Gannex Pharma Co Ltd.

VANCOUVER, Wash., Oct. 30, 2024 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTCQB: CYDY) ("CytoDyn" or the "Company"), a biotechnology company developing leronlimab, a CCR5 antagonist with the potential for multiple therapeutic indications, announced today that Dr. Melissa Palmer, M.D., has been engaged as Lead Consultant in Hepatology. In this role, Dr. Palmer will drive the Company’s strategy for research and development in Hepatology, leveraging her expertise to further CytoDyn’s clinical evaluation of leronlimab in treating liver conditions, including MASH and liver fibrosis. This engagement follows the recent breakthroughs with SMC Laboratories (“SMC”). In addition, the Company announced that following promising initial results from its preclinical study with SMC, it has commissioned the lab to conduct two follow-up studies to confirm and extend the observation of fibrosis reversal observed in the study concluded in September 2024. Both follow-up studies are underway, with results expected in early 2025. An internationally renowned hepatologist, Dr. Palmer brings more than three decades of deep research experience to the CytoDyn team. She has held leadership positions at several biotech and pharmaceutical companies, including serving as Chief Medical Officer of Gannex/Ascletis and Head of Liver Disease at Takeda Pharmaceutical Company. She has also worked as a hepatology consultant with over 60 biotech and pharmaceutical companies since 1991 and previously served as interim Chief Medical Officer of CytoDyn. In addition to consulting, Dr. Palmer has been the primary investigator for numerous clinical trials in MASH and other liver diseases. Her work has been published in over 100 publications, abstracts, manuscripts, books and book chapters, including several guidelines she co-authored with colleagues from the FDA and EMA concerning drug-induced liver injury among patients in clinical trials evaluating potential drugs to treat MASH and other liver diseases. She also maintained a solo medical practice treating patients with liver disease for over 20 years. Dr. Palmer will work with the CytoDyn team to oversee the two follow-up studies with SMC. These studies will again compare leronlimab alone and in combination with other therapies, including both resmetirom, the only approved treatment for MASH, and a GLP-1 agonist in an increased number of mice evaluated in both a proprietary STAM model of MASH which includes T2DM (previously studied), as well as a second model of liver fibrosis driven by CCL4 toxicity that is independent of fat deposition. “As we continue to capitalize on our momentum and push forward the path of scientific discovery here at CytoDyn, we are pleased to welcome Dr. Palmer to the team,” said Dr. Jacob Lalezari, CEO. “Dr. Palmer’s robust research and consulting background, and past familiarity with CytoDyn, will provide the tailored expertise we need to maximize opportunities to pursue breakthroughs in new treatment paths for MASH and liver fibrosis.” Dr. Palmer added, “This is an exciting time in liver health research, as scientific innovation paves the way for improved treatments for conditions like MASH and liver fibrosis. I look forward to collaborating with the CytoDyn team to advance clinical evaluations of leronlimab, including the studies in motion, and explore new treatments that have the potential to truly transform patient outcomes.” Dr. Palmer trained in Hepatology at Mount Sinai School of Medicine, where she also received her M.D. degree. She also holds a B.S. from Columbia University and is a Fellow of the American Association for the Study of Liver Diseases. About CytoDyn CytoDyn is a clinical-stage biotechnology company focused on the development and commercialization of leronlimab, an investigational humanized IgG4 monoclonal antibody (mAb) that is designed to bind to C-C chemokine receptor type 5 (CCR5), a protein on the surface of certain immune system cells that is believed to play a role in numerous disease processes. Leronlimab is being studied for oncology and inflammation, as well as other potential indications, including but not limited to HIV and MASH. About SMC Laboratories SMC Laboratories, Inc. is a CRO, with a focus on conducting the non-clinical research necessary for the drug development process. As a global consulting company that designs studies according to customer requests, it supports cutting-edge non-clinical pharmacological studies. The company owns a variety of mouse models for inflammation and fibrosis in various organs, centered on the innovative STAM™ mouse' animal model of liver cancer derived from MASLD (metabolic dysfunction-associated steatotic liver disease). This patented mouse model was developed by SMC Laboratories as a worldwide-first model based on MASLD. We offer non-clinical pharmacological studies using the model mouse. Please check the company's website for further details. Note Regarding Forward-Looking StatementsThis news release contains forward-looking statements relating to, among other things, product development, market position, future operating and financial performance, and business strategy. The reader is cautioned not to rely on these statements, which are based on current expectations of future events. For important information about these statements and our Company, including the risks, uncertainties and other factors that could cause actual results to vary materially from the assumptions, expectations and projections expressed in any forward-looking statements, the reader should review our Annual Report on Form 10-K for the fiscal year ended May 31, 2024, including the section captioned “Forward-Looking Statements” and in Item 1A. CytoDyn Inc. does not undertake to update any forward-looking statement as a result of new information or future events or developments. Media Contacts CytoDynRiyaz LalaniGagnier CommunicationsCytoDyn@gagnierfc.com

--Up to 68.2% mean relative reduction in liver fat content from baseline among biopsy-confirmed metabolic dysfunction-associated steatohepatitis (MASH) patients receiving 12-week treatment of ASC41 --Significant and clinically meaningful reductions in liver fat, alanine aminotransferase (ALT), aspartate aminotransferase (AST) and lipids as well as excellent safety and tolerability profile demonstrated by ASC41 in MASH patients HANGZHOU, China, June 10, 2024 /PRNewswire/ -- Gannex Pharma Co., Ltd. ("Gannex"), a wholly-owned company of Ascletis Pharma Inc. (HKEX:1672, "Ascletis") dedicated to the research and development and commercialization of new drugs in the field of metabolic dysfunction-associated steatohepatitis (MASH), today announced a poster presentation at the European Association for the Study of the Liver (EASL) Congress 2024, held June 5-8, 2024 in Milan, Italy. A copy of the poster is available under the Posters/Publications page of Gannex's website at . The poster presentation titled, "ASC41, a selective THRβ agonist significantly reduces liver fat and ALT in biopsy-confirmed MASH patients after 12-week treatment: an interim analysis of a 52-week serial liver biopsy study", describes significant and clinically meaningful reductions in liver fat, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) in biopsy-confirmed MASH patients receiving 12-week treatment of ASC41 tablet, among which the data of ALT and AST notably differentiates ASC41 from other thyroid hormone receptor β (THRβ) agonists currently at clinical or commercial stages. In addition, baseline characteristics from Phase II clinical trials were comparable between ASC41, conducted in China, and resmetirom, except for lower body mass index (BMI) and more males for ASC41. Please refer to Table 1 below for more details. Table 1. Baseline Characteristics ASC41, a once-daily oral tablet, is a liver targeted small molecule and is highly THRβ-selective. The oral tablet formulation was developed utilizing Ascletis' in-house proprietary technology. Three Phase I or Ib studies in China were completed in healthy or obese subjects with elevated low-density lipoprotein cholesterol (LDL-C) > 110 mg/dL. A U.S. Phase I study demonstrated no clinically significant drug-drug interactions between ASC41/ASC41-A and most frequently used antidepressants and statins, as well as no significant difference in drug exposure between Americans and Chinese at the same dose. Table 2. Changes from Baseline (CFB) in LFC, Liver Enzymes and Lipids Biomarkers at Week 12 "93.3% of patients receiving treatment with ASC41 experienced at least 30% relative reduction from baseline in liver fat content as assessed by magnetic resonance imaging, proton density fat fraction (MRI-PDFF), which we believe is a strong predictor of fibrosis reduction." said Dr. Jinzi J. Wu, Founder, Chairman and CEO of Ascletis, "Reductions in liver inflammatory biomarkers ALT and AST, important for assessing hepatic injury and malfunction, LDL-C, total cholesterol (TC) and triglyceride (TG), which may reduce the risk of cardiovascular-related events, combined with an excellent safety and tolerability profile support our belief that ASC41 is a potentially best-in-class THRβ agonist. We look forward to continuing the clinical development of ASC41." ASC41 was generally well tolerated, with adverse events (AEs) being grade 1 in majority across all cohorts in the Phase II clinical trial, including the placebo cohort (see Table 3). No treatment-related serious adverse event (SAE) was reported in any patients receiving ASC41 treatment or placebo. As in prior studies, ASC41 demonstrated excellent gastrointestinal (GI) tolerability. Table 3. Safety Data About ASC41 ASC41, a once-daily oral tablet in clinical development for the treatment of MASH, is a liver targeted small molecule which is converted into its active metabolite, ASC41-A, a potent and highly selective THRβ agonist. ASC41 tablet was developed using Ascletis' in-house proprietary formulation technology. The patent of ASC41 tablet formulation has been granted in the U.S. About the Phase II Clinical Trial The randomized, double-blind, placebo-controlled and multi-center Phase II clinical trial (ClinicalTrials.gov: NCT05462353) is being conducted in China and is expected to enroll approximately 180 liver biopsy-confirmed MASH patients to be randomized into two treatment cohorts of ASC41 tablet (2 mg or 4 mg), once-daily and one placebo control cohort at the ratio of 1:1:1 for 52-week treatment and 4-week follow-up. Enrollment included patients with at least 7.5% liver fat content at baseline as measured by MRI-PDFF, as well as F2 and F3 liver fibrosis. The study allows up to 15% of enrolled patients to have F1 liver fibrosis. Two liver biopsies will be performed, one at baseline and the other at the end of 52-week treatment. MRI-PDFF will be performed at baseline, Week 12 and Week 52, respectively. The pre-specified interim analysis was conducted when 42 enrolled patients completed 12-week treatment of ASC41 tablet or placebo. Primary objective is a histological reduction in nonalcoholic fatty liver disease (NAFLD) activity score (NAS) ≥ 2 points that results from reduction of necro-inflammation (inflammation or ballooning) without worsening fibrosis. Secondary objectives include MASH resolution and fibrosis improvement. About Ascletis Pharma Inc. Ascletis is an innovative R&D driven biotech listed on the Hong Kong Stock Exchange (1672.HK), covering the entire value chain from discovery and development to GMP manufacturing. Led by a management team with deep expertise and a proven track record, Ascletis focuses on three therapeutic areas with unmet medical needs from a global perspective: viral diseases, MASH and oncology. Through excellent execution, Ascletis rapidly advances its drug pipeline with an aim of leading in global competition. To date, Ascletis has multiple clinical stage drug candidates in its R&D pipeline. The most advanced drug candidates include ASC22 (CHB functional cure), ASC40 (acne), ASC40 (recurrent glioblastoma), ASC40 (MASH), ASC41 (MASH) and ASC61 (advanced solid tumors). For more information, please visit . About Gannex Pharma Co., Ltd. Founded in 2019, Gannex is a clinical-stage, wholly-owned company of Ascletis, dedicated to the R&D and commercialization of new drugs in the field of MASH. Gannex has two clinical-stage drug candidates against two different targets, i.e. THRβ (ASC41) and fatty acid synthase (FASN) (ASC40). For more information, please visit . SOURCE Ascletis Pharma Inc.

Ascletis’ most advanced candidate is ASC22, an injected PD-L1 antibody in phase 2 development as a functional cure for chronic hepatitis B and HIV. China’s Ascletis has been developing the farnesoid X receptor (FXR) agonist ASC42 in a raft of conditions ranging from primary biliary cholangitis (PBC) to metabolic-associated steatohepatitis (MASH). But the company announced this morning that work is being halted on the drug after getting a glimpse of data from a phase 2 trial of three different doses of ASC42 to treat PBC. The results “indicated that ASC42 did not show competitiveness to new PBC drug candidates currently in development and registrational stages,” the company explained in an April 4 release. Based on this failure, Ascletis has also decided to drop other programs involving the drug. These include testing the therapy for hepatitis B virus (HBV) as well as part of a combo treatment for MASH. The biotech, which entered the year with cash and equivalents of 2.4 billion Chinese Yuan ($330 million), attributed today’s decision to “efforts to continue to evaluate and optimize its research and development pipeline to increase efficiency and preserve cash.” With ASC42 thrown on the discard pile, Ascletis still has more promising options to treat MASH, a fatty liver disease that has previously been known as non-alcoholic steatohepatitis (NASH). At the start of the year, the company’s subsidiary Gannex Pharma linked a THRβ agonist, dubbed ASC41, to significant reductions in liver fat and pointed to findings that it sees providing an edge over Madrigal Pharmaceuticals and Viking Therapeutics. Viking has previously accused Ascletis of stealing trade secrets to support the development of a drug candidate to rival its MASH prospect VK2809. That dispute rumbled on throughout last year, during which time Gannex continued to work toward midphase data on the molecule at the center of the row.  Ascletis’ most advanced candidate is ASC22, an injected PD-L1-targeted antibody in phase 2 development as a functional cure for chronic hepatitis B and HIV. The company's clinical-stage pipeline also includes a FASN inhibitor called ASC40 that’s being assessed as a treatment for both MASH and acne, as well as a PD-L1 small molecule inhibitor called ASC61 in early-stage trials for solid tumors. Part of the savings from discontinuing the various ASC42 programs will be funneled into the continued clinical development of ASC41 and ASC40 for MASH, the biotech explained in today’s release.