AIM ImmunoTech Highlights Key 2024 Achievements and Outlines Upcoming 2025-26 Value-Driving Milestones

Rhea-AI Summary

AIM ImmunoTech (NYSE American: AIM) highlighted its 2024 achievements and outlined upcoming milestones for 2025-26. The company reported progress in Ampligen® clinical development programs, particularly in pancreatic cancer and Long-COVID treatments.

Key 2024 achievements include: commencement of the DURIPANC Phase 1b/2 study combining Ampligen with AstraZeneca's Imfinzi®; positive preliminary data from multiple pancreatic cancer trials; favorable results from a Phase 2 study in post-COVID fatigue; and completion of cGMP manufacturing of 9,042 Ampligen clinical vials.

Upcoming milestones include: completion of Phase 1b DURIPANC study in Q1 2025; launch of Phase 2 in early Q2 2025; initiation of multiple clinical trials across various cancers including melanoma, triple-negative breast cancer, and ovarian cancer; and publication of final post-COVID study results in Q1 2025. Several trials are partially funded by the National Cancer Institute, AstraZeneca, and Merck.

Positive

• Multiple ongoing clinical trials partially funded by major partners (NCI, AstraZeneca, Merck)
• Positive preliminary data from Phase 1b/2 pancreatic cancer combination therapy study
• Successful manufacturing of 9,042 clinical vials of Ampligen
• Positive topline results from Phase 2 post-COVID fatigue study
• Grant of two new patents for Ampligen treatment applications

Negative

• Protocol amendments required for pancreatic cancer study, indicating potential initial design issues

Insights

Clinical Research Analyst

This comprehensive clinical development update showcases multiple Phase 1/2 trials across various high-value indications. The DURIPANC study combining Ampligen with AstraZeneca's Imfinzi in pancreatic cancer is particularly noteworthy, with Phase 1b completion expected in Q1 2025. The collaboration with major pharmaceutical companies and the National Cancer Institute adds significant credibility and reduces financial burden.

The positive preliminary data in pancreatic cancer and post-COVID fatigue represents meaningful progress. The 9,042 clinical vials manufacturing completion ensures trial continuity. The new patents for endometriosis and post-COVID fatigue expand the intellectual property portfolio and potential market opportunities.

For general understanding: Think of Ampligen as a key that helps unlock the body's immune system to fight diseases better. The partnerships with big pharma companies are like having powerful allies who believe in your product enough to invest their resources.

Financial Analyst

With a market cap of just $12.3M, AIM's extensive clinical pipeline and prestigious partnerships present a compelling risk-reward profile. The company's strategy to pursue multiple indications while leveraging external funding through collaborations with AstraZeneca, Merck and NCI demonstrates efficient capital allocation.

The well-structured clinical roadmap with multiple catalysts throughout 2025-26 provides numerous value-inflection points. The focus on high-value indications like pancreatic cancer and Long-COVID, combined with intellectual property expansion, creates multiple paths to potential value creation.

In simple terms: The company is running many important medical trials without bearing all the costs, thanks to partnerships with bigger companies. This approach helps preserve cash while maintaining multiple shots at success.

Oncology Specialist

The multi-pronged approach in oncology is strategically sound. The combination of Ampligen with checkpoint inhibitors in pancreatic cancer, melanoma and triple-negative breast cancer targets some of the most challenging areas in oncology. Pancreatic cancer, with its particularly poor prognosis, represents a significant market opportunity if the DURIPANC study proves successful.

The positive preliminary data from multiple trials suggests Ampligen's potential as an immunotherapy enhancer. The involvement of prestigious institutions and pharmaceutical companies validates the scientific approach.

For the general audience: These trials are testing whether Ampligen can help make existing cancer treatments work better by boosting the immune system's ability to fight cancer cells. It's like adding a power-up to current cancer medicines.

– Continued execution across Ampligen^® (rintatolimod) clinical development programs in areas with critical unmet needs, especially in the high-value pancreatic cancer and Long-COVID spaces

– Expected milestones over the course of the next 18 months provide significant value-driving opportunities, including some trials being partially funded by the National Cancer Institute, AstraZeneca and Merck

OCALA, Fla., Jan. 15, 2025 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE American: AIM) (“AIM” or the “Company”) today highlighted key clinical, regulatory and corporate milestones achieved over 2024 and outlined its expected upcoming milestones.

“It is clear that 2024 was a foundational year for AIM on the clinical, regulatory and corporate fronts. Without a doubt, our team continued to drive our strategy forward and deliver results. We believe this progress has positioned AIM for an exciting 2025 and the opportunity to drive value for our stockholders,” stated Thomas K. Equels, Chief Executive Officer of AIM ImmunoTech. “Looking ahead, we believe we are poised for an exciting 2025 with a number of key milestones expected over the next 18 months across important clinical trials addressing major unmet medical needs. Certain of these trials are being funded in part by major oncology interests such as the National Cancer Institute, AstraZeneca and Merck, which we believe emphasizes their great potential to change lives for the better. Our team is committed to the seamless execution of our clinical development programs and, if successful, we believe each holds the potential to drive significant value in the near and long term.”

2024 Clinical Achievement Highlights

Metastatic Pancreatic Ductal Adenocarcinoma Program

• Commenced enrollment and dosing in DURIPANC Phase 1b/2 study combining Ampligen with AstraZeneca’s anti-PD-L1 immune checkpoint inhibitor Imfinzi^® (durvalumab) for the treatment of late-stage pancreatic cancer;
• Announced that the first dose level was generally well-tolerated in the DURIPANC Phase 1b/2 study of Ampligen and Imfinzi as a combination therapy for late-stage pancreatic cancer; and
• Reported positive preliminary data from Phase 1b/2 study of Ampligen and Imfinzi as a combination therapy for late-stage pancreatic cancer.
  

Phase 2 Locally Advanced Pancreatic Adenocarcinoma Program

• Received authorization from the Erasmus Medical Center Ethics Committee to open a European site for the ongoing Phase 2 study (“AMP-270”) of Ampligen as a therapy for locally advanced pancreatic cancer; and
• Announced the publication of new positive data analysis from a long-term Early Access Program studying Ampligen for the treatment of advanced pancreatic ductal adenocarcinoma.
• The Company sought FDA guidance on expansion of inclusion criteria and treatment arms, and then subsequently amended the study protocol. The study is recruiting patients. These adjustments are also expected to result in substantial reductions in clinical costs.
  

Phase 2 Recurrent Ovarian Cancer Program

• Reported positive top-line, protocol-planned interim report data from the study of Ampligen combined with pembrolizumab for the treatment of recurrent ovarian cancer.
  

Phase 2 Post-COVID Conditions Program

• Reported positive topline results from the Company’s Phase 2 study evaluating the efficacy and safety of Ampligen as a potential therapeutic for people with the post-COVID condition of fatigue (“AMP-518”); and
• Reported an analysis of the AMP-518 clinical trial, based upon statistically significant data, which supports the Company’s belief in Ampligen as a potential therapeutic for people with the moderate-to-severe post-COVID-19 condition of fatigue, and that this would be the likely subject population for AIM’s planned follow-up clinical trial.

Grants of Intellectual Property in 2024
Further, the Company was also granted two important patents covering Ampligen for the treatment of:

• Endometriosis, a painful chronic condition that affects nearly 10% of women of reproductive age, or approximately 6.5 million women in the United States. This patent was granted in the United States.
• The Post-COVID Condition of Fatigue. This method and compositions patent was granted in the Netherlands.

Additionally, AIM successfully completed cGMP manufacturing of 9,042 clinical vials of Ampligen. The Company announced the publication of new pre-clinical data of Ampligen as part of a combinational therapy in the treatment of melanoma.

Expected Upcoming, Value-Driving Milestones

Metastatic Pancreatic Ductal Adenocarcinoma
Phase 1b/2 Combining Anti-PD-L1 Immune Checkpoint Inhibitor Durvalumab with TLR-3 Agonist Ampligen in Patients with Metastatic Pancreatic Ductal Adenocarcinoma for Therapy Efficacy (DURIPANC) (NCT05927142); Funded through collaboration of AstraZeneca and Erasmus Medical Center

• Q1 2025: Complete Phase 1b
• Early Q2 2025: Launch of Phase 2
• Q2/Q3 2026: Last patient enrolled in Phase 2
  

Locally Advanced Pancreas Cancer (LAPC)
Phase 2 Ampligen Combined with Standard of Care (SOC) versus SOC Alone Following First-Line Therapy in Subjects with LAPC (NCT05494697); AIM funded        

• Q1 2025: Buffet Cancer Center expected to enroll first subject
• H1 2025: first subject dosed

Refractory Melanoma
Phase 2 Polarized Dendritic Cell (aDC1) Based Treatment, Interferon Alpha-2, Ampligen, and Celecoxib for the Treatment of HLA-A2+ Refractory Melanoma (NCT04093323); Grant funded by National Cancer Institute

• H1 2025: First patient dosed
  

Stage 4 Triple Negative Breast Cancer
Phase 1/2a Study of Ampligen, Celecoxib and Interferon Alpha 2b with Pembrolizumab for the Treatment of Patients with Metastatic or Unresectable Triple Negative Breast Cancer (NCT05756166); Grant funded by Merck and National Cancer Institute

• Q2 2026: Expected completion of enrollment
  

Advanced Recurrent Ovarian Cancer
Phase 2 Systemic Immune Checkpoint Blockade and Intraperitoneal Chemo-Immunotherapy in Recurrent Ovarian Cancer (NCT03734692); Grant funded by Merck

• H1 2025: Expected last patient dosed and completion of study
  

Advanced Recurrent Ovarian Cancer
Phase 2 Intensive Locoregional Chemoimmunotherapy for Recurrent Ovarian Cancer Plus Intranodal DC Vaccines (NCT02432378); Grant funded by the National Cancer Institute

• H1 2025: First patient dosed
  

Post COVID Chronic Fatigue Conditions / Long Covid
Phase 2 Study to Evaluate the Efficacy and Safety of Ampligen in Patients with Post-COVID Conditions (NCT05592418); AIM funded

• Q1 2025: Final approved study results to be published on clinicaltrials.gov
  

About AIM ImmunoTech Inc.

AIM ImmunoTech Inc. is an immuno-pharma company focused on the research and development of therapeutics to treat multiple types of cancers, immune disorders and viral diseases, including COVID-19. The Company’s lead product is a first-in-class investigational drug called Ampligen^® (rintatolimod), a dsRNA and highly selective TLR3 agonist immuno-modulator with broad spectrum activity in clinical trials for globally important cancers, viral diseases and disorders of the immune system.

For more information, please visit aimimmuno.com and connect with the Company on X, LinkedIn, and Facebook.

Cautionary Statement

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 (the “PSLRA”). Words such as “may,” “will,” “expect,” “plan,” “anticipate,” “continue,” “believe,” “potential,” “upcoming” and other variations thereon and similar expressions (as well as other words or expressions referencing future events or circumstances) are intended to identify forward-looking statements. Many of these forward-looking statements involve a number of risks and uncertainties. Data, pre-clinical success and clinical success seen to date do not guarantee that Ampligen will be approved as a therapy for any of the disorders or diseases included above. The Company urges investors to consider specifically the various risk factors identified in its most recent Form 10-K, and any risk factors or cautionary statements included in any subsequent Form 10-Q or Form 8-K, filed with the U.S. Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. Among other things, for those statements, the Company claims the protection of the safe harbor for forward-looking statements contained in the PSLRA. The Company does not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof.

FAQ

What are the key milestones expected for AIM's DURIPANC study in 2025?

AIM expects to complete Phase 1b in Q1 2025 and launch Phase 2 in early Q2 2025 for the DURIPANC study, which combines Ampligen with AstraZeneca's Imfinzi for metastatic pancreatic cancer treatment.

How many Ampligen clinical vials did AIM manufacture in 2024?

AIM successfully completed cGMP manufacturing of 9,042 clinical vials of Ampligen in 2024.

What new patents did AIM receive for Ampligen in 2024?

AIM received two patents in 2024: one in the US for treating endometriosis and another in the Netherlands for treating post-COVID fatigue condition.

When will AIM publish final results of its post-COVID fatigue study?

AIM plans to publish the final approved study results on clinicaltrials.gov in Q1 2025.

Which major pharmaceutical companies are funding AIM's clinical trials?

AIM's clinical trials are partially funded by AstraZeneca, Merck, and the National Cancer Institute.