The U.S. FDA accepted for review Daiichi Sankyo Co. Ltd.’s and Astrazeneca plc’s BLA for datopotamab deruxtecan to treat adults with unresectable or metastatic hormone receptor-positive, HER2-negative breast cancer who have received prior systemic therapy for unresectable or metastatic disease.
Phase II/III results from Gritstone Bio Inc. with Granite, a personalized neoantigen cancer vaccine for colorectal cancer, turned up the opposite of what some investors expected, and the company’s shares (NASDAQ:GRTS) ended April 2 at $1.20, down $1.15, or 49%.
Jumping in for the first time to the hot antibody-drug conjugate (ADC) space, Paris-based Ipsen SA pulled in exclusive global rights to a preclinical ROR1-targeting candidate from Sutro Biopharma Inc. in a deal worth up to $900 million. STRO-003, the first ADC to join Ipsen’s portfolio, contains an anti-ROR1 human IgG1 antibody (SP-11385) conjugated to an exatecan warhead, or payload.
South Korean confectionary giant Orion Holdings Inc. has completed the acquisition of antibody-drug conjugate developer Ligachem Biosciences Inc., which recently changed its name from Legochem Bioscience Inc.
South Korean biosimilar-focused Alteogen Inc. said on March 27 that Chung Hye-shin, former chief strategy officer (CSO) and co-founder, sold 1.6 million of Alteogen shares for ₩316.4 billion (US$234.24 million) to foreign institutional investors.
In a potential watershed moment for South Korea’s Hanmi Group, a hair-splitting vote at the 51st shareholder meeting favored the two sons of the late founder and Chairman Lim Sung-ki, effectively halting a merger between Hanmi and OCI Holdings Co. Ltd.
Xilio Therapeutics Inc. retreated with its lead oncology IL-2 drug, XTX-202, after phase II data indicated stable disease was the best response, prompting the company to reprioritize its pipeline and cut its workforce by 21% – but investors focused more on a $647.5 million IL-12 program deal the company signed with Gilead Sciences Inc., as well as an $11.3 million private placement financing.
Boundless Bio Inc. got a lukewarm welcome on Nasdaq after pricing its IPO of 6.25 million shares at the midpoint price of $16 per share, raking in about $100 million in gross proceeds to advance its pipeline of ecDNA-driven drugs targeting oncogene-amplified tumors.
An increasingly popular target across varied cancer types is the immune system regulator V-domain Ig suppressor of T-cell activation (VISTA), where a number of developers have taken early stage aim – among them Sensei Biotherapeutics Inc., with SNS-101, which Wainwright analyst Edward White believes could be the first anti-VISTA monoclonal antibody approved as a therapeutic agent. But there’s plenty of work ahead.
Japan’s Ministry of Health, Labor and Welfare approved Astellas Pharma Inc.’s Vyloy (zolbetuximab) to treat a type of advanced gastric cancer on March 26, making it the first anti-claudin 18.2 monoclonal antibody to gain regulatory clearance worldwide.