Global Roundup: Astellas, Mogrify Battle Sensorineural Hearing Loss & More
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.
InnoCare Pharma: Beijing-based InnoCare announced that it has received Investigational New Drug approval for its novel targeted protein degrader ICP-490 for the treatment of multiple myeloma (MM) and non-Hodgkin's lymphoma (NHL) from the National Medical Products Administration. ICP-490's approval will allow the company to provide better treatment options for MM and NHL patients globally.
Zhiyi Biotech: China's Zhiyi Biotech has raised $15 million in its B++ funding round that will support its lead drug candidate SK08, its first live biotherapeutic product (LBP), and other LBPs in its pipeline. The Phase II clinical trial of SK08 for the treatment of IBS-D is expected to be completed this year, while its Phase Ib/II trial with PD-1 inhibitor for advance solid tumor has already begun. The company has garnered $45 million in B, B+, and B++ funding.
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.