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Artios’ Alnodesertib Obtains the US FDA’s Fast Track Designation for ATM-negative Metastatic Colorectal Cancer

Shots: The US FDA has granted FTD to alnodesertib + low-dose irinotecan as the 3L treatment of adults with ATM-negative metastatic colorectal cancer (mCRC) Designation was based on the P-I/II (STELLA) trial (ongoing in the US) assessing the regimen in solid tumors with ATM deficiency, which showed responses in 3L mCRC & 7 additional solid…

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Daiichi Sankyo

Daiichi Sankyo Reports the EMA’s MAA Acceptance of Enhertu to Treat Solid Tumors

Shots: The EMA has validated the Type II Variation MAA for Enhertu (trastuzumab deruxtecan) to treat previously treated adults with HER2+ (IHC 3+) unresectable or metastatic solid tumors, who have unsatisfactory alternative treatment options MAA was supported by 3 P-II (DESTINY-PanTumor02, DESTINY-CRC02 & DESTINY-Lung01) trials, where DESTINY-PanTumor02 (n=267, incl. 111 HER2+ pts) assessed Enhertu (5.4mg/kg)…

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Next-Gen T Cell Engagers for Solid Tumors: Shaun Murphy in a Riveting Dialogue Exchange with PharmaShots

Shots:   Unlike hematologic malignancies, where the elimination of most or all tumor cells results in immunosuppression, making headways in solid tumors requires a new holistic approach when using T Cell Engagers  Abpro’s ABP-102/CT-P72, co-developed by Celltrion leverages a tetravalent format; bivalent for both HER2 and CD3  PharmaShots welcomes Shaun Murphy, Vice President, Nonclinical Research and…

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Tracer Biotechnologies Collaborates with QIAGEN to Co-Develop and Commercialize Tracer dPCR & Tracer WGS for Solid Tumors

Shots: Tracer has entered into a strategic collaboration with QIAGEN to co-develop & commercialize Tracer dPCR & Tracer WGS MRD assays for solid tumors on QIAGEN’s QIAcuity digital PCR platform Collaboration aims to provide highly sensitive, cost-effective, & decentralized MRD testing using QIAcuity’s PCR platform, allowing oncologists to monitor cancer recurrence & guide personalized treatment…

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Astellas & Evopoint Bio

Astellas Enters a ~$1.54B Licensing Agreement with Evopoint Biosciences to Develop & Commercialize XNW27011

Shots: Evopoint Biosciences has granted Astellas exclusive license to develop & commercialize XNW27011 globally, excl. Mainland China, Hong Kong, Macao & Taiwan As per the deal, Evopoint will receive $130M upfront as well as ~$70M as near-term payments in addition to ~$1.34B in development, regulatory & commercial milestones, with net sales-based royalties XNW27011, an CLDN18.2-specific…

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