Mersana Therapeutics announced the initiation of patient dosing in its Phase 1 clinical trial of XMT-2056, the company’s lead Immunosynthen product candidate.
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Amgen and Hummingbird to use technologies from Synaffix to develop novel ADCs
CLINICAL AND REGULATORY
Mersana announced initiation of Phase 1 of XMT-2056 in HER2-expressing tumors
XMT-2056 is a systemically administered Immunosynthen STING agonist ADC that is designed to target a novel HER2 epitope and locally activate STING signaling in both tumor-resident immune cells and in tumor cells to provide the potential to treat patients with HER2-high or -low tumors as monotherapy or in combination with standard-of-care agents.
The U.S. Food and Drug Administration (FDA) has granted orphan drug designation to XMT-2056 for the treatment of gastric cancer. The multicenter Phase 1 open-label trial will investigate XMT-2056 in previously treated patients with advanced/recurrent solid tumors expressing HER2, including breast, gastric, colorectal and non-small-cell lung cancers. The dose escalation and dose expansion portions of the trial will evaluate and characterize the relationship of safety, tolerability and exposure of XMT-2056 and the ADC’s effect on patient responses by overall response rate, duration of response and disease control rate.
DEALS AND FINANCING
Amgen enters a deal with Synaffix to use its ADC and linker technologies
Amgen will gain access to Synaffix’ GlycoConnect, HydraSpace and toxSYN antibody-drug conjugate and linker technologies — the twelfth licensing agreement for the Dutch company, and the second to be announced this week after a partnership with Hummingbird Bioscience. Synaffix will be eligible to receive up to $2 billion in payments spanning signature, program nomination and milestone payments, plus tiered royalties on commercial sales.
Bliss completed Series B adding $15 million to develop its ADC pipeline
Chinese Bliss Biopharma completed a series B+ round of more RMB100 million ($15 million) to help fund clinical development of its pipeline of ADCs including BB-1701 and BB-1705 to treat solid tumors. The financing was led by IN Capital, with participation from existing investors Oriental Fortune Capital and Sherpa Healthcare Partners. Bliss is led by CEO Ziping Wei, formerly of Novavax, MedImmune, Bristol Myers Squibb and Johnson & Johnson.
