ALX Oncology announces first patients dosed with evorpacept and Sarclisa in phase 1/2 UMBRELLA study with Sanofi
- ALX Oncology and Sanofi have dosed the first patients in the UMBRELLA phase 1/2 clinical study.
- The study evaluates evorpacept in combination with Sarclisa and dexamethasone in patients with relapsed or refractory multiple myeloma (RRMM).
- Part 1 of the study focuses on determining the recommended dose of evorpacept, while Part 2 assesses the efficacy and safety of the combination.
- Sanofi will conduct the trial, and ALX Oncology will supply evorpacept, retaining worldwide commercial rights.
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Synthekine granted U.S. FDA fast track designation for CD19 CAR-T and orthogonal IL-2 investigational therapy
- Synthekine's SYNCAR-001 + STK-009 therapy receives FDA Fast Track designation for treating severe, refractory systemic lupus erythematosus (SLE) without lymphodepletion.
- SYNCAR-001 is an autologous CD19-targeting CAR-T cell therapy, while STK-009 is an engineered IL-2 cytokine.
- The therapy is currently in a Phase 1 study for CD19+ hematologic malignancies and has an IND application cleared for a Phase 1 study in non-renal SLE and lupus nephritis (LN).
- The multi-center, dose escalation trial will assess the safety and clinical activity of SYNCAR-001 + STK-009 in patients with non-renal SLE and LN.
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Merck and EyeBio announce initiation of Phase 2b/3 clinical trial for Restoret for the treatment of diabetic macular edema
- Merck and EyeBio have initiated the Phase 2b/3 BRUNELLO trial for Restoret (MK-3000) targeting diabetic macular edema (DME).
- The trial is a randomized, double-masked study comparing two dose levels of Restoret to ranibizumab in patients with DME.
- Participants will receive treatments every four weeks for the first year, with a personalized treatment interval algorithm in the second year.
- The primary endpoints are safety and mean change in best-corrected visual acuity (BCVA) from baseline to week 52.
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Merck to present survival data and new research on 10 investigational or approved medicines at ESMO Congress 2024
- Merck will present data for four approved medicines and six pipeline candidates in over 20 types of cancer at ESMO Congress 2024.
- Key presentations include Phase 3 trials: KEYNOTE-522 (TNBC), KEYNOTE-A18 (cervical cancer), and LEAP-012 (hepatocellular carcinoma).
- Ten-year overall survival data for KEYTRUDA in advanced melanoma will be showcased.
- New data on investigational candidates like patritumab deruxtecan and ifinatamab deruxtecan will also be presented.
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Daiichi Sankyo unveils new research across industry-leading ADC portfolio in multiple cancers at WCLC and ESMO
- Daiichi Sankyo will present over 25 abstracts at WCLC and ESMO, including six late-breaking presentations.
- Key presentations include interim results from the NeoCOAST-2 phase 2 trial and TROPION-Lung01 phase 3 trial in NSCLC.
- At ESMO, the first clinical data of DS-9606, a CLDN6 directed ADC, will be presented.
- Additional data will cover various cancers including lung, breast, gastric, ovarian, and endometrial cancers.
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Adaptin Bio announces FDA clearance of IND application for APTN-101 in glioblastoma
- Adaptin Bio has received FDA clearance for its IND application for APTN-101 in glioblastoma (GBM).
- APTN-101 is a BRiTE therapeutic targeting EGFRvIII, showing a 7-fold increase in brain distribution in preclinical studies.
- The Phase 1 clinical trial will assess the safety and efficacy of APTN-101 in patients with WHO Grade IV Malignant Glioma.
- Current GBM treatments include surgery, radiotherapy, and chemotherapy, but the disease often recurs due to its invasive nature.
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