Just months after Jazz Pharmaceuticals plc's inventory of a therapy key to treating certain acute lymphoblastic leukemia and lymphoblastic lymphoma patients appears to have run out, FDA approval has arrived for an alternative: a recombinant version of the medicine the company developed, Rylaze (asparaginase Erwinia chrysanthemi (recombinant)).
Arrivent Biopharma Inc. has raised a series A financing worth up to $150 million to in-license compounds from China and bring them to the rest of the world. Arrivent’s focus is in oncology and its first in-licensed asset is furmonertinib, a third-generation EFGR tyrosine kinase inhibitor from Shanghai-based Allist Pharmaceuticals Co. Ltd.
As the first flagship action of Europe’s plan to beat cancer, the European Commission launched its Cancer Knowledge Center June 30. The new online platform will map the latest evidence on cancer, provide health care guidelines and quality assurance schemes, and monitor and project trends in cancer incidence and mortality across the EU, where cancer is the No. 1 killer for people younger than 65.
China’s drug regulator granted a first CAR T therapy approval to Fosun Kite Biotechnology Co. Ltd.’s FKC-876. Marketed as Yescarta (axicabtagene ciloleucel) in the U.S. and EU, the approval by the National Medical Production Administration for the CD19-directed CAR T therapy came 3.5 years after the FDA nod.
Hutchmed Ltd.’s savolitinib became the first selective MET inhibitor approved in China to treat patients with non-small-cell lung cancer with MET exon 14 skipping alterations who have progressed following prior systemic therapy or are unable to receive chemotherapy.
PERTH, Australia – Startup Currus Biologics Pty Ltd. has launched with a AU$10 million (US$7.5 million) series A round with the mission of improving the success of CAR T-cell therapies against solid tumors such as breast, ovarian and pancreatic cancers.
Shares of Sensei Biotherapeutics Inc. (NASADQ:SNSE) fell 16% to $9.10 on June 29 after an announcement by President and CEO John Celebi that the antigen display technology used in its prior lead candidate, SNS-301, "is suboptimal for use in an active cancer vaccine." A phase I/II trial evaluating it will be discontinued, he said. Now, work on a next-generation vaccine, SNS-401-NG, and the monoclonal antibody SNS-VISTA will take precedence in a portfolio reprioritization at the company, with IND-enabling studies for the anti-VISTA program planned to start by the end of 2021 and for the next-gen vaccine in second half of 2022.
Swiss biotech Polyphor AG is facing an uncertain future after a pivotal phase III study of the company’s balixafortide in HER2-negative breast cancer showed the drug did not improve response rates compared with standard therapy alone.
Boehringer Ingelheim GmbH has begun a three-year collaboration with researchers at Australia’s WEHI, looking into a potentially powerful approach to targeted protein degradation also being studied by its German rival Merck KGaA.
Wall Street must wait a while longer to find out if Gilead Sciences Inc. will exercise its $275 million option for Arcus Biosciences Inc.’s TIGIT binder, domvanalimab. Meanwhile, investors took heart from an optimistic – albeit vague – interim report on the phase II ARC-7 trial.