Welcome to our dedicated page for Aim Immunotech news (Ticker: AIM), a resource for investors and traders seeking the latest updates and insights on Aim Immunotech stock.
About AIM ImmunoTech Inc.
AIM ImmunoTech Inc. (NASDAQ: AIM) is a pioneering immuno-pharma company dedicated to the research, development, and commercialization of innovative therapeutics designed to address complex medical challenges in oncology, viral diseases, and immune-deficiency disorders. Operating at the intersection of biotechnology and immunology, AIM leverages cutting-edge science to develop treatments that harness the body's immune system to combat diseases with high unmet medical needs.
Core Products and Therapeutic Focus
The company's flagship product, Ampligen® (Rintatolimod), is a first-in-class macromolecular RNA-based therapeutic with broad potential applications. Ampligen is currently under investigation for its efficacy in treating a range of cancers, including renal cell carcinoma, malignant melanoma, triple-negative breast cancer, and ovarian cancer. Additionally, it is being explored as a potential therapy for viral infections such as HIV, Hepatitis B, and post-COVID chronic fatigue conditions, as well as a vaccine adjuvant for enhancing immune responses to influenza and other pathogens.
Another key product, Alferon N Injection®, is a natural alpha interferon injectable approved for the treatment of specific categories of genital warts. This product underscores AIM's commitment to addressing both common and rare conditions through innovative immune-based solutions.
Research and Development Initiatives
AIM ImmunoTech is deeply invested in advancing its clinical pipeline, with multiple ongoing and planned trials funded by grants and partnerships. The company collaborates with leading research institutions and pharmaceutical companies, including the Japanese National Institute of Infectious Diseases and Shionogi & Co., Ltd., to explore Ampligen's potential as an adjuvant therapy for emerging infectious diseases such as COVID-19.
Notably, AIM is exploring the use of Ampligen in combination therapies to enhance the efficacy of existing treatments. For example, Ampligen is being studied alongside checkpoint inhibitors, chemotherapy, and other immunomodulatory agents to improve outcomes in advanced and recurrent cancers.
Strategic Vision and Market Position
AIM operates within the highly competitive and innovation-driven biotechnology sector, focusing on immunotherapy—a rapidly growing area of medicine that seeks to revolutionize how diseases are treated. By targeting both oncology and infectious diseases, the company positions itself at the forefront of addressing some of the most pressing global health challenges. Its strategy involves leveraging Ampligen's versatility as a platform technology, expanding its indications through rigorous clinical trials, and forming strategic partnerships to accelerate development and commercialization.
Challenges and Opportunities
While AIM faces challenges typical of the biotech industry, such as high R&D costs, regulatory approvals, and market competition, it also stands to benefit from increasing demand for immunotherapies and the growing recognition of RNA-based treatments. The company's focus on niche yet impactful therapeutic areas provides a competitive edge, while its collaborative approach to research enhances its capacity for innovation.
Conclusion
AIM ImmunoTech Inc. represents a compelling opportunity within the immuno-pharma space, driven by its commitment to scientific innovation and its focus on addressing critical unmet medical needs. By advancing its robust pipeline and leveraging strategic partnerships, AIM aims to solidify its position as a leader in the development of immune-based therapeutics.
AIM ImmunoTech has announced that Dr. Paul Goepfert from the University of Alabama-Birmingham will lead a planned clinical study combining Ampligen and AstraZeneca's FluMist as an intranasal vaccine for influenza, including avian influenza. This follows a previous UAB trial where Ampligen, used as a vaccine adjuvant, increased immune response to seasonal variants by over 4-fold and induced cross-reactive protection against highly pathogenic avian influenza strains H5N1, H7N9, and H7N3.
The company has engaged Amarex Clinical Research to prepare an Investigational New Drug application and manage the clinical study. AIM is seeking industry or governmental grants for study funding, with CEO Thomas K. Equels highlighting the potential cost-effectiveness of this approach at approximately $10 million in development costs compared to potentially billions for new mRNA vaccine development.
AIM ImmunoTech (NYSE American: AIM) has received acceptance from the NYSE American for its compliance plan to meet minimum stockholders' equity requirements under Sections 1003(a)(ii) and 1003(a)(iii) of the American Company Guide. The company has been granted until June 11, 2026 to regain compliance with the NYSE's Continued Listings Standards. CEO Thomas K. Equels expressed satisfaction with the approval and mentioned ongoing developments in the company's oncology and antiviral pipelines.
AIM ImmunoTech (NYSE American: AIM) has appointed David Chemerow as an Independent Director to its Board of Directors, effective immediately. Chemerow brings over 40 years of finance, accounting, and operations leadership experience to the role.
Chemerow previously served as CFO, Treasurer, and Chief Revenue Officer at Comscore, and as COO and CFO of Rentrak until its 2016 merger with Comscore. He currently serves on the Board of Directors for Dunham's Athleisure and the Advisory Board of Huntington Outdoor.
The appointment was unanimously approved by AIM's Board. Board Chairman William Mitchell highlighted Chemerow's proven track record of leadership and financial acumen as valuable additions to AIM's mission. Chemerow expressed optimism about AIM's position in the immuno-pharma space, particularly noting Ampligen's potential across various high-value indications.
AIM ImmunoTech (NYSE American: AIM) has dosed the first new subject in Phase 2 of their Phase 1b/2 clinical trial studying the combination of Ampligen (rintatolimod) and AstraZeneca's Imfinzi (durvalumab) for treating late-stage pancreatic cancer. The trial, known as DURIPANC, is being conducted at the Erasmus Medical Center in the Netherlands.
Several subjects from Phase 1 who received the highest dose will also be included in Phase 2. The investigator-initiated, exploratory, open-label, single-center study expects to enroll up to 25 patients in the Phase 2 portion.
AIM CEO Thomas K. Equels expressed confidence in steady enrollment, noting that unlike many pancreatic cancer studies where accrual can be challenging, they expect consistent patient recruitment for this trial combining the TLR-3 agonist rintatolimod with the anti-PD-L1 immune checkpoint inhibitor durvalumab.
AIM ImmunoTech (NYSE American: AIM) has released a Virtual Investor segment featuring CEO Thomas K. Equels and Professor Casper H.J. van Eijck from Erasmus Medical Center discussing their Phase 1b/2 clinical trial DURIPANC. The trial investigates the combination of AIM's Ampligen® and AstraZeneca's Imfinzi® for treating late-stage pancreatic cancer.
The Erasmus MC Safety Committee has approved advancing to Phase 2 after reviewing Phase 1 safety data, which showed the combination treatment was generally well-tolerated with no treatment-related severe adverse events or dose-limiting toxicities. The study is being conducted as an investigator-initiated, exploratory, open-label, single-center trial in the Netherlands at Erasmus MC.
AIM ImmunoTech (NYSE American: AIM) has announced it will postpone its planned offering under Registration Statement Form S-1. The company will not proceed with the offering until after filing its Annual Report on Form 10-K for the fiscal year ended December 31, 2024.
AIM ImmunoTech (NYSE American: AIM) has announced plans to advance Ampligen as a vaccine adjuvant for avian influenza. The company will conduct a follow-up clinical study combining Ampligen with AstraZeneca's FluMist nasal spray vaccine. This initiative builds on previous research at the University of Alabama-Birmingham, which showed that intranasal Ampligen administration after FluMist increased immune response by over four-fold and induced cross-reactive antibodies against highly pathogenic avian influenza strains H5N1, H7N9, and H7N3.
Pre-clinical studies demonstrated significant protective effects, with 50-100% survival rates against various H5N1 strains in mice. Non-human primate studies showed protection against H5N1 symptoms and generated neutralizing antibodies. Previous human trials indicated that intranasal Ampligen was generally well-tolerated with no serious treatment-related adverse events.
AIM ImmunoTech (NYSE American: AIM) has received Safety Committee approval to advance to Phase 2 of their Phase 1b/2 clinical trial studying the combination of Ampligen® and Imfinzi® for late-stage pancreatic cancer treatment. The approval follows positive Phase 1 safety data showing the combination therapy was generally well-tolerated with no severe treatment-related adverse events.
The DURIPANC study, conducted at Erasmus Medical Center in the Netherlands, will enroll up to 25 patients in Phase 2, including six patients from Phase 1. Early observations indicate improvements in quality of life, with some patients showing stable disease for 15+ months after starting FOLFIRINOX treatment. This is notable considering approximately 80% of similar patients at Erasmus MC typically show disease progression after three months without this treatment.
The study aims to address a significant unmet need in oncology, as pancreatic cancer claims approximately 50,000 American lives annually with currently no effective therapy available.
AIM ImmunoTech (NYSE American: AIM) has published final clinical study results for its AMP-518 Phase 2 trial evaluating Ampligen as a treatment for Post-COVID conditions. The study showed promising results, particularly for patients with moderate-to-severe Post-COVID fatigue.
Key findings revealed that Ampligen-treated patients with Long COVID demonstrated improved walking capacity compared to placebo groups. Specifically, patients with a baseline Six-Minute Walk Test (6MWT) less than 205 meters showed significant improvement, achieving a mean increase of 139 meters versus 91 meters in the placebo group (p <0.02).
The company highlighted recent NIH RECOVER initiative data showing that ME/CFS (Myalgic Encephalomyelitis/Chronic Fatigue Syndrome) prevalence is now five times higher than pre-pandemic levels due to COVID-19 infections. Based on these results, AIM plans to conduct a follow-up clinical trial focusing on patients with moderate or worse COVID-related fatigue or ME/CFS symptoms.
AIM ImmunoTech (NYSE American: AIM) comments on a new study published in the Journal of General Internal Medicine that reveals significant links between COVID-19 and ME/CFS. The study found that among COVID-19 infected participants, ME/CFS incidence was 15 times higher than pre-pandemic rates, with 4.5% prevalence among infected participants.
The company's drug Ampligen showed promising results in their AMP-518 clinical program for Post-COVID fatigue treatment. Patients with baseline Six-Minute Walk Test less than 205 meters showed significant improvement, with a mean increase of 139 meters compared to 91 meters in the placebo group (p<0.02).
Earlier data published in PLOS One demonstrated Ampligen's effectiveness in treating ME/CFS when administered early (2-8 years of symptom onset), with 51.2% of treated subjects showing at least 25% improvement in exercise duration (p=0.003).
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