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D3 Bio Receives the US FDA IND Clearance to Initiate P-I trial of D3S-003 & P-II Combination Study of Elisrasib (D3S-001) with D3S-002

Shots: FDA has granted IND clearance to initiate D3S-003 a P-I, and a P-II combination study of D3S-001 (elisrasib), a next-gen KRAS G12C inhibitor, with D3S-002, an oral ERK1/2 inhibitor The P-II trial will evaluate the D3S-001 + D3S-002 combination in KRAS G12C–mutant NSCLC patients who have progressed on prior KRAS G12C therapies to assess…

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ImmunityBio Reports Positive Clinical Results of ANKTIVA Plus Checkpoint Inhibitors in NSCLC

Shots: ImmunityBio announced positive results from two clinical studies evaluating ANKTIVA (nogapendekin alfa inbakicept) in combination with checkpoint inhibitors (CPI) in non-small cell lung cancer (NSCLC), demonstrating statistically significant immune restoration across 151 pts In 1L NSCLC, the randomized QUILT-2.023 study showed a significant and sustained increase in absolute lymphocyte count (ALC) with ANKTIVA +…

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J&J Reports P-III Trial Outcomes Showing Tecvayli Monotherapy Extends PFS and OS in R/R Multiple Myeloma

Shots: J&J has reported positive topline Phase III (MajesTEC-9) results demonstrating that Tecvayli (teclistamab) monotx. significantly outperformed SoC in r/r multiple myeloma The study included patients with 1–3 prior therapies, all previously treated with anti-CD38 antibodies and lenalidomide. Most patients were refractory to anti-CD38 mAbs (85%), lenalidomide (79%), and their last therapy (>90%). Tecvayli achieved…

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AbbVie Enters PD-1×VEGF Bispecific Race with ~$5.6B Deal for Remegen’s RC148 

Shots: RemeGen has granted AbbVie exclusive rights to develop, manufacture, & commercialize RC148 outside of the Greater China In return, RemeGen will receive $650M upfront, ~$4.95B in development, regulatory, & commercial milestones, with tiered, double-digit royalties on sales in AbbVie’s licensed areas RC148 is a PD-1/VEGF-targeted bispecific antibody that is being developed as a monotx.…

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RefleXion Medical Reports the US FDA Clearance of RefleXion X2 Platform for Improved Tumor Detection

Shots: The US FDA has cleared RefleXion X2 with SCINTIX therapy for the treatment of primary & metastatic lung & bone tumors X2 platform provides a 20-fold increase in PET sensitivity, increasing detectable biological signal levels for tumor imaging & potentially broadening the population eligible for SCINTIX therapy based on imaging criteria Its wide field-of-view PET detector…

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Pierre Fabre Partners with Iktos for AI-Driven Drug Discovery in Oncology

Shots: Pierre Fabre Laboratories has entered into an integrated drug discovery collaboration with Iktos to identify & develop novel small-molecule drug candidates in oncology As per the deal, Iktos will apply its AI-driven generative design platform to rapidly identify optimized small-molecule candidates for an undisclosed oncology target, while Pierre Fabre will contribute oncology & preclinical expertise…

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InduPro Therapeutics Collaborates with Eli Lilly in ~$950M Oncology Therapeutic Discovery Deal

Shots: InduPro has entered into a global strategic collaboration & licensing agreement with Eli Lilly to discover novel oncology treatments using InduPro’s proximity-guided platform Lilly will gain access to InduPro’s AI/ML-enabled MInt platform, with InduPro leading early discovery to identify co-target pairs & advance bispecific & multispecific antibody programs from the collaboration As per the…

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Cartography Biosciences and Pfizer Forge ~$865M Deal for Discovery of Tumor-Selective Antigens

Shots: Cartography has entered into a strategic collaboration with Pfizer to discover tumor-selective antigens, leveraging Cartography’s ATLAS & SUMMIT platforms Under a multi-year deal, Cartography will discover & validate tumor-selective antigens in an undisclosed cancer, with Pfizer holding opt-in rights for research, development & commercialization; Cartography retains full ownership of its lead asset CBI-1214 Cartography…

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Amgen Acquires Dark Blue Therapeutics for ~$840M

Shots: Amgen has acquired Dark Blue Therapeutics, strengthening its early oncology discovery efforts & pipeline As per the deal, Amgen acquired Dark Blue Therapeutics in a transaction valued at ~$840M, integrating Dark Blue into its existing research organization Acquisition will add a preclinical small molecule that degrades MLLT1/3 in select acute myeloid leukemia subtypes, showing differentiated anti-cancer activity…

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Insilico Medicine and Servier Enter ~$888M R&D Alliance to Advance Novel Oncology Therapies

Shots: Insilico Medicine has entered into a multi-year R&D collaboration with Servier to identify & develop novel oncology therapeutics for challenging targets using Insilico's Pharma.AI As per the deal, Servier will share R&D costs &, upon successful identification of potential candidates, assume responsibility for clinical validation, regulatory engagement, & global commercialization of the resulting oncology drug candidates…

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