Interferon-α(Avadel Pharmaceuticals Plc)

Year marked by noteworthy operational execution and clinical development progress across pipeline Company reiterates commitment to continued communication and activity with the investment and scientific communities Poised to achieve multiple clinical and regulatory value-driving milestones in 2023 OCALA, Fla., March 06, 2023 (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 issued a letter to stockholders highlighting key accomplishments in 2022 and outlining corporate objectives for 2023. The full text of the letter is as follows: March 6, 2023 To our valued stockholders, Over the course of the past year, the AIM management team and Board have worked dedicatedly to position the Company for continued success. In 2022, our team successfully executed across our clinical development programs, including the initiation of clinical studies and commenced patient enrollment, as well as noteworthy progress on the corporate front. I am incredibly proud of our team and pleased with the advancements we’ve made. As we come to the new year and milestones ahead, I think it’s worth reviewing some of the key accomplishments made in 2022, highlighted below: Oncology Development Programs Advanced Late-Stage Pancreatic Cancer March 2022: IND Clearance for Phase 2 Clinical StudyMarch 2022: Publication of Positive Data from EAP ProgramJuly 2022: Positive Data from Single-Center Named Patient Program as Maintenance TherapyAugust 2022: Commencement of Phase 2 Study Stage 4 Triple-Negative Breast Cancer April 2022: Positive Data from Phase 1 Study in Stage 4 Metastatic TNBC Advanced Recurrent Ovarian Cancer January 2022: Publication of Positive Results from Phase 1/2 StudyApril 2022: Positive Interim Data Published Combining Ampligen with KEYTRUDA Stage 4 Melanoma August 2022: Commenced Enrollment in Phase 2 Clinical Study Late-Stage Colorectal Cancer April 2022: Positive Data from Phase 2a Clinical Study Long COVID Development Program June 2022: Expanded IP Portfolio July 2022: Positive Pilot Study Data from EAP ProgramOctober 2022: IND Clearance for Phase 2 Clinical Study Other Diseases November 2022: AIM ImmunoTech Receives FDA Orphan Drug Designation for Ampligen (rintatolimod) for the Treatment of Ebola Virus DiseaseDecember 2022: Reported Positive Safety, Tolerability and Biological Activity Data for Intranasal Ampligen® in Healthy Subjects Corporate March 2022: AIM ImmunoTech Appoints Robert Dickey, IV as Chief Financial OfficerJune 2022: New State-of-the-Art Facility for Product Development and TestingOctober 2022: Delaware Court Rules in Favor of AIM ImmunoTech and Declines to Declare Activist Group’s Nominations ValidNovember 2022: AIM ImmunoTech Shareholders Elect All Three Company Director Nominees at 2022 Annual Meeting PUBLICATIONS Oncology Advanced Late-Stage Pancreatic Cancer March 2022: Rintatolimod (Ampligen®) Enhances Numbers of Peripheral B Cells and Is Associated with Longer Survival in Patients with Locally Advanced and Metastasized Pancreatic Cancer Pre-Treated with FOLFIRINOX: A Single-Center Named Patient ProgramMarch 2022: EP02C-111 Treating Pancreatic Ductal Adenocarcinoma Patients with Rintatolimod: Hitting Two Targets with One Arrow? Stage 4 Triple-Negative Breast Cancer June 2022: Negative impact of paclitaxel on human breast tumor microenvironment and its reversal by the combination of interferon-α with TLR3 agonist rintatolimodJune 2022: Systemic rintatolimod and interferon-α2b selectively reprogram local tumor microenvironment in patients with metastatic triple negative breast cancer for enhanced influx of cytotoxic T-lymphocytes but not regulatory T-cells Advanced Recurrent Ovarian Cancer April 2022 - Combined loco-regional and systemic, triple agent chemoimmunotherapy increases biomarkers of T cell chemotaxis in ovarian cancerMay 2022: Phase I Trial Combining Chemokine-Targeting with Loco-Regional Chemoimmunotherapy for Recurrent, Platinum-Sensitive Ovarian Cancer Shows Induction of CXCR3 Ligands and Markers of Type 1 Immunity Late-Stage Colorectal Cancer June 2022: Initial results of a phase II study evaluating a chemokine-modulatory (CKM) regimen in patients with colorectal cancer metastatic to the liver We have continued to be encouraged by the data we have seen to date demonstrating Ampligen’s potential for the treatment of multiple types of cancers, immune disorders, and viral diseases, including COVID-19, and continue to establish a growing body of data as a priority. With 10 active clinical programs, 2023 is poised to be a busy and exciting year. In addition to a number of publications for pipeline data expected throughout the year, anticipated upcoming milestones include: Q1 2023 Post-COVID Conditions: Commence Phase 2 studyLocally Advanced Pancreatic Cancer: Enroll first patient in Phase 2 study Q2 2023 Locally Advanced Pancreatic Cancer: Dose first patient in Phase 2 studyPost-COVID Conditions: Enroll and dose first patient in Phase 2 study Q3 2023 Advanced Recurrent Ovarian Cancer: Announce Formal interim results Q4 2023 Metastatic Pancreatic Cancer: Begin clinical trialPost-COVID Conditions: Complete patient enrollment in Phase 2 study In addition to executing on our clinical development, we have a number of corporate initiatives we are committed to in 2023, which include building diversity among our Board of Directors. We are actively working to identify individuals with key leadership and expertise and look forward to providing updates as those plans come to fruition. Another priority for us is to maintain active communication with the investment community. With this in mind, we plan to commence quarterly conference calls in the first quarter of 2023. We also plan to continue engaging with the scientific and investment communities by actively participating in meetings and key conferences throughout the year. We encourage you to stay up to date with our activities by visiting our website, aimimmuno.com and connecting with us on Twitter, LinkedIn, and Facebook. We had a truly transformative 2022, but believe 2023 holds significant potential as we advance toward a number of targeted milestones ahead. On behalf of the entire Company, we are grateful for the continued support of our stockholders and remain committed to generating near- and long-term value for all stakeholders. 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, Ampligen® (rintatolimod) is an immuno-modulator with broad spectrum activity being developed for globally important cancers, viral diseases and disorders of the immune system. Ampligen is currently being used to treat pancreatic cancer patients in an Early Access Program (EAP) approved by the Inspectorate of Healthcare in the Netherlands at Erasmus Medical Center and AIM has commenced a Phase 2 clinical study in locally advanced pancreatic cancer. The Company also has multiple ongoing clinical trials to evaluate Ampligen as a combinational therapy for the treatment of a variety of solid tumor types both underway and planned at major cancer research centers. Additionally, Ampligen is approved in Argentina for the treatment of severe chronic fatigue syndrome (CFS) and is currently being evaluated in many aspects of SARS-CoV-2/COVID-19 myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) and Post COVID Conditions. For more information, please visit aimimmuno.com and connect with the Company on Twitter, LinkedIn, and Facebook. Forward-Looking Statements This press release contains certain forward-looking statements that involve risks, uncertainties and assumptions that are difficult to predict. Words and expressions reflecting optimism, satisfaction or disappointment with current prospects, as well as words such as “believes,” “hopes,” “intends,” “estimates,” “expects,” “projects,” “plans,” “anticipates” and variations thereof, or the use of future tense, identify forward-looking statements, but their absence does not mean that a statement is not forward-looking. The Company’s forward-looking statements are not guarantees of performance, and actual results could vary materially from those contained in or expressed by such statements due to risks, uncertainties and other factors. 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 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. Except as required by law, the Company does not undertake any responsibility to update any forward-looking statements to take into account events or circumstances that occur after the date of this press release. The information found on our website is not incorporated by reference into this press release and is included for reference purposes only.

BI-2601 (BRII-179) and BRII-835 combination was generally well-tolerated with no new safety signals observed Initial data suggest VBI-2601 (BRII-179) and BRII-835 combination induced meaningfully stronger anti-hepatitis B surface antigen (HBsAg)-specific T-cell and antibody responses compared to BRII-835 alone Data to be featured in oral presentation, given by Dr. Man Fung Yuen, M.D., Ph.D., D.Sc., at the 32nd Conference of the Asian Pacific Association for the Study of the Liver (APASL) 2023 in Taipei, Taiwan on February 18, 2023 VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease, today announced interim data from the Phase 2 study evaluating the combination of VBI-2601 (BRII-179), VBI’s HBV immunotherapeutic candidate, and BRII-835 (VIR-2218), an HBV-targeting siRNA candidate, in chronically infected HBV patients. The data, which will be featured in an oral presentation at APASL on February 18, 2023, demonstrated that the combination therapy was generally well-tolerated, restored strong anti-HBsAg antibody responses, and led to improved HBsAg-specific T-cell responses, when compared to BRII-835 alone. Notably, in two participants who received the combination therapy, maximum reductions in HBsAg to an undetectable level or to the lower limit of quantification (LLOQ) were achieved by Week 40, which were associated with robust HBV-specific antibody and T-cell responses. Dr. Francisco Diaz-Mitoma, M.D., Ph.D., VBI’s Chief Medical Officer, commented: “Numerous studies have assessed the potential of siRNA candidates in hundreds of chronically infected HBV patients, but this is the first time we’ve seen data from the combination of an HBV siRNA with an HBV-specific immunomodulator. Consistent with the known mechanism of action of VBI-2601 and its inclusion of the pre-S1 and pre-S2 antigens in addition to the S antigen, these interim data indicate that VBI-2601 may be able to break tolerance to the S antigen, achieving immune restoration. Additionally, the reduction of S antigen to at or below the LLOQ, as seen in the two patients, is a noteworthy achievement in this population. We are very encouraged by these interim data, which suggest that the combination of VBI-2601 and an HBV siRNA has the potential to be a meaningful part of a functional cure regimen. We look forward to additional data from this study, as well as data from the ongoing Phase 2 study of VBI-2601 as an ‘add-on’ to existing pegylated interferon (PEG-IFN-α) and nucleos(t)ide reverse transcriptase inhibitor (Nrtl) therapy in non-cirrhotic chronic HBV patients, both of which are expected later this year.” An abstract summarizing the interim data is available at the following link: . The interim data will be shared in an oral presentation, titled Preliminary Safety and Efficacy of the Combination Therapy of BRII-835 and BRII-179 Treating Chronic HBV Infection, at the 32nd Annual Conference of the Asian Pacific Association for the Study of the Liver (APASL) taking place in Taipei, Taiwan, on Saturday, February 18, 2023, at 14:10 local time. About the Phase 2 Study The randomized, multi-center Phase 2 study is being conducted at clinical sites in Australia, Taiwan, Hong Kong Special Administrative Region of China, South Korea, New Zealand, Singapore, and Thailand. VBI’s partner, Brii Biosciences (Brii Bio), is the study sponsor. The interim data were generated from a total of 50 adult, non-cirrhotic patients who received nucleos(t)ide reverse transcriptase inhibitor (NRTI) therapy for at least 12 months and who were randomized and dosed across three cohorts: Cohort A: BRII-835 Alone Regimen – Nine subcutaneous 100mg doses of BRII-835, dosed every four (4) weeks through Week 32 Cohort B: BRII-835 Alone Regimen + nine 40µg intramuscular doses of VBI-2601 admixed with interferon-alpha (IFN-α) as co-adjuvant every four weeks from Week 8 through Week 40 Cohort C: BRII-835 Alone Regimen + nine 40µg intramuscular doses of VBI-2601 without IFN-α every four weeks from Week 8 through Week 40 About Hepatitis B Hepatitis B is one of the world’s most significant infectious disease threats with more than 290 million people infected globally. HBV infection is the leading cause of liver disease and, with current treatments, is very difficult to cure, with many patients going on to develop liver cancers. An estimated 900,000 people die each year from complications of chronic HBV such as liver decompensation, cirrhosis, and hepatocellular carcinoma. About VBI-2601 (BRII-179) VBI-2601 (BRII-179) is a novel recombinant, protein-based HBV immunotherapeutic candidate that builds upon the 3-antigen conformation of VBI’s prophylactic 3-antigen HBV vaccine candidate and is designed to target enhanced B-cell and T-cell immunity. VBI-2601 (BRII-179) is being developed in collaboration with Brii Biosciences in the licensed territory of China, Hong Kong, Macau, and Taiwan as part of a potential functional cure for chronic hepatitis B infection. About VBI Vaccines Inc. VBI Vaccines Inc. (“VBI”) is a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease. Through its innovative approach to virus-like particles (“VLPs”), including a proprietary enveloped VLP (“eVLP”) platform technology, VBI develops vaccine candidates that mimic the natural presentation of viruses, designed to elicit the innate power of the human immune system. VBI is committed to targeting and overcoming significant infectious diseases, including hepatitis B, coronaviruses, and cytomegalovirus (CMV), as well as aggressive cancers including glioblastoma (GBM). VBI is headquartered in Cambridge, Massachusetts, with research operations in Ottawa, Canada, and a research and manufacturing site in Rehovot, Israel. For more information, visit . Cautionary Statement on Forward-looking Information Certain statements in this press release that are forward-looking and not statements of historical fact are forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and are forward-looking information within the meaning of Canadian securities laws (collectively, “forward-looking statements”). The Company cautions that such statements involve risks and uncertainties that may materially affect the Company’s results of operations. Such forward-looking statements are based on the beliefs of management as well as assumptions made by and information currently available to management. Actual results could differ materially from those contemplated by the forward-looking statements as a result of certain factors, including but not limited to, the impact of general economic, industry or political conditions in the United States or internationally; the impact of the ongoing COVID-19 pandemic on our clinical studies, manufacturing, business plan, and the global economy; the ability to successfully manufacture and commercialize PreHevbrio; the ability to establish that potential products are efficacious or safe in preclinical or clinical trials; the ability to establish or maintain collaborations on the development of pipeline candidates and the commercialization of PreHevbrio; the ability to obtain appropriate or necessary regulatory approvals to market potential products; the ability to obtain future funding for developmental products and working capital and to obtain such funding on commercially reasonable terms; the Company’s ability to manufacture product candidates on a commercial scale or in collaborations with third parties; changes in the size and nature of competitors; the ability to retain key executives and scientists; and the ability to secure and enforce legal rights related to the Company’s products. A discussion of these and other factors, including risks and uncertainties with respect to the Company, is set forth in the Company’s filings with the SEC and the Canadian securities authorities, including its Annual Report on Form 10-K filed with the SEC on March 7, 2022, and filed with the Canadian security authorities at sedar.com on March 7, 2022, as may be supplemented or amended by the Company’s Quarterly Reports on Form 10-Q. Given these risks, uncertainties and factors, you are cautioned not to place undue reliance on such forward-looking statements, which are qualified in their entirety by this cautionary statement. All such forward-looking statements made herein are based on our current expectations and we undertake no duty or obligation to update or revise any forward-looking statements for any reason, except as required by law. 内容来源于网络，如有侵权，请联系删除。