Gilead Sciences is looking ahead to a February 2023 PDUFA date on its sBLA for Trodelvy sacituzumab govitecan-hziy to treat unresectable locally advanced or metastatic HR-positive HER2-negative breast cancer.
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Trodelvy will be examined in February for label expansion under Priority Review
CLINICAL AND REGULATORY
Trodelvy up for another label extension in February next year
FDA has granted the application priority review based on data from the Phase 3 TROPIC-02 study, in which Trodelvy led to a 34% reduction in risk of disease progression or death and a 21% decrease in risk of death versus chemotherapy. The TROP2 antibody drug conjugate is approved to treat triple-negative breast cancer and urothelial cancer.
DEALS AND FINANCING
Sofinnova Partners and Mérieux back French ADC company Mablink
Sofinnova Partners and Mérieux Equity Partner led a €31 million series A investment in Lyon-based Mablink Bioscience, whose linker technology can improve the tolerability and pharmacokinetics of antibody-drug conjugates. Existing shareholders Elaia Partners, UI-Investissement / Pertinence Invest 2, Sham Innovation Santé, Fondation Fournier-Majoie, Simba Santé and Crédit Agricole Création participated in the financing. Mablink’s lead ADC is MBK-103, a preclinical therapy comprising the biotech’s linker and TOP1 inhibitor exatecan and targets FOLR1.
Araris Biotech AG Closes $24 Million Financing Round
Araris Biotech AG, a company pioneering a proprietary ADC-linker technology, today announced the closing of a $24 million financing round, bringing the total funds raised to $40 million to date. The round was co-led by 4BIO Capital and Pureos Bioventures, with participation from new investors, including Wille AG and the Institute for Follicular Lymphoma Innovation. The round also included participation from existing investors VI Partners, Schroders Capital, btov Partners and Redalpine. Damir Illich, Ph.D. from Wille AG and Sophie Allauzen, Ph.D. from the Institute for Follicular Lymphoma Innovation will also be joining the Araris team as board observers. Proceeds from the financing will be used to support the further development and advancement of Araris’ ADC candidates, created using the Company’s proprietary linker technology, as Araris moves closer towards clinical development.
