Global Roundup: Astellas, Mogrify Battle Sensorineural Hearing Loss and More

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Mogrify Limited in UK and Japan Astellas Pharmaceuticals have established a collaboration surroundings live regenerative medicine approaches to treat sensorineural hearing loss.

The companies will leverage Mogrify’s proprietary direct cell 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 costs of the work and contribute its expertise in adeno-associated virus (AAV)-based genetic medicine and translational capabilities to conduct experiments in preclinical models. Mogrify will then review and validate the process of characterizing potential therapeutic factors using its platform.

“Mogrify’s human regulatory network-centric approach is well positioned to identify superior factor combinations, thereby increasing the efficiency of direct conversion to the target cell type in the ear. Combined with Astellas’ capabilities for gene therapy and neurosensory research, this provides a path for the development of a novel live 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 worldwide suffer from hearing loss. Of these, data suggests that more than 10% have severe to profound sensorineural hearing loss in at least one ear. This hearing loss represents a large unmet need, the companies said.

Other news around the world

CardiNor: Norwegian company CardiNor has signed a US distribution agreement with IBL-America for the CardiNor Secretoneurin ELISA test. Secretoneurin is the only biomarker associated with calcium-related biological processes of cardiac cells, a key mechanism in the regulation of arrhythmia. It has been described as the “missing link biomarker” in cardiovascular disease risk assessment. Through this collaboration, CardiNor intends to raise awareness of its front-line biomarker test to pave the way for future commercialization in the United States.

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 funding will support the advancement of candidate vaccines from its pan Betacoronavirus program through preclinical studies. Codiak’s pan Betacoronavirus vaccine construct carries the receptor binding domain protein of SARS-CoV-1 and SARS-CoV-2 at high density on the surface of the exosome. This design closely resembles natural viral structures, and these modified exosomes stimulate a broad immune response including both antibody and T cell-mediated immunity.

InnoCare Pharma: Beijing-based InnoCare announcement 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. Approval of ICP-490 will enable the company to provide better treatment options for MM and NHL patients worldwide.

Zhiyi Biotech: The Chinese 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. SK08’s Phase II clinical trial for the treatment of IBS-D is expected to complete this year, while its Phase Ib/II trial with a PD-1 inhibitor for advanced solid tumor has already begun. The company raised $45 million in B, B+ and B++ funding.

ProteoNic BV: Dutch company ProteoNic and German FyoniBio GmbH have entered into a technology license agreement, which grants FyoniBio non-exclusive commercial rights for the application of ProteoNic technology in its proprietary CHOnamite platform.

Intravac: Also based in the Netherlands, Intravacc and the German Center for Neurodegenerative Diseases have received 2.5 million euros from the European Union to develop a prototype vaccine against ALS. The project aims to develop the vaccine candidate identified at DZNE until it can be clinically tested in humans.

Juvise Pharmaceuticals: France-based Juvisé has entered into an agreement with AbbVie to acquire worldwide commercial rights to Pylera, a treatment for gastric/intestinal ulcers caused by H. pylori bacteria. Details of this transaction remain undisclosed. In parallel with the conclusion of the operation, the company obtained financing of 400 million euros backed by Société Générale.

InflaRx SA: Also based in Germany, InflaRx secured Fast Track Designation from the United States Food and Drug Administration for the development of its first anti-C5a monoclonal antibody, vilobelimab, which is being developed for the treatment of ulcerative pyoderma gangrenosum (PG). The company previously announced that vilobelimab had been granted orphan drug designation for the treatment of PG by the US FDA and European Medicines Agency.

Oryzon Genomics SA: Based in Spain, Oryzon announced a convertible bond financing agreement with the American company Nice & Green. The financing program consists of 4 tranches, one tranche of €8 million and three optional future tranches of €4 million to be drawn at Oryzon’s discretion, subject to customary conditions.

Ayala Pharmaceuticals: Ayala from Israel announced positive half-year results of Part A of the ongoing pivotal Phase II/III RINGSIDE clinical trial evaluating AL102 in desmoid tumors. AL102 is a potent oral selective 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 this part of the study in the third quarter of this year.

Kamada Ltd. : Also based in Israel, Kamada secured an $11.4 million deal to provide Varizig to an undisclosed international organization operating primarily in Latin America. Varizig is one of four FDA-cleared commercial products recently acquired by Kamada, contains specific antibodies to varicella zoster virus and is indicated for post-exposure prophylaxis of varicella (chickenpox) in high-risk patient groups , including immunocompromised children, neonates, and pregnant women. The US Centers for Disease Control recommends VARIZIG for post-exposure prophylaxis of varicella in people at high risk of severe disease who lack evidence of immunity to varicella.

Hutchmed: The Chinese Hutchmed and its partner Immagene Biopharmaceuticals, announced the first participant in the global Phase I study evaluating IMG-007, an investigational OX40 antagonist monoclonal antibody, was assayed in Australia. The phase I study will be used to evaluate the safety, tolerability and efficacy of IMG-007 in patients with atopic dermatitis.

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