CXCL11

DONGTAN, KOREA, June 10, 2024 - iLeadBMS, a new drug R&D company under Ildong Pharmaceutical Group, announced on the 10th that it presented in vivo study results on its liver fibrosis treatment candidate 'IL1512' at the European Association for the Study of the Liver (EASL) 2024, held in Milan, Italy, from June 5th to the 8th. IL1512 is an oral CXCR7 agonist and is classified as a first-in-class drug, a type of drug that has never been developed for the same therapeutic indication previously. Last month, iLeadBMS presented the efficacy results of this drug for idiopathic pulmonary fibrosis (IPF) at the American Thoracic Society (ATS 2024), and this time around it announced the anti-fibrotic effects of the drug in the liver. CXCR7 is a G protein-coupled receptor that binds to chemokine ligands CXCL11 and CXCL12, targeting various pathways related to fibrosis such as fibroblast activation, inflammation, tissue repair, and angiogenesis. This makes it an ideal therapeutic target for treating fibrotic diseases. Given that CXCR7 agonists exerts their anti-fibrotic properties through a novel mechanism, iLeadBMS plans to develop anti-fibrotic drugs to treat fibrosis in various organs including but not limited to the lungs, liver, heart, kidneys, and skin, and is also considering utilizing the expedited review and Orphan Drug Designation (ODD) pathways offered by the FDA. Based on the presentation at the conference, iLeadBMS has confirmed the anti-fibrotic effects of IL1512 in the well-established CCl4 (carbon tetrachloride) liver fibrosis model with oral administration of the test article. Significant improvements in various anti-fibrotic indicators (col 1a1, hydroxyproline content, TGF-beta) were observed compared to the placebo. The presentation emphasized that IL1512, with its novel mechanism targeting CXCR7, demonstrated direct anti-inflammatory effects on the liver and improvement in fibrosis. Additionally, it highlighted that IL1512 showed either superior or at minimum, comparable efficacy and safety profiles compared to Elafibranor, the comparator drug. Based on these research results, iLeadBMS has identified preclinical candidate molecules with even greater improvements over IL1512 and, plans to start GLP (Good Laboratory Practice) toxicology studies in the second half of this year. About iLeadBMS Established in 2020, iLeadBMS specializes in the discovery and development of novel drugs, with an R&D pipeline targeting fibrotic diseases, protease inhibitors, solid tumors, and neurodegenerative diseases. For more information on iLeadBMS, please visit:

DONGTAN, KOREA, May 21, 2024 – iLeadBMS, a leading biotech company dedicated to the discovery and development of novel drugs for high unmet medical needs, has announced a positive outcome of IL1512, a first-in-class CXCR7 agonist, as a potential therapy for pulmonary fibrotic diseases at the American Thoracic Society (ATS 2024) conference held in San Diego from May 17th to 22nd. Idiopathic pulmonary fibrosis (IPF) is a rare lung disease characterized by progressive fibrosis of lung parenchyma, with a less than 40% survival rate five years after diagnosis. Research And Markets projects the IPF treatment market to reach approximately $6.1 billion (about 8 trillion KRW) by 2030, indicating significant unmet medical needs in this area. To address these high unmet needs, iLeadBMS has concentrated its research on CXCR7 (C-X-C chemokine receptor 7), a key mediator in signal transduction amplifying fibrosis and inflammation. CXCR7 selectively binds to chemokine ligands CXCL11 and CXCL12, targeting various pathways associated with fibrosis, inflammation, tissue repair, and angiogenesis. IL1512 has exhibited high selectivity for CXCR7 without binding to other chemokine receptors and demonstrated promising pharmacokinetics (DMPK) in mice and rats when orally administered. In a bleomycin-induced pulmonary fibrosis model, IL1512 showed dose-dependent improvements in the Ashcroft score, confirming its potentially superior anti-fibrotic efficacy compared to the standard therapy. Additionally, IL1512 displayed a favorable safety pro by the absence of weight loss associated with drug administration. Based on these results, it is anticipated that IL1512 will have a better safety and efficacy pro compared to currently available standard treatments. Preclinical studies for the selected CXCR7 agonist candidate have been initiated and GLP toxicity studies are planned for the second half of this year. The Company’s strategy aims to develop therapies with minimal side effects while providing broad anti-fibrotic effects, covering multiple organs beyond just the lungs. It is anticipated that expedited regulatory pathways such as Orphan Drug Designation (ODD) will be considered for the fibrosis program and concurrently, CXCR7 agonists with blood-brain barrier penetration potential, are also being explored for neurological disorders. About iLeadBMS Established in 2020, iLeadBMS specializes in the discovery and development of novel drugs, with an R&D pipeline targeting fibrotic diseases, protease inhibitors, solid tumors, and neurodegenerative diseases. For more information on iLeadBMS, please visit:

OCALA, Fla., April 10, 2024 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE American: AIM) (“AIM”) today announced top-line interim data indicating that combining Ampligen (rintatolimod) with Keytruda (pembrolizumab) in the treatment of recurrent ovarian cancer may have a powerful synergistic effect, leading the investigator to conclude that the combination therapy could be far more effective than pembrolizumab alone as a therapy for the disease. See further details on the study “Systemic Immune Checkpoint Blockade and Intraperitoneal Chemo-Immunotherapy in Recurrent Ovarian Cancer” at ClinicalTrials.gov: NCT03734692. Additionally, the immunological signature supporting this synergistic enhancement has been seen in other clinical trials, including with pancreatic cancer (1,2) metastatic triple-negative breast cancer and colorectal cancer metastatic to the liver. Ampligen is a dsRNA product candidate that acts via the TLR-3 receptor present on several immune cells, epithelial cells and most solid tumors. In the ongoing, investigator-initiated Phase 2, single-arm efficacy/safety trial, University of Pittsburgh Medical Center researchers saw an Objective Response Rate (“ORR”) of 45% when combining Ampligen, pembrolizumab and cisplatin in platinum-sensitive subjects with recurrent ovarian cancer. ORR includes complete response (“CR”) and partial response (“PR”) to treatment. There was a total Clinical Benefit Rate (“CBR”) of 55% when including patients who experienced stable disease (“SD”). Researchers also reported a median Progression-Free Survival (“PFS”) of 7.8 months. Robert Edwards, MD, Chair of the Department of Obstetrics, Gynecology & Reproductive Sciences and Co-Director of Gynecologic Oncology Research at Magee-Womens Hospital of UPMC, stated: “These results are incredibly favorable when compared to data from the hallmark Phase 2 study Keynote-100, which looked at the use of pembrolizumab alone in the treatment of recurrent ovarian cancer in both platinum-resistant and platinum-sensitive subjects. Keynote-100 reported an ORR of approximately 8% in these subjects – meaning that the new data analysis showed that combining pembrolizumab treatment with Ampligen created a greater than 500% increase in ORR over the Keynote-100 findings. Additionally, Keynote-100’s median PFS was 2.1 months, or significantly less than that seen in the ongoing Ampligen study. Additionally, the new ovarian cancer data analysis revealed an acute increase in anti-tumor immunity — specifically in biomarkers CXCL9, CXCL10, CXCL11 — which is consistent with the immune-stimulatory effects of Ampligen that researchers have seen in clinical studies of other solid tumors, including triple-negative breast cancer, pancreatic cancer and colorectal cancer. We look forward to publishing a more detailed analysis of these data in a peer-reviewed clinical journal this summer.” AIM Chief Executive Officer Thomas K. Equels stated: “These interim data clearly suggest that there may be a massive positive impact on efficacy when Ampligen is combined with pembrolizumab for the treatment of recurrent ovarian cancer. Other research suggests a similar effect in other solid tumor types. We therefore see an Ampligen combination therapy as having potential across multiple types of cancers. We look forward to the additional clinical studies underway and planned in many of these types of tumors to further confirm these effects.” 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 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. For more information, please visit aimimmuno.com and connect with the Company on X, LinkedIn, and Facebook. Cautionary Statement This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 (the “PSLRA”). Words such as “may,” “will,” “expect,” “plan,” “anticipate,” “continue,” “believe,” “potential,” “upcoming” and other variations thereon and similar expressions (as well as other words or expressions referencing future events or circumstances) are intended to identify forward-looking statements. Many of these forward-looking statements involve a number of risks and uncertainties. Publication of this data and clinical success seen to date does not guarantee that Ampligen will be approved for the commercial treatment of ovarian cancer. 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 U.S. 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. Among other things, for those statements, the Company claims the protection of the safe harbor for forward-looking statements contained in the PSLRA. The Company does not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. A photo accompanying this announcement is available at Investor Contact: JTC Team, LLC Jenene Thomas (833) 475-8247 AIM@jtcir.com Robert Edwards, MD, Chair of the Department of Obstetrics, Gynecology & Reproductive Sciences and Co-Director of Gynecologic Oncology Research at Magee-Womens Hospital of UPMC Robert Edwards, MD, Chair of the Department of Obstetrics, Gynecology & Reproductive Sciences and Co-Director of Gynecologic Oncology Research at Magee-Womens Hospital of UPMC