The U.S. FDA has approved Daiichi Sankyo Co. Ltd. and Astrazeneca plc’s Enhertu (fam-trastuzumab deruxtecan) as the first HER2-directed therapy for patients with HER2-low metastatic breast cancer.
It’s an august August for Hutchmed Ltd. as it reported positive business results and a number of trial developments, including results from its pivotal global phase III FRESCO-2 trial evaluating the investigational use of fruquintinib in patients with advanced, refractory metastatic colorectal cancer, which met its primary endpoint of overall survival.
Innovent Biologics Inc. has formed a partnership with Sanofi SA to jointly develop and commercialize two of Sanofi’s oncology candidates in combination with sintilimab in China, namely SAR-408701 (tusamitamab ravtansine) and SAR-444245.
Mersana Therapeutics Inc. is getting $100 million up front in an option deal with GSK plc for preclinical-stage antibody-drug conjugate (ADC) XMT-2056, which could bring up to $1.36 billion more in an option exercise payment, development, regulatory and commercial milestones. It’s the second potential $1 billion-plus ADC deal for Cambridge, Mass.-based Mersana in 2022 and the first for its Immunosynthen platform, which uses a STING agonist payload specifically designed for ADCs.
Oricell Therapeutics Co. Ltd. has raised $120 million in a series B financing to support development of its cell therapy pipeline and technology platform, as well as the construction of a manufacturing plant. The round was jointly led by Qiming Venture Partners and Quan Capital Management LLC.
With data due later this summer from the phase II Pioneer trial testing Blueprint Medicines Corp.’s approved Ayvakit (avapritinib), many investor eyes are on the potential label expansion into indolent systemic mastocytosis – but the company has another potential ace in the hole with BLU-451, which targets EGFR exon 20 insertion mutations in non-small-cell lung cancer (NSCLC).
No one denies that fewer new drugs will be a consequence of the Medicare drug pricing provisions the Democrats are trying to push through the U.S. Congress ahead of the midterm election campaign season.
Shares of Poseida Therapeutics Inc. (NASDAQ:PSTX) closed at $4.51, up $2.08, or 85%, as a result of the collaboration and licensing deal with Roche Holding AG that brings $110 million up front as well as the same amount in near-term milestone payments described by CEO Mark Gergen as “highly achievable,” and the arrangement could be worth as much as $6 billion if goals farther down the road are met.
Lepu Biopharma Co. Ltd. has been given conditional approval by China’s NMPA for its anti-PD-1 monoclonal antibody, Puyouheng (pucotenlimab injection), based on data from a phase II study. The drug was conditionally greenlighted for patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) advanced solid tumors.
Idrx Inc. launched with a $122 million oversubscribed series A round to boost precision drug combinations in cancer, with a first focus on non-PDGFR-driven gastrointestinal stromal tumors (GIST). The Plymouth, Mass.-based firm aims to develop a pairing, potentially with add-ons, powerful enough to handle existing mutations and those that turn up during treatment. Combo therapy attacks “not just the driver mutations, but also the key secondary mutations,” co-founder and CEO Ben Auspitz told BioWorld, and thereby “block every escape route the cancer has.”
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