Navigator Medicines Inc. is charting a course through the autoimmune disease drug landscape, having raised $100 million in a series A funding round to advance an OX40 ligand (OX40L)-targeted portfolio licensed from South Korea’s Imbiologics Corp.
Hemogenyx Pharmaceuticals plc has developed a new and improved version of its bispecific antibody CDX for the treatment of relapsed/refractory acute myeloid leukemia, a subset of acute lymphoblastic leukemia, and potentially for conditioning in bone marrow transplantations.
Antibodies targeting cytotoxic T-lymphocyte protein 4 (CLTA-4) have faced challenges due to frequent adverse events and limited efficacy, thus pushing the search for next-generation anti-CTLA-4 antibodies that balance T regulatory cell (Treg) depletion with CD8 T-cell activation for cancer immunotherapy.
Mestag Therapeutics Ltd. has been awarded a £1.5 million ($1.9 million) grant from Innovate UK’s Cancer Therapeutics program to accelerate the development of MST-0300.
Imbiologics Inc. scored a potential ₩430 billion (US$315.5 million) deal with China’s Hangzhou Zhongmei Huadong Pharmaceutical Co. Ltd. for Oxtima, an autoimmune disease program with two assets co-developed by Seoul, South Korea-based HK Inno.N Corp.
Invenra Inc.’s bispecific antibody, INV-724, developed for the treatment of neuroblastoma, has been awarded orphan drug and rare pediatric disease designations by the FDA.
Five months after getting a complete response letter from the U.S. FDA, Regeneron Pharmaceuticals Inc. has landed conditional European marketing approval for odronextamab, a bispecific antibody for treating lymphoma. Now named Ordspono, the approval is for treating adult patients with relapsed or refractory follicular lymphoma or diffuse large B-cell lymphoma, after two or more lines of therapy. The European Commission also approved Merck & Co. Inc.’s Winrevair (sotatercept) for pulmonary arterial hypertension and ARS Pharmaceuticals Inc.'s Eurneffy (inhaled epinephrine) for anaphylaxis.
Regeneron Pharmaceuticals Inc. suffered an unsurprising hitch in the form of a complete response letter (CRL) related to linvoseltamab, a bispecific antibody designed to bridge B-cell maturation antigen on multiple myeloma cells containing CD3-expressing T cells, for relapsed/refractory multiple myeloma.
The U.S. FDA approved Janssen Biotech Inc.’s Rybrevant (amivantamab-vmjw) plus a new oral tyrosine kinase inhibitor called Lazcluze (lazertinib) as a first-line combination treatment to treat select non-small-cell lung cancers.
Imbiologics Inc. scored a potential ₩430 billion (US$315.5 million) deal with China’s Hangzhou Zhongmei Huadong Pharmaceutical Co. Ltd. for Oxtima, an autoimmune disease program with two assets co-developed by Seoul, South Korea-based HK Inno.N Corp.
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