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Kairos Pharma Reports Positive Interim P-II Data for ENV-105 in Metastatic Prostate Cancer

Shots: Kairos Pharma announced positive interim efficacy data from its ongoing P-II study evaluating ENV-105 (carotuximab) in combination with apalutamide in pts. with metastatic castration-resistant prostate cancer (mCRPC) The combination demonstrated a statistically significant improvement in progression-free survival, with median PFS of 17.7 mons. vs 2 mons. with apalutamide alone (P=0.0008) Following the interim results,…

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Genmab and AbbVie

AbbVie and Genmab Report Positive Data from the P-III Study of Epcoritamab Plus R-CHOP in Newly Diagnosed DLBCL

Shots: AbbVie and Genmab announced positive topline results from the P-III (EPCORE DLBCL-2) study, demonstrating a statistically significant and clinically meaningful improvement in PFS vs R-CHOP alone (SoC) in newly diagnosed diffuse large B-cell lymphoma (DLBCL) pts. with an IPI score of 2-5 The study evaluated fixed treatment duration epcoritamab(SC) plus rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine, and…

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Merck and SciBrunch Sign ~$2.13B Exclusive Global License Agreement for SPR2015

Shots: Merck & SciBrunch have entered into an exclusive global license agreement for SPR2015, with Merck receiving exclusive rights to develop, manufacture & commercialize SPR2015 worldwide As per the deal, SciBrunch will receive ~$400M upfront & payment associated with development, commercialization & other milestones across multiple indications, representing the total deal value of ~$2.13B SPR2015…

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Earendil Labs Inks $1.5B+ Research Collaboration with Genentech to Advance Bispecific Antibodies in Oncology

Shots: Earendil Labs has entered into a research collaboration with Genentech to discover and develop multiple therapeutic bispecific antibody programs in oncology Earendil Labs will lead antibody discovery & research through early clinical development for programs targeting certain pre-agreed target combinations, while Genentech will take over global clinical development & commercialization As per the deal,…

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Astellas Reports First Patient Dosing in P-III Study of Setidegrasib in Previously Treated KRAS G12D-Mutated NSCLC

Shots: Astellas has dosed the first patient in a P-III study assessing setidegrasib vs docetaxel in ~356 pts with KRAS G12D-mutated locally advanced (unresectable) or metastatic NSCLC who progressed on or after initial Pt-based CT & checkpoint inhibitor therapy The P-III study in previously treated NSCLC builds on P-I data published in The NEJM in Mar…

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Envisagenics and Boehringer Ingelheim Sign >$1B Cancer Drug Development Deal

Shots: Envisagenics has entered a multi-year research collaboration & option agreement with BI to validate tumor-specific targets for developing first-in-class precision therapies for solid tumors, using Envisagenics’ AI-powered SpliceCore platform  Collaboration builds on targets identified through SpliceCore to validate their potential across ADCs, TCEs & multispecific Abs, with BI having an option to exclusively license…

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Shilpa Biologicals and SPIMACO Bio Partner to Advance Access to PD-1 Inhibitor Biosimilars in MENA Region  

Shots:  Shilpa Biologicals has entered into an exclusive MENA licensing & commercialization agreement with SPIMACO Bio for a portfolio of PD-1 inhibitor biosimilars used in cancer immunotherapy  Shilpa Biologicals will lead exclusive development & manufacturing, with phased technology transfer to enable local biosimilar production in Saudi Arabia, while SPIMACO Bio will handle regulatory execution, market…

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Cipla Partners with Qilu Pharmaceutical to Commercialize QL2107 (Biosimilar, Keytruda) in the US

Shots: Invagen Pharmaceuticals, a wholly owned subsidiary of Cipla, has entered into a strategic partnership with Qilu Pharmaceutical for the exclusive licensing & supply of QL2107, a biosimilar version of Keytruda (pembrolizumab), for the US As per the deal, Qilu will handle product development, regulatory registration & supply, while Cipla USA will commercialize the asset across the…

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