Tumor mutational burden (TMB), a biomarker used to assess whether a patient will respond to immunotherapy, needs to be recalculated in order to be useful for patients of Asian or African descent. Scientists at the Dana-Farber Cancer Institute found a significant bias in the estimated TMB values affecting these populations and adjusted them for those patients.
The U.S. FDA has approved Taiho Oncology Inc.’s Lytgobi (futibatinib) for adults with previously treated, unresectable, locally advanced or metastatic intrahepatic cholangiocarcinoma harboring fibroblast growth factor receptor 2 (FGFR-2) gene fusions or other rearrangements. The approval arrived on its Sept. 30 PDUFA date.
Calithera Biosciences Inc.’s in-licensing deal to take ownership of a pair of oncology assets from Takeda Pharmaceutical Co. Ltd. may be on its way to paying off, perhaps especially with regard to the oral Syk/FLT3 inhibitor mivavotinib, formerly known as CB-659/TAK-659.
Zai Lab Ltd. has agreed to pay $30 million up front to in-license from Seagen Inc. exclusive rights to the antibody-drug conjugate (ADC) Tivdak (tisotumab vedotin) in mainland China, Hong Kong, Macau and Taiwan. Seagen is also eligible to receive development, regulatory, and commercial milestone payments of undisclosed value, as well as tiered royalties on net sales of the drug in Zai’s territory.
Pheon Therapeutics Ltd. is working to bring next-generation antibody-drug conjugate (ADC) payloads and enhanced tolerability into the clinic after closing a $68 million series A.
Researchers at the Walter and Eliza Hall Institute of Medical Research (WEHI) in Melbourne, Australia, have developed a new genome editing technique than can activate any gene, including those that have been silenced, allowing new drug targets and causes of drug resistance to be explored.
CRISPR-based cell therapies continued to gain steam Sept. 27 with the announcements of a potentially valuable big pharma collaboration and an ambitious global regulatory push.
Japan’s Ministry of Health, Labor and Welfare approved Daiichi Sankyo Co. Ltd.’s Ezharmia (valemetostat tosilate), the first dual inhibitor of histone methyltransferases EZH1 and EZH2 for the treatment of patients with relapsed or refractory adult T-cell leukemia and lymphoma. It’s Daiichi Sankyo’s fifth new oncology medicine approved in Japan in the past three years.
Shares of Lava Therapeutics NV rocketed by more than 90% Sept. 26 as the company disclosed a licensing deal with Seagen Inc. to develop and commercialize preclinical-stage EGFR-targeting bispecific candidate LAVA-1223, which comes with $50 million in up-front funding and up to a potential $650 million in milestones. It also adds further validation for harnessing gamma-delta T cells to treat cancer, an approach that is growing increasingly popular.
Stratosvir Ltd. aims to overcome the drawbacks experienced with oncolytic viruses, using technology based around vaccinia viruses that allow for a systemic injection and with a larger payload capacity. Stratosvir was started up by CEO Chris Ullman and co-founder Antonio Postigo in 2020 with funding from Cancer Research UK and the Deep Science Ventures, tasked with finding new ways of treating solid tumors.
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