The rough ride presaged by briefing documents came to pass for GSK plc with the drug first approved by the U.S. FDA as Blenrep (belantamab mafodotin, bel-maf), as the agency’s Oncologic Drugs Advisory Committee (ODAC) appraised the possibility that the antibody-drug conjugate could return to market for relapsed/refractory multiple myeloma (r/r MM).
Sino Biopharmaceutical Ltd. agreed to fully acquire Lanova Medicines Ltd. by buying an additional 95.09% stake in Lanova at a valuation of up to $950.92 million. Considering Lanova’s estimated cash and deposit of $450 million, Hong Kong-headquartered Sino agreed to pay $500.9 million to Lanova on the date of the transaction, set to close within 30 days of all conditions being satisfied, or July 31, 2025.
Immuno-oncology company Imugene Ltd.’s allogeneic, off-the-shelf CD19 CAR T, azercabtagene zapreleucel (azer-cel), has resulted in seven complete responses and three partial responses in a phase Ib trial in relapsed diffuse large B-cell lymphoma patients, according to an interim analysis. The responses to date show a 75% overall response rate.
As the July 23 PDUFA date nears for GSK plc’s Blenrep (belantamab mafodotin), the U.S. FDA’s Oncologic Drugs Advisory Committee will decide July 17 on whether available data justify the return to market of the antibody-drug conjugate as a therapy for relapsed/refractory multiple myeloma, and briefing documents made public ahead of the meeting laid out the issues.
The complete remission of a testicular cancer patient receiving Mink Therapeutics Inc.’s allogeneic, off-the-shelf invariant natural killer T-cell therapy Agent-797 with nivolumab drove the company’s shares up by 730% July 11. The results, published in Nature’s Oncogene, described the complete, durable remission of a 49-year-old man with a germ cell neoplasm, showing no evidence of disease two years after receiving a single infusion.
China’s National Medical Products Administration approved Ascentage Pharma Group Corp. Ltd.’s Bcl-2 selective inhibitor lisaftoclax (APG-2575) for treating adults with chronic lymphocytic leukemia/small lymphocytic lymphoma who previously received at least one systemic therapy including Bruton’s tyrosine kinase inhibitors.
Shanghai Circode Biomed Co. Ltd. is set to begin clinical trials of HM-2002, a circular RNA (circRNA)-based drug for ischemic heart disease, having gained IND clearance in China Jan. 10 and the U.S. on May 30, Circode CEO Chenxiang Tang recently told BioWorld.
Nearly six years after Ichnos Sciences Inc. launched operations, a subsidiary of the now-named Ichnos Glenmark Innovation (IGI) Inc. has signed with Abbvie Inc. a global licensing partnership for trispecific antibody ISB-2001 worth $1.925 billion plus royalties. ISB-2001, which targets BCMA, CD38 and CD3, is in a phase I trial for relapsed/refractory multiple myeloma and has orphan drug and fast track status in the U.S
China has proved to be a fertile ground for innovation as evidenced by some big deals in the antibody-drug conjugate (ADC) space, and the number of candidates entering clinical trials in China or being advanced in the U.S. by Chinese companies.
Actithera A/S is poised to bring small-molecule pharmacokinetics to radiopharmaceuticals after closing a $75.5 million series A that will fund initial clinical development of a candidate targeting the elusive fibroblast activation protein (FAP).
RSS
