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WEEKLY SNAPSHOT

PharmaShots Weekly Snapshots (May 05, 2025 – May 09, 2025) 

This week PharmaShots’ news was all about the updates on Clinical Trials, Regulatory, Pharma, MedTech, Biosimilar & Animal Health. Check out our full report below:    Recursion Presents Preliminary P-Ib/II (TUPELO) Trial Data of REC-4881 for Familial Adenomatous Polyposis (FAP) at DDW 2025  Read More: Recursion  Chengdu Origen and Vanotech Report the First Patient Dosing in P-I (VAN-2401)…
May 9, 2025

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GSK New
NEWS

GSK Reports the P-III (GLISTEN) Study Results of Linerixibat for Primary Biliary Cholangitis (PBC) Patients with Cholestatic Pruritus

Shots: GSK has reported P-III (GLISTEN) trial data assessing linerixibat (n=119) vs PBO (n=119) to treat PBC pts (N=238) with cholestatic pruritus; pts could switch to linerixibat in Part B of the trial Trial met its 1EP, showing significantly reduced itch per WI-NRS scale in PBC pts, as assessed by monthly itch score, over 24wks.…
May 8, 2025

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Astrazeneca and Daiichi-Sankyo New
NEWS

Daiichi Sankyo and AstraZeneca Report Topline P-III (DESTINY-Breast11) Trial Data of Neoadjuvant Enhertu for HER2+ Early-Stage Breast Cancer

Shots: Daiichi Sankyo & AstraZeneca has reported topline P-III (DESTINY-Breast11) trial data assessing neoadj. Enhertu (5.4mg/kg) monotx. or Enhertu followed by paclitaxel, Herceptin & Perjeta (THP) vs SoC + THP in high-risk, locally advanced HER2+ early-stage breast cancer pts (n=927) Trial showed that Enhertu regimen achieved significant improvement in pCR rate (1EP), while EFS (2EP) data was…
May 7, 2025

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Immutep
NEWS

Immutep Reports P-IIb (KEYNOTE-C34/ TACTI-003) Trial Data of Eftilagimod Alfa + Keytruda for Head and Neck Squamous Cell Carcinoma (HNSCC)

Shots: Immutep has reported Cohort B data from P-IIb (KEYNOTE-C34/ TACTI-003) trial, with Cohort B assessing eftilagimod alfa + Keytruda as a 1L treatment of recurrent/metastatic HNSCC pts with PD-L1 expression (CPS <1) As of Mar 31, 2025, trial showed improved mOS of 17.6mos. in evaluable pts (n=31) compared to historical mOS of cetuximab +…
May 6, 2025

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Vanotech
NEWS

Chengdu Origen and Vanotech Report the First Patient Dosing in P-I (VAN-2401) Trial of KH658 for Wet Age-related Macular Degeneration

Shots: Chengdu Origen & Vanotech has reported the first pts dosing in Vanotech-led P-I (VAN-2401) trial assessing KH658 for wet age-related macular degeneration (wet AMD) in the US The P-I trial will assess safety, tolerability, & efficacy of single suprachoroidal KH658 gene therapy in ~9 previously treated wet AMD pts that are responsive to anti-VEGF therapy…
May 5, 2025

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Recursion
NEWS

Recursion Presents Preliminary P-Ib/II (TUPELO) Trial Data of REC-4881 for Familial Adenomatous Polyposis (FAP) at DDW 2025

Shots: P-Ib/II (TUPELO) trial (enrolment ongoing) assessed REC-4881 (4 or 8mg, QD) in FAP, with P-II evaluating efficacy via upper & lower endoscopy at Wk. 0, 13 (on-treatment), & 25 (off-treatment) in pts (≥55yrs.) with APC mutations As of Mar 17, 2025, 4mg (n=6) showed a median 43% polyp burden decrease; 5/6 had reductions of…
May 5, 2025

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Astrazeneca
NEWS

AstraZeneca Reports P-III (LOGOS & KALOS) Trial Findings of Breztri Aerosphere for Uncontrolled Asthma

Shots: AstraZeneca has reported P-III (LOGOS & KALOS) trial results evaluating Breztri Aerosphere (BGF; 320/28.8/9.6μg or 320/14.4/9.6μg) vs PT009 (ICS/LABA via Aerosphere) & Symbicort pressurized metered-dose inhaler (pMDI) in pts (n=~4400) with uncontrolled asthma Trial met its 1EP, with BGF 320/28.8/9.6μg showing significant improvement in forced expiratory volume in 1 second (FEV1) AUC 0 to 3hrs. at…
May 2, 2025

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