Pancreatic adenocarcinoma

– 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 Jan. 15, 2025 -- 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.” 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. 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. 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 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. The content above comes from the network. if any infringement, please contact us to modify.

The therapy proved safe and tolerable in advanced PDAC subjects. Credit: sasirin pamai/Shutterstock. The Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has granted breakthrough therapy designation (BTD) to Innovent Biologics’ IBI343as a monotherapy treatment for CLDN18.2-positive pancreatic ductal adenocarcinoma (PDAC). The designation includes subjects who have experienced progression after a minimum of one previous systemic treatment. It is supported by the data from an ongoing Phase I trial carried out across the US, Australia and China. The therapy was shown to be safe and tolerable as a single agent, with significant antitumour activity in advanced PDAC subjects. 43 subjects with this condition were treated with the therapy. The treatment resulted in a confirmed overall objective response rate (ORR) of 23.3%. Median progression-free survival was recorded at 5.3 months. Innovent Biologics senior vice-president Dr Hui Zhou stated: “As the world’s first CLDN18.2 ADC to receive BTD in this difficult-to-treat cancer, IBI343 monotherapy has shown encouraging efficacy and tolerable safety in late-line treatment of patients with advanced pancreatic cancer. “Subject to PoC data readout, we plan to initiate pivotal MRCT studies to further confirm its efficacy and safety in this indication. Additionally, we will also explore the potential of IBI343 in combination therapy for pancreatic cancer and other solid tumours, including gastric cancer.” Pancreatic cancer, known for its low five-year survival rate of around 10%, is a particularly aggressive form of the disease. In May 2024, the therapy was granted its first BTD by CDE for treating individuals with CLDN18.2-positive advanced junction gastric/gastro-oesophageal adenocarcinoma (GC). In June, the US Food and Drug Administration granted the therapy fast track status for advanced PDAC treatment.

Pancreatic Cancer Action Network Calls for Urgently Needed Research and Funding for Effective Early Detection Strategy and New Treatments for Patients LOS ANGELES, Jan. 16, 2025 /PRNewswire/ -- After increases over the past three years, the five-year relative survival rate for pancreatic cancer remains flat at 13%, and just 8% for people diagnosed with the most common form of pancreatic cancer, pancreatic adenocarcinoma, according to the American Cancer Society's Cancer Statistics, 2025, report released today. While overall cancer mortality is decreasing, the annual report highlights that pancreatic cancer remains the third-leading cause of cancer-related deaths in the United States. Evidence suggests that it is on track to become the second-leading cause in the coming years. Diagnoses and deaths from pancreatic cancer are on the rise, with an estimated 67,440 Americans expected to be diagnosed with pancreatic cancer and an estimated 51,980 predicted to die from the disease this year. The five-year relative survival for Black people with pancreatic cancer is lower at 11%, consistent with the disparities seen for cancer overall. Continue Reading The five-year pancreatic cancer survival rate remains at 13% "While we've seen incremental progress in the treatment of pancreatic cancer, it's sobering to know that pancreatic cancer survival has not increased and remains the only major cancer with a five-year survival rate below 20%," said Anna Berkenblit, M.D., MMSc, Chief Scientific and Medical Officer at PanCAN. "The minimal improvement in survival in recent years is in part related to more people being diagnosed with incidentally detected, well differentiated neuroendocrine tumors, which are less aggressive than pancreatic adenocarcinomas. This highlights the need for screening and surveillance strategies for pancreatic adenocarcinoma as well as the need for better therapies, which will require more research funding. I am hopeful that with the approval of new drugs for the treatment of diabetes and obesity, both of which are risk factors for pancreatic cancer, and the development of targeted therapies like RAS inhibitors for pancreatic cancer, we will begin to see improved outcomes in the years ahead."    As one of the five most lethal cancers, pancreatic cancer, unlike lung, breast, prostate and colorectal cancer, is the only one that does not have a standard screening strategy. The lack of progress highlights the need for focused research efforts to narrow the gap between outcomes from pancreatic cancer and other major cancer types. PanCAN is the leading organization dedicated to advancing progress against pancreatic cancer with a goal of increasing the five-year survival rate to 20% by 2030. For 25 years, PanCAN has been at the center of a vibrant, diverse community that, together, has been the catalyst for every moment of extraordinary progress realized for this disease. In order to increase survival, PanCAN is:  Pioneering the advancement of an early detection strategy for pancreatic cancer. PanCAN's Early Detection Initiative looks at the connection between high blood sugar and pancreatic cancer with a goal to develop a screening method that detects pancreatic cancer when it can be surgically removed.  Revolutionizing the development of advanced and personalized treatments. In 2024, there were four FDA approvals for new pancreatic cancer treatments. The accelerating pace of progress highlights the power of precision medicine, which tailors treatment to each patient and their specific biology. PanCAN's network of research grant recipients dating back 25 years – its Community for Progress – has created a solid foundation and the momentum needed for more breakthroughs. Supporting pancreatic cancer patients and their families through PanCAN Patient Services. PanCAN supports more pancreatic cancer patients and their families than any other organization in the world. This team of trained professionals and a full suite of educational resources are available free of charge for anyone impacted by the disease. For more information about the Pancreatic Cancer Action Network and its urgent mission to save lives, visit pancan.org or follow PanCAN on X, Instagram, and Facebook. About the Pancreatic Cancer Action Network PanCAN is the leading organization dedicated to advancing progress against pancreatic cancer. We empower patients and caregivers with the resources and knowledge they need to advocate for the care they deserve; we are pioneering the advancement of an early detection strategy for pancreatic cancer and revolutionizing the development of advanced and personalized treatments; and we are building and mobilizing the pancreatic cancer field to ensure better outcomes for all those who face pancreatic cancer today and all those who will fight this disease tomorrow. Media Contact: Charaighn Sesock, Associate Director, Public Relations, Pancreatic Cancer Action Network: Direct: 559-972-4877 Email: [email protected] SOURCE Pancreatic Cancer Action Network WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED