage than the currently approved vaccination programs, with the added simplicity of being delivered intranasally.'
• Thomas K. Equels stated: 'Specifically, there is already both pre-clinical and clinical data which demonstrates potential for synergy between our lead compound Ampligen to provide greater efficacy and potential epitope spreading and cross-reactivity for avian influenza when combined with AstraZenecas FluMist vaccine.'
• Thomas K. Equels stated: 'Based on the UAB clinical data to date, we believe such a combination therapy could also be an effective barrier against avian flu infections.'

Industry Context

The announcement comes amid growing concerns about avian influenza outbreaks and the need for more effective vaccination programs. The collaboration with AstraZeneca and the focus on intranasal delivery align with current trends in vaccine development.

Comparison to Industry Standards

• The study aims to improve upon existing influenza vaccination programs, such as those offered by companies like Sanofi and GSK, by providing broader coverage and simpler intranasal delivery.
• The use of Ampligen as an adjuvant is similar to strategies employed by other companies using adjuvants to enhance vaccine efficacy, such as Novavax with its Matrix-M adjuvant.
• The focus on cross-reactivity against avian influenza strains aligns with efforts by companies like Moderna and BioNTech to develop mRNA vaccines that can target multiple variants.

Stakeholder Impact

• Shareholders may be impacted by the potential for a new revenue stream if the clinical study is successful.
• Employees may be impacted by the increased workload associated with the clinical study.
• Customers (potential vaccine recipients) may benefit from a more effective avian influenza vaccine.

Next Steps

• AIM will advance Ampligen as a vaccine adjuvant for avian influenza.
• AIM will seek collaborative grants from government and industry to defray the cost of the study.
• AIM will file an Investigational New Drug (IND) application for the study.

Key Dates

Keywords

Ampligen, FluMist, avian influenza, clinical study, vaccine adjuvant, AIM ImmunoTech, AstraZeneca, Amarex, H5N1, H7N9, H7N3