Swine Vesicular Disease

HANOVER, N.H., March 25, 2025 /PRNewswire/ -- Hubble Therapeutics LLC a patient-focused biotechnology company developing a gene therapy to cure pediatric blindness, announces the successful closing of a $7.3 million Series A funding round, which will advance its lead candidate, HUB-101, into human clinical trials. Hubble Therapeutics' gene therapy, HUB-101, targets two rare and devastating eye disorders: Leber Congenital Amaurosis (LCA16) and Snowflake Vitreoretinal Degeneration (SVD). This innovative treatment, developed by Dr. Bikash Pattnaik at the University of Wisconsin-Madison School of Medicine and Public Health and licensed from the Wisconsin Alumni Research Foundation (WARF), aims to address the root cause of these conditions. LCA16 and SVD are severe, early-onset retinal dystrophies caused by mutations in the KCNJ13 gene, which is crucial for the function of a vital ion channel in the retina's pigment epithelium cells. These disorders typically manifest in children before the age of five, leading to progressive retinal degeneration over the following two decades and ultimately resulting in blindness. "For over the past 20 years, my lab has developed in vitro and in vivo models of ion channelopathy to develop curative gene therapies for several devastating pediatric blindness diseases," Dr. Bikash Pattnaik, professor in the Departments of Pediatrics, Ophthalmology and Visual Science at the University of Wisconsin–Madison, Daniel M. Albert Chair McPherson Eye Research Institute and scientific co-founder of Hubble Therapeutics LLC, "The development of the HUB-101 gene therapy for LCA16 represents not just the scientific breakthrough, but hope for patients and families affected by such devastating conditions caused by defective ion channels. As we push these therapeutic boundaries, we empower a future where innovative ion channel therapies in our lab address genetic diseases at their core." To date, HUB-101 has received Rare Pediatric Disease Designation and Orphan Disease Designation from the FDA for this program. It has partnered with Andelyn Biosciences in Columbus, Ohio, and Virscio in New Haven, Connecticut, to develop, manufacture, and conduct IND-enabling studies. Hubble Therapeutics expects to enter the clinic to conduct Phase I / II trials in 2026 to demonstrate the safety and efficacy of HUB-101. "This groundbreaking research aims to restore vision in patients affected by a rare eye disease that ultimately results in complete blindness, with WARF's investment in Hubble Therapeutics as the Series A co-lead investor, we are thrilled to continue our support for the development of a disease-modifying treatment," says Greg Keenan, Senior Director of WARF Ventures & Accelerator and Hubble Therapeutics Board of Director. "The collaboration between Hubble Therapeutics and the pioneering research of UW-Madison inventor, Dr. Bikash Pattnaik, exemplifies the transformative potential of academic-industry partnerships and we are honored to continue our support in advancing this critical research alongside the dedicated team at Hubble Therapeutics." "We are grateful for our investors, leading scientists, industry experts, best-in-class partners, patient families, and the University of Wisconsin-Madison who share our commitment to realizing the promise of improving vision for patients suffering from LCA16 and SVD," said Jeff Sabados, Founder and President of Hubble Therapeutics LLC. Sabados continued, "with our new financing and the establishment of key partnerships, we hope to scale up HUB-101 manufacturing and conduct additional IND-enabling studies to enter the clinic within the next two years to realize our steadfast, unwavering promise to support families throughout the world impacted by this devastating genetic disease." About Hubble Therapeutics, LLC Hubble Therapeutics LLC ("HubbleTx") is a patient-focused biotechnology company developing research from Professor Bikash Pattnaik's lab at the University of Wisconsin-Madison. Our primary focus is on developing novel gene therapy for Leber Congenital Amaurosis Type 16 (LCA16) and Snowflake Vitreoretinal Degeneration (SVD), two debilitating retinal diseases that lead to severe vision loss in adult and pediatric patients. Our mission is to restore vision and improve the quality of life for affected individuals and their families by harnessing the power of gene delivery technology to target the underlying genetic mutation responsible for the disease. Our team of leading scientists, industry experts, and best-in-class partners are committed to rigorous research and clinical development, ensuring that our therapies are safe, effective, and accessible. HubbleTx strives to bring hope to those affected by this condition through collaboration and innovation. Together, we aim to illuminate the path to a brighter future for patients battling LCA16 and SVD. For Hubble media inquiries, please contact: [email protected] Logo - WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

SHANGHAI and HONG KONG, Dec. 9, 2024 /PRNewswire/ -- Antengene Corporation Limited ( "Antengene", SEHK: 6996.HK), a leading innovative, commercial-stage global biopharmaceutical company dedicated to discovering, developing and commercializing first-in-class and/or best-in-class medicines for hematologic malignancies and solid tumors, today announced that it presented the latest data from two clinical studies of selinexor in two posters at the 2024 American Society of Hematology Annual Meeting (ASH 2024). Details on the Posters: Title: Weekly Selinexor, Bortizomib and Dexamethasone (SVd) Versus Twice Weekly Bortizomib and Dexamethasone (Vd) in Chinese Patients with Relapsed and Refractory Multiple Myeloma (RRMM): Primary Analysis of Phase III Bench Study Publication Number: 4748 Session: 654. Multiple Myeloma: Pharmacologic Therapies: Poster III Date: Monday, December 9, 2024 Time: 6:00 PM - 8:00 PM (Pacific time) 10:00 AM - 12:00 PM, December 10, 2024 (Beijing time) The BENCH study is a Phase III randomized, open-label, multicenter clinical trial, aiming to evaluate the efficacy and safety of selinexor, bortezomib and dexamethasone (SVd) regimen against bortezomib and dexamethasone (Vd) regimen in Chinese adult patients with R/R MM who have received one to three prior lines of therapy. At present, a New Drug Application (NDA) based this study has already been submitted to and accepted by China's National Medical Products Administration (NMPA). As of May 9, 2024, a total of 154 Chinese R/R MM patients were randomized to SVd group (n=101) or Vd group (n=53) and 152 patients received at least one dose of study drug (safety population). Efficacy results showed that the median progression-free survival (mPFS) was 8.1 months with SVd group and 6.3 months with Vd group. The overall response rate (ORR) was higher in SVd group than in Vd group. SVd group had a significantly higher proportion of patients with a very good partial response (VGPR) or better responses. The median time to response and the median duration of response were 0.8 vs 1.4 months and 9.7 vs 7.2 months (SVd vs Vd), respectively. During the study, some subjects experienced treatment emergent adverse events (TEAEs). The most frequent Grade 3-4 adverse events (AEs) for SVd and Vd (≥10%) included thrombocytopenia, lymphocytopenia, and anemia. The incidence of Grade≥2 peripheral neuropathy (PN) was significantly lower in SVd than in Vd group. The BENCH study has met its primary and key secondary endpoints, with results consistent with the BOSTON study. These results showed that the SVd regimen decreased the risk of progression and obtained much more profound responses compared to standard Vd regimen in Chinese patients with R/R MM. The incidence of Grade ≥2 PN were significantly reduced. Title: Selinexor Combined with Tislelizumab in Patients with Relapsed or Refractory Extranodal NK/T-Cell Lymphoma (R/R ENKTL): Preliminary Results of Arm C, from a Multicenter, Single-Arm, Phase I/II Study, Touch Publication Number: 4448 Session: 625. T Cell, NK Cell, or NK/T Cell Lymphomas: Clinical and Epidemiological: Poster III Date: Monday, December 9, 2024 Time: 6:00 PM - 8:00 PM (Pacific time) 10:00 AM - 12:00 PM, December 10, 2024 (Beijing time) The Phase I/II TOUCH study is investigating selinexor combined with different drugs in R/R ENKTL. Arm C of the study aims to evaluate the safety, tolerability and preliminary efficacy of selinexor in combination with anti-PD-1 antibody tislelizumab. As of 18 May 2024, 17 R/R ENKTL patients were enrolled in Arm C [Sel 40mg (n=3); Sel 60mg (n=14)]. Sixteen patients previously exposed to both L-asparaginase (L-Asp) and checkpoint inhibitors (CPIs) including 8 patients who had received prior Tislelizumab (Tis); eleven (64.7%) patients were refractory to their last-line therapy. Efficacy results showed that, of 16 CPIs exposed patients (one patient was efficacy non-evaluable), the ORR was 75% (12/16), including 7 CRs and 5 PRs; and the median PFS was 6.7 months (95% CI 1.5, NE). During the study, all patients experienced TEAEs. The most common TEAEs included anemia, neutropenia, asthenia, decreased appetite, weight loss, and thrombocytopenia. Ten patients (58.8%) experienced Grade≥3 TEAEs. Treatment emergent serious adverse events (TESAEs) occurred in 4 patients (23.5%), of which two were considered treatment related. No patient discontinued due to TEAEs. Most of toxicities were manageable by dose modification and supportive care. In the study, the chemo-free regimen, Sel plus Tis, showed a favorable response rate and manageable safety profile in R/R ENKTL. This approach may probably reverse drug resistance in ENKTL that has progressed after prior CPI treatment. About Antengene Antengene Corporation Limited ( "Antengene", SEHK: 6996.HK) is a leading commercial-stage R&D-driven global biopharmaceutical company focused on the discovery, development, manufacturing and commercialization of innovative first-in-class/best-in-class therapeutics for the treatment of hematologic malignancies and solid tumors, in realizing its vision of "Treating Patients Beyond Borders". Since 2017, Antengene has built a pipeline of 9 oncology assets at various stages going from clinical to commercial, including 6 with global rights, and 3 with rights for the APAC region. To date, Antengene has obtained 31 investigational new drug (IND) approvals in the U.S. and Asia, and submitted 10 new drug applications (NDAs) in multiple Asia Pacific markets, with the NDA for XPOVIO® (selinexor) already approved in Mainland of China, Taiwan China, Hong Kong China, Macau China, South Korea, Singapore, Malaysia, Thailand and Australia. Forward-looking statements The forward-looking statements made in this article relate only to the events or information as of the date on which the statements are made in this article. Except as required by law, we undertake no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise, after the date on which the statements are made or to reflect the occurrence of unanticipated events. You should read this article completely and with the understanding that our actual future results or performance may be materially different from what we expect. In this article, statements of, or references to, our intentions or those of any of our Directors or our Company are made as of the date of this article. Any of these intentions may alter in light of future development. For a further discussion of these and other factors that could cause future results to differ materially from any forward-looking statement, please see the other risks and uncertainties described in the Company's Annual Report for the year ended December 31, 2023, and the documents subsequently submitted to the Hong Kong Stock Exchange. For more information, please contact: Investor Contacts: Donald Lung E-mail: [email protected] Mobile: +86 18420672158 PR Contacts: Peter Qian E-mail: [email protected] Mobile: +86 13062747000 SOURCE Antengene Corporation Limited WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Heparin, the world's most widely used blood thinner, is used during procedures ranging from kidney dialysis to open heart surgery. Currently, heparin is derived from pig intestines, but scientists have discovered how to make it in the lab. They have also developed a path to a biomanufacturing process that could potentially revolutionize how the world gets its supply of this crucial medicine. Heparin, the world's most widely used blood thinner, is used during procedures ranging from kidney dialysis to open heart surgery. Currently, heparin is derived from pig intestines, but scientists at Rensselaer Polytechnic Institute have discovered how to make it in the lab. They have also developed a path to a biomanufacturing process that could potentially revolutionize how the world gets its supply of this crucial medicine. "In recent years, with disease and contamination issues disrupting the global supply chain of pig heparin and potentially putting millions of patients at risk, it's clear we need to diversify the way we make this drug," said Jonathan Dordick, Ph.D., Institute Professor of Chemical and Biological Engineering, and vice president of Strategic Alliances and Translation at RPI. "Our work will make it possible to manufacture heparin that is both consistently available and safe." With their patented process, detailed in a study published in the journal PNAS, the researchers are already working with FDA and have initiated scale-up leading to commercial production. "While the current study describes the laboratory-scale production of heparin, we are also moving toward a commercial-scale process, affording the same high quality heparin, to generate the drug for clinical studies," said Robert Linhardt, Ph.D., Ann and John H. Broadbent Jr. '59 Senior Constellation Professor Emeritus of Biocatalysis and Metabolic Engineering at RPI and a co-author of the study. Both Dordick and Linhardt are members of RPI's Shirley Ann Jackson Center for Biotechnology and Interdisciplinary Studies. "This multidisciplinary research is a prime example of how discoveries made in the lab can successfully translate into new tools to advance global health," said Shekhar Garde, Ph.D., dean of the RPI School of Engineering. Recognized by the World Health Organization as an essential medicine, heparin is always in high demand. To meet the need, the intestines of billions of pigs are processed annually, producing about 100 tons of purified heparin. More than 70% of the supply comes from China. Animal-based products are susceptible to shortages, and heparin is no exception. The 2008 heparin contamination crisis, recurring swine diseases outbreaks, and the supply chain issues of the COVID-19 pandemic have all disrupted heparin availability, prompting researchers to investigate how to make heparin without animals. At RPI, the quest for non-animal heparin led to the creation of the Heparin Applied Research Center in 2015. Over the next several years, the team of scientists developed a novel method of synthesizing heparin that would not only be virtually indistinguishable from animal-derived heparin but could also be made at scale. "Heparin was discovered more than 100 years ago, but only recently have we had the techniques to start trying to make it in the lab," said Dordick, senior author of the study. "Unlike insulin -- another very important medicine that used to come from pigs and is now man-made -- heparin isn't just a single protein or molecule, but a complex chain of various carbohydrates. That makes it very hard to synthesize in a way that translates into a more traditional large manufacturing setting." Dordick likens synthesizing heparin in the lab to decorating a Christmas tree. "We start with the core of the heparin structure, which is like the bare tree. Then, using various enzymes, we add molecules -- the ornaments, the tinsel, the lights. As you can imagine, there are many ways to decorate a tree, so getting the decoration just right to make heparin is the challenge," he said. In recent decades, scientific teams around the world have been attempting to do just that, but without success. "Past research used native enzymes to replicate what happens in pig intestines to make heparin. However, this produces a tiny amount of heparin and can't be done at scale. Our biggest achievement was the insight to optimize the enzymes for higher yield and stability," said Elena Paskaleva, Ph.D., senior research scientist at RPI and one of the study's co-authors. "Synthesizing those enzymes in such large scale was uncharted territory for us in an academic lab," said Marc Douaisi, Ph.D., first author of the study and senior research scientist RPI. "It took a large, coordinated effort across the whole center to synthesize the volume needed to synthesize a product with a structure and biological activity equivalent to the pig-derived drug. At the end of the day, it was exhilarating to know that what we ultimately made matched all the criteria of heparin." The discovery is an example of how universities can drive research and development of new life-saving drugs and technologies, Dordick said. "Our goal was to find an alternative to a drug that's been on the market since 1935. For a private company, that kind of project would bring too much risk. But a university, especially one like RPI, is the perfect place to pursue this kind of project," Dordick said.