Company continues progress across Ampligen^® clinical development programs

Growing body of promising data demonstrates Ampligen’s potential to address multiple high-value indications

OCALA, Fla., Feb. 29, 2024 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE American: AIM) (“AIM” or the “Company”) today highlighted recent accomplishments and provided a business outlook. AIM’s dsRNA product candidate, Ampligen^® (rintatolimod), is being evaluated as a combinational therapy for the treatment of a variety of solid tumor types in multiple clinical trials – both underway and planned – at major cancer research centers around the country.

Recent Highlights

• AMP-518 Clinical Study: Phase 2 study evaluating Ampligen as a potential therapeutic for people with the Post-COVID condition of fatigue

  • Completed treatment in study

  • Reported positive topline results offering preliminary evidence that Ampligen may reduce fatigue in subjects with Post-COVID conditions

• Bolstered intellectual property estate with issuance of key U.S. patent for Ampligen in combination with an anti-PD-L1 antibody for the treatment of cancer

• DURIPANC Clinical Study: Phase 1b/2 clinical trial combining AIM’s Ampligen with AstraZeneca’s anti-PD-L1 immune checkpoint inhibitor Imfinzi^® (durvalumab) for the treatment of pancreatic cancer

  • Opened for enrollment and enrolled first subject at Erasmus Medical Center (“Erasmus MC”)

  • First subject dosed at Erasmus MC
    

“AIM’s emphasis throughout 2024 will be building upon our strong foundation of scientific success,” said AIM Chief Executive Officer Thomas K. Equels. “Our drug Ampligen is being evaluated in multiple indications — including pancreatic cancer, ovarian cancer and Post-COVID conditions — and we believe that success in any one of these areas would mean both dramatic improvement in people’s lives and significant value for our stockholders.”

Upcoming Expected Ampligen Milestones

Q1 2024

• Advanced Recurrent Ovarian Cancer – Protocol-planned interim results
  

Q2 2024

• Post-COVID Conditions (AMP-518) – Final dataset
  

2024

• Locally Advanced Pancreatic Adenocarcinoma (AMP-270) – First subject dosed

• Publications of data in scientific journals

Ongoing Business Development Update

As previously announced, the Company engaged Azenova, LLC (“Azenova”), a professional business development (BD) consulting firm, to support efforts to partner AIM’s pipeline programs with a particular focus on the Company’s lead asset, Ampligen^®, for the treatment of various malignant solid tumors. Discussions for potential partnership, licensing, and other transactional activities remain ongoing.