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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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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 & 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 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 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 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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The CHMP has recommended Pebrilzo, a biosimilar version of Perjeta (pertuzumab), as the 420 mg concentrate solution for infusion for the treatment of HER2+ breast cancer across multiple disease stages
The EC will conduct the final review and issue its decision; if positive, the SmPC will be available in all EU official languages, with…
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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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1cBio & Lee's Pharmaceutical have entered into a licensing agreement granting Lee's Pharm exclusive rights to develop & commercialize OC-3, a preclinical PARP1 inhibitor, in China & certain countries in SE Asia
As per the deal, 1cBio will receive an upfront payment, development milestones & potential sales milestone payments totaling ~$27M, as well as…
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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…

