TLR3

AIM ImmunoTech Announces Publication of Data from Roswell Park Comprehensive Cancer Center Phase 1 Study Evaluating Ampligen® as a Component of a Chemokine-Modulating (CKM) Regimen in Metastatic Triple-Negative Breast Cancer

Retrieved on: 
Tuesday, November 14, 2023

OCALA, Fla., Nov. 14, 2023 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE American: AIM) (“AIM” or the “Company”) today announced the publication of results from the Phase 1 study at Roswell Park Comprehensive Cancer Center in patients with metastatic triple-negative breast cancer using chemokine modulation therapy, including AIM ImmunoTech Inc.’s drug candidate Ampligen® (also known as rintatolimod), interferon α-2b and celecoxib, followed by pembrolizumab.

Key Points: 
  • OCALA, Fla., Nov. 14, 2023 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE American: AIM) (“AIM” or the “Company”) today announced the publication of results from the Phase 1 study at Roswell Park Comprehensive Cancer Center in patients with metastatic triple-negative breast cancer using chemokine modulation therapy, including AIM ImmunoTech Inc.’s drug candidate Ampligen® (also known as rintatolimod), interferon α-2b and celecoxib, followed by pembrolizumab.
  • The data were published in a manuscript titled, “ Systemic Infusion of TLR3-Ligand and IFNα in Breast Cancer Patients Reprograms Local Tumor Microenvironment for Selective CTL Influx ,” in The Journal for ImmunoTherapy of Cancer.
  • The pilot study evaluated the safety of systemic CKM composed of intravenous rintatolimod (Ampligen; selective TLR3 ligand), interferon α-2b and celecoxib, and the combination’s ability to promote local CTL influx to mTNBC lesions.
  • For more information about the study, please visit ClinicalTrials.gov: NCT03599453 .

AIM ImmunoTech Outlines Recent Significant Progress Across Clinical Development Pipeline and Provides Update on Positive Pre-Clinical and IP Developments

Retrieved on: 
Monday, June 12, 2023

Ampligen continues to demonstrate significant potential across multiple types of cancers, immune disorders and viral diseases.

Key Points: 
  • Ampligen continues to demonstrate significant potential across multiple types of cancers, immune disorders and viral diseases.
  • AMP-270 is expected to enroll approximately 90 subjects in up to 30 centers across the United States and Europe.
  • The Company is recruiting patients for its AMP-270 Phase 2 study of Ampligen as a therapy for LAPC.
  • The lead site at the University of Nebraska Medical Center is now open and actively working to enroll patients.

AIM ImmunoTech Announces Late-Breaking Presentation at the International Conference on Antiviral Research Regarding Ampligen as a Potential Therapy Against Ebola Virus Disease

Retrieved on: 
Thursday, March 16, 2023

Highlights of the recently published Ampligen data that was presented include:

Key Points: 
  • Highlights of the recently published Ampligen data that was presented include:
    As a TLR3 agonist, Ampligen induces and enhances innate immunological responses to EBOV infection.
  • AIM CEO Thomas K. Equels commented, “In vivo pre-clinical analysis shows that Ampligen has potential as both a prophylactic and an early-onset therapeutic in Ebola virus disease.
  • Animal studies with Ampligen at the United States Army Medical Research Institute of Infectious Diseases Biosafety Level 4 laboratories demonstrated 100% protective survival, as compared to 100% mortality in Ebola virus disease.
  • Ultimately, the Company's goal is to seek a Tropical Disease Priority Review Voucher for new drug applications associated with these indications.

AIM ImmunoTech Announces Publication of New Analysis of the Mechanism of Action of Ampligen as a Potential Prophylactic Therapy Against Ebola Virus Disease

Retrieved on: 
Wednesday, March 8, 2023

Ebola virus (EBOV) is a highly infectious and lethal pathogen responsible for sporadic, self-limiting clusters of Ebola virus disease (EVD) in Central Africa capable of reaching epidemic status.

Key Points: 
  • Ebola virus (EBOV) is a highly infectious and lethal pathogen responsible for sporadic, self-limiting clusters of Ebola virus disease (EVD) in Central Africa capable of reaching epidemic status.
  • Previously announced data found that Ampligen provided 100% protection against EVD in a mouse model.
  • The newly published analysis supports a dual mechanism of action when Ampligen is used as a prophylactic therapy against EVD.
  • Ultimately, the Company's goal is to seek a Tropical Disease Priority Review Voucher for new drug applications associated with these indications.

AIM ImmunoTech Enters into Pancreatic Cancer Clinical Research Agreements with AstraZeneca and Erasmus Medical Center

Retrieved on: 
Tuesday, January 17, 2023

DURIPANC Study,” in which it will use both Study Drugs provided by AstraZeneca and AIM ImmunoTech.

Key Points: 
  • DURIPANC Study,” in which it will use both Study Drugs provided by AstraZeneca and AIM ImmunoTech.
  • In the previously conducted human clinical studies, Ampligen has shown synergistic potential with PD-1 checkpoint blockade therapeutics.
  • van Eijck, MD, PhD, Pancreato-biliary Surgeon at Erasmus MC, added, “PD-L1 expression levels in the malignant tumors of pancreatic cancer patients correlates to poor prognosis.
  • Additionally, there is published data from two recent clinical studies – in triple-negative breast cancer and advanced recurrent ovarian cancer – that further support Ampligen’s potential to enhance checkpoint blockade therapy efficacy.

AIM ImmunoTech Reports Positive Safety, Tolerability and Biological Activity Data for Intranasal Ampligen® (Rintatolimod) in Healthy Subjects

Retrieved on: 
Thursday, December 8, 2022

OCALA, Fla., Dec. 08, 2022 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE American: AIM) (“AIM” or the “Company”), 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 disease caused by the SARS-CoV-2 virus, today reported that data were recently presented by Lisanne C.A. Smidt - Centre for Human Drug Research (CHDR), Leiden, the Netherlands in a poster titled, “Safety, tolerability and biological activity of repeated intranasal administration of TLR3 agonist Ampligen (Poly I:Poly C12U) in healthy subjects,” at the British Society for Immunology Congress 2022 . The data showed positive safety, tolerability and biological activity of a 13-day dosing regimen conducted in Q2 2021 for intranasal Ampligen® (rintatolimod) in healthy subjects.

Key Points: 
  • Smidt - Centre for Human Drug Research (CHDR), Leiden, the Netherlands in a poster titled, “Safety, tolerability and biological activity of repeated intranasal administration of TLR3 agonist Ampligen (Poly I:Poly C12U) in healthy subjects,” at the British Society for Immunology Congress 2022 .
  • The data showed positive safety, tolerability and biological activity of a 13-day dosing regimen conducted in Q2 2021 for intranasal Ampligen® (rintatolimod) in healthy subjects.
  • Intranasal administration of Ampligen could induce an innate mucosal immune response, thereby inhibiting respiratory viruses at the point of entry.
  • Among other things, for those statements, the Company claims the protection of safe harbor for forward-looking statements contained in the PSLRA.

Vaxart Announces Collaborative Funding from Leading Foundation to Study Its Norovirus Vaccine Candidate in Breastfeeding Mothers

Retrieved on: 
Thursday, December 1, 2022

SOUTH SAN FRANCISCO, Calif., Dec. 01, 2022 (GLOBE NEWSWIRE) -- Vaxart, Inc. (Nasdaq: VXRT) today announced it will commence a new study of Vaxart’s oral pill norovirus vaccine candidate focused on protecting breastfeeding mothers and their infants.

Key Points: 
  • The study will receive significant funding and support from the Bill & Melinda Gates Foundation (Gates Foundation).
  • This funding follows Vaxarts previous collaboration with Duke University on a pre-clinical COVID-19 transmission study also funded by the Gates Foundation.
  • The study will examine whether Vaxarts vaccine candidate induces antibodies in the breast milk of lactating mothers and whether infants up to 6 months of age can acquire those antibodies.
  • Vaxart is also currently studying its norovirus vaccine candidate in a challenge study that will provide the vaccine 30 days before exposure to actual norovirus, and then determine whether people get infected or have severe gastroenteritis.

Vaxart to Present at World Vaccine & Immunotherapy Congress West Coast 2022 on November 29

Retrieved on: 
Tuesday, November 22, 2022

SOUTH SAN FRANCISCO, Calif., Nov. 22, 2022 (GLOBE NEWSWIRE) -- Vaxart, Inc. (Nasdaq: VXRT) today announced that Dr. Sean Tucker, Founder and Chief Scientific Officer, will present at the World Vaccine & Immunotherapy Congress West Coast 2022 in San Diego on Tuesday, November 29, 2022 at 1:50 p.m. PT / 4:50 p.m.

Key Points: 
  • SOUTH SAN FRANCISCO, Calif., Nov. 22, 2022 (GLOBE NEWSWIRE) -- Vaxart, Inc. (Nasdaq: VXRT) today announced that Dr. Sean Tucker, Founder and Chief Scientific Officer, will present at the World Vaccine & Immunotherapy Congress West Coast 2022 in San Diego on Tuesday, November 29, 2022 at 1:50 p.m. PT / 4:50 p.m.
  • Dr. Tucker will provide an overview of Vaxarts Phase II trial for its oral pill COVID-19 vaccine candidate.
  • Vaxart recently announced positive top-line Phase II clinical study results for its Wuhan S-only COVID-19 pill vaccine candidate.
  • Vaxart is a clinical-stage biotechnology company developing a range of oral recombinant vaccines based on its proprietary delivery platform.

Vaxart Provides Business Update and Reports Third Quarter 2022 Financial Results

Retrieved on: 
Tuesday, November 8, 2022

SOUTH SAN FRANCISCO, Calif., Nov. 08, 2022 (GLOBE NEWSWIRE) -- Vaxart, Inc. (NASDAQ: VXRT) issued its business update today for the third quarter of 2022, during which the Company made significant progress on its oral vaccine candidates.

Key Points: 
  • ET
    SOUTH SAN FRANCISCO, Calif., Nov. 08, 2022 (GLOBE NEWSWIRE) -- Vaxart, Inc. (NASDAQ: VXRT)issued its business update today for the third quarter of 2022, during which the Company made significant progress on its oral vaccine candidates.
  • Research and development expenses were$22.5 millionfor the third quarter of 2022, compared to$12.4 million for the third quarter of 2021.
  • General and administrative expenses were$7.0 millionfor the third quarter of 2022, compared to$5.0 million for the third quarter of 2021.
  • The Vaxart senior management team will host a conference call to discuss the business update and financial results for the third quarter of 2022 today, beginning at 4:30 p.m.

Vaxart to Host Third Quarter 2022 Business Update and Financial Results Conference Call on November 8

Retrieved on: 
Thursday, October 20, 2022

SOUTH SAN FRANCISCO, Calif., Oct. 20, 2022 (GLOBE NEWSWIRE) -- Vaxart, Inc. (NASDAQ: VXRT) today announced it will provide a business update and report financial results for the third quarter ended September 30, 2022 after the market close on Tuesday, November 8, 2022. The Vaxart senior management team will host a conference call on the same day, beginning at 4:30 p.m. ET.

Key Points: 
  • ET
    SOUTH SAN FRANCISCO, Calif., Oct. 20, 2022 (GLOBE NEWSWIRE) -- Vaxart, Inc. (NASDAQ: VXRT)today announced it will provide a business update and report financial results for the third quarter ended September 30, 2022 after the market close on Tuesday, November 8, 2022.
  • The Vaxart senior management team will host a conference call on the same day, beginning at 4:30 p.m.
  • Vaxart is a clinical-stage biotechnology company developing a range of oral recombinant vaccines based on its proprietary delivery platform.
  • Vaxart vaccines are designed to be administered using tablets that can be stored and shipped without refrigeration and eliminate the risk of needle-stick injury.