Corestemchemon Inc. is planning to file a BLA for Neuronata-R (lenzumestrocel) by the end of 2025 to gain accelerated approval from the U.S. FDA, company officials confirmed to BioWorld during a June 2 interview. Neuronata-R is an autologous bone marrow-derived mesenchymal stem cell therapy that first gained approval in South Korea in 2014 to delay the progression of amyotrophic lateral sclerosis (ALS), a progressive neurodegenerative disorder also known as Lou Gehrig’s disease.
Epimab Biotherapeutics Inc. licensed out a development-ready KLK2/CD3 bispecific T-cell engager (TCE) for advanced prostate cancer to Juri Biosciences Inc. through a potential $210 million deal.
Nibec Co. Ltd. announced May 28 the signing of a potential $435 million license deal for NP-201, its phase II-ready peptide-based pulmonary fibrosis therapy candidate, with an undisclosed U.S.-based biotech company.
Samsung Biologics Co. Ltd. plans to establish a new holding company and to spin off its biosimilar division, Samsung Bioepis Co. Ltd., by October. The corporate restructuring will draw clear lines between Samsung Biologics’ CDMO operations and Samsung Bioepis’ biosimilar business.
Alteogen Inc. completed a merger between two subsidiaries – Altos Biologics Inc. and Alteogen Healthcare Inc. – branding the new entity as Alteogen Biologics Inc.
Although HER2-targeted therapies have become a mainstay in cancer treatment, some tumors evade them by stripping away the portion of the HER2 receptor that most therapies are built to recognize and bind to, but Taiwan’s AP Biosciences Inc. is developing bispecific antibody AP-402 to address treatment-resistant HER2+ cancers.
Japanese-founded Regcell Inc. has raised $45.8 million and is redomiciling to the U.S. to accelerate clinical development of its pioneering regulatory T-cell (Treg) platform for autoimmune diseases and transplantation.
Astellas Pharma Inc. is setting up a joint venture with Yaskawa Electric Corp. to develop a new cell production platform using Yaskawa’s dual-arm humanoid robot called Maholo.
HBM Alpha Therapeutics Inc. signed a potential $395 million licensing deal Feb. 26 with an unnamed “business partner” for its endocrine asset, HAT-001, adding another contender to the congenital adrenal hyperplasia space.
Antibody-drug conjugate (ADC)-focused Callio Therapeutics debuted on March 3 with the closing of a $187 million series A financing round based on cancer drug technology and assets in-licensed from Hummingbird Bioscience Pte Ltd.
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