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News and reporting on HER2 biomarkers.
The Quantum Leap-sponsored I-SPY 2 trial will evaluate Byondis' antibody-drug conjugate SYD985 against standard of care for HER2-low, early-stage breast cancer.
Enhertu, or trastuzumab deruxtecan, will also receive accelerated assessment by the European Medicines Agency's Committee for Medicinal Products for Human Use.
Bolt's lead candidate, BDC-1001, is an immune-stimulating antibody conjugate currently being studied in a Phase I clinical trial in HER2-expressing solid tumors.
Healthcare professionals can inject the regimen, containing Perjeta, Herceptin, and hyaluronidase, in patients' homes after intravenous chemotherapy.
The new drug developer's current pipeline consists of CAR-NK cell drugs targeting HER2-positive tumors and CD19-positive B-cell malignancies, as well as a universal NK cell therapy.
In the study, pelareorep will be combined with paclitaxel and the PD-L1 inhibitor Bavencio in patients with HR-positive, HER2-negative breast cancer.
The company will initiate a Phase I/II clinical trial in patients with HER2-positive solid tumors later this year.
At the American Society of Clinical Oncology's virtual meeting, investigators presented two new studies of BluePrint classification patterns.
The firms will jointly study the combination, and Sanofi will have an exclusivity period to negotiate the in-licensing of KN026, contingent on certain milestones.
The company will start Phase I/II trials to evaluate the safety and anti-tumor activity of its natural killer cells in combination with Herceptin or Erbitux in the third quarter of 2020.