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 &…
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…
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…
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…
Shots:
Daiichi Sankyo has dosed the first patient in the P-I trial with DS1025 for the treatment of advanced or metastatic solid tumors with disease progression on or after ≥1 prior line of standard therapy
The P-I trial of DS1025 will evaluate safety, tolerability, PK & preliminary efficacy above-mentioned pts (n=~45), assessing safety & tolerability,…
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…
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;…
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…
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,…
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…

