Ampligen (rintatolimod)

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AIM ImmunoTech Highlights Growing Body of Compelling Data of Ampligen for the Treatment of Pancreatic Cancer at Conference in Poland
Globenewswire· 2025-09-04 15:00
Core Insights - AIM ImmunoTech Inc. presented positive progress on its lead program Ampligen for pancreatic cancer at the 5th Annual Marie Skłodowska-Curie Symposium on Cancer Research and Care, highlighting improvements in Progression-Free Survival and Overall Survival from the DURIPANC clinical trial and Early Access Program [1][2][3] Company Overview - AIM ImmunoTech Inc. is focused on developing therapeutics for various cancers, immune disorders, and viral diseases, with its lead product being Ampligen, a first-in-class investigational drug [5] Clinical Trials and Data - The Phase 2 DURIPANC clinical trial is currently evaluating the combination of Ampligen and AstraZeneca's anti-PD-L1 immune checkpoint inhibitor durvalumab for late-stage metastatic pancreatic cancer patients [3] - The clinical data presented indicates a strong potential for Ampligen in treating late-stage pancreatic cancer, addressing a significant unmet medical need [3] Regulatory and Market Position - Ampligen has patent protection for its combination therapy in the U.S. until 2039 and has received orphan drug designations in both the U.S. and EU, which will provide market protections for an approved drug [3]
AIM ImmunoTech Reports Second Quarter 2025 Financial Results and Provides Corporate Update
Globenewswire· 2025-08-15 13:00
Core Insights - AIM ImmunoTech Inc. reported promising mid-year results for Ampligen in combination with AstraZeneca's Imfinzi for pancreatic cancer treatment, showing no significant toxicity and improved progression-free survival (PFS) and overall survival (OS) [1][2] - The company has strengthened its cash position, raising $8.0 million in a public equity offering, which is expected to fund operations for approximately 12 months [10] Financial Highlights - As of June 30, 2025, AIM reported cash, cash equivalents, and marketable investments totaling $835,000 [10] - Research and development expenses for Q2 2025 were $1.2 million, an increase from $1.1 million in Q2 2024 [10] - General and administrative expenses decreased to $1.5 million in Q2 2025 from $2.6 million in Q2 2024 [10] - The net loss from operations for Q2 2025 was $2.8 million, or $(3.68) per share, compared to a net loss of $1.8 million, or $(3.00) per share, in Q2 2024 [10] Clinical Development - The company is prioritizing the development of Ampligen in a Phase 2 trial for locally advanced pancreatic cancer in collaboration with Erasmus Medical Center and AstraZeneca [2] - Positive clinical data has been reported, indicating a clear path toward government approval for Ampligen in treating pancreatic cancer [2] - Upcoming presentations are scheduled at significant cancer research symposiums, highlighting the ongoing research efforts [10]
AIM ImmunoTech to Present at the Webull Financial Corporate Connect Webinar Series: Biotech/MedTech
Globenewswire· 2025-08-14 12:55
Company Overview - AIM ImmunoTech Inc. is an immuno-pharma company focused on the research and development of therapeutics for various cancers, immune disorders, and viral diseases, including COVID-19 [3] - The company's lead product is Ampligen (rintatolimod), a first-in-class investigational drug that acts as a dsRNA and highly selective TLR3 agonist immuno-modulator with broad spectrum activity in clinical trials [3] Event Announcement - AIM ImmunoTech will present at the Webull Financial Corporate Connect Webinar Series: Biotech/MedTech, which will be held virtually from August 19-21, 2025 [1] - The presentation is scheduled for August 20, 2025, at 2:40 PM ET, and will be led by Thomas Equels, the Chief Executive Officer, President & Executive Vice Chairman of the company [1]
Why Is Micro-Cap AIM ImmunoTech Stock Surging?
Benzinga· 2025-07-28 15:12
Core Insights - Biotechnology firms are increasingly focusing on innovative combination therapies for difficult-to-treat cancers, generating significant investor interest, particularly in AIM ImmunoTech Inc. following a positive update from the DURIPANC Phase 2 study [1][5] Company Summary - AIM ImmunoTech is conducting the DURIPANC study, which evaluates Ampligen (rintatolimod) in combination with AstraZeneca's anti-PD-L1 inhibitor, Imfinzi, for metastatic pancreatic cancer patients who have stable disease after FOLFIRINOX treatment [2] - The DURIPANC study is a collaboration with AstraZeneca and Erasmus Medical Center, aiming to enroll up to 25 subjects in its Phase 2 portion [2] - As of the mid-year report, 14 subjects have been enrolled, with the primary objective being to determine the clinical benefit rate of the combination therapy [3] Study Results - The DURIPANC study has shown promising early signs of no significant toxicity, with 21% of patients experiencing progression-free survival (PFS) of over 6 months, and an additional 21% not yet progressed [4][6] - The overall survival (OS) rate for eligible patients is 64% over 6 months, which exceeds expectations for this treatment setting [6] - AIM has secured a U.S. patent for Ampligen as an oncology treatment in combination with an anti-PD-L1, extending protection until August 9, 2039 [4] Market Reaction - Following the positive mid-year report, AIM ImmunoTech shares increased by 36.79%, reaching $11.49 [5]
AIM ImmunoTech Announces Recent Presentation on the Potential of Private-Public Partnerships for the Development of Oncology Therapies
Globenewswire· 2025-07-02 12:55
Core Insights - AIM ImmunoTech Inc. presented its drug Ampligen at the U.S.-Poland Science and Technology Symposium 2025, highlighting its potential in immunotherapy [1][2] - Dr. Pawel Kalinski emphasized the importance of public-private partnerships in advancing cancer research and treatment development [2][4] - The conference focused on "Opportunities in Singularity," showcasing collaboration between various institutions and organizations [3] Company Overview - AIM ImmunoTech Inc. is an immuno-pharma company dedicated to developing therapeutics for cancers, immune disorders, and viral diseases, including COVID-19 [5] - Ampligen, the company's lead product, is a first-in-class investigational drug that acts as a dsRNA and TLR3 agonist with broad-spectrum activity in clinical trials [5] Future Initiatives - The CEO of AIM stated the goal of establishing clinical partnerships and licensing agreements in Europe, particularly in Poland, to enhance cancer research [4]
AIM ImmunoTech Announces NYSE American Notice of Noncompliance With Minimum Stockholders' Equity Requirements
Globenewswire· 2025-06-20 20:15
Core Viewpoint - AIM ImmunoTech Inc. has received a warning from NYSE American regarding non-compliance with minimum stockholders' equity requirements, with a deadline to regain compliance by June 11, 2026 [2][3]. Group 1: Compliance Issues - As of March 31, 2025, AIM reported a stockholders' deficit of negative $3.9 million, failing to meet the required equity of $4.0 million due to losses in three of the last four fiscal years [2][3]. - The NYSE American had previously issued a warning on December 17, 2024, and the current notification indicates that the deficiency remains unresolved [3]. - AIM has submitted a plan to regain compliance, which has been accepted by NYSE American, allowing until June 11, 2026, to rectify the situation [3]. Group 2: Trading Status - AIM's common stock resumed trading on NYSE American under the symbol "AIM" on June 17, 2025, and the warning does not affect trading or the company's business operations [4]. Group 3: Company Overview - AIM ImmunoTech Inc. is focused on developing therapeutics for various cancers, immune disorders, and viral diseases, including COVID-19, with its lead product being Ampligen (rintatolimod) [5].
AIM ImmunoTech Announces NYSE American Removal of Trading Suspension
Globenewswire· 2025-06-12 12:00
Core Viewpoint - AIM ImmunoTech Inc. has announced the withdrawal of its delisting determination by NYSE Regulation, allowing its common stock to resume trading on the NYSE American starting June 17, 2025 [1] Company Overview - AIM ImmunoTech Inc. is an immuno-pharma company focused on developing therapeutics for various cancers, immune disorders, and viral diseases, including COVID-19 [2] - The company's lead product is Ampligen (rintatolimod), a first-in-class investigational drug that acts as a dsRNA and highly selective TLR3 agonist immuno-modulator, showing broad-spectrum activity in clinical trials [2]
AIM ImmunoTech Announces the Presentation of Ampligen Oncology Data at the Recent Annual Meeting of the American Association of Immunologists
Globenewswire· 2025-05-08 12:45
Core Insights - AIM ImmunoTech Inc. presented clinical trial data for its drug Ampligen at the Annual Meeting of the American Association of Immunologists, highlighting its potential in treating cancers and immune disorders [1][2]. Company Overview - AIM ImmunoTech Inc. is focused on developing therapeutics for various cancers, immune disorders, and viral diseases, including COVID-19. Its lead product, Ampligen (rintatolimod), is a first-in-class investigational drug that acts as a highly selective TLR3 agonist [3]. Clinical Data Presentation - The presentation by Dr. Pawel Kalinski discussed the unique selectivity of Ampligen in promoting CTL (cytotoxic T lymphocyte) influx into the tumor microenvironment (TME) while avoiding Treg (regulatory T cell) attraction. This selectivity differentiates Ampligen from other treatments like poly-I:C [2]. - Mechanistic data indicated that Ampligen's selectivity is due to its avoidance of helicase-dependent activation of NFkB, which prevents the induction of undesirable inflammatory factors while focusing on tumor tissues [2]. CEO Commentary - The CEO of AIM ImmunoTech expressed confidence in Ampligen's potential as a therapeutic option for unmet medical needs, particularly in the context of deadly cancers [3].