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CAMBRIDGE, Mass.--(BUSINESS WIRE)-- HiFiBiO Therapeutics, a clinical stage global biotech company focusing on improving patient lives with single cell precision, today announced that Fierce Biotech has named it as one of 2023’s “Fierce 15” biotechnology companies. The annual special report features the most innovative and promising early-stage biotechnology companies in the industry. This press release features multimedia. View the full release here: “HiFiBiO Therapeutics is at the forefront of harnessing single-cell insights to bring innovative immunomodulatory therapeutics into the clinic,” remarked Liang Schweizer, PhD, Founder, Chairperson, and CEO of HiFiBiO Therapeutics. “The Fierce 15 recognition reflects our passionate dedication to patients with unmet medical needs, and further highlights our unique Drug Intelligence Science (DIS®) approach to enhance the probability of success of immunotherapy from targets to drugs to patients.” HiFiBiO Therapeutics is differentiated by its pioneering DIS® approach which combines a proprietary microfluidic single-cell platform with advanced AI/ML-based data analytics to gain unprecedented insights into human disease biology. Through this high-resolution translational approach, HiFiBiO Therapeutics has advanced three programs into Phase 1 trials, a first-in-class TNFR2 agonist (HFB200301, NCT05238883), a best-in-class BTLA antagonist (HFB200603, NCT05789069), and a 2nd generation OX40 agonist (HFB301001, NCT05229601). Since 2017, HiFiBiO Therapeutics has built a sustainable pipeline targeting key mechanisms of immune modulation, with eight clinical candidates discovered, mainly across oncology and autoimmune diseases. With more than $180M in financing from world-class investors and an experienced top-tier scientific and clinical team, HiFiBiO is well-positioned to deliver effective therapeutic solutions for patients globally. “For the past 21 years, we have assessed hundreds of early-stage companies for inclusion in the 'Fierce 15' special report. To curate this list, we consider a diverse range of factors, including the robustness of their technology, partnerships, venture support and their competitive positioning within the market,” said Ayla Ellison, Editor-in-Chief, Fierce Life Sciences and Healthcare. “Our special report celebrates innovation and creativity in the face of intense competition.” About Fierce Biotech Fierce Biotech is the biotech industry’s daily monitor, providing the latest news, articles, and resources related to clinical trials, drug discovery, FDA approval, FDA regulation, patent news, pharma news, biotech company news and more. More than 300,000 top biotech professionals rely on Fierce Biotech for an insider briefing on the day’s top stories. About HiFiBiO Therapeutics HiFiBiO Therapeutics is a clinical stage global biotech pioneering a unique high-resolution translational solution (DIS®, Drug Intelligence Science) to enhance the probability of success for immunotherapies. DIS® combines unique single cell capabilities with AI/ML approaches using patient samples to discover novel targets, effective antibody drugs, and predictive biomarkers. With DIS®, HiFiBiO gains an unprecedented understanding of immune modulation in human diseases which drives a robust clinical pipeline of transformative immunotherapies. Additionally, HiFiBiO has partnered with major multinational pharmaceutical and biotech companies applying its innovative DIS® approach. Additional information can be found at . HiFiBiO Therapeutics, HiFiBiO Therapeutics logo, and DIS® are trademarks of HiFiBiO and its affiliates. View source version on businesswire.com: Contacts Media Vincent Tse Senior Director of Staff and Strategy HiFiBiO Therapeutics media@hifibio.com Source: HiFiBiO Therapeutics Smart Multimedia Gallery Photo View this news release and multimedia online at:

The United Kingdom's Mogrify Limited and Japan's Astellas Pharma have forged a collaboration surrounding in vivo regenerative medicine approaches to address sensorineural hearing loss. The companies will harness Mogrify's proprietary direct cellular reprogramming platform to identify novel combinations of transcription factors involved in cell differentiation to generate new cochlear hair cells. Astellas Gene Therapies, a division of Astellas, will cover the research cost of the work and contribute its expertise in adeno-associated virus (AAV) based genetic medicine and translational capabilities to complete experiments in pre-clinical models. Mogrify will then screen and validate the process to characterize potential therapeutic factors using its platform. "Mogrify's human regulatory network-centric approach is well placed to identify superior factor combinations, therefore increasing the efficiency of direct conversion toward the target cell type in the ear. Combined with Astellas' capabilities for gene therapy and research of sensorineural, this provides a clear path for the development of a novel in vivo reprogramming therapy for sensorineural hearing loss," Dr. Louise Modis, chief scientific officer of Mogrify, said in a statement. It is estimated that 1.57 billion people globally suffer from hearing loss. Of those, data suggests that over 10% have severe to profound sensorineural hearing loss in at least one ear. This loss of hearing represents a large unmet need, the companies said. Other News Across the Globe CardiNor: Norway-based CardiNor inked a U.S. distribution agreement with IBL-America for the CardiNor Secretoneurin ELISA test. Secretoneurin is the only biomarker associated with biological processes linked to heart cell calcium, a key mechanism in regulating arrhythmia. It has been described as the "missing link biomarker" in cardiovascular disease risk assessment. Through the collaboration, CardiNor intends to spread awareness of its frontline biomarker test in order to pave the way for future U.S. commercialization. CEPI: Also based in Norway, CEPI, the Coalition for Epidemic Preparedness Innovations, provided Codiak BioSciences with $2.5 million to advance the development of vaccines that provide broad protection against SARS-CoV-2, including its variants, and other Betacoronaviruses. The financing will support the advancement of vaccine candidates from its pan Betacoronavirus program through preclinical studies. Codiak's pan Betacoronavirus vaccine construct carries the receptor-binding domain protein of both SARS-CoV-1 and SARS-CoV-2 at high density on the surface of the exosome. This design closely resembles the natural viral structures, and these engineered exosomes stimulate a broad immune response comprising both antibody and T-cell-mediated immunity. ProteoNic BV: Netherlands-based ProteoNic and Germany's FyoniBio GmbH entered into a technology licensing agreement, which grants FyoniBio non-exclusive commercial rights for the application of ProteoNic technology in its proprietary CHOnamite platform. Intravacc: Also based in The Netherlands, Intravacc and the German Center for Neurodegenerative Diseases have been awarded €2.5 million from the European Union to develop a prototype ALS vaccine. The project aims to develop the vaccine candidate identified at DZNE to the point where it can be clinically tested in humans. Juvisé Pharmaceuticals: Based in France, Juvisé completed a deal with AbbVie regarding the acquisition of the worldwide commercial rights of Pylera, a treatment for stomach/intestinal ulcers caused by the bacteria H. pylori. Details of this transaction remain undisclosed. At the same time the deal was struck, the company secured €400 million in financing backed by Société Générale. InflaRx NV: Also based in Germany, InflaRx secured Fast Track designation from the U.S. Food and Drug Administration for the development of its first-in-class anti-C5a monoclonal antibody vilobelimab, which is being developed for the treatment of ulcerative pyoderma gangrenosum (PG). The company had previously announced that vilobelimab was granted orphan drug designation for the treatment of PG by both the FDA in the U.S. and the European Medicines Agency. Oryzon Genomics SA: Based in Spain, Oryzon announced a convertible bonds financing agreement with U.S.-based Nice & Green. The financing program consists of 4 tranches, one tranche of €8 Million and three future optional tranches of €4 Million to be drawn at the discretion of Oryzon, subject to customary conditions. Ayala Pharmaceuticals: Israel's Ayala announced positive interim results from Part A of the ongoing RINGSIDE Pivotal Phase II/III clinical trial evaluating AL102 in desmoid tumors. AL102 is a potent, selective, oral gamma-secretase inhibitor (GSI). The results from Part A will be used to determine the dose of AL102 to be evaluated in Part B of RINGSIDE, the randomized portion of the study. Ayala is on track to begin that portion of the study in the third quarter of this year. Kamada Ltd.: Also based in Israel, Kamada secured an $11.4 million agreement to supply Varizig to an undisclosed international organization operating principally in Latin America. Varizig is one of four recently acquired FDA-approved commercial products by Kamada, contains antibodies specific for the Varicella zoster virus, and is indicated for post-exposure prophylaxis of varicella (chickenpox) in high-risk patient groups, including immunocompromised children, newborns, and pregnant women. The U.S. Centers for Disease Control recommends VARIZIG for postexposure prophylaxis of varicella for persons at high risk for severe disease who lack evidence of immunity to varicella. Hutchmed: China's Hutchmed and its partner Immagene Biopharmaceuticals, announced the first participant in the global Phase I study assessing IMG-007, an investigational OX40 antagonistic monoclonal antibody, was dosed in Australia. The Phase I study will be used to evaluate the safety, tolerability and efficacy of IMG-007 in patients with atopic dermatitis.