It took resolving issues from two complete response letters for Fennec Pharmaceuticals Inc. to finally land U.S. FDA approval of Pedmark. The injectable formulation of sodium thiosulfate is for reducing the risk of platinum-induced ototoxicity associated with cisplatin in pediatric patients 1 month and older with localized, non-metastatic solid tumors. Approval of the NDA arrived Sept. 20, three days before its Sept. 23 PDUFA date.
About four months after starting its search for strategic alternatives, Sesen Bio Inc. disclosed an all-stock merger with privately held cell-therapy specialist Carisma Therapeutics Inc., a move that sent shares (NASDAQ:SESN) down 22 cents, or 32.7%, to close at 45 cents. Sesen stockholders are expected to own about 41.7% of the combined firm, and Carisma the remainder.
Abpro Corp. and Celltrion Healthcare Inc. entered a global partnership valued at up to $1.75 billion involving ABP-102, a bispecific antibody targeting HER2-positive cancers, a move Abpro CEO Ian Chan said would help “accelerate this type of therapy for patients in need.” With ABP-102 in preclinical development, Abpro decided to start looking for a partner. HER2 is “one of the biggest targets in biotech, mostly relevant for breast, colorectal and gastric cancers,” Chan told BioWorld. “Celltrion happened to have a lot of experience in the space.”
Aptabio Therapeutics Inc. has identified new pyrazole derivatives acting as reactive oxygen species (ROS) production inhibitors reported to be useful for the treatment of cancer, neurodegeneration, fibrosis, liver diseases and dermatological, eye and inflammatory disorders, among other disorders.
Oncolinx Pharmaceuticals LLC and the U.S. Department of Health and Human Services have presented new signal transducer and activator of transcription 3 (STAT3) inhibitors reported to be useful for the treatment of cancer, inflammatory disorders, and bacterial and viral infections.
Blossomhill Therapeutics Inc. has divulged macrocyclic compounds acting as epidermal growth factor receptor (EGFR: HER1; erbB1) and EGFR mutant inhibitors reported to be useful for the treatment of cancer.
Invenra Inc. has announced preclinical data supporting the ongoing development of INV-322, a Sniper bispecific antibody co-targeting CTLA-4 and CD25 for cancer developed using Invenra's B-Body Platform.
Researchers from Sun Yat-sen University, Southern Medical University and Gannan Medical University reported the discovery of novel quinazoline-based KRAS G12C inhibitors as potential anticancer agents.
Basilea Pharmaceutica Ltd., having advanced a first-in-class cancer drug through preclinical studies, is selling some rights and sublicensing others for the dual-kinase inhibitor to Sillajen Inc.
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