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Acepodia Reports the US FDA IND Clearance to Initiate P-I Trial of ACE723 in HCC

Shots: The US FDA has granted IND clearance to ACE723 for the initiation of P-I trial to treat patients with unresectable or metastatic hepatocellular carcinoma (HCC) The P-I study will assess ACE723’s safety, tolerability, dose-limiting toxicities, PK & preliminary antitumor activity in above-mentioned pts, with dose-escalation portion of establishing recommended dose for further development &…

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Styx Biotechnologies Partner with ZoeNCure Therapeutics to Advance ADC Development

Shots: Styx Biotechnologies has entered into a strategic agreement with ZoeNCure Therapeutics to accelerate selected Styx ADC programs toward first-in-human clinical studies for multiple solid tumor indications The collaboration gives Styx a capital-efficient path to advance selected ADC assets through coordinated preclinical, CMC, regulatory & clinical activities while preserving opportunities for global development & strategic partnering As…

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DualityBio Inks $1B+ Deal with Genentech to Develop Next-Generation ADCs 

Shots: DUALITYBIO has entered into a collaboration & license agreement with Genentech to develop next-generation ADCs, leveraging DUALITYBIO’s DUPAC (DualityBio Unique Payload Antibody Conjugate) platform DualityBio will discover & develop ADCs against Genentech-selected oncology targets using DUPAC payloads, leading discovery & early global development, while Genentech will secure exclusive global rights & take over development…

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SOTIO Biotech Receives FDA Fast Track Designation for SOT106 to Treat Soft Tissue Sarcoma

Shots: The US FDA has granted Fast Track Designation (FTD) to SOT106 for the treatment of soft tissue sarcoma SOT106 is an ADC that targets LRRC15, a clinically validated target broadly expressed across multiple prevalent sarcoma subtypes, & has received FDA Orphan Drug Designation for osteosarcoma treatment SOTIO plans to initiate a first-in-human clinical trial of SOT106…

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Natera and Angiex Partner to Monitor AGX101 Response Using Signatera

Shots: Natera has entered into collaboration with Angiex to use longitudinal Signatera testingfor circulating tumor DNA (ctDNA) to assess treatment response monitoring during AGX101 treatment AGX101 is designed to target TM4SF1-expressing tumor cells & tumor-associated endothelial cells, delivering a cytotoxic payload to both the tumor & its vasculature Angiex is conducting a P-I trial of…

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Astrazeneca and Daiichi-Sankyo New

Daiichi Sankyo and AstraZeneca Report P-III (DESTINY-Lung04) Trial Data on Enhertu for HER2 Mutant Non-Squamous NSCLC

Shots: Daiichi Sankyo & AZ have reported P-III (DESTINY-Lung04) trial data assessing Enhertu (5.4mg/kg) vs SoC (Pt-pemetrexed doublet CT + Keytruda) in 454 pts with unresectable, locally advanced or metastatic, nsq-NSCLC harboring a HER2 exon 19 or 20 mutation Trial showed that Enhertu improved PFS as 1L treatment, with trial continuing to evaluate 2EPs incl. OS;…

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Sandoz & Henlius

Henlius and Sandoz Partner on Up to 10 Biosimilar mAbs and ADC Products

Shots: The deal incl. ~10 biosimilars or related components, incl. 3 initial assets: HLX05-N (cetuximab), HLX16 (evolocumab), & a proposed belimumab biosimilar, plus an option for HLXTE-HAase1001, a recombinant human hyaluronidase Sandoz will receive exclusive rights to register & commercialize the assets globally outside China, with both parties sharing development & lifecycle activities. Territories vary…

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Pathos AI Inks ~2.2B Licensing Deal with Alphamab Oncology for JSKN016

Shots: Pathos AI has entered into a licensing agreement with Jiangsu Alphamab Biopharmaceuticals for JSKN016, a TROP2/HER3 bispecific ADC independently developed by Alphamab As per the deal, Pathos AI will receive exclusive rights to research, develop, manufacture & commercialize JSKN016 outside Greater China, funding all related costs, while Alphamab retains exclusive rights in mainland China,…

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Hansoh Pharma Reports P-III (ARTEMIS-011) Trial Data on Ris-Rez for Osteosarcoma

Shots: Hansoh has reported P-III (ARTEMIS-011) trial data assessing risvutatug rezetecan (HS-20093), a B7-H3–directed ADC, vs CT in pts with osteosarcoma who had progressed or relapsed after receiving ≥2 prior lines of systemic therapy Trial met its 1EP of improved PFS as assessed by the IRC, with consistent benefits observed across 2EPs, incl. OS & investigator-assessed…

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